Laboratory%20Accreditation%20Program - PowerPoint PPT Presentation

About This Presentation
Title:

Laboratory%20Accreditation%20Program

Description:

Cytopathology Quality Improvement. Defined QI plan with active surveillance ... Enrollment in a peer educational program in NON - GYN Cytopathology (Phase I) ... – PowerPoint PPT presentation

Number of Views:208
Avg rating:3.0/5.0
Slides: 41
Provided by: dianedav
Learn more at: https://webapps.cap.org
Category:

less

Transcript and Presenter's Notes

Title: Laboratory%20Accreditation%20Program


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?
Write a Comment
User Comments (0)
About PowerShow.com