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 CLIA88
• 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-recomme
  nded 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
  cytotechnologists 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 5tile Median 95tile
• Unsatisfactory 0.1 0.5 4.0
• ASCUS 0.6 4.4 13.0
• LSIL 0.4 1.6 6.0
• HSIL lt0.1 0.5 1.9
• AGUS lt0.1 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?