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Laboratory Accreditation Program. Cytopathology Inspection College of American Pathologists Robert R. Rickert, MD, FCAP AudioConference March 21, 2001. Mission. To improve the quality of laboratory services through peer review and education. Philosophy . Voluntary Quality Peer Review

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laboratory accreditation program

Laboratory Accreditation Program

Cytopathology Inspection

College of American Pathologists

Robert R. Rickert, MD, FCAP

AudioConference March 21, 2001


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

  • Voluntary
  • Quality
  • Peer Review
  • Education
laboratory accreditation program4
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

cytopathology inspection
Cytopathology Inspection
  • Special Aspects of Cytopathology
    • Concerns of public and media
    • Regulatory environment - CLIA ’88,deemed status, checklist revisions
    • Quality improvement principles
cytopathology inspection6
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
cytopathology inspection7
Cytopathology Inspection

Cytopathology Checklist 8A

  • Quality Improvement
  • Quality Control
  • Personnel
  • Physical Facilities
  • Safety
cytopathology inspection8
Cytopathology Inspection
  • Regardless of laboratory size, the inspector should plan to spend at least several hours inspecting cytopathology
cytopathology inspection9
Cytopathology Inspection
  • Will Require:
    • Observation of technical procedures
    • Review of QI program and indicators
    • On-site microscopic review
cytopathology inspector
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”
cytopathology inspection11
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)
specimen collection and receipt
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
cytology stains
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
  • 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 review
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

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 reports
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
retention guidelines
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

slide storage
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)
information physical requirements
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
personnel and workload
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
cytopathology quality improvement
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
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 rescreening
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)
cytopathology inspection26
Cytopathology Inspection

The Five-Year Lookback

  • Triggered by a new HGSIL or malignant diagnosis
  • A CLIA requirement
amended reports
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
cytologic histologic correlation
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
statistical analysis
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
1997 reporting rates in pap labs
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

laboratory safety
Laboratory Safety
  • Documented procedures for infectious / contaminated material disposal
  • Formaldehyde / xylene vapor concentrations
  • In compliance with Laboratory General Checklist
proposed checklist changes
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)
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 deficiencies36
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?
most frequent phase ii deficiencies37
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?
most frequent phase i deficiencies
Most Frequent Phase I Deficiencies

CYP.09000 Phase I

  • Is sufficient space provided for processing cytologic material?
most frequent phase i deficiencies39
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?
most frequent phase i deficiencies40
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?