2014 continuing compliance master series checklist updates

2014 Continuing Compliance Master SeriesChecklist Updates

www.cap.org

Gerald A. Hoeltge, MD, FCAPSeptember 17, 2014

Today’s PresenterToday s Presenter

Gerald A. Hoeltge, MD, FCAPg , ,

Chair, Checklists Committee

2© 2014 College of American Pathologists. All rights reserved.

ObjectivesObjectives

• Identify key changes to the Laboratory Accreditation y y g yProgram requirements (checklists).

• List the most common deficiencies reported in 2013.

• Use the checklist changes to prepare your laboratory for inspection.


Change Topics That Will be Covered:Change Topics That Will be Covered:

• Changes that affect the whole laboratoryg y

• Changes in pre-analytics

• Changes to test method managementChanges to test method management

• Changes in post-analytics

New sections for new technologies• New sections for new technologies

• Changes within the specialty Checklists


Editorial Timeline for 2014 ChecklistsEditorial Timeline for 2014 Checklists

P blicationNew edition

Changesvetted

within CAPFinal draftreviewed

t CMS Publicationon

April 21

drafted

July thruNovember

December thru

January

at CMS

Februaryand March

January

The 2014 timeline was abbreviated. The 2015 timeline is likely to be extended.


Changes affecting the whole laboratory...


Activity Menu COM 01200Activity Menu

The laboratory's current CAP Activity Menu accurately reflects the

COM.01200

testing performed.

Key points:

• All tests in useDiscontinued tests removed

Key points:

• Discontinued tests removed• Include methods and services• Call CAP to discuss tests or services not listed

on the Master Activities Menu


PT Attestation COM 01400PT Attestation COM.01400

The proficiency testing attestation statement is signed by the laboratory director or designee and the individual performing the testing.

Key points:

• Physical signatures must appear on the original paper attestation form.

Key points:

attestation form. • A listing of typed names on the attestation statement

does not meet the intent of the requirement.


Document Control GEN.20375Document Control

The laboratory has a document control system to manage policies, procedures, and forms.

Key points:

• “Forms” has been moved to the stem of the requirement

Key points:

requirement• Only the current policies, procedures, and forms are

in use• A control log is recommended


New Director Procedure Approval TLC.11485New Director Procedure Approval

Following a change in laboratory directorship, the new laboratory director approves the laboratory policies and procedures over adirector approves the laboratory policies and procedures over a reasonable period of time.

K i t

• Moved from COM to TLCAll d t b i d

Key points:

• All procedures must be reviewed• Format is at the discretion of the lab director• Itemization of the documents reviewed andItemization of the documents reviewed and

approved and dates• Should be completed within 3 months of a change

in directorship


in directorship

Growth of the All Common Checklist

75

Growth of the All Common Checklist

60 requirementspages

45

15

30

2011 2012 2013 20140


Thermometers COM 30700 COM 30800Thermometers

Five requirements have been moved to the All Common Checklist:

COM.30700 — COM.30800

Checklist:

• Availability of an accurate device traceable to NIST standard

All non certified thermometers are checked against the• All non-certified thermometers are checked against the standard

• All temperature-dependent equipment and environments p p q pchecked and recorded each day of use

• Acceptable ranges have been defined

• Corrective action is evident when ranges have been exceeded


Instruments and Equipment COM 30525 COM 30675Instruments and Equipment

Seven requirements have been moved to the All Common Checklist:

M f t ' i t ti f ll d f i d t ti d i

COM.30525 — COM.30675

• Manufacturer's instructions followed for waived testing devices

• Performance verified upon installation & after repair or reconditioning

Standard procedures for start up operation and shutdown• Standard procedures for start-up, operation, and shutdown

• Maintenance and function checks are performed and documented

• Tolerance limits are defined and corrective actions are documentedTolerance limits are defined and corrective actions are documented

• Instructions are provided for minor troubleshooting and repairs

• Records are available to, and usable by, the technical staff , y,


Instrument/Equipment Record Review COM 04200Instrument/Equipment Record Review COM.04200

Instrument and equipment maintenance and function check records are reviewed and assessed at least monthly by the director orare reviewed and assessed at least monthly by the director or designee.

Key points:

The long Note has been removedSee TLC 11425 for delegation of director

Key points:

See TLC.11425 for delegation of director responsibilities


Comparability of Instruments & Methods COM 04250Comparability of Instruments & Methods COM.04250

If the laboratory uses more than one non-waived instrument/method t t t f i l t th i t t / th d h k dto test for a given analyte, the instruments/methods are checked against each other at least twice a year for comparability of results.

Key points:

• Written protocol and acceptance criteria.• Only for non-waived instruments/methods accredited

Key points:

• Only for non-waived instruments/methods accreditedunder a single CAP number.

• Only applies when the instruments/reagents are d i th t bl ltproducing the same reportable result.

• Quality control data may be used for comparison in some cases.


Comparability Criteria Corrective Action COM 04300Comparability Criteria, Corrective Action COM.04300

Acceptability criteria are defined for comparability of instruments/ methods used to test the same analyte with documentation ofmethods used to test the same analyte, with documentation of corrective actions when the criteria are not met.

• Limits should be defined statistically for quantitative t t

Key point:

tests


Personnel Records GEN 54400Personnel Records GEN.54400

Personnel files are maintained on all current technical personnel and l d i l d ll f th f ll i itpersonnel records include all of the following items.

• Laboratory personnel license if required by state province orKey changes:

Laboratory personnel license, if required by state, province, or country

• Appropriate documentation of qualifications varies by laboratory locale

• Description of current duties and responsibilities as specified bythe laboratory director:

a) Procedures the individual is authorized to perform,b) Whether supervision is required for specimen processing,

test performance or result reporting, c) Whether supervisory or section director review is required to

report patient test result


report patient test result

Competency of Testing Personnel GEN 55500Competency of Testing Personnel GEN.55500

The competency of each person performing patient testing to perform his/her assigned duties is assessed.his/her assigned duties is assessed.

A t

Key points:

• Assessment– Initially and at 6 & 12 months, then annually; all 6

elements required (non-waived)– Initially and annually; elements may be selected

(waived)• AssessorAssessor

– Section director or general supervisor (high-cx)– Technical consultant (mod-cx)


Performance Assessment GEN 55525Performance Assessment GEN.55525

The performance of section directors/technical supervisors, general supervisors and technical consultants is assessed and satisfactorysupervisors, and technical consultants is assessed and satisfactory.

Key points:

• Refers to role in management of patient testing• Unsatisfactory performance must be addressed in a

y p

y pplan of corrective action

• GEN.55500 applies if the individual also performspatient testingpatient testing


Professional Competency ANP 10255Professional Competency ANP.10255

The laboratory director ensures the professional competency of pathologists who provide interpretive services to the anatomic pathology laboratory.

Key points:• Written policy for assessing professional

competency, criteria for the assessment, and records of the assessment

y p

records of the assessment • Documentation may consist of:

– Participation in a peer educational program– Metrics developed from diagnostic QM reports– Quality management records

Individual assessment according to defined criteria


– Individual assessment according to defined criteria

Testing Personnel Qualifications GEN.54750, CYG.50200, MOL 49660Testing Personnel Qualifications MOL.49660

All testing personnel meet the following requirements:high complexity associates degreehigh complexity... associates degree...moderate complexity... high school diploma...

• Standardized across the Checklists wherever possible

Key points:

possible• Significant change for cytogenetics and molecular

testing


ConsultantsConsultants

Technical consultants meet defined qualifications and fulfill expected responsibilities.responsibilities. Clinical consultants meet defined qualifications and fulfill expected responsibilities.

• Applies to laboratories performing moderately complex testing

Key points:

complex testing• Qualifications must be in accordance with CLIA

regulations• Responsibilities must be in accordance with CLIA

regulationsMust be available for consultation


• Must be available for consultation

Director's Responsibility for Personnel TLC 11300Director s Responsibility for Personnel TLC.11300

The laboratory director ensures sufficient numbers of personnel with i t d ti l lifi ti d t d t i i dappropriate educational qualifications, documented training and

experience, and adequate competency to meet the needs of the laboratory.

• Staffing should be considered insufficient only if

Key point:

there is clear evidence from quality monitoring records, data derived from complaints or concerns, turnaround time, and error statistics, etc.


Director's Responsibility for Equipment & Services TLC 11475Equipment & Services TLC.11475

The laboratory director or designee is directly involved in the l ti f ll l b t i t li d i ithselection of all laboratory equipment, supplies, and services with

respect to quality.

• To ensure administrative control over technical processes

Key points:

processes• Includes reagents, fluids, parts, materials, and other

items supplied by the laboratory meet the requirements for use with instruments andrequirements for use with instruments and equipment


Pre-analytics


Unacceptable Specimens ANP, CBG, CHM, CYG, FLO, HEM HSC IMM RLM URNUnacceptable Specimens HEM, HSC, IMM, RLM, URN

There are documented criteria for the rejection of unacceptable specimens, instructions for the special handling of sub-optimal specimens, and documentation of disposition of all unacceptable specimens in the patient/client report and/or quality management records.

• Applies to all types of testingKey points:

• Evidence of compliance– Records of rejected specimens AND

Instructions for special handling of sub optimal– Instructions for special handling of sub-optimal specimens AND

– Documentation of disposition of unacceptable specimens


specimens

Specimen Collection Training GEN 40470Specimen Collection Training GEN.40470

There is documentation that all personnel collecting patient specimens have been trained in collection techniques and in thespecimens have been trained in collection techniques and in the proper selection and use of equipment/supplies.

Key points:

• Applies to all types of specimens and all collectionmodesA li t ll l ll ti l d• Applies to all personnel collecting samples under that laboratory's number (including those at remotesites)

• Training must be documented in accord with anymanufacturer's instructions


Phlebotomy Adverse Reactions GEN.40508Phlebotomy Adverse Reactions

The laboratory has procedures to care for patients who experience adverse reactions from phlebotomy.adverse reactions from phlebotomy.

Key points:

• Emphasize injury prevention in training.• Serious reactions must be recorded in an incident

log (eg vomiting nerve damage seizures andlog (eg, vomiting, nerve damage, seizures and head injuries)


Tissue/Cytology Assessment ANP 11525 CYP 03850Tissue/Cytology Assessment ANP.11525, CYP.03850

If a statement of adequacy, preliminary diagnosis, or recommendations for additional studies is provided at the time of tissue and cytology sample collection, documentation of that statement is maintained.

D t ti b i th di l d i th

Key point:

• Documentation may be in the medical record, in the final report, or in a laboratory record


Test Method Management


Monthly QC Review most ChecklistsMonthly QC Review most Checklists

Quality control data are reviewed and assessed at least monthly by y y ythe laboratory director or designee.

Key points:

• New language in the Note: “The review of quality control data must be documented and include

Key points:

follow-up for outliers, trends, or omissions that were not previously addressed.”

• Delegation of functions must be in writing• Delegation of functions must be in writing (TLC.11425)


Method Performance Specifications from COMMethod Performance Specifications from COM

• Validation/verification required for all non-waived tests qregardless of date of implementation– Validation: tests not FDA cleared/approved (LDTs)

Verification: unmodified FDA cleared/approved tests– Verification: unmodified, FDA cleared/approved tests

• Retain records as long as the method is in use and for gtwo years thereafter


Method Validation/Verification Approval COM 40000Method Validation/Verification Approval COM.40000

There is a summary statement, signed by the laboratory director (or y g y y (designee who meets CAP director qualifications) prior to use in patient testing, documenting evaluation of validation/verification studies and approval of each test for clinical use.

• Include a written assessment of the study the

Key points:

• Include a written assessment of the study, the acceptability of the data, and approval for patient testingI l d lid ti f li i l l i• Include validation of any clinical claims


AMR VerificationCBG.12300, CHM.13600, HEM.38009, IMM, 33818, AMR VerificationMOL.33983

Verification of the analytical measurement range (AMR) is performed with matrix-appropriate materials which, at a minimum, include thewith matrix appropriate materials which, at a minimum, include the low, mid, and high range of the AMR, appropriate acceptance criteria are defined, and the process is documented at least every 6 months and following defined criteria.g

• After a change in reagent lotsExpected:

• If QC is out of range and other corrective actions have failed to correct the problem

• After major preventive maintenance or change of a• After major preventive maintenance or change of a critical component

• When recommended by the manufacturer


IHC Assay Performance ANP 22780IHC Assay Performance ANP.22780

The laboratory confirms assay performance when conditions change that may have affected performancethat may have affected performance.

E t d ft tib d dil ti tib d dKey points:

• Expected after antibody dilution, antibody vendor (same clone), or the incubation or retrieval times (same method) — at least 2 positive and 2 negative

lexamples• Fixative type, antigen retrieval method (eg, change in

pH, different buffer, different heat platform), antigen p p ) gdetection system, tissue processing or testing equipment, environmental conditions of testing (eg, laboratory relocation), or laboratory water supply —


y ), y pp y“sufficient number”

Body Fluid Validation COM 40620Body Fluid Validation COM.40620

Testing of body fluid specimens using methods intended for other specimen types (eg blood or other fluid) has been validated by thespecimen types (eg, blood or other fluid) has been validated by the laboratory for accuracy, precision, analytic sensitivity, analytic specificity, interferences, and reportable range.

• Applies to routine, orderable testsValidation using blood specimens acceptable if

Key points:

• Validation using blood specimens acceptable if the laboratory can reasonably exclude matrix effects

• Reference ranges may be taken from the literature

• Alternative performance assessment is required


e a e pe o a ce assess e s equ ed

Post-analytics


Patient Data Accessibility GEN 41304Patient Data Accessibility GEN.41304

There is a documented protocol in place to ensure that patient data are accessible only to those individuals who are authorized toare accessible only to those individuals who are authorized to review test results.

Key points:

• Changed to comply with 42 CFR 493.1291(l)• Includes

Key points:

• Includes– Authorized healthcare personnel– The patient– The patient’s personal representative


Amended Reports ANP 12185Amended Reports ANP.12185

Amendments to reports that would significantly affect patient care are reported promptly to the responsible clinician(s)are reported promptly to the responsible clinician(s).

Key points:

• Records should include date, time, and person notifiedEvaluation of amended reports records should be part• Evaluation of amended reports records should be part of the quality management program


Reference Laboratory Reports GEN 41096Reference Laboratory Reports GEN.41096

(Addition to Note on Report Elements)

Key points:

• Reference laboratories must send a copy of the report to the referring laboratoryResults may be sent to the ordering physician by• Results may be sent to the ordering physician by either the referring or reference laboratory

• Exceptions may be made (eg, drugs of abuse or employee drug testing)


Returning Surgical Material to Patients ANP 24200Returning Surgical Material to Patients ANP.24200

Infectious tissues and other potentially contaminated materials are disposed of with minimum danger to professional technical anddisposed of with minimum danger to professional, technical, and custodial personnel, and to recipients.

Note:“Specimens returned to patients (eg, gallstones) or otherwise released to others (eg, pacemaker or

th i t it f t ) t b di i f t d

Note:

prosthesis to its manufacturer) must be disinfected before release.”


New Technologies


Circulating Tumor Cell Analysis ANP 29500 – ANP 29640Circulating Tumor Cell Analysis ANP.29500 ANP.29640

• Calibration, recalibration,

• Quality control

S l t / j ti it i• Sample acceptance/rejection criteria

• Guidelines for morphologic assessment

• Reporting requirements

• Qualifications, training, competency of testing personnelQualifications, training, competency of testing personnel

• Qualifications of supervision


Whole Slide Imaging GEN 52900 GEN 52920Whole Slide Imaging GEN.52900, GEN.52920

The laboratory validates whole slide imaging systems used for clinical diagnostic purposes by performing its own validation studies ... g p p y p gbefore the technology is used for the intended diagnostic purpose.

There is documentation showing that all users of the whole slide i i t h b t i dimaging system have been trained.

Key points:• Validation by a trained pathologist using “real world”

components

Key points:

• Training must include each pathologist who will use the system


Specialty Checklists


HER2 ANP.22978, ANP.22979, ANP 22983 ANP 23002HER2 ANP.22983, ANP.23002

• Revised according to 2014 ASCO/CAP criteriag

• Validation requires– 20 positive x 20 negative for FDA cleared/approved tests– 40 positive x 40 negative for LDTs

• Fixation time may be up to 72 hours

• Scoring either according manufacturer's instructions or ASCO/CAP criteria

• Carly-stage tumor, recurrent tumor, and metastatic disease must be tested


Molecular Internal Controls MOL 34280Molecular Internal Controls MOL.34280

For FDA-cleared/approved test systems not modified by the laboratory that involve a closed system incorporating all steps ... batch-specific controls may be limited to the electronic/procedural/ built-in internal controls only for tests meeting all of the following criteria:

1. The laboratory has performed validation studies (on at least 20 samples representing the expected heterogeneity of testing results) to validate the adequacy of limiting daily QC to the electronic/procedural/built-in controls.

2. External surrogate sample controls are run for each new lot number and/or shipment of test materials; after major system maintenance; and after software upgrades.upgrades.

3. External surrogate sample controls are run as frequently as recommended by the test manufacturer, or every 30 days, whichever is more frequent.


Sanger Sequencing and Pyrosequencing MOL 34610 MOL 34913Sanger Sequencing and Pyrosequencing

• Validation of sequencing in mixed-cell populations and

MOL.34610 - MOL.34913

q g p plower limit of detection

• Adequacy of information regarding sequence variants q y g g q(both pathogenic and benign)

• Sequencing assay signal optimizationq g y g p

• Use of professional guidelines for interpretation (eg, ACMG guidelines or COSMIC database)


NGS – Wet Bench Testing MOL 34934 MOL 34953NGS Wet Bench Testing

• Standard operating procedure

MOL.34934 - MOL.34953

p g p

• Wet bench process validation

Q lit t f t b h t ti• Quality management of wet bench testing

• Confirmatory testing of detected variants

• Test referral policy


NGS – Bioinformatics Pipeline MOL 34958 MOL 34966NGS Bioinformatics Pipeline

• Standard operating procedure, QC to assess run

MOL.34958 - MOL.34966

p g p , Qperformance

• Validation of the pipeline; confirmation or revalidation p p ;after changes to the software

• Documentation of patches and upgradesp pg

• Data storage requirements

Quality management program• Quality management program


NGS – Bioinformatics Pipeline MOL 34968 MOL 34985NGS Bioinformatics Pipeline

• Version traceability for every report

MOL.34968 - MOL.34985

y y p

• Log of exceptions from standard operating procedure

P ti t fid ti lit d it• Patient confidentiality and security

• Interpretation and reporting of sequence variants

• Policy for reporting of incidental findings unrelated to the clinical purpose of testing


Mass Spectrometry (LC-MS) CHM 18825 CHM 18850Mass Spectrometry (LC MS)

• Assessment for matrix effects during test development

CHM.18825, CHM.18850

g p

– Requirements for number of samples and acceptance criteria

• Monitoring for matrix effects on patient samples g p p

– Use of internal standards and signal-to-noise ratios


D-dimer Studies HEM.37924, HEM.37925, POC.09150, POC.09153, D dimer Studies

• Report in the units generated by the method

HEM.37930, HEM.37935 POC.09156, POC.09160

p g y

• FDA approval/clearance is either

F l i f th b b li (VTE)– For exclusion of venous thromboembolism (VTE)

– As an aid to the diagnosis of VTE

• Report the cutoff value as well as the reference range for both

• Issue disclaimer if the method is insufficiently sensitive to exclude VTE


Flow Cytometry Antibodies and Reagents FLO 23275 FLO 23325Flow Cytometry Antibodies and Reagents FLO.23275, FLO.23325

The laboratory has documented the initial validation of new antibodies, prior to use in patient diagnosis., p p g

The performance of new lots/shipments of antibody and detection system reagents is compared with old lots/shipment before or

tl ith b i l d i t i

Key points:

concurrently with being placed into service.

• Validate on the cell sub-population of interest in the context of the antibody combination used in an assay

• Compare each individual antibody by using a side p y y gscatter vs. fluorescence plot (recommendation)


Histocompatibility Testing HSC 40100Histocompatibility Testing HSC.40100

If the histocompatibility laboratory participates as a member of the United Network for Organ Sharing (UNOS), there is a policy to notify the CAP's Laboratory Accreditation Program when there is a change in section director/technical supervisor.

Required under the deemed status agreementKey points:

• Required under the deemed status agreement between CAP and UNOS

• Must occur no later than 30 days prior to the change; or in the case of an unexpected change, no later than two working days afterwards


Histocompatibility Testing HSC 30056Histocompatibility Testing HSC.30056

K i t

The flow cytometry crossmatch identifies antibodies to T and B-cells.

B-cell crossmatching had previously been optional Key point:


QC of Media in Bacteriology MIC 21240QC of Media in Bacteriology MIC.21240

... an appropriate sample from each lot and shipment of each purchased medium ... is checked for …1. Ability to support growth2. Biochemical reactivity

3. End-user quality control for C l b t di

Key addition:

– Campylobacter media– Chocolate agar– Media for selective isolation of NeisseriaMedia for selective isolation of Neisseria– Mueller-Hinton agar for AST– and others


Microbiology MIC 11375Microbiology MIC.11375

The laboratory incorporates taxonomic changes that potentially affect the choice of appropriate antimicrobials to report and/or the interpretative breakpoints to use.

• Changes to the naming of microorganisms may affect the choice of antimicrobials or breakpoints

Key points:

the choice of antimicrobials or breakpoints• Incorporate clinically relevant changes even when

commercial systems have not been updated


Microbiology MIC 63259Microbiology MIC.63259

If the laboratory chooses to pool specimens for tests performed using test systems that have not been FDA cleared/approved for thatusing test systems that have not been FDA-cleared/approved for that purpose ... the testing procedure for pooled samples must be validated, including limit of detection (sensitivity), reproducibility, and accuracy (method comparison).

Validation protocol must compare pooled vs nonKey point:

and accuracy (method comparison).

• Validation protocol must compare pooled vs non-pooled samples and include both weakly positive and strongly positive samples


Provider-Performed Testing (PPT) POC.09200, POC.09300, Provider Performed Testing (PPT)

• Written policy for including training requirements, sample

POC.09400, POC.09500

p y g g q , pcollection, the use of personal protective equipment, reporting policies, competency assessment, and quality managementmanagement

• Written procedure for each test

• Quality management (including PT)

• Training prior to performing testing (medical staff credentialing is not acceptable)


PPT Competency Assessment POC 09600PPT Competency Assessment POC.09600

There is a documented program to ensure that all providers performing non waived PPT maintain satisfactory levels ofperforming non-waived PPT maintain satisfactory levels of competence.

• Non-waived testing requirement parallels GEN.55500• Competency must be assessed by an individual

Key points:

• Competency must be assessed by an individual qualified as a Technical Consultant

• Director may determine competency assessment for i d t tiwaived testing


Fire Safety GEN 75100 GEN 75400Fire Safety GEN.75100, GEN.75400

Policies and procedures are documented and adequate for fire prevention and control.prevention and control.

Fire safety training is performed for new employees, with a fire safety review conducted at least annually.

• Fire safety plans must include the use of alarms, response to alarms isolation of the fire evacuation of

Key points:

response to alarms, isolation of the fire, evacuation of the area, extinguishment of the fire, and the responsibilities of laboratory personnel for those elementselements.

• While fire exit drills are not required, yearly evaluation of the escape routes should be documented.


Inspection Readiness


Uncertainty in Citing a DeficiencyU ce ta ty C t g a e c e cy

neverhardly eversometimesoften


Top Ten DeficienciesTop Ten Deficiencies

• GEN.55500 – competency records 22.3%p y• GEN.20375 – document control 13.5%• GEN.54400 – personnel files 9.2%• GEN.75400 – annual fire drills 8.8%• GEN.77400 – emergency eye wash 7.3%• CHM 13600 AMR verification 7 1%• CHM.13600 – AMR verification 7.1%• ANP.23075 – instrument maintenance 6.7%• CHM.13800 – correlation of instruments 6.5%• ANP.23410 – cryostat decontamination 6.2%• TRM.31450 – instruments & equipment 6.0%


Top Ten ExpungementsTop Ten Expungements

1. COM.01000 – adequate PT proceduresq p2. COM.40300 – analytic accuracy/precision3. GEN.23584 – interim self-inspection4. GEN.16902 – QM implementation5. COM.01300 – PT participation6 COM 01500 alternative performance assessment6. COM.01500 – alternative performance assessment7. COM.30100 – critical result readback8. COM.10100 – biennial procedure manual reviewp9. COM.10300 – knowledge of procedures10.COM.10200 – new procedure review


(>100 citations/year; >20% expunged)

Versions of the ChecklistsVersions of the Checklists

• Custom Checklists for your laby

• Master Checklists include instructions to inspectors

S d h t f t• Spreadsheet format

• Change document to see the additions and deletions in d t ildetail


Thank you! Thank you!

Questions?


2014 continuing compliance master series checklist updates

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