A National Survey of Quality Assurance Practices in Gynecologic Cytology: Preliminary Results from a Pilot Study of Ten Labs

Transcription

1 A National Survey of Quality Assurance Practices in Gynecologic Cytology: Preliminary Results from a Pilot Study of Ten Labs Joseph Tworek, MD, Bruce Jones, MD, Michael Henry, MD, Rhona Souers, MS, Barbara Blond, MBA I have no relationship that represents a possible conflict of interest with respect to the content of this presentation.

2 CAP-CDC GRANT Investigate all aspects of QA practices Anonymous survey of all laboratories Post results on web for discussion Convene consensus conference Publish QA consensus guidelines

3 QUALITY METRCIS 1. Diagnostic rates 2. Re-screen of NILM Pap tests 3. Look backs following HSIL Pap 4. Pap - biopsy correlations 5. Pathologist - cytotech agreement 6. Proficiency testing 7. HPV rates 8. Turn around time

4 QUERIES PER METRIC 1. What is measured 2. Frequency 3. Use of benchmarks 4. Variance prompts action 5. Action is taken 6. What metrics are most useful

5 PILOT STUDY 10 Laboratories Pap test volumes 1, ,391 Median 19,855 9 labs ThinPrep 1 lab SurePath

6 DIAGNOSTIC RATES (8) ASC-H (7) NILM (8) AGC (7) UNSAT (8) LSIL (5) Malignancy (8) ASC-US (4) SCC (8) ASC-US:SIL (1) NILM:SIL (7) HSIL (1) None

7 ANALYSIS OF PERFORMANCE DIAGNOSTIC RATES Check for rate of change (5) Action limits based on literature (5) Lab defined action limits (2) Other (1)

8 RE-SCREEN OF NILM PAPS Percentage 10-99%, median 14% Most common enrich a random sample with high-risk patients Previous abnormal Pap (10) Previous abnormal biopsy (7) Clinical information (6) Previous positive HR-HPV (5)

9 TRACK LESIONS FOUND BY RE-SCREEN OF NILM 5 of 8 responders monitor lesions identified by re-screen (median) ASC_US 24.5 LSIL 1.5 HSIL 1.0 ASC-H 1.0

10 RE-SCREEN PERFORMANCE DATA ANALYZED BY Lab defined action limits (3) Check for rate change (2) Action limits based on literature (1) Other (2)

11 LOOK BACKS OF NILM PAP AFTER HSIL/AIS 70% monitor upgrades Diagnosis Median # Responders ASC_US LSIL ASC_H HSIL 0 3 AGC 0 3

12 LOOK BACK PROMPTED BY BIOPSY WITH DYSPLASIA 4 labs performed (3) CIN-1 (4) CIN-2

13 BENCHMARKING OF LOOK BACK DATA Lab defined action limits (5) Check for rate change (2) Action limits based on literature (1) Compare with SDs (1) Other (1)

14 PROFICIENCY TESTING All labs have a policy to monitor pass/fail rates 7 labs monitor both cytotechnologists and pathologists pass/fail rates 1 lab monitors incorrect responses from successful tests

15 ACTION FOR FIRST TIME FAILURE Action Cytotech Pathologist None 20% 20% Reenroll 80% 100% No screening 10% Counsel 10% Increase ReScr 10%

16 FIRST FAILURE OF PROFECIENCY TEST Over the past four years 3 labs a pathologist or cytotechnologist had not passed 1 cytotechnologist failed for classifying HSIL as NILM 1 pathologist s sign out privileges were restricted

17 PAP-BIOPSY CORRELATION Discrepancy with biopsy (6) Investigate at time of sign-out (5) Investigate at retrospective QC (1) No policy

18 DISCREPANCY RESOLUTION PAP TEST AND BIOPSY Written policy specifying steps (2) Additional levels (2) Second pathologist review biopsy (2) Second pathologist review Pap

19 DISCREPANCY ADDRESSED IN BIOPSY REPORT (6) No policy (5) Only at discretion of pathologist (2) Written policy Pap HSIL and biopsy negative Biopsy >= CIN 1 and Pap NILM

20 ANALYSIS OF CORRELATION DATA (5) % positive Pap tests correlate (2) Other Lab defined levels of correlation % Negative Pap tests correlate (1) Screening sensitivity (1) Interpretive sensitivity

21 CYTOTECHNOLOGIST PATHOLOGIST AGREEMENT 3 of 9 follow upgrades TO HSIL FROM NILM (3) ASC-US (3) LSIL (2) TO ASC- H FROM NILM (3) TO LSIL FROM NILM (3)

22 CYTOTECHNOLOGIST PATHOLOGIST AGREEMENT (4/8) Monitor downgrades TO NILM FROM HSIL (4) LSIL (4) ASC-H (4) ASC (3)

23 RESOLUTION OF 2 GRADE DISCREPANCIES (6) Pap shown to second pathologist (3) Pap shown to second cytotechnologist (4) Review with original cytotechnologist (5) Pathologist diagnosis stands Written policy? 5 No 4 Yes

24 RESOLUTION OF 1 GRADE DISCREPANCIES (8) Pathologist diagnosis stands (2) Pap shown to second pathologist (2) Pap shown to second cytotechnologist (2) Review with original cytotechnologist (2) By HPV testing Written policy? 5 No 3 Yes

25 MONITORING HPV RATES (4) None (4) Total positive HPV-HR rate (3) NILM (3) ASC-US (2) Positive HPV-HR rate stratified by age (2) ASC-H (1) LSIL, HSIL, AGC

26 BENCHMARKING HPV RATES Check for rate change (3) Lab defined action limits (2) Compare with lab s historical mean (1) Other (1) Action limits based on literature (0)

27 Range TURN AROUND TIME 2-14 days, median 4 days TAT clock starts (6) Date/time accessioned (3) Date/time collected (1) Date/time received for processing TAT clock stops (9) Date/time report finalized (1) Date/time report received by clinician

28 TAT MONITORING (6) Percentile distribution occurring within certain TAT (3) Median TAT (2) Mean TAT (1) % deviating from expected TAT (3) Other

29 ACTIONS TO IMPROVE LABORATORY PERFORMANCE (7) Attempt to find root cause (5) Conduct in-lab re-education (3) Increase real time re-screen of NILM (3) Retrospective re-screening of previous NILM cases (2) Decrease slide work load (1) Outside re-education

30 PAST ACTION In past 2 years 3 labs took action (2) Diagnostic rates (2) Routine re-screen of NILM cases (2) Re-screen results of NILM Pap tests from CIN 2-3 biopsy

31 MOST USEFUL MONITORS Pap test biopsy correlations Look backs after HSIL Review of NILM pap after >= CIN-2 Cytotech-pathologist agreement

32 WE NEED YOUR HELP Now- fill out the survey and be counted Barbara Blond Winter Join the discussion site at June 4, Come to the consensus conference, Chicago