You Asked for it: Your Questions Answered - Presentation

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You Asked For It: Your Questions AnsweredCAP Technical Staff:Rodney Stewart(ASCP) MBARodney Stewart(ASCP), MBALyn Wielgos MT(ASCP)Carolyn Gandy MT(ASCP)SM

November 21, 2012www.cap.org v. 1.0

ObjectivesObjectives

• Identify challenges in laboratory accreditation and y g ybest practices for addressing them.

• Describe tools to assist with laboratory accreditation practices.

© 2012 College of American Pathologists. All rights reserved. 2

Topics to be DiscussedTopics to be Discussed

• Accreditation Topics:po Personnel Fileso Competency Assessmento Proficiency Testing Evaluations & Materials Handlingo Proficiency Testing Evaluations & Materials Handlingo Nuances of Procedure Reviewo Waived Testing


Topics to be Discussed continuedTopics to be Discussed, continued

• Discipline Specific Topics:p p po Molecular Pathology Internal Controls

o Wet Preps for Identification of BV

o IHC – Reagent controls and New Lotso Anatomic Pathology Annual Comparisonso ER/PgR Validationo ER/PgR Validationo New Prothrombin Time (PT)Reagent Lot Verification o Hematology Differential Reporting

f i di io Transfusion Medicineo Cytology Workload Recording


Personnel Records for Non laboratory StaffPersonnel Records for Non-laboratory Staff

We have a large number of nurses and respiratory therapists performing non-waived point of care testing in our institution. Will a copy of their nursing licenses and respiratory therapist licenses meet the requirement for documentation of their educational d ? degree?


Personnel Records for Non laboratory StaffPersonnel Records for Non-laboratory Staff

GEN.54400 addresses what is required:

• A copy of the employee’s diploma/transcript is required as proof of academic achievement for all non-laboratory personnel performing non-waived POC testing. personnel performing non waived POC testing.

• Per CMS, copies of state licensure for non-laboratory personnel (nurses, respiratory therapists, etc) are notacceptable documentation of academic achievementacceptable documentation of academic achievement.

• The documentation must be retained in the employee file.

• Third party verification of education is not acceptable in lieu Third party verification of education is not acceptable in lieu of the degree or transcript.

• It is ultimately the responsibility of the Medical Director listed on the CLIA certificate to ensure that all testing personnel are on the CLIA certificate to ensure that all testing personnel are qualified to provide and report accurate test results.


Personnel Files Attestation statementsPersonnel Files - Attestation statements

May we use attestation statements when we are ymissing personnel records?• When initial training documents are missing• After efforts to obtain a diploma for an employee’s

files are futile


Competency Assessment PhlebotomyCompetency Assessment – Phlebotomy

Is phlebotomy considered a test system and are all p y ysix elements of competency required?• Phlebotomy is considered a job duty, not a test• Only the elements that are applicable must be assessed• Only the elements that are applicable must be assessed

- Exception: phlebotomist does testing – such as bleeding times


Competency Assessment Test SystemCompetency Assessment – Test System

Do the required six elements have to be performed q pon one test/instrument per department (hematology, chemistry, etc. ) or do they have to be performed per instrument?be performed per instrument?• All six elements must be done per test system


Competency Assessment FrequencyCompetency Assessment - Frequency

Please define the frequency of competency q y p yassessment.• Competency assessment occurs after independent patient

testing has been initiatedtesting has been initiated• A new employee must have competency assessed twice

in their first year of employment• After the second of the two assessments it may be done After the second of the two assessments, it may be done

annually • A seasoned employee, may stay on annual assessment

even if they learn a new discipline unless the director even if they learn a new discipline, unless the director deems otherwise


Competency Assessment Polling #1Competency Assessment – Polling #1

When do all six elements of competency need to be When do all six elements of competency need to be performed?


Proficiency TestingProficiency Testing

The instructions for some of the proficiency testing (PT) p y g ( )products require handling of the PT samples in a different way than we process patient samples. Is this in compliance with Checklist requirements?in compliance with Checklist requirements?• Units of measure require calculations

Special processing instructions• Special processing instructionso Different processing stepso Perform testing on examples not normally used


Proficiency Testing PT Attestation Proficiency Testing - PT Attestation

Who is considered a qualified designee for signing the q g g gPT attestation statement?Does it need to be signed prior to the submission of results?

COM.01400 Phase IIThe proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testingthe individual performing the testing.


Proficiency Testing Nongraded Result ReviewProficiency Testing – Nongraded Result Review

Is our laboratory responsible for evaluating PT results y p gthat are not graded and are marked educational?• Review of educational results is considered best

practice, not a requirement*** Exception: results that are used to meet the

alternative assessment requirements must be alternative assessment requirements must be evaluated


Change of Director Procedure ReviewChange of Director – Procedure Review

Is this laboratory in compliance?


Change of Director Procedure ReviewChange of Director – Procedure Review

COM.10400 Phase IIIf there is a change in laboratory directorship, the new laboratory director ensures (over a reasonable period of time) that laboratory procedures are current and have been appropriately reviewed.


Change of Director – Procedure Review Polling #2Polling #2

Is the laboratory meeting the requirement for y g qCOM.10400?


Change of Director Procedure Review Change of Director – Procedure Review

• How to show compliance:po Re-review of all procedures not requiredo Work with designees to complete processo Document actions takeno Re-approve/revise delegations


Procedure ReviewProcedure Review

The requirement for procedure review has been q pchanged from annual to biennial effective in the July 11, 2011checklist edition. What is the CAP definition of annual and biennial?annual and biennial?

• Annual – every 12 calendar months• Biennial – every 24 calendar months


System Inspection ProceduresSystem Inspection – Procedures

• Can a system laboratory director approve all y y ppprocedures manuals if they have separate laboratory directors?

• Can a laboratory use the same procedure for multiple sites?


System Inspection ProceduresSystem Inspection - Procedures

• Does the institution name and address need to be on each procedure?


Waived Testing Waived Testing

You also asked “What is waived testing?”g• A category of tests defined by CLIA as “simple laboratory

examinations and procedures which have an insignificant risk of an erroneous result ” Tests are assigned to the waived of an erroneous result. Tests are assigned to the waived category by the US Food and Drug Administration (FDA). Laboratories performing waived tests are subject to minimal regulatory requirements under CLIA.regulatory requirements under CLIA.

• The current list of tests waived under CLIA may be found at accessdata.fda.gov/scripts/cdrh/cfdocs/cfClia/analyteswaived cfm Use the following link on the FDA website to ed.cfm. Use the following link on the FDA website to determine the complexity of your test or instrument:

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/Search.cfm


Waived TestingWaived Testing

• Do I need to do lot to lot correlations on my occult blood slides and my urine dipsticks? No

• Do I need to correlate my waived glucometers with the main laboratory instrument? NoM t I f lib ti ifi ti d AMR lid ti • Must I perform calibration verification and AMR validation every six months on my waived glucometers? No, not unless required by the manufacturer.

• Do I need to perform method performance evaluations for my • Do I need to perform method performance evaluations for my waived hemoglobin analyzers? No, only reference range validations are required.


Quality Control Molecular Genetics Nonwaived TestsQuality Control – Molecular Genetics Nonwaived Tests

We perform Factor V Leiden testing using the p g gGeneXpert instrument. The test cartridges include an internal control. Does CAP now allow for the use of the internal control as the daily QC for Factor use of the internal control as the daily QC for Factor V Leiden testing and how can I perform the 20 day QC validation study without using so many test

t id ?cartridges?


Quality Control Molecular Genetics Nonwaived TestsQuality Control – Molecular Genetics Nonwaived Tests

• Revision in the 2012 checklist (MOL.34220) allows for ( )use of the internal control as the daily control for genetic testing

• 20 consecutive day validation study required prior to limiting daily QC to the internal controlsComparison of external and internal controls • Comparison of external and internal controls

• Following acceptable validation study, external controls required every 30 days lot/shipment controls required every 30 days, lot/shipment changes


Diagnosing Bacterial VaginosisDiagnosing Bacterial Vaginosis

Micro supervisor InspectorMicro supervisor Inspector


Anatomic Pathology QC AntibodiesAnatomic Pathology-QC Antibodies

Is it true that we no longer have to run a negative g greagent control for our IHC testing that uses polymer-based detection systems (biotin-free)?


Anatomic Pathology QC AntibodiesAnatomic Pathology-QC Antibodies

ANP.22570 - QC – AntibodiesQFor laboratories that use biotin-based detection systems, appropriate negative controls are used.• Modification to the second paragraph of the note:

o Immunohistochemical tests using polymer-based d t ti t (bi ti f ) ffi i tl detection systems (biotin-free) are sufficiently free of background reactivity to obviate the need for a negative reagent control and such g gcontrols may be omitted at the discretion of the laboratory director.


QC Antibodies ContinuedQC Antibodies - Continued

• This recent revision (7/31/12) allows for the ( / / )background of the patient or positive reagent control to serve as the negative reagent control as long as it is free of background reactivitylong as it is free of background reactivity

• This would apply to the “polymer”-based as well as the “multimer”-based detection systems (biotin-the multimer based detection systems (biotinfree)

• Must have laboratory director approval for the modification


IHC New Reagent Lot VerificationIHC – New Reagent Lot Verification

ANP.22760 Phase IIThe performance of new lots of antibody and detection system reagents is compared with old lots before or concurrently with being placed into service.New lot verification is easier than initial validation• New lot verification is easier than initial validation

• Ensures consistent staining from lot to lotI l d i tib d d d t ti t • Includes primary antibody and detection system reagents

• Use slides cut from the same control block• Use slides cut from the same control block.


IHC and FISH/ISH Result ComparisonIHC and FISH/ISH – Result Comparison

Can you please clarify ANP.22970 regarding annual y p y g gresult comparison of IHC and FISH test for predictive markers?


IHC and FISH/ISH Result Comparison/Benchmarking

ANP.22970 Phase I

IHC and FISH/ISH – Result Comparison/Benchmarking

For immunohistochemical and FISH/ISH tests that provide independent predictive information, the laboratory at least annually compares its patient results with published annually compares its patient results with published benchmarks…

• Does not require test method revalidation but verification of test method by comparisontest method by comparison

• Use Peer reviewed published articles, databases from a reliable source, or similar types of laboratories

• Quality Assurance measure to ensures predictive marker results are not higher or lower than benchmark


IHC and FISH/ISH Annual Result ComparisonIHC and FISH/ISH - Annual Result Comparison

Does the laboratory have to ANNUALLY evaluate yinterobserver variability or just once per provider?


IHC and FISH/ISH Result Comparison/ConcordanceIHC and FISH/ISH – Result Comparison/Concordance

ANP.22970 Phase I

For immunohistochemical and FISH/ISH tests that provide independent predictive information, the laboratory at least annually evaluates interobserver variability among the annually evaluates interobserver variability among the pathologists in the laboratory.

• Individuals interpreting assay have 95% concordance

• Ensures that scoring criteria are applied appropriately

• Can use proficiency testing and in-house cases


ER/PgR ValidationER/PgR Validation

Another participant asked that we review the p prequirements for validation of predictive markers:ANP.22976 requires that the laboratory has documented appropriate validation for the assay(s).• Minimum of 40 cases (20 positives and 20 negatives)• Proficiency testing, QC, and patients may be used• Concordance: 90% for positive and 95% for

tinegative• No grandfathering for this test


HER2 Assa ValidationHER2 Assay Validation

ANP.22978 addresses the validation for HER2• Minimum of 25 cases (recommend 25-100)• No grandfathering for this test must have No grandfathering for this test, must have

documentation regardless of start date• Proficiency testing, QC, and patients are good y g p g

resources for the validation• Concordance should be 95%


Prothrombin Time New Reagent Lot ValidationProthrombin Time - New Reagent Lot Validation

What is required when we are implementing a new lot of Prothrombin Time (PT) reagent?

Scenario – During a CAP inspection, the inspector compares the ISI value listed in the PT reagent manufacturer’s package the ISI value listed in the PT reagent manufacturer s package insert to the ISI value entered into the coagulation instrument. The inspector notes that the two ISI values do not match.

• In addition the patient mean value had not been • In addition, the patient mean value had not been recalculated. o Result: Laboratory placed on probation with immediate

jeopardy and had to cease all testing of Prothrombinjeopardy and had to cease all testing of ProthrombinTimes.

• What should have been done to prevent this situation?


Prothrombin Time New Reagent ValidationProthrombin Time - New Reagent Validation

• Collect a group of patient specimens with normal PT g p p presults (>20 statistically valid)

• Place the new reagent lot on the instrument and test the normal patients normal patients. o May be done before actual lot change over or

during new lot change over If before do not test any l th th th i l t t d l samples other than the previously tested samples

being used for calculating the geometric mean

• Compare patient results for the old reagent lot to Compare patient results for the old reagent lot to patient results of the new reagent lot (use patient samples that span the instrument range)


Prothrombin Time New Reagent Validation cont’Prothrombin Time - New Reagent Validation – cont

• Calculate the Geometric Mean using a program g p gthat can perform this calculation

• When it is time to change PT reagent lots enter the new calculated geometric mean and the manufacturer’s ISI value corresponding to the reagent lot and instrument type into either in the LIS reagent lot and instrument type into either in the LIS or instrument.


Prothrombin Time New Reagent Validation cont’Prothrombin Time - New Reagent Validation – cont

• Run several test patients (Normal INR, INR =2.0, and p ( , ,INR = 3.0) Manually calculate the INR or use a program that calculates the INR.

• Compare the Instrument/LIS INR result to the manually calculated INRPerform and document this calculation comparison • Perform and document this calculation comparison at least once per year


Hematology – Automated Differential ReportingReporting

The recently revised requirement HEM.23050 contains y qa specific note about reporting reference ranges for WBC differential absolute cell counts. Our physicians want both the absolute cell count numbers and the want both the absolute cell count numbers and the percentages. Is this acceptable?• The absolute count is the preferred reporting method for the p p g

WBC differential. The percentage could also be reported in conjunction with the absolute value if so desired.


Hematology – Automated Differential ReportingReporting

Joan Etzell, MD, vice-chair of the CAP Hematology and Clinical Microscopy Resource Committee states the following in the WBC Differentials report in absolute numbers article:

• “It is generally not necessary for clinical assessment, the percentage s ge e a y o ecessa y o c ca assess e , e pe ce age result could also be reported in conjunction with the absolute value if so desired. Of note, classification of various hematopoietic neoplasms, including acute leukemias, myelodysplastic syndromes, myeloproliferative neoplasms and myeloproliferative neoplasms, and myelodysplastic/myeloproliferative overlap disorders, depends on the proportion (percentage) of blasts present. In these situations it may also be appropriate to denote the blast percentage within an y pp p p ginterpretive comment.”

Can be found CAP Home>CAP Reference Resources and Publications>CAP Today>CAP Today 2010 Archive>March>For WBC differentials, report in absolute

bnumbers


Transf sion Medicine Method ComparisonTransfusion Medicine – Method ComparisonHow can we compare the different testing methods that we use for Transfusion Medicine testing when the that we use for Transfusion Medicine testing when the results may be different?

TRM.31450 Phase II

If the laboratory uses more than one instrument/method to test for a given analyte, the instruments/methods are checked against each other at least twice a year for correlation of results.


Transf sion Medicine Method Comparison

• A major correlation study is not required

Transfusion Medicine – Method Comparison

• Identical results may not be the expectation

• Need to establish the relationship between the two methods

• Can use data for processes already in place

• Medical director determines the extent of the comparison

• Follow the approved policy


Transfusion Medicine – Training TransfusionistsTransfusion Medicine Training Transfusionists

At my institution, we have problems getting nursing to comply with annual in services for transfusionists Any suggestions?with annual in-services for transfusionists. Any suggestions?

TRM.41025 II

Personnel involved in transfusion are trained in the Personnel involved in transfusion are trained in the identification of transfusion recipients and blood components, and in observation of recipients during and after transfusion, with in-service education at least annually.y

TRM.41650 II

Criteria for the recognition of transfusion reactions are documented, and there is documentation of at least annual in-service education on the recognition of such reactions.


Transf sion Medicine Training Transf sionists

Examples of strategies to help achieve compliance:

Transfusion Medicine – Training Transfusionists

p g p p• Work with nursing education or transfusion safety

officer• “Skills Days”• On-line approved continuing educationpp g• Presentations by the Laboratory or Nursing---with

documentation of completion


CAP & AABB Coordinated InspectionCAP & AABB Coordinated Inspection

Why does my laboratory need to be inspected with y y y pboth the CAP and AABB inspection tools during a coordinated inspection? Will this change?

• CAP & AABB are committed to make coordinated inspections workp

• Allow same inspectors using CAP & AABB inspection tools

• Inspectors participate in training from both organizations


Cytology Workload RecordingCytology Workload Recording

Is the laboratory in compliance?



CYP.08500 Phase IIThere is a documented workload policy for the manual screening of cytology slides, with evidence of data recording.NOTE: This checklist requirement applies only to laboratories subject to US regulations. The final rule implementing CLIA requires that each individual evaluating cytology

ti b l i i t h i t i th 100 lid preparations by manual microscopic technique must examine no more than 100 slides (gynecologic and non-gynecologic or both) in 24-hours. Gynecologic slides include new routine slides, 10% rescreen slides, and 5-year look-back negative slides. Records must be maintained showing the total number of slides examined by each individual during each 24-hours.


Cytology Workload Recording Polling #3Cytology Workload Recording – Polling #3

Is the laboratory is compliance with the Checklist y prequirement CYP.08500?



• Applies to all primary screenerspp p y• Applies to gynecology and non-gynecology

cytology• Can be documented in the computer system or

using a manual log• Include number of slides screened per day• Include amount of time spent screening per day• Record screening activities performed at other

laboratories on the same day


Cytology Workload Recording

• May not exceed 100 slides per 8 hours of screening


y p g• Individual workload limits must be set• Must not exceed 12 5 slides per hour (pro-rate if less Must not exceed 12.5 slides per hour (pro rate if less

than 8 hours)• Field of view slides count as 0.5 of a slide• Slides undergoing FOV and full manual review

count as 1.5 slides• Tool kit example form



During review of our cytology workload log, what


g y gy g,do we do if we notice that workload limits were exceeded?



• Demonstrate that laboratory can correctly y ydocument daily workload

• Develop an internal corrective action plano For example, re-review cases pertaining to the

workload violation in questiono Comparison of individual statistics with overall lab o Comparison of individual statistics with overall lab

statistics

• Document completion of the planDocument completion of the plan


Cytology CYP 07680 Cross Contamination Cytology - CYP.07680 Cross Contamination

If our laboratory is using a monolayer preparation y g y p pmethod for highly cellular body fluids only, do we need to isolate the slides during staining to prevent cross contamination?cross-contamination?Can we stain FNA smears with non-gynecologic monolayer prepared slides?monolayer prepared slides?


Cytology - CYP.07680 Cross Contamination (Cont )(Cont.)

• Use of a rapid stain, such as toluidine blue, to detect cellular cases. Filter all stains after each cellular specimen is stained

• Prepare cellular body fluids by liquid-based methods, cytocentrifuge techniques, or filter methods to obtain a thin, cytocentrifuge techniques, or filter methods to obtain a thin, uniform layer of cells

• Use a staining sequence, staining paucicellular specimens before highl cellular ones filtering or changing sol tions after before highly cellular ones, filtering or changing solutions after staining a cellular specimen

• Use at least two staining setups and, while using one, filter the other so that a clean set is always available

• Document each time the stains are filtered or changed to keep track of these stepskeep track of these steps


Thank you!Thank you!

• Thank you to our participants for some great y p p gquestions!

• We hope this webinar has been helpful and that you received clarity on a few assorted accreditation issues.


Additional questions? Additional questions?

Our panel: p• Joan Rose

• Dawna Mateski

• Adrienne Malta

• Denise Driscoll


59© 2012 College of American Pathologists. All rights reserved.

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You Asked for it: Your Questions Answered - Presentation