Laboratory Accreditation Program Cytopathology Inspection College of American Pathologists Robert R....

Laboratory Accreditation Laboratory Accreditation ProgramProgram

Cytopathology Inspection

College of American Pathologists

Robert R. Rickert, MD, FCAPRobert R. Rickert, MD, FCAP

AudioConference March 21, 2001AudioConference March 21, 2001

MissionMission

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

Philosophy Philosophy

Voluntary Quality Peer Review Education

Laboratory Accreditation ProgramLaboratory 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

Cytopathology InspectionCytopathology Inspection

Special Aspects of Cytopathology Concerns of public and media Regulatory environment - CLIA ’88,

deemed status, checklist revisions Quality improvement principles


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


Cytopathology Checklist 8A Quality Improvement Quality Control Personnel Physical Facilities Safety


Regardless of laboratory size, the inspector should plan to spend at least several hours inspecting cytopathology


Will Require: Observation of technical procedures Review of QI program and indicators On-site microscopic review

Cytopathology InspectorCytopathology 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”


General Elements of QI Technical and procedural (QC) Professional/diagnostic activities of

cytotechnologists and pathologists (QI) Quality of the diagnostic report (QC/QI)

Specimen Collection and ReceiptSpecimen 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

Cytology StainsCytology 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

InstrumentationInstrumentation

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

Instrumentation (2)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

On-Site Microscopic ReviewOn-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

On-Site Microscopic Review (2)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

Cytopathology ReportsCytopathology 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

Retention GuidelinesRetention 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

Slide StorageSlide 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)

Information / Physical RequirementsInformation / 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

Personnel and WorkloadPersonnel 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

Cytopathology Quality ImprovementCytopathology 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

Cytopathology Quality Improvement (2)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

Pap RescreeningPap 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)


The Five-Year Lookback

Triggered by a new HGSIL or malignant diagnosis

A CLIA requirement

Amended ReportsAmended 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

Cytologic / Histologic CorrelationCytologic / 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

Statistical AnalysisStatistical 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

1997 Reporting Rates in Pap Labs1997 Reporting Rates in Pap Labs

Category 5%tile Median95%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

Laboratory SafetyLaboratory Safety

Documented procedures for infectious / contaminated material disposal

Formaldehyde / xylene vapor concentrations In compliance with Laboratory General

Checklist

Proposed Checklist ChangesProposed 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)

Proposed Checklist Changes (2)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)

Proposed Checklist Changes (3)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)

Most Frequent Phase II Deficiencies 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?

Most Frequent Phase II DeficienciesMost 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?

Most Frequent Phase II DeficienciesMost 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?

Most Frequent Phase I DeficienciesMost Frequent Phase I Deficiencies

CYP.09000 Phase I Is sufficient space provided for processing

cytologic material?


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?


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?

Laboratory Accreditation Program Cytopathology Inspection College of American Pathologists Robert R....

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