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www.AllianceBiosciences.com
Alliance BiosciencesMalcolm Barth, Ph.D.
Marian Downing, RBP, CBSP, SM(NRCM)Ryan Burnette, Ph.D., Director
Biosafety Program Management Refresher Course
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What does a BSO have to know?◦ No correct answer – “It depends”◦ ABSA’s definition of a Biosafety Officer is outlined in the NRCM
(National Registry of Certified Microbiologists) task list for Biological Safety
◦ Some of these tasks may not apply to your institution, e.g., BSC certification (but you need to know the basics) How to pack and ship infectious materials (you may have a trained
shipping group) Select Agent regulations
Definition of a BSO
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Develops, implements, maintains and monitors biosafety programs, policies and procedures◦ Goal is to reduce/eliminate
exposure to biological hazards Provides recommendations for
use/storage/disposal of infectious waste in accordance with applicable laws
Manages/performs laboratory inspections
Develops and delivers biosafety training
May supervise and develop staff
Reviews/advises on research protocols for rDNA, human-sourced materials, Select Agents/Toxins
Sits on various committees: IBC, IACUC, IRB, Occupational Health, etc.
Responds/investigates spills and accidental exposures
Finds time for personal professional development!
In General, a BSO:
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A BSO is required if:◦ There is rDNA ongoing at an institution, and◦ There is large scale (>10 Liters) of recombinant work, or◦ There is BSL-3 work with rDNA materials
Select Agent regulations do not specify a “BSO”, but leave the door open for a PI to potentially fulfill all the registration requirements.
Some institutions – the BSO does very little beyond reviewing IBC research proposals and lab inspections.
Other institutions – the bulk of the IBC operational issues are handled by a Research Compliance Group.
BSO
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Management commitment to safety, which may be classified as including:◦ Prioritization of safety over production (or research, in this case)◦ Maintaining a high profile for safety in meetings◦ Personal attendance of managers at safety meetings and in walk-abouts◦ Face-to-face meetings with employees that feature safety as a topic◦ Job descriptions that include safety contracts◦ Communication about safety issues (both formal and informal)◦ Regular communication between management, supervisors and the workforce
Involvement of employees, including:◦ Empowerment◦ Delegation of responsibility for safety◦ Encouraging commitment to the organization.
Developing a “Safety Culture”
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Encourage PI commitment to safety (new PI interviews?) Setting a good example (e.g., wearing PPE) Setting aside a few minutes in lab meetings to discuss safety
issues or staff concerns about safety Promote reporting of incidents (non-punitive) Upper management support (written commitment to safety
for the School, signed by the Dean, and posted) Reward good safety practices (certificates for good lab audits
or reporting unsafe practices) Self-audits of lab areas by staff (with PI involvement)
How could that work here?
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Must occur for rDNA, frequency is determined by IBC (should be in writing)
SA – committed to quarterly? Recommend all labs inspected at
least annually◦ Safety technicians can be trained
to do lab audits, supervised by the BSO Checklists – can use ones provided
by CDC on SA website, or make your own. Need to document audits, notification of deficiencies, corrective action.
◦ Labs can do self-audits (documented) to increase frequency of inspections and buy in to “safety culture” Provide checklists
◦ Fire dept. weekly inspections Could be used to cover many of
the labs that need inspection
◦ Scheduled vs. drop-in?◦ Start audit program with sister
campuses◦ Summer worker? Could be
trained to do audits◦ Team audits with radiation,
fire, etc. (safety in numbers)
Recurring internal lab audits
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Follow up:◦ Near misses◦ Spills◦ Releases◦ Any report of loss or release to a govt. agency◦ Lab associated infection◦ Noted deficiencies after previous inspection◦ Fire department observations while doing rounds
New PI (after orientation and lab setup) New agent in use Change-over of lab
Inspections
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Should be non-confrontational but thorough Should be documented (spreadsheets/databases
available for this) Provide solutions for most common deficiencies at the
time of the audit◦ Carry vacuum setup diagram for lab vacuum◦ List of appropriate disinfectants◦ Extra signage for doors◦ Handout on proper sharps disposal
Inspections
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Repeat offenders, or labs that do not correct deficiencies◦ Attempt to correct any IDLH situations before you
leave◦ Arrange meeting with PI, EHS Manager, if necessary◦ IBC policy on this issue would help
Some institutions give additional time to correct deficiencies, then escalate it to the Dept. Chair, and if necessary, to the Dean Must be published for PIs to read in advance (Safety
Bulletin?) Need upper administration buy in
Difficult Issues
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Eating/drinking in the lab◦ Definitely a no-no and hard to defend◦ An easy catch for regulators◦ Includes drinks on desks in the lab,
unless there is a wall with a door◦ PIs have to enforce◦ Carry a copy of a LAI that was
contracted via ingestion – hand out to violators?
Drinking water dispenser in the lab
Some Common Observations
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PPE Issues◦ A tough nut to crack in most academic institutions, but not impossible
Carry pairs of safety glasses on inspections and hand out if they cannot produce them?
Information on how to order safety glasses Remind them that eyes cannot be replaced Compliance is possible. Industry is able to get 99% compliance, but only after
working on the “safety culture” and enforcing use of PPE by putting a letter in the file of offenders, followed by probation for repeat offenders
◦ Even at BSL-1, safety glasses should be worn for any manipulation involving chemicals or organisms Eye infection from a yeast culture in the lab Do not want common lab chemicals in eyes (bleach, 7X, SDS, etc.)
Common Observations
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BSC issues◦Moldy collection flasks
Carry copy of flask setup and disinfectant suggestions
Remind them that good science (i.e., tissue culture) depends on scrupulous cleaning.
Collection flasks should be plastic or have tape or netting on them, and if they are under the BSC, they should be in a plastic pan (secondary containment).
Common Observations
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Sharps (such as Pasteur pipets) in regular trash◦ Carry a handout on proper sharps disposal◦ Provide a small poster to be posted in the labs (with pictures) that
summarizes disposal of broken glass, sharps, glass tubes, etc. Expired BSC certifications◦ Hands on training should include teaching staff to check Magnahelic
gauge and last certification date before working inside BSC◦ Different way to handle annual certification – many institutions do not
leave this up to the PIs. They have a program that tracks the dates (in Maintenance or EHS) and prompts for annual testing.
Observations
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Young children in the labs ◦ Definitely not in the “business” area of the
lab. May be acceptable if they are in an office with a door. Concerns are chemical as well as biological. There should be a written policy about where children can go.
Cloth chairs◦ BMBL – even at BSL-1, chairs must be
impermeable and able to be disinfected Quick fix – cover with a heavy duty plastic
bag or duct tape until chair can be replaced
Observations
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◦ Dirty BSCs Training course should discuss routine lab cleaning and
include monthly wipe down of BSC, including under work surface (if removable)
Many problems avoided by cleaning/disinfecting BSC thoroughly (walls, glass, work surface) before and after work. Use a “Swiffer” duster.
All equipment going into the BSC is wiped down with alcohol or disinfectant.
All items coming out of the BSC after work is done are decontaminated with an appropriate disinfectant.
Chemicals and other items should not be stored in the BSC
Common Observations
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Lab equipment and surfaces◦Monthly decontamination of water baths
and incubators Discard old cultures After any spill, for sure Follow manufacturers instructions, or use
disinfectant followed by alcohol or sterile water
◦ Daily wipedown of bench tops◦Who cleans the floors?
Use appropriate detergent disinfectant, such as Vesphene
Common Observations
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Training of lab staff◦ Ask to see their SOPs for lab tasks or equipment operation◦ Ask to see the documentation that the SOPs were read
Is there a copy of the research proposal(s) available in the lab, and have the employees doing the research signed off that they have read it?◦ Various agencies conduct interviews to determine if
PI and/or staff are informed. This is an easy catch for a regulator.
The staff should be able to describe the spill procedure, who to notify, where to go to report an exposure, etc.◦ Ask informal questions during your visits to test their
understanding◦ Post emergency procedures in lab (spills, exposures, etc.)
Observations
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Should have a biohazard symbol and the word “Biohazard” List contact information for lab, including a night contact
◦ Can Security contact PI at home if they have a name to call? Should list Biosafety Level, infectious agents in use (BSL-2 and
above), human-sourced products, etc.◦ Unless security is a concern, SA may not have to be listed, but
since building is secured, this should not be a big issue List any special entry requirements or concerns, e.g.,
◦ Need a respirator when work is ongoing◦ Vaccinations needed to enter◦ Agent may put pregnant or immune suppressed person at
increased risk◦ Anyone entering should have Occupational Health approval
Door Signage
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Disinfection◦ List of appropriate disinfectants included in Biosafety Manual
Should be based off of EPA Approved lists, and targeted for type of organism as well as application
It is illegal to use/prepare disinfectants in opposition to label claims E.g., using on porous surfaces when claims are for hard surfaces or not
using on precleaned surfaces Alcohol is not an appropriate disinfectant for most infectious
agents OSHA will cite you for using alcohol with human sourced materials Alcohol is appropriate for controlling environmental contamination on
clean surfaces Wiping down materials going into a BSC, etc.
Disinfection
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For BBP and most infectious agents, use:◦ List B (tuberculocides)◦ List A Sterilants◦ List D, List E (eff vs. TB, HBV)
Commonly used:◦ 2 -10% bleach (@5.25% NaOCl)◦ Cavicide, Citrex, Amphyl, Dispatch◦ “Lysol” has many different
formulations – make sure you are using one that is tuberculocidal
Floors: Vesphene, LpH Hand sanitizers do not
belong next to the sink!
Disinfection
Disinfection website:http://www.epa.gov/oppad001/chemregindex.htm
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Classroom Training Should provide copies of slides so those that may
not understand immediately can have a reference Exercises and ice-breakers to keep people focused◦ Gameshow Pro game – load your own questions, force
audience participation◦ Crossword puzzle, fill in the blank, break into groups and
discuss an issue, case studies, etc. Lab Associated Infection case study◦ Have trainees point out all of the mistakes that
were made◦ Use to reinforce timely reporting, knowing signs and
symptoms, use of PPE, etc.
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AAALAC demanded animal handler training sessions for all infectious agents in the facility
Training of animal handlers (in a group) is a good way to get to know them so they feel comfortable telling you about their concerns
Game format works well (Gameshow Pro or manual game of Jeopardy or Tic-Tac-Toe)◦ Hand out candy as prizes (they will remember you)
Animal Handler Training
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Handouts written in layman’s terms (esp. for infectious agents – modify Canadian MSDS to focus on mode of transmission, signs and symptoms, incubation period)◦ Give them your phone # and e-mail address
on the handouts Keep it fun and interesting Document all session attendance
Animal Handler Training
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4 hour classroom for all BSL2, 8 hour classroom for all BSL3, including all new MDs, PIs, grad students, etc.◦ Minimum 6 hours hands-on
EHS training for all BSL3◦ BSL2 hands-on offered --
mandatory for SA work 12 page test for BSL3, 4
page test for BSL2
BSL3 workers – ◦ Mandatory verbal test with RO
covering all emergency procedures, spills, exposure reporting, BMBL, agent specific info, etc.
Voluntary serum banking, medical surveillance, mental fitness check
UTMB Training Program
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Even experienced PIs, MDs, etc. may have marginal technique◦ Some non-nationals may not have had much
lab experience, or may not have used appropriate equipment
Making training mandatory for everyone (BSL-3) gives a baseline of institutional expectations and eliminates feeling of being singled out◦ People will know what they are supposed to be
doing, even if they may choose not to do it
Hands-on Training
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Focus on use of BSC◦ Cleaning and decontamination of BSC, placement of
equipment, hand movements, decon of equipment, entering and leaving BSC, spills in the cabinet
Table-top exercises for centrifuge spills and leaks, spills in the lab, demonstration of BSC airflow with smoke stick or machine
Use of PPE, training on PAPR (if appropriate) and wearing PAPR while working in the BSC during the training
UTMB Hands-On training
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Trainee given new safety glasses to keep, appropriate PPE
Simple lab experiment (serial dilution) given to trainee, who does it with their normal technique, observed by the biosafety trainer (~2 hours)◦ Usually use diluted fluorescein as
“virus” for procedure Lapses in technique discussed with
trainee Black light can be used to point out
aerosols, drips, etc.
Next, trainee comes back another day and performs a similar experiment, attempting to correct procedure based on trainer comments
Trainee returns at least one more time to work, ideally with good technique.
Trainee may have to come back for additional sessions until they have mastered use of the BSC, able to answer questions about spills, cleanup, use of centrifuges, etc.
Hands-on Procedure
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Select Agents/Toxins
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73.9 Responsible Official◦Have authority and
responsibility to act on behalf of the institution
◦ Ensure compliance◦Document annual
inspections and correct deficiencies
◦May designate alternate
73.10 Restricting Access and SRAs◦Access
Possession or the ability to gain possession
Do you have access defined in your document?
No access with approved SRA
Can request expedited approval
Can appeal denial Valid for a max. of 5 years
Select Agent
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Physical security Inventory control Information systems control Access control Routine cleaning, maintenance,
repairs Removing unauthorized or
suspicious persons Badge, key and card control Reporting Training Drilled and reviewed annually
SA Security 73.11 Security◦ Develop and implement a
written security plan Site specific risk assessment Provide graded protection in
accordance with the risk
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Only individuals with approved SRA have unescorted access
Unapproved individuals are continuously escorted by an approved individual
Separate SA from the public areas
Storage containers are secured
Inspect all suspicious packages
Establish a protocol for intra-entity transfers
Prohibit sharing pins, keycards, passwords
Plan for how/who will receive packages of SA
Security
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The RO will be immediately notified:◦ Loss or compromise of
keys, passwords, combination
◦ Suspicious persons/activities
◦ Loss or theft of SA◦Release of SA◦ Inventory record
alteration or discrepancy
SA Security
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Written Biosafety Plan Describe the biosafety
and containment procedures sufficient to contain the SA or toxin◦ Physical structure◦Operational and
procedural safeguards
Consider ◦BMBL◦OHSA 29 CFR parts 1910.
1200 (HazCom) and 1910.1450 (Occ Exp to Hazardous Chemicals)
◦NIH Guidelines for rDNA Annual drills/exercises
to test plan◦Revise as necessary
SA Biosafety 73.12
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Need approval from CDC or USDA for◦ Transfer of a drug
resistance◦Biosynthesis of select
toxins with LD50<100ng/kg body weight
Restricted Experiments (SA) 73.13
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Written Incident Response Plan◦ Coordinated with any entity-
wide plans◦ Kept in the workplace and
available to employees for review
◦ Drills/exercises held annually
Entity’s response procedures for:◦ Theft, loss, release ◦ Inventory discrepancies◦ Security breaches (including
information systems◦ Severe weather and natural
disasters◦ Workplace violence◦ Bomb threats◦ Suspicious packages◦ Emergencies (fire, gas leak,
explosion, power outage)
73.14 Incident Response
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The response procedures must account for:◦ Hazards associated with the SA
or toxin◦ Appropriate actions to contain
the SA/toxin Name and contact info for
key individuals◦ Backup for people on vacation,
ill
Personnel roles, lines of authority and communication
Emergency medical treatment and First Aid
PPE and emergency equipment
Site security and control Procedures for emergency
evacuation Decontamination
procedures
Incident Response Plan
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Provide training prior to access
Training address:◦ Particular needs of the
individual◦ The work they will do◦ The risks posed by the SA
Annual refresher training Training records maintained
73.15 Training
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CDC or APHIS must authorize all transfers◦ Form 2
Transfer only to registered entities/individuals◦ The sender is either registered
for the SA/toxin, is exempt, or is outside the US and meets all import requirements
◦ The recipient must be registered for the SA or toxin
73.16 Transfers
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Accurate, current inventory for each SA held in long term storage◦ Guidance on CDC website for
definition of “long term storage”
List of approved individuals Record of all entries into SA
areas
Accurate, current records associated with◦ RO, Security, Biosafety,
Incident Response, Training sections
Written explanation of any discrepancies
Ensure that all records and databases are accurate, have controlled access, and authenticity may be verified
Maintain for 3 years
73.17 Records
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When?◦Without prior notification ◦ Prior to issuing a certificate of registration
73.18 Inspections
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Immediately notify CDC or APHIS for:◦ Theft or loss of SA or toxin◦ Release of an agent causing occupational exposure or outside
the primary barriers of the biocontainment area Some people regard this as a spill outside the BSC, if this is the
primary biocontainment area Notifications that are overly cautious are preferred to no
notifications. They would rather know about anything you are unsure about.
73.19 Notification of Theft, Loss or Release
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73.20 Administrative Review◦ Person or entity my
appeal a denial, revocation, suspension, limitation or revocation in writing if submitted within 30 days
73.21 Civil Money Penalties
The Inspector General (DHHS only) is the delegated authority to conduct investigations and to impose civil money penalties against any individual or entity for violations
Review and Penalties
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Updates on the CDC Select Agent home page◦ http://
www.selectagents.gov/index.html
Biosafety Listserve notices of changes and proposals
Bill to move Select Agent process under Homeland Security
SA Updates
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Info from Texas Society for Biomedical Research meeting◦ Southwest Foundation (San Antonio)
Deficiencies in training and inventory system Implemented a computerized bar-coding system
for identifying all vials of SA Implemented a computer based training and
tracking system
Select Agent Inspection
Research at SW Foundation
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Present outline of course training topics Define record keeping requirements ensuring
compliance Refresher training annually “Means used to verify that the employee
understood the training”◦Quiz with passing grade and retraining on missed
questions GAP notification for training due/missed Provide “Proficiency Statement” and/or Training
Certificate for completed training modules
SA Training Requirements
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Inventory discrepancies --common citation◦ Provide form to researchers
(examples on internet)◦ BSO or staff should do spot
checks of inventory (Quarterly?)
SA Inventory
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ABSA involvement and meeting attendance◦ Keep up with current issues◦Make contacts that last a lifetime◦ Find a mentor for new projects◦ Attend courses to broaden knowledge and
fulfill continuing education requirements Local affiliate (MABSA)◦ CM credits for meetings/seminars
RBP ◦Will be required to recertify every 5 years with 40 points,
similar to CBSPs
Biosafety Profession
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Sign up for MMWR (Morbidity and Mortality Weekly Reports) from CDC. Free, interesting and sent via e-mail (http://www.cdc.gov/mmwr/)
Read ABSA Journal for notices, research into biosafety issues
List Serve – don’t need to read everything, but often there are timely notices of legislation, news items, etc.
NIH outreach sessions◦ Keep up with NIH proposed
regulations, interpretations of the guidelines
Staying on top of it all:
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Ryan Burnette, Ph.D.Director9011 Arboretum Parkway, Suite 310Richmond, VA 23236866-654-6674www.AllianceBiosciences.cominfo@AllianceBiosciences.com
Contact
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