42
FLORIDA BERTHA W. HENRY, County Administrator 115 S. Andrews Avenue. Room 409 • Fort Lauderdale. Florida 33301 • 954-357-7362 • FAX 954-357-7360 MEMORANDUM DATE: April4, 2012 TO: Board of County . FROM: Bertha Henry, County SUBJECT: Medical Examiner Review· As you recall, in response to the issue regarding handling of medication at the Medical Examiner's Office, I enlisted the assistance of an independent consultant to review the operations and procedures of the Medical Examiner's Office. County Administration has received the consultant's report and is working with staff to address the recommendations and timeline for implementation. A copy of the report is attached for your information. I am also evaluating retaining additional resources to assist with the implementation of the recommendations. This implementation can be done simultaneously with our search for a Medical Examiner. While the report recommends a number of changes to policies and procedures in order to achieve efficiencies and implement best practices, it does not note any significant deficiencies in the quality of the work or product produced by the Office. The search for the Medical Examiner is coming to a close. The interview committee convened last week to conduct interviews. The committee composition included Pam Madison, Kevin Kelleher and a representative of the Broward Sheriffs Office, State Attorney's Office, Public Defender, the Broward Police Chiefs Association, the Florida Cemetery, Cremation and Funeral Association, as well as Miami- Dade Medical Examiner Dr. Bruce Hyma, who also serves as the Chair of the Florida Medical Examiner's Commission. I am currently working with the executive search firm to finalize the remaining due diligence issues with the finalists and expect to announce a new Chief Medical Examiner next week. Pam Madison will be contacting your offices to offer a briefing should you wish to discuss the findings in more detail. cc: Pam Madison, Deputy County Administrator Joni Armstrong Coffey, County Attorney Evan Lukic, County Auditor John W. Scott, Inspector General Broward County Board of County Commissioners Sue Gunzburger • Dale V.C. Holness • Kristin Jacobs • Chip LaMarca • Ilene Lieberman • Stacy Ritter· John E. Rodstrom, Jr. • Barbara Sharief • Lois Wexler www.broward.org

MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

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Page 1: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

FLORIDA

BERTHA W HENRY County Administrator 115 S Andrews Avenue Room 409 bull Fort Lauderdale Florida 33301 bull 954-357-7362 bull FAX 954-357-7360

MEMORANDUM

DATE April4 2012

TO Board ofCounty Cornmissi~

FROM Bertha Henry County A~~

SUBJECT Medical Examiner Reviewmiddot

As you recall in response to the issue regarding handling of medication at the Medical Examiners Office I enlisted the assistance of an independent consultant to review the operations and procedures of the Medical Examiners Office County Administration has received the consultants report and is working with staff to address the recommendations and timeline for implementation A copy of the report is attached for your information

I am also evaluating retaining additional resources to assist with the implementation of the recommendations This implementation can be done simultaneously with our search for a Medical Examiner While the report recommends a number of changes to policies and procedures in order to achieve efficiencies and implement best practices it does not note any significant deficiencies in the quality of the work or product produced by the Office

The search for the Medical Examiner is coming to a close The interview committee convened last week to conduct interviews The committee composition included Pam Madison Kevin Kelleher and a representative of the Broward Sheriffs Office State Attorneys Office Public Defender the Broward Police Chiefs Association the Florida Cemetery Cremation and Funeral Association as well as MiamishyDade Medical Examiner Dr Bruce Hyma who also serves as the Chair of the Florida Medical Examiners Commission

I am currently working with the executive search firm to finalize the remaining due diligence issues with the finalists and expect to announce a new Chief Medical Examiner next week

Pam Madison will be contacting your offices to offer a briefing should you wish to discuss the findings in more detail

cc Pam Madison Deputy County Administrator Joni Armstrong Coffey County Attorney Evan Lukic County Auditor John W Scott Inspector General

Broward County Board of County Commissioners Sue Gunzburger bull Dale VC Holness bull Kristin Jacobs bull Chip LaMarca bull Ilene Lieberman bull Stacy Rittermiddot John E Rodstrom Jr bull Barbara Sharief bull Lois Wexler

wwwbrowardorg

10900 Ulmerton RoadMEDICAL EXAMINER Largo FL 33778 District Six 727-582-6800

(Fax 727-582-6820)Pasco amp Pinellas Counties wwwcopinellasflusforensics

March 13 2012

Evaluation of the Practices and Needs of the

District 17 Medical Examiner

As the District Six Medical Examiner and Executive Director of the Pinellas County Forensic

Laboratory I would like to thank Broward County for allowing us to help with the Medical Examiner

Offices efforts in improving the quality of death investigations for the citizens of Broward County Our

agency is the second largest Medical Examiner Office employer in Florida and the only Florida Medical

Examiner District that administrates the local crime laboratory Our Medical Examiner operation is

accredited by the National Association of Medical Examiners and the Forensic Laboratory is accredited by

ASCLAD-LAB to the newest ISO standards We used our collective experience in 7 Florida Medical

Examiner Districts and years of service to accrediting bodies and commissions in this evaluation We

began the evaluation of the office on December Bh We approached this evaluation of the Broward

County Medical Examiner Office as knowledgeable fact finders for Broward County Administration We

visited the office interviewed and met with staff members and discussed our findings with

representatives of Broward County Administration The implementation of any of our recommendations

is beyond the scope of this assessment

-Jon R Thogmartin MD

Executive summary

The District 17 (Broward) Medical Examiner Office is tasked with the determination of cause and

manner of death pursuant to Ch 406 of the Florida Statutes Despite being one of the larger

jurisdictions in Florida the District 17 Office is not accredited by the National Association of Medical

Examiners (NAME) Neighboring District Offices of similar size possess such accreditation As is typical

for most jurisdictions decedent transport is handled by a contracted body transport company The

office is one of a minority of Medical Examiner Offices that manages the countys indigentunclaimed

decedent disposition program The Medical Examiner Office is one of only two offices that perform local

DUI testing for law enforcement and it is the only Medical Examiner Office that is tasked with a local

trauma management service The District 17 Medical Examiner Office determines the cause and

manner of death appropriately in the vast majority of cases but lacks a coherent operational philosophy

The death investigations that the office is obligated to perform by Florida Statutes suffer greatly due to

the performance of multiple tasks and functions that fall outside of their official duties The DUI

program management of Trauma Services the indigentunclaimed body program frequent autopsy

observers and acceptance of cases that fall outside of their official duties have significant negative

impacts on the statutory function of the office After examinations the decedents are not released in a

timely fashion The Medical Examiner Office (MEO) takes possession of property and evidence that falls

outside of their statutory duties and retains such property and evidence for a longer period than

necessary At the time of our initial evaluation the office had numerous (almost daily meetings) which

take significant time away from official duties The office possesses standard operating procedures for

many tasks and comprehensive job descriptions yet the procedures are often not followed and the

tasks in the job descriptions are often not performed The MEO needs an experienced Operations

Manager The Forensic Investigators need to be more involved in independent case decisions The

office lacks a consistent systematic approach to death investigations Such a consistent philosophy

should be applied office-wide and not based on the individual pathologists desire for that particular

day The pathologists have chronically lacked intellectual leadership and severely overuse technical

forensic diagnostic tools such as histology and toxicology to the detriment of the office The backlog of

toxicology is primarily the result of overuse of service by the pathologists and this is one of the offices

many obstacles to accreditation The office would benefit from more efficient placement of employees

within the facility

2

Assessment and Recommendations

We have been assigned to evaluate the 017 Medical Examiner operations in key areas that we think are

essential in the proper operation of a Florida Medical Examiner Office

EvidencePropertyMedication Handling

Medications Medications collected as part of death investigations are secured but not routinely

counted The current medication procedure is complicated and involves too many MEO staff members

In many cases the MEO collects and retains medication that does not pertain to cause andor manner of

death

Recommendations

bull The MEO should collect only medications when pertinent to the cause andor manner of death

The medications should be secured to prevent mishandling or theft A single member of the

MEO staff should retrieve the medications count and identify them record the prescription

information and then secure the medications until disposal

bull The medication counts identifications and prescription information shall be available for the

purpose of determining cause and manner of death and to aid in determining appropriate

toxicology testing

bull The medications shall at a minimum be randomly recounted prior to disposal by a second

rotated and randomly selected member of the MEO staff and disposed of after establishing a

procedure in liaison with law enforcement

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary medication transport Unnecessary items could be left at the scene of death or

given to law enforcement

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized medication transport

Property The MEO collects property of decedents as part of death investigations The MEO does not

have a consistent practice of releasing property in a systematic and timely manner The Forensic

Technicians (FTs) are not allowed sufficient autonomy in handling and documenting property

Recommendations

bull Educate the staff of the MEO about the purpose of property procurement and only when

serving the purposes of Ch 406 should property or valuables be brought to the office

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary property storage All such items should be removed at the scene of death and

given to law enforcement or when appropriate left at the location of death

3

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized property transport

bull TheFTs should be utilized more efficiently in documenting and handling property

Evidence The Medical Examiner Office often encounters situations where evidence pertinent to the

investigation of a crime is recovered at the scene of death or later at the MEO The MEO often collects

and retains items of evidence that do not pertain to either cause andor manner of death or a law

enforcement investigation Soiled or wet clothing is being dried in a drying room at the MEO As

described in the body transport contract upon depositing the decedent in the cooler at the morgue the

transport company removes any sheetsblankets from around the delivered body

Recommendations

bull The MEO should only retrieve evidence pertinent to cause andor manner of death They could

assist law enforcement in retrieving other evidence but this should only be at the specific

request of an investigating agency

bull The Medical Examiner Office should encourage the law enforcement agency to retrieve

evidence prior to body transport

bull If the law enforcement agency wishes to process the body for evidence at the morgue the

Medical Examiner should cooperate but with insistence that the agency take the evidence with

them after procurement

bull We strongly recommend not utilizing the drying room for evidentiary materials Any aspirations

in regards to MEO involvement in evidence handling should be coordinated with the locally

funded crime laboratory

bull The body transport company should not remove sheetsblankets from bodies after delivery of

remains

bull The MEO should develop an evidence procedure in liaison with local law enforcement

bull These processes should be part of a written procedure and operating philosophy

StaffingOrganization

District Medical Examiner (OM E) Broward County is in the process of soliciting applicants for the

position of District (Chief) Medical Examiner utilizing a national search process A search committee as

described in Ch 406 will be used in the selection process

Recommendations

4

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 2: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

10900 Ulmerton RoadMEDICAL EXAMINER Largo FL 33778 District Six 727-582-6800

(Fax 727-582-6820)Pasco amp Pinellas Counties wwwcopinellasflusforensics

March 13 2012

Evaluation of the Practices and Needs of the

District 17 Medical Examiner

As the District Six Medical Examiner and Executive Director of the Pinellas County Forensic

Laboratory I would like to thank Broward County for allowing us to help with the Medical Examiner

Offices efforts in improving the quality of death investigations for the citizens of Broward County Our

agency is the second largest Medical Examiner Office employer in Florida and the only Florida Medical

Examiner District that administrates the local crime laboratory Our Medical Examiner operation is

accredited by the National Association of Medical Examiners and the Forensic Laboratory is accredited by

ASCLAD-LAB to the newest ISO standards We used our collective experience in 7 Florida Medical

Examiner Districts and years of service to accrediting bodies and commissions in this evaluation We

began the evaluation of the office on December Bh We approached this evaluation of the Broward

County Medical Examiner Office as knowledgeable fact finders for Broward County Administration We

visited the office interviewed and met with staff members and discussed our findings with

representatives of Broward County Administration The implementation of any of our recommendations

is beyond the scope of this assessment

-Jon R Thogmartin MD

Executive summary

The District 17 (Broward) Medical Examiner Office is tasked with the determination of cause and

manner of death pursuant to Ch 406 of the Florida Statutes Despite being one of the larger

jurisdictions in Florida the District 17 Office is not accredited by the National Association of Medical

Examiners (NAME) Neighboring District Offices of similar size possess such accreditation As is typical

for most jurisdictions decedent transport is handled by a contracted body transport company The

office is one of a minority of Medical Examiner Offices that manages the countys indigentunclaimed

decedent disposition program The Medical Examiner Office is one of only two offices that perform local

DUI testing for law enforcement and it is the only Medical Examiner Office that is tasked with a local

trauma management service The District 17 Medical Examiner Office determines the cause and

manner of death appropriately in the vast majority of cases but lacks a coherent operational philosophy

The death investigations that the office is obligated to perform by Florida Statutes suffer greatly due to

the performance of multiple tasks and functions that fall outside of their official duties The DUI

program management of Trauma Services the indigentunclaimed body program frequent autopsy

observers and acceptance of cases that fall outside of their official duties have significant negative

impacts on the statutory function of the office After examinations the decedents are not released in a

timely fashion The Medical Examiner Office (MEO) takes possession of property and evidence that falls

outside of their statutory duties and retains such property and evidence for a longer period than

necessary At the time of our initial evaluation the office had numerous (almost daily meetings) which

take significant time away from official duties The office possesses standard operating procedures for

many tasks and comprehensive job descriptions yet the procedures are often not followed and the

tasks in the job descriptions are often not performed The MEO needs an experienced Operations

Manager The Forensic Investigators need to be more involved in independent case decisions The

office lacks a consistent systematic approach to death investigations Such a consistent philosophy

should be applied office-wide and not based on the individual pathologists desire for that particular

day The pathologists have chronically lacked intellectual leadership and severely overuse technical

forensic diagnostic tools such as histology and toxicology to the detriment of the office The backlog of

toxicology is primarily the result of overuse of service by the pathologists and this is one of the offices

many obstacles to accreditation The office would benefit from more efficient placement of employees

within the facility

2

Assessment and Recommendations

We have been assigned to evaluate the 017 Medical Examiner operations in key areas that we think are

essential in the proper operation of a Florida Medical Examiner Office

EvidencePropertyMedication Handling

Medications Medications collected as part of death investigations are secured but not routinely

counted The current medication procedure is complicated and involves too many MEO staff members

In many cases the MEO collects and retains medication that does not pertain to cause andor manner of

death

Recommendations

bull The MEO should collect only medications when pertinent to the cause andor manner of death

The medications should be secured to prevent mishandling or theft A single member of the

MEO staff should retrieve the medications count and identify them record the prescription

information and then secure the medications until disposal

bull The medication counts identifications and prescription information shall be available for the

purpose of determining cause and manner of death and to aid in determining appropriate

toxicology testing

bull The medications shall at a minimum be randomly recounted prior to disposal by a second

rotated and randomly selected member of the MEO staff and disposed of after establishing a

procedure in liaison with law enforcement

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary medication transport Unnecessary items could be left at the scene of death or

given to law enforcement

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized medication transport

Property The MEO collects property of decedents as part of death investigations The MEO does not

have a consistent practice of releasing property in a systematic and timely manner The Forensic

Technicians (FTs) are not allowed sufficient autonomy in handling and documenting property

Recommendations

bull Educate the staff of the MEO about the purpose of property procurement and only when

serving the purposes of Ch 406 should property or valuables be brought to the office

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary property storage All such items should be removed at the scene of death and

given to law enforcement or when appropriate left at the location of death

3

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized property transport

bull TheFTs should be utilized more efficiently in documenting and handling property

Evidence The Medical Examiner Office often encounters situations where evidence pertinent to the

investigation of a crime is recovered at the scene of death or later at the MEO The MEO often collects

and retains items of evidence that do not pertain to either cause andor manner of death or a law

enforcement investigation Soiled or wet clothing is being dried in a drying room at the MEO As

described in the body transport contract upon depositing the decedent in the cooler at the morgue the

transport company removes any sheetsblankets from around the delivered body

Recommendations

bull The MEO should only retrieve evidence pertinent to cause andor manner of death They could

assist law enforcement in retrieving other evidence but this should only be at the specific

request of an investigating agency

bull The Medical Examiner Office should encourage the law enforcement agency to retrieve

evidence prior to body transport

bull If the law enforcement agency wishes to process the body for evidence at the morgue the

Medical Examiner should cooperate but with insistence that the agency take the evidence with

them after procurement

bull We strongly recommend not utilizing the drying room for evidentiary materials Any aspirations

in regards to MEO involvement in evidence handling should be coordinated with the locally

funded crime laboratory

bull The body transport company should not remove sheetsblankets from bodies after delivery of

remains

bull The MEO should develop an evidence procedure in liaison with local law enforcement

bull These processes should be part of a written procedure and operating philosophy

StaffingOrganization

District Medical Examiner (OM E) Broward County is in the process of soliciting applicants for the

position of District (Chief) Medical Examiner utilizing a national search process A search committee as

described in Ch 406 will be used in the selection process

Recommendations

4

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 3: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Executive summary

The District 17 (Broward) Medical Examiner Office is tasked with the determination of cause and

manner of death pursuant to Ch 406 of the Florida Statutes Despite being one of the larger

jurisdictions in Florida the District 17 Office is not accredited by the National Association of Medical

Examiners (NAME) Neighboring District Offices of similar size possess such accreditation As is typical

for most jurisdictions decedent transport is handled by a contracted body transport company The

office is one of a minority of Medical Examiner Offices that manages the countys indigentunclaimed

decedent disposition program The Medical Examiner Office is one of only two offices that perform local

DUI testing for law enforcement and it is the only Medical Examiner Office that is tasked with a local

trauma management service The District 17 Medical Examiner Office determines the cause and

manner of death appropriately in the vast majority of cases but lacks a coherent operational philosophy

The death investigations that the office is obligated to perform by Florida Statutes suffer greatly due to

the performance of multiple tasks and functions that fall outside of their official duties The DUI

program management of Trauma Services the indigentunclaimed body program frequent autopsy

observers and acceptance of cases that fall outside of their official duties have significant negative

impacts on the statutory function of the office After examinations the decedents are not released in a

timely fashion The Medical Examiner Office (MEO) takes possession of property and evidence that falls

outside of their statutory duties and retains such property and evidence for a longer period than

necessary At the time of our initial evaluation the office had numerous (almost daily meetings) which

take significant time away from official duties The office possesses standard operating procedures for

many tasks and comprehensive job descriptions yet the procedures are often not followed and the

tasks in the job descriptions are often not performed The MEO needs an experienced Operations

Manager The Forensic Investigators need to be more involved in independent case decisions The

office lacks a consistent systematic approach to death investigations Such a consistent philosophy

should be applied office-wide and not based on the individual pathologists desire for that particular

day The pathologists have chronically lacked intellectual leadership and severely overuse technical

forensic diagnostic tools such as histology and toxicology to the detriment of the office The backlog of

toxicology is primarily the result of overuse of service by the pathologists and this is one of the offices

many obstacles to accreditation The office would benefit from more efficient placement of employees

within the facility

2

Assessment and Recommendations

We have been assigned to evaluate the 017 Medical Examiner operations in key areas that we think are

essential in the proper operation of a Florida Medical Examiner Office

EvidencePropertyMedication Handling

Medications Medications collected as part of death investigations are secured but not routinely

counted The current medication procedure is complicated and involves too many MEO staff members

In many cases the MEO collects and retains medication that does not pertain to cause andor manner of

death

Recommendations

bull The MEO should collect only medications when pertinent to the cause andor manner of death

The medications should be secured to prevent mishandling or theft A single member of the

MEO staff should retrieve the medications count and identify them record the prescription

information and then secure the medications until disposal

bull The medication counts identifications and prescription information shall be available for the

purpose of determining cause and manner of death and to aid in determining appropriate

toxicology testing

bull The medications shall at a minimum be randomly recounted prior to disposal by a second

rotated and randomly selected member of the MEO staff and disposed of after establishing a

procedure in liaison with law enforcement

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary medication transport Unnecessary items could be left at the scene of death or

given to law enforcement

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized medication transport

Property The MEO collects property of decedents as part of death investigations The MEO does not

have a consistent practice of releasing property in a systematic and timely manner The Forensic

Technicians (FTs) are not allowed sufficient autonomy in handling and documenting property

Recommendations

bull Educate the staff of the MEO about the purpose of property procurement and only when

serving the purposes of Ch 406 should property or valuables be brought to the office

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary property storage All such items should be removed at the scene of death and

given to law enforcement or when appropriate left at the location of death

3

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized property transport

bull TheFTs should be utilized more efficiently in documenting and handling property

Evidence The Medical Examiner Office often encounters situations where evidence pertinent to the

investigation of a crime is recovered at the scene of death or later at the MEO The MEO often collects

and retains items of evidence that do not pertain to either cause andor manner of death or a law

enforcement investigation Soiled or wet clothing is being dried in a drying room at the MEO As

described in the body transport contract upon depositing the decedent in the cooler at the morgue the

transport company removes any sheetsblankets from around the delivered body

Recommendations

bull The MEO should only retrieve evidence pertinent to cause andor manner of death They could

assist law enforcement in retrieving other evidence but this should only be at the specific

request of an investigating agency

bull The Medical Examiner Office should encourage the law enforcement agency to retrieve

evidence prior to body transport

bull If the law enforcement agency wishes to process the body for evidence at the morgue the

Medical Examiner should cooperate but with insistence that the agency take the evidence with

them after procurement

bull We strongly recommend not utilizing the drying room for evidentiary materials Any aspirations

in regards to MEO involvement in evidence handling should be coordinated with the locally

funded crime laboratory

bull The body transport company should not remove sheetsblankets from bodies after delivery of

remains

bull The MEO should develop an evidence procedure in liaison with local law enforcement

bull These processes should be part of a written procedure and operating philosophy

StaffingOrganization

District Medical Examiner (OM E) Broward County is in the process of soliciting applicants for the

position of District (Chief) Medical Examiner utilizing a national search process A search committee as

described in Ch 406 will be used in the selection process

Recommendations

4

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 4: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Assessment and Recommendations

We have been assigned to evaluate the 017 Medical Examiner operations in key areas that we think are

essential in the proper operation of a Florida Medical Examiner Office

EvidencePropertyMedication Handling

Medications Medications collected as part of death investigations are secured but not routinely

counted The current medication procedure is complicated and involves too many MEO staff members

In many cases the MEO collects and retains medication that does not pertain to cause andor manner of

death

Recommendations

bull The MEO should collect only medications when pertinent to the cause andor manner of death

The medications should be secured to prevent mishandling or theft A single member of the

MEO staff should retrieve the medications count and identify them record the prescription

information and then secure the medications until disposal

bull The medication counts identifications and prescription information shall be available for the

purpose of determining cause and manner of death and to aid in determining appropriate

toxicology testing

bull The medications shall at a minimum be randomly recounted prior to disposal by a second

rotated and randomly selected member of the MEO staff and disposed of after establishing a

procedure in liaison with law enforcement

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary medication transport Unnecessary items could be left at the scene of death or

given to law enforcement

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized medication transport

Property The MEO collects property of decedents as part of death investigations The MEO does not

have a consistent practice of releasing property in a systematic and timely manner The Forensic

Technicians (FTs) are not allowed sufficient autonomy in handling and documenting property

Recommendations

bull Educate the staff of the MEO about the purpose of property procurement and only when

serving the purposes of Ch 406 should property or valuables be brought to the office

bull The transport company can be made into an effective gate keeper for shielding the office from

unnecessary property storage All such items should be removed at the scene of death and

given to law enforcement or when appropriate left at the location of death

3

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized property transport

bull TheFTs should be utilized more efficiently in documenting and handling property

Evidence The Medical Examiner Office often encounters situations where evidence pertinent to the

investigation of a crime is recovered at the scene of death or later at the MEO The MEO often collects

and retains items of evidence that do not pertain to either cause andor manner of death or a law

enforcement investigation Soiled or wet clothing is being dried in a drying room at the MEO As

described in the body transport contract upon depositing the decedent in the cooler at the morgue the

transport company removes any sheetsblankets from around the delivered body

Recommendations

bull The MEO should only retrieve evidence pertinent to cause andor manner of death They could

assist law enforcement in retrieving other evidence but this should only be at the specific

request of an investigating agency

bull The Medical Examiner Office should encourage the law enforcement agency to retrieve

evidence prior to body transport

bull If the law enforcement agency wishes to process the body for evidence at the morgue the

Medical Examiner should cooperate but with insistence that the agency take the evidence with

them after procurement

bull We strongly recommend not utilizing the drying room for evidentiary materials Any aspirations

in regards to MEO involvement in evidence handling should be coordinated with the locally

funded crime laboratory

bull The body transport company should not remove sheetsblankets from bodies after delivery of

remains

bull The MEO should develop an evidence procedure in liaison with local law enforcement

bull These processes should be part of a written procedure and operating philosophy

StaffingOrganization

District Medical Examiner (OM E) Broward County is in the process of soliciting applicants for the

position of District (Chief) Medical Examiner utilizing a national search process A search committee as

described in Ch 406 will be used in the selection process

Recommendations

4

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 5: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Broward County may have to develop amended body transport contract language that

discourages unauthorized property transport

bull TheFTs should be utilized more efficiently in documenting and handling property

Evidence The Medical Examiner Office often encounters situations where evidence pertinent to the

investigation of a crime is recovered at the scene of death or later at the MEO The MEO often collects

and retains items of evidence that do not pertain to either cause andor manner of death or a law

enforcement investigation Soiled or wet clothing is being dried in a drying room at the MEO As

described in the body transport contract upon depositing the decedent in the cooler at the morgue the

transport company removes any sheetsblankets from around the delivered body

Recommendations

bull The MEO should only retrieve evidence pertinent to cause andor manner of death They could

assist law enforcement in retrieving other evidence but this should only be at the specific

request of an investigating agency

bull The Medical Examiner Office should encourage the law enforcement agency to retrieve

evidence prior to body transport

bull If the law enforcement agency wishes to process the body for evidence at the morgue the

Medical Examiner should cooperate but with insistence that the agency take the evidence with

them after procurement

bull We strongly recommend not utilizing the drying room for evidentiary materials Any aspirations

in regards to MEO involvement in evidence handling should be coordinated with the locally

funded crime laboratory

bull The body transport company should not remove sheetsblankets from bodies after delivery of

remains

bull The MEO should develop an evidence procedure in liaison with local law enforcement

bull These processes should be part of a written procedure and operating philosophy

StaffingOrganization

District Medical Examiner (OM E) Broward County is in the process of soliciting applicants for the

position of District (Chief) Medical Examiner utilizing a national search process A search committee as

described in Ch 406 will be used in the selection process

Recommendations

4

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 6: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Broward County should strongly consider hiring a DME that appreciates how the medical

concept of triage is useful in the practice of all branches of medicine including forensic

pathology

bull The DME should be licensed upon hire board certified in forensic pathology by the American

Board of Pathology and possess sufficient administrative experience to run the D17 MEO

bull Experience with acquiring NAME accreditation would be desirable

bull Special attention should be paid to the candidates knowledge of the mechanics of a medical

examiner operation in Florida as well as Florida laws and rules

Associate Medical Examiners The D17 MEO has had obvious difficultly with the recruitment and long

term retention of Board Certified Forensic Pathologists as Associate Medical Examiners (AMEs) The

office currently hosts an American College of Graduate Medical Education accredited forensic fellowship

program in which pathology residents are trained in forensic pathology This program has been a good

source of replacement AMEs lost through resignation Currently the position is funded by Nova

Southeastern University but the salary provided is low The agreement with the University requires

that the Residency Program Director (RPD) possess appropriate professional and academic credentials

yet the current AME in charge of the fellow is not board certified in Forensic Pathology

Recommendations

bull Increase the salary of pathologists that are board certified

bull Broward County should strive to find a DME that is experienced qualified and ready to provide

the consistent operational philosophy and intellectual leadership all competent AMEs crave

bull Broward County should ensure that any collective bargaining agreement language is in

alignment with Ch 406 regarding the appointment of AMEs

bull Broward County should consider continuing the fellowship program as it has repeatedly

provided replacements for the chronic loss of competent AMEs The salary of the fellow may

need to be supplemented to acquire good candidates The RPD should be a pathologist board

certified in forensic pathology

bull The new DME should possess the fortitude to make the tough personnel decisions necessary to

build a staff of good AMEs

bull Once the new DME is appointed all of the AMEs appointments will terminate and for them to

continue performing forensic autopsies pursuant to Ch 406 they must be reappointed by the

new DME The interim DME is a candidate for the position If he is appointed no

reappointments are necessary

5

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 7: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Administration The Medical Examiner Office lacks a traditional Operations Manager This position is

typically filled by an administrator that is skilled in management as well as vastly experienced in death

investigations

Recommendations

bull The MEO needs a knowledgeable Operations Manager who reports directly to the DME and has

extensive experience in death investigations

bull The Operations Manager should supervise the non-physician staff members of the office and

have an excellent working relationship with the DME in a working relationship comparable to a

Chief Deputy or Undersheriff serving the Sheriff

bull The new District Medical Examiner will likely wish to choose the person that fills this position

and this is typical of many Medical Examiner Offices

Investigations The Forensic Investigators have functioned more as clerks than investigators The

investigators take little ownership responsibility for their cases with identification body release or

follow up The investigators are allowed no access to the networked autopsy photos or even their own

scene photographs Two Forensic Investigators are utilized on the weekends one to perform

investigations and one to answer the phones and release bodies This is not necessary with the

adjustments we are recommending

Recommendations

bull Allow the Forensic Investigators to view autopsy photographs at work and certainly their own

scene photographs

bull To improve the quality of information surrounding the death that should be provided to the

forensic pathologist the investigators should attend every scene of death on apparent violent

deaths (non-natural manner of death) where the body is still located where found or where the

injury occurred Such a change in scene procedure after decades of minimal scene work would

require a slow process of orientation for both the investigators and the law enforcement

agencies

bull The Forensic Investigators should take ownership from acceptance to release of the deaths they

investigate and be as responsible as possible for all aspects of death registration assistance with

identification and supplemental reports

bull Only one Forensic Investigator needs to be on duty on any holiday or weekend and that a lesser

paid part-time non-high risk retirement qualified clerical employee be used to answer the

phone With changes in the body release procedure only one Forensic Investigator is needed

Chief Investigator The position of Medical Legal Death Investigator Supervisor is currently vacant If

the job description was followed this person would be a key functional employee of the investigative

6

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 8: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

section of the office According to the MEO staff the position in the past dealt primarily with the

disposition of indigentunclaimed bodies the unidentified and the occasional destruction of

medications

Recommendations

bull The vacant position of Chief Investigator will need to be filled by an individual that has sufficient

experience in death investigations Ch 406 and management

bull The new DME may prefer to participate in the selection of the Chief Investigator

Photographers Broward County employs a full time photographer and two part time photographers

The photographers perform multiple redundant and unnecessary photograph backups The MEO does

not have an up to date photography SOP The photographers are taking all of the pictures at a higher

than necessary resolution that is approximately lOx more than necessary This results in the

photographs occupying excessive server space slow downloads and increased costs furthermore the

high resolution photographs impede the backups that are performed by Enterprise Technology Services

(ETS)

Recommendations

bull Eliminate the photography positions andor incorporate the positions into the FT staff Train

theFTs to take and upload photographs or have the photographers perform other duties such

as technician work

bull Reallocate the funds from the staff reductions to areas of the MEO with functional deficiencies

bull ETS performs sufficient backups nightly The data on the camera SD cards for the day can be

preserved for a day or two and rotated The pictures could also be saved on a local hard drive

The multiple daily CD production and watermark production can cease

bull The Records Clerk should handle the simple process of reproducing these electronic records

Forensic TechniciansMorgue Operations The Forensic Technician (FT) staff aids the pathologists in

performing autopsies They also perform radiographs file histology slides release bodies and prepare

morgue paperwork During one of our visits to the office theFTs performed their duties with an

excellent level of skill and speed The number of FTs appears commensurate with the workload The

pay of theFTs appears to be adequate compared to other Medical Examiner Offices

The body release procedures are unnecessarily complicated and are not completed consistently The

body cooler inventory process is insufficient and the temperature is not monitored or recorded

TheFT staff has limited knowledge of maintenancerepair contracts warranties or vendor information

for critical morgue equipment to include the X-Ray machine and digital X-Ray receiver

7

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 9: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

The processing of bodies is not complete until mid morning and this limits the ability of the MEO to

complete the examinations in a timely manner

TheFT staff and the pathologists are not adequately familiar with Florida Administrative Code 11-G

TheFTs are underutilized in handling routine procedures within their capabilities and are permitted too

much autonomy in areas that should involve the pathologists Many of these tradition based

procedures hamper the routine morgue case throughput

The MEO does not routinely collect a second set of fingerprints for law enforcement even when

requested

Recommendations

bull Streamline the body release procedure keeping all the paperwork property and evidence in the

morgue area Decrease the paperwork and logbooks

bull Body release authorization should be verified with LABLynx data

bull Do not permit funeral homes to pick up bodies without supervision by an MEO staff member

bull Familiarize the MEO staff with all of the appropriate sections of FAC 11-G

bull Begin body processing at an earlier hour

bull Allow the FTs the appropriate autonomy

bull The FT staff should become more responsible for the maintenance of the autopsy equipment

bull The MEO should be more cooperative with law enforcement requests for fingerprints

Organization The following organizational hierarchy (as displayed in the chart on the following page)

has time and time again been demonstrated to be the optimum method of organization of a Medical

Examiner Office

8

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

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Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 10: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

District MEI I

~ Operations

Manager I Deputy Chief ME

I

I Chief

Toxicologist

Associate MEs II I Toxicology LabI

Forensic

Techs

Admin

Staff

Staff

Chief

Investigator

I

I Investigators I

The MEO currently has a gap of communication between the members of the investigative team and

this is partially due to the way the MEO facility and staffing offices are arranged

Recommendations

bull We recommend a rearrangement of the work locations of the administrative staff and death

investigative staff as well as altering the main public access point of the building

o The morgue (north) building should house the investigators doctors morgue staff and

transcriptionist

o The south building will become the main public access point The building is closer to

the parking lot and is more visible and accessible by the public The lobby of the south

building is larger secured with glass partitions and has a service window The south

building should house the majority of the administrative staff and the Toxicologists

o Some of the cubicles may have to be moved to the morgue building

o The investigative staff can occupy the space vacated by the receptionists the space that

is currently public lobby area andor the offices and space currently used by the Trauma

Services staff Some minor architectural alterations may be necessary in the morgue

building The front area of the south building will easily accommodate the displaced

administrative staff

9

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 11: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

o The Trauma Management staff will have to be relocated (see discussion of Trauma

Services below)

Unidentified By law the identification of decedents is the responsibility of the investigating law

enforcement agency (Ch 406145)

The written procedure for unidentified remains appears to have been updated within the last 5 years

An up to date list of unidentified decedents could not be produced The D17 MEO contact E-mail that is

listed on the National Missing and Unidentified Persons System (NamUs) is not correct Case files on the

unidentified persons are kept in various locations in the MEO This makes it difficult to locate a file

when questions on the particular case arise

The MEO is also somewhat slow in acquiring the information and samples necessary to make

identification possible NamUs entries were not complete on many ofthe unidentified bodies

The MEO is overly dogmatic with many procedures involving identifying decedents resulting in delays of

body release

Recommendations

bull All D17 ME unidentified cases should be listed on NamUs these entries should be complete and

M EO contact information should be updated

bull The Investigators should take ownership of their cases including the unidentified and should

perform all procedures that are reasonably necessary for identification in a timely manner

bull TheM EO staff should become familiar with 406145 and cooperate fully with law enforcement

as it pertains to decedent identification

bull The MEO should employ science and common sense in assisting law enforcement in decedent

identification

Tissue samples The MEO retains routine tissue samples from autopsies as part of their official duties

Some tissues samples are retained in the office longer than necessary In some cases the retained

tissue is not examined

The office reuses containers and several of the older containers have the wrong name or have more

than one name and case number On several containers the label was placed on the lid only and this

could result in mislabeling at any time the lids are removed and switched

Recommendations

bull The office should write and implement procedures that govern the retention of tissue and

manages their destruction in compliance with Administrative Code 11-G

bull Tissue storage containers should be consistently labeled

10

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 12: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Histology The Medical Examiner Office performs routine histology on almost every autopsy with little

discretion The office pays an average $73000 per year FAC 11G requires histology in certain infant

deaths otherwise histology is performed purely at the discretion of the Medical Examiner If samples

are taken for histology they have to be processed ($9-10 each) read by the doctors and filed

Furthermore the individual glass slides have to be archived forever It is evident that the prepared

slides were not always examined The MEO pays 2 Yz times more per slide than most Florida Medical

Examiners and pays for pickup and delivery

Recommendation

bull The pathologist should only perform histology when it is pertinent to cause andor manner of

death and write a report of the findings

bull Broward County should shop for a more affordable histology laboratory

bull The cost saving should be applied to areas of the MEO that are deficient

Media Relations The MEO is a small office as compared to the Sheriff but the frequency of media

interest in case work can be much higher than a law enforcement agency The MEO has a reasonable

written SOP regarding media relations but in practice has an extremely poor process of dealing with

release of information to the media The poor media relations practice has resulted in over reactive

changes in policy or establishing new policy in response to the erroneous release of information in the

past The policies regarding Police Holds separation of homicide case files and the policy of the MEO

shredding suicide notes all relate to poor media relations practices

Recommendations

bull For the time being the MEO should designate a responsible person as the primary media

contact

bull The MEO should hire a knowledgeable Operations Manager who would have the capability to

take control of media relations on a day to day basis and become a reliable trusted media

contact person

Toxicology

Similar to histology toxicology tests and quantifications are over utilized by the pathologists This is the

underlying cause of the current and historical backlog of toxicology cases The pathologists of the D17

MEO were disciplined by the Medical Examiners Commission approximately 10 years ago because of the

backlog We estimate that at least 30 of the laboratory testing has no significant forensic value and

considering the total cost of the Toxicology section is about $13 million the excess cost is likely

significant

11

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 13: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Recommendations

bull The toxicology laboratory does need improvement in their policies and procedures (see

attached laboratory evaluation for detailed recommendations including grant and equipment

information)

bull Toxicology services should not be out sourced unless the backlog of cases continues

bull The pathologists should order toxicology testing only as appropriate to determine cause andor

manner of death or to remain in compliance with FAC 11-G

Records The public records at the MEO are stored in multiple areas and this includes MEO case files

There is no formal designated flow for the case files There is no formal written and implemented policy

regarding records specifically the process of the case file public record requests and the day to day

functions of the Records Clerk The MEO has no designated and cross-trained person that functions as

backup for the Records Clerk during times of absence vacation etc Records searches are impeded by

the limitations of the LABLynx database

A policy was established in 2007 designating that medical records obtained pursuant to Ch 406 will be

destroyed after 2 years This destruction policy was implemented to save space in the records room

In response to an erroneous records release incident the MEO established a policy where all copies of

suicide notes are destroyed after being reviewed

Periodically individuals that are not employed by the MEO are allowed unrestricted access to the MEO

case file room where public and confidential records are stored

The MEO has no plans or discussion for developing electronic records in the future to replace the paper

Local law enforcement agencies developed a procedure where they place cases on Police Hold as a

simple straightforward method of ensuring that Medical Examiner employees do not release

information to the media or family members of the decedent that would compromise their criminal

investigation This Police Hold procedure appears to stem directly from the MEOs lack of a coherent

media relations policy and lack of familiarity with Ch 119

Recommendations

bull All of the MEO staff should become more familiar with Ch 119

bull The MEO should develop and implement a records policy that includes a description of case file

flow

bull Active and recent MEO case files should be stored in one area under the control of the Records

Clerk

12

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 14: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull A clerical staff member at the MEO should be cross trained to perform the duties of the Records

Clerk

bull Medical Records should be retained longer than 2 years

bull Suicide notes should be retained with the case file for a period in compliance with standard

retention schedules

bull The MEO should not allow unrestricted access to the records room that are not employed at the

MEO

bull The police hold procedure should be reexamined and cases currently being withheld from

release should be audited

bull The MEO should consider electronic archiving of records perhaps with the assistance ofthe

county clerk

Contractual and Other Relationships

Body Transport Broward County contracts with a body transport company to transport cases that fall

under Medical Examiner jurisdiction and for transport and storage of indigentunclaimed bodies The

fees are similar to many other Medical Examiner jurisdictions that rely on a private contractor to

perform body removal services Utilizing private contractors for body removal is the most common

arrangement that counties use for body removal

Routine auditing of transport invoices is not facilitated with the use of the MEO LABLynx database

The D17 MEO receives reports of death of unclaimed bodies that fall outside their jurisdiction and

callsdispatches for their removal and storage by the same contracted company that is contracted to

transport Medical Examiner cases

The transport contract specifications do not require the contractor to possess a valid body transport

license Fortunately the contractor does indeed possess a transport license The contract does not

require that the contractor have a validactive license as a refrigeration facility or any other license

required to store deceased persons and the contractor does not appear to possess such a license The

contractor reportedly utilizes another companys refrigeration facility and this third party company

does have the required license

Recommendations

bull An audit report should be developed in the LABLynx database for body transport

bull The Chief Investigator or Operations Manager (not an administrative clerk or purchasing agent)

should review the transport invoices and correlate those with documented transport times and

information gained from the investigators handling the death investigations

13

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 15: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull A system of communication with law enforcement agencies should be developed for them to

report delayed transport responses

bull As previously discussed the transport contract should contain sections about the unauthorized

transportation of unwanted medication property and evidence (see

MedicationPropertyEvidence)

bull The Broward County Attorney Office should examine the assignment clause ofthe transport

contract and the storage facility arrangement

bull Broward County should regularly inspect any refrigeration facility within which

unclaimedindigent bodies are being stored

IndigentUnclaimed contract This contract has currently gone out for bid as it does annually and deals

mainly with final disposition by cremation The fees specified in the contract are commensurate with

similar contracts in other Florida counties The current contractor has reportedly performed

indigentunclaimed dispositions admirably The contract is currently out for bid

The time involved and burden for MEO staff in dealing with indigentunclaimed bodies is not

insubstantial The MEO has no current written and implemented procedure for the handling of

indigentunclaimed remains Only one MEO staff member remains that is acquainted with the

indigentunclaimed program The loss (or the temporary absence) of this MEO staff member would

paralyze the disposition of indigent bodies

The current indigentunclaimed program has no incentives for timely duty performance and according

to MEO staff unclaimed bodies (that had fallen under Medical Examiner jurisdiction) have lingered in

the body cooler for excessive periods oftime The current indigentunclaimed arrangement has

resulted in the storage of cremated remains at the MEO

The current contract removes all financial incentives for funeral establishments to bid on the service

The current contract essentially is for low cost cremation All financial incentives for participation are

removed and are absorbed (primarily to the detriment of the taxpayers) by the terms of the decedent

body transport contract

Recommendations

bull Remove the indigentunclaimed program from the MEO (see discussion below)

bull Remove all unclaimed cremated remains from the MEO

bull The contract should be made on a longer term basis

bull Revamp the body transport arrangement where the decedent body transport company only

transports Medical Examiner cases

14

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 16: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Create a new contract arrangement for unclaimedindigent bodies that provides for removal

and storage of unclaimed bodies and tasks the funeral home provider with indigent

investigations and when applicable appropriate taxpayer reimbursement for cost

Forensic Anthropology Broward County has a contract with Florida Gulf Coast University (FGCU) This

contract involves a $250 monthly payment to the University and teaching of forensic anthropology

students by the Medical Examiners In return the Medical Examiner Office receives forensic

anthropology services In addition to the monthly cost to FGCU Broward County pays its own contract

body transport company for each trip to FGCU ($400 one way) At our office we pay nothing to our

local University for forensic anthropology services The MEO had an inaccurate inventory of cases that

were currently being examined by the anthropologist

Recommendations

bull Other forensic anthropology options are available to the MEO and these should be considered if

a cost reduction can be realized without a compromise in service quality

bull The MEO must keep an inventory of the cases located at the anthropology facility

Forensic Odontology Broward County has a similar agreement with Nova Southeastern University for

forensic odontology services The agreement does not require that the dentist possess board

certification by the American Board of Forensic Odontology (ABFO) Eight months after the agreement

was initiated it was amended to require Broward County to pay $250month for the performance of

this service ($3000year) The current Dentist being utilized by the D17 MEO does not have board

certification by ABFO and the reports are of inadequate detail The MEO appears to overuse dental

identification to some degree As a cost comparison our District that has a slightly larger volume of

cases yet paid an ABFO certified Odontologist consultant a total of $950 in all of last fiscal year and

$2255 in the prior year

Recommendations

bull The MEO should consider cancelling the Nova agreement

bull The MEO should utilize one of the local ABFO certified Odontologists that would provide a

formal report and reliable dental charting for NCIC and NamUs entries of the unidentified

Visitors to the morgue The MEO hosts many autopsy observers In our opinion the frequency of the

visits is excessive distracting libelous and of limited benefit to the office The office is a death

investigation agency and the lack of focus on this simple fact appears to be a recurring theme

hampering the operation of the office

Recommendations

bull A clear consistent SOP should be developed pertaining to what types of visitors should be

allowed into the morgue during examinations

15

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 17: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Visitors should be limited specifically to those individuals that have or will have a direct

involvement in death investigations in Broward County It is our understanding that such a

policy is being developed

SecurityFacility

The two separate buildings that comprise the Office of the Medical Examiner amp Trauma Services possess

multiple recorded security cameras both interior and exterior a monitored security intrusion alarm

system and programmable and auditable card reader door access The main public entry on the north

(morgue) building does not have controlled access once the person is admitted Unreasonable visitors

would have open access to the DME AMEs and the morgue without physical barriers and we have

addressed this under Organization

The contracted body transport company has significant access to the MEO facility They have nonshy

monitored access to the body cooler and open access to morgue and cooler areas during business hours

Transport company personnel have the ability as needed to enter the demographic information on the

decedent into the computer system via a login that reportedly limits their access to the database

Recommendations

bull The north (morgue) building should not be the main public access point

bull We recommend that Broward County confirm the limited login computer access and audit any

alarm codes the transport company personnel possess

Alarm Every employee is supposed to be assigned their own unique alarm code for the MEO facility

however seven employees do not have their own alarm codes They share codes with others Alarm

codes of terminated employees are not routinely removed from the active alarm code list No audits are

performed of current alarm users and assignments The delivery system of alarm codes to employees is

not secure As of the date of our initial evaluation there was no MEO staff on the alarm activation

notification list in the event there is an activation of the security alarm system due to intrusion

Recommendations

bull Every alarm code assigned to the MEO facility should be reset as soon as feasible

bull The MEO should perform routine audits of the codes assignments

bull The periodic audits of the alarm code assignments could be a task for the new Operations

Manager

bull The DME or new Operations Manager (or both) should have the ability to go to the keypad

enter a managers code and add new users or delete users as needed

bull A hierarchical list of appropriate MEO staff members should be developed for alarm activation

notification purposes

16

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 18: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Security Access Cards The MEO has no ability to assign activate deactivate or audit the persons who

have access to the facility via magnetic access cards This is controlled by the Facilities Maintenance

Division Requests to deactivate individual(s) access cards are not performed in a timely manner No

routine or random audits are performed on who has access to the MEO via the cards The exterior

doors are not being locked with a dead bolt or a key If the card system malfunctions the building

would not be secured

Recommendations

bull Designated MEO staff should be provided the computer access necessary to view and audit the

security card access database for the MEO facility

bull The MEO access cards should only allow employees appropriate access to the areas essential to

their job descriptions

bull The MEO should consider a process where redundant locking mechanisms are engaged on the

exterior doors

Fire The building has a Knox-box for use by Fire Rescue to gain entry in case of fire This box is not

alarmed yet it contains exterior door keys and security access cards for the building The key cards in

the Knox-box do not allow access to all controlled entry doors

The north (morgue) building does not have a fire alarm system The north building has duct detectors

and local type annunciation as its fire alarm but has no fire panel or fire monitoring The main

refrigerator has fire sprinkler protection and an outside bell There are fire extinguishers present This

is currently the public access building and has a large conference room where the Trauma Conference is

held yet no fire alarm pull stations are present Reportedly FMD has a planned project to install a fire

alarm system in the north building The south building has a complete fire alarm system and fire

suppression with a backflow preventer The records room and toxicology lab instrument room in the

south building has water sprinkler suppression and fire detection which monitors the system with flow

alarms and tampers on the valves

Recommendations

bull The Knox-box should be alarmed and monitored as soon as feasible

bull A complete audit of all entry doors that allow Knox-box card access should be performed

bull A detailed review of the fire alarm system and HVAC system of the north (morgue) building is

necessary

bull The south building should become the main public access point

bull Broward County may wish to consider a different type of fire suppression system in the

toxicology section and records room(s)

17

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 19: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Body Cooler Temperature The body cooler has no temperature monitor or alarm No manual logbook of

body cooler temperatures is kept Some type of body cooler temperature log is necessary for NAME

accreditation

Recommendations

o A monitoring system should be installed with electronic notification of MEO staff and facilities

staff The system should record periodic cooler temperatures during each day

o A manual logbook of cooler temperatures should be immediately implemented until such an

automated system is in place and functioning

Medical Examiner DatabaseComputers

The MEO has 41 budgeted positions yet has 60 desktop computers to include multiple computers in the

morgue area and at vacant workstations Many of the computers (at least 25) have dual flat panel LCD

monitors to include the computers in the Forensic Technicians office In addition to the desktop

computers each investigator has a take home laptop computer assigned to them

Recommendations

o Broward County should consider reducing the number of computers assigned to the MEO

o The cost savings should be reallocated to other areas of need within the office

LABLynx Database Until recently and only following the missing medication incident any MEO LABLynx

user was able to delete any data field and these data changes or deletions were not tracked or audited

in any way

The database has a limited ability to generate searches and reports to the ME staff Custom searches

to comply with public record requests research projects public health concerns or annual statistical

data requested by the Medical Examiners Commission have to be done by ETS and cannot be done by

ME staff utilizing LABLynx

The MEO should have the ability to produce a current inventory of bodies residing in the body cooler

The MEO staff has no way to know via LABLynx the status of bodies present in the building at any given

time For instance the LABLynx database should be able to show which bodies are present which ones

have been examined which are ready to be released or if any are on hold and where they are going If

the body has been released LABLynx should be able to provide where it went and when

The narrative investigative report is generated within the database with limited word processing

functions yet autopsy reports are a separate Microsoft Word document The reports from the Forensic

Investigators are limited in their content due to LABLynx The Forensic Investigators are further

hampered in their job duties by their inability to view autopsy photographs or the scene photographs

that they create

18

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 20: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

LABLynx is a relatively new database for the office and has basic essential functions and capabilities that

the MEO staff has not thought to request or utilize In essence LABLynx has massive untapped potential

just like the entire MEO The MEO pays $32000 a year and pays for Y FTE from ETS for maintenance

and support of the LABLynx database

Recommendations

bull Data deletions should be tracked and be available for audit Reportedly this feature has been

added and an audit should now be performed at regular intervals and in response to any

incident

bull The LABLynx investigative entry should be a general brief case synopsis for quick entry and

review

bull Allow narrative investigative report to be generated using Microsoft Word to allow for use of

editing features and link access to this document using LABLynx LABLynx could have a similar

link to autopsy and scene photos for the investigators and others to conveniently review

bull Broward County should reexamine the cost of support for the LABLynx database

Document amp Image servedsl The fileprint server is located within the histology storage room that

contains documents autopsy reports photographs etc A master key (currently possessed by at least 5

persons) is required to enter the storage room Backups on MEO data are done once a day during

nighttime due to large file size and slow data transfer rate due to the inordinately large photograph size

issue previously discussed Reportedly there is no current formal policy by ETS to secure autopsy

photographs from unauthorized access

Recommendations

bull Reduce the digital photograph size

bull Ensure that ETS develops an adequate policy to secure access to autopsy photographs

MEOTrauma Services web site As of 120811 upon initial request to conduct the administrative and

procedural review of the Broward County Medical Examiner the office website had not been updated

With one notable exception involving the public documents of a prominent death investigation there

are only 2 sentences about the Medical Examiner with multiple paragraphs devoted to Trauma Services

and additional pages providing detail on how Trauma Services works This is a small piece of credible

evidence demonstrating the disparity of performance between Trauma Services and the Medical

Examiner The website is essentially a brochure

Recommendations

bull The website should provide more functionality such as online report requests and links to office

statistics

19

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 21: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Law and Rule Compliance

Ch 406 Part 1 In reviewing files from the office in a random manner it was apparent that the office

accepts jurisdiction on cases that fall outside of Ch 40611 For example the office accepts all

decomposed remains regardless of circumstances The office accepts jurisdiction on a significant

number of attended natural deaths

Recommendations

bull The MEO should not automatically accept jurisdiction on decomposed bodies regardless of the

circumstances of death

bull The MEO staff should be trained on the nuances of jurisdiction for borderline Medical Examiner

cases

bull The pathologists should be explicitly restricted from using autopsy photographs in educational

lectures unless compliance with Ch 406135 is assured

bull The MEO should restrict educational activities to cases that do not involve active criminal

investigations

Rule 11G The MEO staff members appear to perform their duties based on the traditional office

practice of the D17 MEO Autopsy performance and morgue procedures are in general compliance with

Rule however the MEO should use FTs in a more limited fashion in the performance of autopsies

The contents of reviewed autopsy reports display the standard format seen in many Medical Examiner

Districts They are generally consistent in content The vast majority of cases reviewed had acceptable

cause and manner of death determinations One item that was included in virtually every autopsy

report was a written opinion as to the history circumstances and opinions regarding the death Some of

these case opinions were lengthy and unnecessary

In some of the cases we reviewed histology slides were not examined and the findings of toxicology had

not been incorporated into the cause of death We notified the M EO staff and the cases were amended

as appropriate

Recommendations

bull The MEO staff should acquaint themselves with the minimal operational standards described in

Rule 11-G

bull The pathologists should review and consider the toxicology findings in determining cause and

manner of death and amend cases as necessary

bull A quality assurance program for the MEO should be developed

20

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 22: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Ch 382 (Vital Records Act) The office generally complies with this law On most deaths the MEO does

file the appropriate death certificate but such filings are not always timely

The Office of Vital Statistics sends quarterly E-mails listing incomplete cases from Florida Medical

Examiner Offices In the Broward MEO these E-mails do not make it to the investigator in charge of

these backlogged cases To the MEGs credit they developed a written logbook of these backlogged

cases where the delivery of finalized death certificates to the local Vital Statistic Registrar is

documented The local Registrar apparently has difficulties of their own in properly forwarding the

completely death certificates to the State Office of Vital Statistics in Jacksonville

Another cause for many of the unfinished or non-filed death records is the Police Hold policy The

MEO receives a request to hold the cause of death yet the MEO staff fails to follow up with the agency

pursuant to the MEO SOP Our review of a sample of Police Hold indicates that withholding

certification of these deaths is rarely warranted

Recommendations

bull The death certificate issued by the D17 MEO for each death investigated should be completed in

a timely manner with completion of the permanent record as soon as possible

bull The MEO should notify the Office of Vital Statistics of the correct E-mail address to send the

quarterly pending death certificate reports

bull The MEO should bypass the local Registrar and deal directly with the Jacksonville Office of Vital

Statistics on these backlogged cases

bull An audit in cooperation with the Office of Vital Statistics should be performed to ensure that all

deaths handled by the D17 MEO over the years have been appropriately registered

bull The Police Hold procedure should be phased out

Ch 112 This law in conjunction with Broward Ordinances and policies mandate that outside

employment and other conflicts of interests are to be avoided Employment with agencies or

companies that may interact with the MEO could present unanticipated conflicts We could find no

evidence of nepotism

Recommendations

bull Broward County should examine each employees outside employment disclosures and perhaps

interview the employees for details regarding each employment relationship

bull The office should not accept gifts from outside agencies or vendors

bull The MEO should be mindful of conflicting employment of their pathologists that could violate

Ch 112313 This should apply to the AMEs from other Districts that hold cross covering

appointments

21

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 23: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

BudgetFinance

Financial Relationship with Broward County The office currently is organized as a county department

All employees are county employees and receive county benefits with a significant portion of the

employees eligible for special risk retirement benefits This direct county relationship is actually not

typical of Medical Examiner Offices Most Florida counties have a contractural relationship with the

Medical Examiner The State of Florida requires counties to provide funding for the local DME while the

performance of the Medical Examiners is regulated by the Medical Examiners Commission The Medical

Examiners Commission can discipline andor remove the District and Associate Medical Examiners even

in Home Rule Districts County control and influence is essentially redundant and subservient to state

control and regulation Most contractual Medical Examiner Offices also indemnify the taxpayers and

typically operate at substantially less cost (including saving on administration cost outside of the MEO)

In Districts with direct employment relationships like Broward County the indemnification is reversed

with the taxpayers indemnifying the Medical Examiner

Recommendations

bull Broward County should continue the direct county employment of the MEO staff

bull If difficulties continue in the D17 MEO Broward County should consider a contractual

relationship with the MEO

Budget The MEO has an adequate overall budget as compared to other similar offices Under the

current county employee arrangement the majority of the staff is entitled to special risk retirement

benefits pursuant to Ch 1210515 This accounts for much of the cost of benefits to the county The

MEO budget has several line items that clearly are not routinely expended and these act as reserve

funds for other budget line items that may be depleted during a budget term The MEO takes good

advantage of grant funding using grants primarily for education of the professional staff

Recommendations

bull The office does have areas where the budget can be reduced andor reallocated Broward

County could choose to decrease the office budget in response however due to areas of poor

functioning within the office we recommend that any cost savings in one fund area be

reallocated to areas of deficiency

bull The previously discussed elimination of the photographer positions would save tens of

thousands of dollars that could be allocated to other areas of the MEO

bull Utilizing a part time clerical person on the weekend to answer phones instead of a more highly

compensated Forensic Investigator will reduce costs

22

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 24: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Estimates of cost savings (some previously discussed)

Current Adjusted $Change+(-)

Histology $73000 $15000 ($58000)

Toxicology $13 mil $1 mil ($200000)

Toxicology (outsourced) $13 mil $500K ($800000)

Cases Accepted -1800 -1700 ($30000)

Laundry $29000 $9000 ($20000)

Comment We do not at this time recommend out sourcing all of the toxicology The estimate for savings in toxicology from decreased

testing (triage) should be reapplied into resolving the backlog and hiring a quality manager for the laboratory

Our estimates for savings on histology could be greater but it is our opinion that the pathologists will require some time to adjust down their

histology samples to refect the true diagnostic need Any savings on histology should be reallocated to the pay of competent board certified

AMEs

The MEO currently accepts jurisdiction on cases that fall well outside Ch 406 Our best estimate is that the office accepts approximately 200

extra cases per year However if the MEO improves the quality of death investigations by concentrating on the official duties described inCh

406 it is likely that additional deaths (perhaps 100) that fall under Medical Examiner jurisdiction will be detected and accepted resulting in a

net change of 100 fewer cases per year The reduced cases would result In $15500 per year savings on body transport alone The morgue

work toxicology and ancillary costs will easily account for the remaining portion of the $30000 per year savings

The laundry service (washing and providing towels scrubs gowns and coats) cost $29000 per year To give a frame of reference for the scope

of laundry costs over 22 months the MEO spent $18000 on laundering lab coats $10000 on towels and $30000 on scrubs By the nature of

Medical Examiner work the employees often have down time The FTs have hours of down time per week that could easily be used to wash

the reusable linens and clothing The MEO will need to purchase and install a dryer and two washers in MEO facility After the initial outlay of

funds for the machinery and the linens the savings year after year will be significant

Additionally it is our opinion that the amount spent on biomedical waste appears excessive We would estimate that if a non-S BE qualified

vendor was used the MEO would save about $8000 per year

Other productivity losses The MEO has other multiple areas where small inefficiencies occur The new

medication procedure and the multiple photography backups are good examples If the SOP from the

MEO is followed an average of 10 various weekly MEO staff meetings would occur This includes

pending case meetings the general staff meetings scene review meetings difficult case review

meeting trauma meeting and police hold case meeting On top of these mandated meetings are the

recently added daily morning meetings where all work stops for discussion of even the most routine

cases These morning meetings also include a toxicologist and occur 5 times per week During our initial

visits an additional afternoon case meeting was being proposed (another 5 meetings per week) These

meetings may be beneficial to some employees but the majority of attendees merely lose this

potentially productive time Clearly the full array of meetings described in the SOP does not occur

Meetings have a place in any organization but too many are burdensome Numerous other small areas

of waste pervade the operation such as excessive production of hard copies of records and printing

documents in color as opposed to black and white

23

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 25: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

The current structure of pending meetings is centered on a multi-headed microscope and histology

slides Only the pathologists participate

Recommendations

bull The number of meetings should be reduced This has been discussed with the interim DME and

reportedly he has reduced these meetings significantly and admits to increased productivity

bull The pending meetings should concentrate less on the histology slides and more on the

photographs circumstances and case discussion The meeting should include the participation

of the toxicologists and investigators and be held on a less frequent basis

Miscellaneous income sources and testimony The MEO sends invoices for DUI testing and provides

invoices to the Broward Circuit Court for expert witness fees in criminal cases The courts then attempt

to recover these costs as investigative and prosecution costs from convicted defendants

In deaths and DUI cases accepted by the office that later are part of civil litigation the MEO bills

attorneys in these civil cases for expert witness testimony The current arrangement is that the

pathologists and toxicologists perform the work and report the billable hours to the administrative staff

for follow up billing The payments go to Broward County not to the experts giving the testimony With

the incentive for billing removed a significant portion of the expert testimony and consultation being

performed for civil attorneys is never recorded or invoiced

The MEO SOP manual has a section titled Requests to Examine Living Persons which describes the

occasional requests from law enforcement agencies to examine the injuries of living persons The

procedure reads Such requests should be invariably accommodated

According to the MEO staff in a situation analogous to pathologists consulting on living persons the

toxicologists are sometimes asked by local law enforcement to consult local cases where the laboratory

testing was not performed at the MEO laboratory

Recommendations

bull The practice of invoicing expert witness fees in criminal cases for later defendant cost recovery

should cease immediately

bull We recommend that the experts be permitted to bill for the services and receive the payments

This direct billing would provide an incentive for consistent billing and aid in recruitment (again

by way of a financial incentive) of competent pathologists and toxicologists without raising the

salaries of these employees (also avoiding the accompanying special risk retirement costs) Of

course Broward County should demand a reasonable hourly rate for use of the MEO facility for

depositions and conferences The fees for use of the MEO facility for consulting and depositions

should not be punitive because it is to the offices benefit to keep these key individuals close at

hand

24

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 26: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull The pathologists at the D17 MEO should not evaluate living persons within the District

bull The toxicologists should not evaluate local toxicology cases where the testing was not

performed at the MEO laboratory

Ancillary programs The Medical Examiners official duty is the reliable determination of cause and

manner of death All other functions are and should certainly be considered secondary If a Medical

Examiner Office (or any county department) is not performing its official duties in a satisfactory manner

functions outside of the official duties should be stripped from the office and housed at appropriate

county departments that are properly functioning

IndigentUnclaimed Program The contracts involved in this program have been previously discussed

The Medical Examiner Office has managed the indigentunclaimed decedent disposition program for

Broward County for many many years Broward County utilizes the same decedent transport company

that is utilized to transport Medical Examiner cases to transport and store unclaimed bodies prior to

cremation or (rarely) burial by contracted funeral directors Some cremated remains are stored at the

Medical Examiner Office

The traditional system of handling unclaimed and indigent bodies utilized by Broward County is not

optimal IndigentUnclaimed bodies fall outside of the official duties of the Medical Examiner and this

service has traditionally occupied a great deal of time and energy from the senior investigative staff at

the MEO with significant negative impacts on death investigations

Recommendations

bull The IndigentUnclaimed service should be removed from the MEO We have made

recommendations to the MEO and Broward County for resolving the unclaimed cremated

remains that are stored at the MEO

bull No matter how Broward County chooses to administrate this program the program should

primarily be considered an Unclaimed body program The goal is to efficiently and effectively

remove non-Medical Examiner cases from the place of death and store them in accordance with

the law Law enforcement does not wait long at the scene of a natural death bodies do not

remain at the hospital for extended periods and unclaimed Medical Examiner cases do not

crowd the body cooler If later claimed by a legally authorized person the final disposition of

the remains will progress in a similar fashion as a decedent that was initially claimed If the

body is not claimed the disposition is handled at taxpayer expense only if the decedent is

confirmed to be indigent based upon the value of hisher assets at death The decedents

progression through the program should be systematic as well as timely

Trauma Services This portion of the operation is completely unrelated to the official duties of the MEO

In speaking with the MEO and Trauma Services staff it is abundantly clear that Trauma Services has an

efficient staff and virtually runs itself Thus Trauma Services could be housed elsewhere within another

25

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 27: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

department of county government or as a stand alone division of Broward County without a negative

impact on trauma management yet the positive impact upon the MEO should not be underestimated

Recommendation

bull We strongly recommend that Trauma Services be removed from the auspices of the Medical

Examiner as soon as feasible

DUI program The MEO performs drug and ethanol testing for local law enforcement agencies This

includes DUI samples from live persons and other testing involving criminal activity including sexual

assaults The MEO provides an invoice for the service but the cost of the laboratory analysis is only paid

through investigative cost recovery through the Circuit Court as previously described By all accounts

the toxicology laboratory does a good job with the DUI program

Death investigations suffer significant negative impact due to the DUI program The testing of these

cases must be prompt and often supersedes testing of Medical Examiner cases Also court testimony

on these cases is frequent and sometimes multiple analysts are absent from the lab as they wait to

testify at the courthouse The specimen storage record retention and preparation for DUI cases take a

significant portion of the toxicologists time and energy Ironically the same individuals who praise the

DUI testing are critical of the time it takes to get toxicology results on Medical Examiner cases

Recommendations

bull We have made suggestions to the toxicology staff ways of mitigating these difficulties

particularly when dealing with specimen storage and the courts DUI testing is very similar to

Medical Examiner testing and if properly adjusted this program can continue without

significant interference with death investigations

bull If the laboratory cant make the suggested adjustments the county should consider relocating

the DUI testing elsewhere or out sourcing the testing to FDLE or another laboratory

26

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 28: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Assessment of Broward County Medical Examiner Toxicology Laboratory

February 24 2012

Executive Summary

This assessment was performed at the request of Dr Jon Thogmartin as a part of a larger review

requested by the Broward County Administrator of the Broward County Medical Examiner Office This

portion of that review was limited to the operations of the toxicology laboratory as it pertains to postshy

mortem and DUI analyses The direction was to evaluate toxicology section and make

recommendations as to ways to improve if warranted the quality efficiency and cost-effectiveness of

that operation

Since this laboratory is not currently accredited by an external forensic science accrediting body the

portion of this assessment that pertains to quality assurance and general operation was evaluated

against the 2006 SOFTAAFS Forensic Toxicology Laboratory Guidelines This document represents the

minimal recommended standard for forensic toxicology laboratory operations the requirements of the

relevant accrediting bodies (ASLCDLAB International ABFT etc) are much more stringent It is highly

recommended that the laboratory pursue and obtain external accreditation however for the purpose

of this report the SOFTAAFS document was deemed sufficient

The laboratory performs a very important function within the Medical Examiner Office and within the

law enforcement community In the course of this investigation it was determined that the laboratory is

staffed with quality professional well-trained personnel The analytical procedures used by the

laboratory are common to and generally accepted the forensic science community The instrumentation

is state-of-the-art and well maintained The case files are well constructed and complete

New procedures are currently being evaluated by the staff to improve turn around time and increase

efficiencies The laboratory staff interviewed was well- versed in the scientific principles and new

method development appears to be well planned

Overall it is my opinion that the toxicology unit has the staff experience technical knowledge and

resources to be effective and efficient

Some concerns however do exist and should be addressed It should be noted that many of these

underlying problems exist due to mismanagement of the laboratories activities outside of the authority

of toxicology staff There is a crucial lack of a systematic mission-defined mission-driven approach to

death investigation that greatly impacts the efficiency and operational costs of the laboratory

Additionally the purchasing and contract review processes outside of the medical examiner authority is

cumbersome and slow

Broward County Toxicology Lab Review Page 1

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 29: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Specifically there is a serious lack of systematic policies controls and processes by the Medical

Examiner Office and the associated bureaucracy that directly impact the toxicology sections

operations

Additionally the toxicology laboratory seriously lacks sufficient quality assurance documentation While

the procedures observed appear to be well within common practice within the field the underlying

documentation which is necessary to ensure this is insufficient andor non-existent

Each of the major concerns will be detailed with objective evidence in the body of this report A

summary is provided here

1) The security of the facility which is managed completely outside the Medical Examiner Office is

not sufficient to ensure the integrity of evidence stored within the toxicology unit The county

has the obligation to secure the facility to maintain an unquestionable chain of custody That is

not the case nor does it appear that the managers associated with or who should be associated

with the security process (Facilities Management staff Medical Examiner Administrative staff)

understand the fundamentals of evidence security

In order for evidence to be considered securely stored (and thus to maintain a chain of custody)

it must be stored in such a manner such that no unnecessary personnel (in the case of forensic

evidence that would be any person outside the direction of the ChiefToxicologist) can have or

perceive to have access A number of county employees completely unassociated with the

Medical Examiner Office have access to all areas this facility

This is a systematic problem that should be addressed immediately Effective written

procedures for who can have or has electronic door access alarm codes and keys are needed

and they need to be enforced As evidence associated with criminal investigations is stored in

this facility documented procedures most include tight controls and routine audits It is highly

recommended that an outside expert familiar with evidence security be involved in developing

these procedures

2) It has been reported to the reviewer that the most common complaint about the toxicology unit

by their stake holders is the excessive turnaround time of laboratory analysis Thus that was

one of the primary focuses of this review

Through interviews case file reviews and an assessment of the units procedure manual it is

apparent that the section has the tools to be efficient and certainly to maintain a reasonable

turnaround time however the operational management and lack of a systematic approach is

inefficient and burdensome The Medical Examiner case management systems is fragmented

inconsistent cumbersome and contributes to a significant backlog and stress between the

laboratory and its stake holders (notably the ME pathologists the law enforcement community

and the State Attorneys Office) Some examples of issues impacting turn around time include

Broward County Toxicology Lab Review Page 2

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 30: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Purchasing needs are not fulfilled in a timely manner thus decreasing efficiencies and

increasing backlogs

bull The meeting-laden requirements of the Medical Examiner Office are a time drain that

unnecessarily takes away from laboratory activities

bull The inconsistencies in management interpretation and directed testing by the Medical

Examiner staff is burdensome inefficient and leads to significant follow-up by toxicology

personnel- reducing their laboratory time and increasing the work load The lack of

mission driven operational policies and procedures is of special concern as it results in

timely expensive and unnecessary testing

bull An over interpretation of Administrative Code 11G a lack of thorough scene and

situational investigations and a lack of routine meds found inventories has resulted in

more expensive and unnecessary analyst and equipment-driven analyses Based on

this review as much as 30 if not more of the death investigation analyses done by

the toxicology staff is unnecessary This contributes significantly to the overall turn

around time and cost of laboratory operations

The operation of the toxicology unit (and the Medical Examiner Office) needs to be mission and

objective driven That mission and those objectives need to be coupled with compliance with

Administrative Codes 11G (Medical Examiner) and 11D (Implied Consent- DUI) A triage system

of performing only necessary or appropriate analyses as it pertains to each case should be

implemented An example of such a process is provided in the body of the body of this report

3) The Quality System in the laboratory is inadequately documented There is a serious need for

detailed written policies and procedures that address the current minimum expectations of the

forensic science community Over the past decade the quality assurance standards for forensic

laboratories especially in the arena of documentation have drastically increased The Quality

System of the toxicology unit has not evolved with those expectations

Documented method validations for quantitative procedures are inadequate or non-existent

The section is in dire need of a Quality Manager position (which is the standard in most public

forensic laboratories in the United States) to bring the documentation up to the currently

accepted standards with the expressed intent of achieving external accreditation by a forensic

science accrediting body (eg ASCLDLAB ABFT) Failure to bring the section to accreditation

readiness will ultimately result in serious backlash within the criminal justice system Future

admissibility of results and testimony has the potential to be limited or disallowed and as the

organization does not indemnify Broward County financial repercussion to the county may

result

Broward County Toxicology Lab Review Page 3

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 31: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Findings

Physical Plant

The toxicology section is housed in one of the buildings on the Medical Examiner site There is more

than sufficient work and office area to accommodate the existing (and future) staff and equipment and

processes The freezerrefrigeration system has a dialer alarm system that notifies toxicology staff in

the event of a failure The laboratory is very clean and well maintained by the custodial and toxicology

staff The environmental conditions of the laboratory temperature humidity etc at the time of the

review were appropriate to the operations

The building has good basic security features including restricted key card access to all evidence and

analytical processing areas and an intrusion alarm system However the management of that system is

inadequate ultimately resulting in a non-secure operation

The most specific area of concern is the management of the access and alarm systems The systems are

not under the direct control of the laboratory director or the Medical Examiner The electronic access

system is managed by Broward County Facilities Maintenance Division and the alarm system is managed

by an outside vendor via human resources department There is no current audit system in place to

ensure that door access is truly limited to existing laboratory personnel or that intrusion alarm pass

codes are unique to existing personnel A limited audit was conducted by another assessor on this team

(refer to the main body report) however a summary is necessary here as DUI specimens are stored in

this area

In the course of that audit it was determined that numerous county and past employees had access to

most areas of the facility Alarm codes were also issued to a significant number of non-laboratory

employees including a blanket facility management code which would provide unlimited access to

unspecified (and un-specifiable) non-Medical Examiner and non-laboratory employees

It was very evident that currently many people outside the laboratory directors (Chief Toxicologist)

authority have access to and the ability to grant access to the toxicology laboratory The current system

does not provide the laboratory director the authority to control the laboratorys security

Recommendations

Broward County Toxicology Lab Review Page 4

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 32: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

1) Immediately change the procedure for who grants access to this facility Require written

authorization from the Chief Toxicologist to allow anyone access this applies to both key card

access as well as the issuance of alarm codes

2) Implement and document an annual security audit (at least annual) of the facility

a This audit should include the following

bull An audit trail from the door access computer system of all personnel (key cards)

that have access to each individual door in the toxicology section

o Cross checks to ensure that only toxicology personnel have access

o Cross checks to ensure that all terminated personnel have been removed

from the system

bull An electronic audit trail of the intrusion alarm system of all personnel that have

assigned alarm codes to the intrusion alarm in the toxicology building

o Cross checks to ensure that all existing personnel are assigned a code

o Cross checks to ensure that all terminated personnel have been removed

from the system

o Cross checks to insure that alarm codes are unique to the toxicology section

This audit should be conducted annually and should at a minimum be extensively reviewed and

approved by the Chief Toxicologist

Equipment and Instrumentation

For the most part the section has quality state-of-the- art analytical instrumentation in the form of

four gas chromatograph-mass spectrometers (GC-MS) one gas chromatograph-flame ionization

detector (GC-FID) a co-oximeterblood gas analyzer and a robotic ELISA workstation Four of the Geshy

MSs are on line and in use for casework The analytical equipment is well maintained by the staff and

maintenance contracts are in place with the instrument manufacturers

The laboratory uses a LIMS system for generating reports While not specifically designed by forensic

applications it appears to meet the needs of the laboratory

Drug screening is currently performed by dip stick (urine) or ELISA (blood) These processes are limited

in scope but sufficient for within the context of the current analytical scheme The laboratory is in the

process of validating a more comprehensive immunoassay system (Randox) that should greatly increase

efficiencies

Broward County Toxicology Lab Review Page 5

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 33: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

Recommendations

bull Streamline a procesdor the purchase of instrument parts The GC-MS-FID has never been used

in casework even though it has been installed for a significant period of time The delay in

acquiring an EPC (electronic pressure controller) has resulted in months of in-operation of an

instrument that could significantly increase analytical throughput

bull Obtainimplement GC-MS analysis protocols that utilize the AM DIS system This is a system for

the rapid and semi-automated evaluation of qualitative GC-MS data Such a system would

reduce the analysts data interpretation time by at least half

bull Bid out the instrument maintenance contracts especially for the Agilent equipment There are

several local vendors who possess the relevant credentials for the maintenance of this type of

equipment at a significant savings to the county

bull The laboratory uses manual vacuum solid phase extraction (SPE) manifolds for the extraction of

drugs from biological samples Consideration should be given to a small scale robotics system

(eg RapidTrace) that would free analysts to do other duties Manual SPE techniques are half to

full day processes that require intensive analyst manipulation Small scale robotic systems are

ideal in that they are cost effective and redundant Their use results in increased productivity

without increasing personnel The laboratory does have a large scale SPE robotics system

however the capacity of the system exceeds the needs of the laboratory and is very

cumbersome ultimately resulting in a loss of productivity due to its extensive maintenance

needs It is better suited for a much larger scale operation

bull Invest in a medium to large capacity scanner and document preservation software The

laboratory generates large amounts of data that is distributed on a regular basis An example is

the validation data associated with blood ethanol analysis This document is hundreds of pages

in length For each request (public records or duces tecum subpoena) the laboratory staff

photocopies this document by hand By scanning these large often reproduced and distributed

documents they could be electronic transferred in a matter of minutes resulting is significant

cost and time savings

bull It is likely however I was unable to confirm that some operation within the county has an

electronic document management system (ie Webextender Documentum) The Medical

Examiner Office should look to implement such a system (to include toxicology data QAQC

records and case files) Not only would such a document management system increase

efficiency Currently in the wake of a catastrophic event (fire water etc) there is a high

probability that irreplaceable documents will be lost

Personnel

Broward County Toxicology Lab Review Page 6

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 34: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

The laboratory is currently staffed with a ChiefToxicologist (lab director) three Toxicologist II two

Toxicologist I one laboratory technician and one administrative clerk There is also an unfilled vacancy

for an additional toxicologist The two Toxicologist I staff members are in the process of being

promoted to the Toxicologist II designation

There is no Quality Manager position or designation for any staff member

With the exception of the Chief Toxicologist no members have received significant external toxicology

professional development (American Academy of Forensic Sciences Society or Forensic Toxicologists

etc) The explanation for which is lack of funding and excessive workloads

Only one staff member the Chief Toxicologist is currently certified by an accepted forensic toxicology

certification program (American Board of Forensic Toxicologists)

An interview of a selection of staff members (NSO) indicates that the analytical staff is well trained and

has a firm understanding of their duties and the underlying scientific principles associated with forensic

toxicology

The salary range for the analytical positions is comparable to most other toxicology programs within the

state but significantly lower than neighboring Miami Dade The lack of salary increases due the

economic conditions does have the potential to result in serious turn-over

The laboratory occasionally utilizes forensic science interns (non-paid positions for students who require

semester long internships to complete their degree requirements) However these interns have been

limited to clerical and administrative duties

Recommendations

bull Employ a Quality Manager This is an essential designated position that is found in most

forensic laboratories The Quality Manager position is typically aligned at the Assistant Lab

Director level on the organizational chart The job duties for this position include managing the

quality system (in this case developing a quality system) aligned with the professional standards

quality assurance guidelines and ultimately accreditation requirements for forensic

laboratories The position should be filled by someone with extensive QAQC training

Qualifications should include significant analytical experience as a forensic toxicologist (with an

emphasis on post-mortem toxicology) training and experience as a certified auditor or assessor

with a recognized accrediting body (ie ASCLDLAB) experience with organizational

management and employee development formal training in laboratory auditing and in depth

knowledge and experience with a least one of the recognized laboratory standards (ie ISO

17025)

bull Ensure that each toxicologist is provided an opportunity to attend external professional

developmenttraining at least once every two years Without exposure to the newer more

efficient techniques and new drug developments the efficiency of the laboratory has suffered

Broward County Toxicology Lab Review Page 7

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 35: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Use interns in a more effective manner The QA documentation notably but not exclusively in

the arena of method validation is seriously lacking Unpaid interns are an excellent cost

effective source to performing method validations and generating method validation reports

Forensic Science interns are typically in their last year of study and are well suited to such task

They have the basic analytical training and knowledge to complete a well planned project

(method validation)

bull Encourage certification for each member of the analytical staff A key recommendation of the

National Academy of Sciences review of the forensic science was that ALL analysts be externally

certified by an accredited certifying body Two such accrediting bodies currently exist for

forensic toxicologists ABFT (American Board of Forensic Toxicologist) and FTCB (Forensic

Toxicology Certification Board) There is a high likelihood that individual analyst certification

will be necessary to provide expert testimony in the courts system within the next 5-10 years

bull Provide funding to send at least two members of the senior toxicology staff to a comprehensive

quality assurance training program specially designed for forensic science practitioners

bull Provide funding to send at least a two of members of the analytical staff to tourvisit accredited

forensic laboratories that conduct post-mortem toxicology

Analytical Procedures

The laboratory has a procedure manual that provides direction for analytical procedures However this

manual has not been updated since 2005 with some methods dating back to 1997 without proper

approval or revision documentation The manual includes handwritten changes to procedures

None of the analytical procedures with the exception of ethanol have comprehensive documented

method validations This is a minimum standard in the forensic science community As a result most of

the documented procedures do not include criteria for acceptance ie minimal QC requirements for

accepting the data as determining that is an element of method validation

It should be noted that most of the procedures that are used are within the norm of the forensic

toxicology community However the use of controls in quantitative methods (except Ethanol) is outside

the accepted practice

Recommendations

bull Employ a Quality Manager (as described above) to manage the process of bringing

documentation and validation up to current standards

Broward County Toxicology Lab Review Page 8

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 36: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Use interns and existing staff to validatere-validate all quantitative and qualitative analytical

methods using current method validation criteria Alternatively contract an outside entity to

perform or manage validation of existing methods

bull Immediately change the current practice of reassigning calibrator points as controls as this is

not acceptable analytical practice Add appropriate independently prepared and tested

controls to all quantitative methods Bracket at least every 10 samples by an appropriate

positive control

bull Generate comprehensive validation reports that address all pertinent aspects of validation

including accuracy precision specificity limit of detection limit of quantitation and robustness

A good reference for proper method validation can be found in

Bertholf RL and RE Winecker ed Chromatographic Methods in Clinical Chemistry and

Toxicology John Wiley amp Sons Ltd 2007

Case management

While some policies for the management of post mortem toxicology cases exist for the most part it

appears that the analytical process is at the whim of the individual forensic pathologist This is the

primary basis for the excessive turn around time in the toxicology section

middotCases are currently classified as fast faster fastest as defined by the status of the case after autopsy

(initial cause of death determination) and the case process is to essentially abandon cases based upon

that criteria As a result the easiest cases are not analyzed or closed for months after the autopsy

The processing of DUI cases while delayed by much of the post mortem case inefficiency is appropriate

The analytical scheme for law enforcement toxicology cases does not need significant changes it simply

needs appropriate redirected resources

Recommendations

bull Develop a mission driven analytical scheme In the simplest terms the mission is the

determination of cause and manner of death Currently a significant number of analyses are

conducted that greatly exceeds the needs of cause and manner determination There clearly is

no systematic approach the impression is that that Medical Examiner staff relies on the

toxicology laboratory to test for everything and then determine the significance based upon the

investigation This is the most inefficient approach to death investigation The laboratory

services are the most expensive and most time consuming elements of the death investigation

process The investigative process should fuel the toxicological process and not vice versa

Broward County Toxicology Lab Review Page 9

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 37: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

o Examples Case 1 Decedent was a passenger in a motor vehicle accident The cause

and manner of death was easily determined at autopsy as blunt traumaaccident In

this situation the toxicology is all but irrelevant for cause and manner To comply with

Administrative code llG ethanol and appropriate- chemical and drug concentrations

are all that are required to be done Since chemical and drug concentrations generally

have no bearing on the cause and manner of death in these types of cases the

appropriate quantitations are dependent on the needs of the pathologists and

depending on the circumstances of the crash no quantitations may be deemed

necessary Ethanol (volatiles) analysis and a routine drug screen (targeting those drugs

specified by the Medical Examiner Commission Drug Report) with appropriate

confirmations may be all that is needed However in this case a drug screen

confirmations and several drug quantitations were conducted

o Case 2 Decedent was a passenger in a motor vehicle accident The cause and manner

or death was blunt traumaaccident The initial drug testing was negative The

pathologist order an additional test of consisting of a quantitation of epinephrine in the

urine There was no documentation for the purpose of this test and neither the

toxicologist nor the interim District Medical Examiner had any explanation for why such

testing was conducted All agreed that such testing had no value

o Case 3 An obese man with significant heart history was examined The findings at

autopsy lead to the determination that the decedent died from heart disease The

death certificate was issued and the manner was determined to be natural A full

toxicology analysis was preformed at the direction of the pathologist There is no

requirement for any toxicology under llG for natural deaths It was reported by the

toxicology staff that most natural deaths receive full analysis

o Case 4 An elderly man was examined by a pathologist No autopsy was performed

The cause and manner of death were determined to be natural causes at the time ofthe

external examine A full toxicological analysis was ordered and performed

o Case 5 An elderly man of extreme age has extensive medical history but no Florida

licensed physician to certify the death The MEO accepts jurisdiction and examines the

body The pathologist certifies the cause of death as heart disease and the manner as

natural The office draws and runs toxicology Drugs are found in the urine and blood

Interpretation of the results in the absence the anatomical findings of an autopsy are

difficult even when the drug concentrations appear significant Neither toxicology

testing nor sampling of is required or in many cases interpretable on these cases

bull An example of a mission driven analytical scheme

o Obvious natural cases and non-autopsy Hold toxicology

Broward County Toxicology Lab Review Page 10

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 38: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

o Non-natural deaths with obvious causes of death Limit toxicology to screens and

confirmations Screens should be semi-quantitative so that in that abnormal readings

filter to drug quantitations but results within expected ranges are reports with

qualitative findings only Note at percentage (estimate 20) of these cases will convert

to full quantitative analysis However the reduction in analytical procedures preformed

on the other 80 will result in significant cost and time savings An example of an

appropriate analytical scheme would include a comprehensive (10+ drug classes) blood

immunoassay coupled with a qualitative urine drug screen that includes mass

spectrometry

o Non-natural causes or unknown causes of death- full comprehensive quantitative

toxicology

bull Other cost and time saving measures

o Minimize or eliminate gastric quantitation procedures There is disagreement in the

forensic science community as to the value accuracy and interpretation of these results

Furthermore the procedure used for gastric quantitation is not sufficiently validated In

drug overdoses suicide vs accident is for the most part a circumstantial

determination Highly elevated blood drug levels support the conclusion Gastric

quantitations in most situations are unnecessary Qualitative (as opposed to

quantitative) gastric analysis is highly valuable for identifying non-routinely found drugs

to target for additional analysis Taxi-lab is a rapid non-quantitative method that can be

used for gastric analysis as opposed to the much more time consuming quantitative

methods currently employed

o In (at least) all suspected overdose cases collect inventory and report on the

medications found at the scene The current (revamped) policy for handling

medications found at the scene is completely inadequate Medication inventories and

identifications are invaluable to the toxicologist for determine target (non-routine)

analytes and to pathologists in assessing potential suicides

bull For security purposes access to medication should be strictly limited to two

personnel One clerk and one manager Routine audits should be conducted to

ensure security

bull Create an inventory for each case that includes the prescription information

(when known) the count and the dosage prescribed and a calculation to

determine the number of pills missing (ie likely taken faster than prescribed)

bull Toxicologists can use this to determine target analysis (beyond drug normally

detected by routine analyses)

Broward County Toxicology Lab Review Page 11

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 39: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

bull Toxicologists use pill identification and counts as the tools to determine nonshy

routine quantitations For example a drug (not routinely quantitated) is

detected in the urine The toxicologist must determine quantitation of that

drug is necessary (a significant cost if it must be sent to a reference lab) If the

medications found report shows that 15 pills were prescribed and 14 remain

thus it is probably not necessary to quantitate The reverse however is that

only 1 pill is remaining Quantitation then is likely needed The cost of a clerk

position to inventory and secure medications is significantly less than that of

additional analytical testing

The laboratory currently has a backlog that dates to April 2011 Many of these cases are from natural

death or cases with known causes of death In September 2011 the laboratory was award a grant (2011

Paul Coverdell Forensic Science Improvement Grant) which was effective October 1 2011 The purpose

of this grant is to out-source the backlogged cases to an accredited reference laboratory in an effort to

alleviate the backlog

The laboratory is to be commended for pursuing such an innovative and cost effective solution

However as of February 1 2012 no samples have been sent The delay has been attributed to

bureaucratic delays on the part ofthe County purchasing process With an anticipated send-out rate of

40 cases per week had the grant been executed within 60 days of the award the backlog would be

more than halved by this time

Summary

The National Academy of Science (NAS) produced a comprehensive review of the state of forensic

science in the United States Several legislative actions at both the national and state levels are in the

process of addressing the concerns identified in that report The main recommendations of the NAS to

improve the quality of forensic science were

1) All forensic laboratories should be accredited by external accrediting bodies and to the

international standard ISO 17025

2) All forensic science practitioners should be externally certified by an accredited

certifying body

3) All analytical methods used in forensic science should be thoroughly vetted and

completely validated prior to use in cases work

These should be the immediate and long term goals of this laboratory

The Chief Toxicologist currently lacks the autonomy and authority to manage laboratory operations in

an efficient manner A redefinition of his role and authority is necessary to increase productivity and

Broward County Toxicology Lab Review Page 12

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 40: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

reduce costs The Broward County Medical Examiner Office toxicology laboratory has the tools

knowledge and personnel to achieve all of the recommendations

The Medical Examiner Office needs to move to mission-based operations with more consistency among

pathologists on testing needs and processes With a budget-minded and mission-minded systematic

approach concerns regarding turnaround time and cost effectiveness will be eliminated The current

ineffective case management is the result of requests and random practice from the forensic

pathologists and not the fault of the toxicology section A minimal estimate of 30 of the laboratory

work performed by the toxicology staff as part of death investigations is unnecessary As a result the

public is bearing the financial burden of costly unnecessary expenses and the backlog of the unit is

increasing

The actual work currently produced by the laboratory appears to be of the highest quality once the

contemporary method validations and reasonable case management practices are in place this

laboratory has the staff and knowledge to be a hallmark laboratory In summary

1) Create a systematic approach to toxicology within the ME organization

a Generate binding policies and procedures for pathologists It is recognized that every

case has specific nuances that may require additional testing However the current

policy is that every case is treated as non-routine

b Classify toxicology cases based on needs for causemanner determination and

requirements of 11G

i Do not perform toxicology on external examinations unless otherwise required

by Florida Administrative Code 11G or warranted by the specific circumstances

of the case

ii Do not perform toxicology on clear natural deaths (ie cases where the

pathologist issued a death certificate upon examination or autopsy without

toxicological results) unless warranted by the specific circumstances of the case

iii Minimize (triage) toxicology of cases with a known cause of death (ie trauma

from auto accidents hanging etc) to coincide with the investigative needs of

the case

iv Do not routinely perform toxicology on trauma cases with a time of death in

excess of 12 hours from the injury

v Perform analyses on all case types (known cause unknown cause etc)

concurrently based upon submission dates Limit the testing not the start date

of testing

Broward County Toxicology Lab Review Page 13

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 41: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

2) Inventory and identify all decedent medications that appear pertinent to cause andor manner

of death The newly proposed decedent medication policy is without meaning Having clerk

level staff inventory medications provides for additional security auditing documentation and

greatly minimizes additional expensive and time consuming testing

3) Reassign as many investigative and administrative activities away from toxicologists as possible

4) Establish a contemporary document management system

5) Create update policies and procedures Generate organized validation reports for all

procedures

6) Hire a Quality Manager

7) Achieve at a minimum external accreditation

8) Develop a system within the county to expedite purchasing and contract review processes for

time critical supplies and resources

Broward County Toxicology Lab Review Page 14

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum
Page 42: MEMORANDUM Cornmissi~ A~~ - Broward CountyApr 04, 2012  · office is one of a minority of Medical Examiner Offices that manages the county's indigent/unclaimed decedent disposition

References

Forensic Toxicology Laboratory Guidelines Society of Forensic Toxicologists 20062 Feb 2012

ltwwwsoft-toxorgfilesjGuidelines_2006_Finalpdfgt

Laws Florida Administrative Code llg Florida Association of Medical Examiners Web Site 2 Feb

2012 lthttpjwwwfameonlineorgflawsgt

Strengthening Forensic Science in the United States A Path Forward Washington DC The National Academies 2009 Aug 2009 The National Academy of Science 3 Feb 2012 ltwwwnapedugt

Broward County Toxicology Lab Review Page 15

  • Memorandum