Laboratory Accreditation Program

1. Laboratory Accreditation Program Cytopathology Inspection College of American Pathologists Robert R. Rickert, MD, FCAP AudioConference March 21, 2001

2. Mission To improve the quality of laboratory services through peer review and education.

3. Philosophy • Voluntary • Quality • Peer Review • Education

4. Laboratory Accreditation Program Standards and Checklists Standards are the broad principles that the laboratory must meet in order to achieve accreditation Checklists provide detailed requirements that inspectors use to determine whether laboratories meet the standards

5. Cytopathology Inspection • Special Aspects of Cytopathology • Concerns of public and media • Regulatory environment - CLIA ’88,deemed status, checklist revisions • Quality improvement principles

6. Cytopathology Inspection • Recent Initiatives • Defined curriculum for inspectors • Separate Checklist (8A Cytopathology) • Emphasis on time required • Defined inspector qualifications • On-site slide review • Participation in PAP Survey proficiency testing or other CLA-approved alternative program

7. Cytopathology Inspection Cytopathology Checklist 8A • Quality Improvement • Quality Control • Personnel • Physical Facilities • Safety

8. Cytopathology Inspection • Regardless of laboratory size, the inspector should plan to spend at least several hours inspecting cytopathology

9. Cytopathology Inspection • Will Require: • Observation of technical procedures • Review of QI program and indicators • On-site microscopic review

10. Cytopathology Inspector • Inspector Qualifications • Pathologists or cytotechnologists with extensive experience • Knowledge of checklists and CLIA’88 • Attendance at recent CAP inspection education seminar highly recommended • Familiar with CAP Publication “Quality Improvement in Anatomic Pathology”

11. Cytopathology Inspection • General Elements of QI • Technical and procedural (QC) • Professional/diagnostic activities of cytotechnologists and pathologists (QI) • Quality of the diagnostic report (QC/QI)

12. Specimen Collection and Receipt • Specimens properly identified • Instructions available for preferred specimen collection/preparation • Requisition: complete data requested including date, source, physician, LMP, pertinent clinical information, etc. • Criteria for specimen rejection and notification of unacceptable specimens

13. Cytology Stains • Stains labelled and dated • Cytology stains: new requirement for annual inventory to ensure proper storage and quality (many stains do not expire) (I) • Papanicolaou stains filtered or replaced regularly • Papanicolaou stain required for Paps • Regular monitoring of stain characteristics

14. Instrumentation • Evidence of active review of results of instrument maintenance and function (II) • Automated instruments (Phase II) • Documentation of adherence to manufacturer-recommended protocol for implementation • Documentation of appropriate technical and interpretive training • Written procedure to verify diagnostic & adequacy performance of screening instrument

15. Instrumentation (2) • Automated screening systems (Phase II) • If tolerance limits exceeded, is there documentation of corrective action? • Documented procedure for handling workload during instrument failure • Documented procedure for handling slides not successfully processed • “Negative” slides subject to 5 year retro review

16. On-Site Microscopic Review • Not meant to be comprehensive rescreen or competency review, but a means of facilitating evaluation of overall procedures • 10 -15 case review recommended including: -Unsatisfactory * -Reactive -SIL -Positive -ASCUS -Non-Gyn *Must have written criteria

17. On-Site Microscopic Review (2) • Evaluate adequacy, technical quality, labels • Determine if significant cells identified • Compare with written interpretive report • Check requisition for complete information • Discrepancies analogous to PAP program • Team leader should discuss significant discrepancies with laboratory director • Record specimen category & discrepancies

18. Cytopathology Reports • Name/unique identifier/accession number • Birth date / age • Physician / clinic • Anatomic source / type of specimen • Collection, receipt, and reporting dates • Description of specimen on receipt • Interpretation (descriptive terminology) • Space for comments / recommendations

19. Retention Guidelines Glass slides 5 years FNA slides 10 years Reports 10 years Accession logs / worksheets 2 years Maintenance records 2 years QC / QA records 2 years Service / repair records instrument life

20. Slide Storage • Stored in accessible manner • Documented policy for protecting and preserving the integrity of original slides • Policy to ensure defined handling and documentation of referral, transfer, receipt of original slides for availability • Documentation when material is loaned to programs such as PAP (including receipt)

21. Information / Physical Requirements • Patient index: easy information retrieval • Cross-index with histology material • Sufficient space: processing, microscopes, slides, records • Utilities, temperature, ventilation control • Ergonomic desks / chairs • Screening performed within approved lab

22. Personnel and Workload • Review qualifications of pathologist director, supervisor, cytotechnologists • Must meet CLIA requirements • Sufficient personnel to handle workload • Written workload policy with periodic determination of workload limit and daily documentation for each screener • Director must ensure competency of all personnel

23. Cytopathology Quality Improvement • Defined QI plan with active surveillance • May include many QC items • Criteria for unsatisfactory specimens • Hierarchical review: written criteria • Rescreening • Retrospective Review • Cytologic / Histologic Correlation

24. Cytopathology Quality Improvement (2) • Correlation with clinical findings • Reconciliation of Disparities • Documentation of consultations • Documentation of technical quality • Participation in PAP program or CLA-approved alternative program

25. Pap Rescreening • Laboratory must rescreen a minimum of 10% of each cytotechnologist’s initially judged as negative • Performed by individual qualified to be supervisor (3 years experience) • Must include both high risk and randomly selected cases • Cases not reported until rescreening complete • Pathologists exempt (but rescreening advised)

26. Cytopathology Inspection The Five-Year Lookback • Triggered by a new HGSIL or malignant diagnosis • A CLIA requirement

27. Amended Reports • Rarely issued in retrospective reviews since treatment is dictated by newly diagnosed abnormal smear • More often used in cytohistologic correlation activities or review prompted for other reasons • ACOG has deferred to laboratory profession for impact on patient care

28. Cytologic / Histologic Correlation • Documented effort to obtain and review histologic reports or material (Phase II) • Actual slide review • When not available within the lab, must show documented effort to obtain histologic reports for correlation (especially HSIL / cancer) • Concurrent review ideal for patient care

29. Statistical Analysis • Similar to CLIA 1988 requirements • By type and source (II) • Minimum is gyn and non-gyn case numbers • Gynecologic cases (I): • By interpretive categories (including unsat) • Current rescreen results in reclassification • Histologic discrepancies & correlation unavail • Benchmark data collected by CAP

30. 1997 Reporting Rates in Pap Labs Category 5%tile Median 95%tile Unsatisfactory 0.1 0.5 4.0 ASCUS 0.6 4.4 13.0 LSIL 0.4 1.6 6.0 HSIL <0.1 0.5 1.9 AGUS <0.1 0.4 1.6 ASCUS/SIL 0.4 1.9 5.1

31. Laboratory Safety • Documented procedures for infectious / contaminated material disposal • Formaldehyde / xylene vapor concentrations • In compliance with Laboratory General Checklist

32. Proposed Checklist Changes • Enrollment in a peer educational program in NON - GYN Cytopathology (Phase I) • Inventory of cytology stains to ensure proper storage and quality (Phase I)

33. Proposed Checklist Changes (2) • Active review of results of instrument maintenance and function (Phase II) • Educational notice to providers of C-V specimens that Pap is a screening test with inherent false negative rate (Phase I)

34. Proposed Checklist Changes (3) • TAT requirement for routine non-gynecologic cytology cases (Phase I) • Use of ASCUS/SIL ratio benchmarking data for gynecologic cases (Phase I)

35. Most Frequent Phase II Deficiencies CYP.02500 Phase II • Is there documentation of at least annual review of all procedures in the cytopathology laboratory section by the current laboratory director or designee?

36. Most Frequent Phase II Deficiencies CYP.03950 Phase II • Are reagents properly labeled, as applicable and appropriate, with the following elements: • 1. content and quantity, concentration or titer, • 2. storage requirements, • 3. date prepared or reconstituted • 4. expiration date?

37. Most Frequent Phase II Deficiencies CYP.07400 Phase II • Are statistical records maintained, and summarized annually, that include the number of cytopathologic specimens and type/sources of specimens?

38. Most Frequent Phase I Deficiencies CYP.09000 Phase I • Is sufficient space provided for processing cytologic material?

39. Most Frequent Phase I Deficiencies CYP.07600 Phase I • For gynecologic cases, are records maintained that include number of cases reported by diagnosis (including unsatisfactories), number of cases with significant cytologic/histologic discrepancies, number of cases where rescreen resulted in reclassification of a result as abnormal, and number of cases where histopathology results are unavailable to compare with malignant or high-grade premalignant (high-grade SIL, CIN II-III, moderate-severe dysplasia) cytopathology results?

40. Most Frequent Phase I Deficiencies CYP.04400 Phase I • Is there a written policy for ensuring that nongynecologic specimens with a high potential for cross-contamination are processed and stained separately from other specimens?