1. cap.org v. 1 Gynecologic Consensus Conference Working Group 2: Prospective and Retrospective Review June 4, 2011

2. Work Group 2 Jennifer Brainard MD, FCAP, Chair Michael Henry MD, FCAP, Senior Author George Birdsong MD, FCAP Tarik Elsheikh MD, FCAP Kalyani Naik MS, SCT(ASCP) Margaret Neal MD, FCAP David Andrew Hartley CT(ASCP) CM, CAP Cytotechnologist Specialist © 2011 College of American Pathologists. All rights reserved. 2

3. Background: Definitions Prospective rescreen o Review, prior to sign-out, by a second cytotechnologist of a subset of Pap tests interpreted as NILM in the first cytotechnologist review o ≠ Prescreen Retrospective rescreen o Review of NILM+ Pap tests that have been signed out – an example is NILM slides from the preceding 5 years in patients with current HSIL+ © 2011 College of American Pathologists. All rights reserved. 3

4. CLIA 88 – Sec 493.1274 (c)1 o Mandates at least 10% of cases screened by a cytotechnologist be rescreened prior to sign-out o Must be randomly selected and include cases at high risk © 2011 College of American Pathologists. All rights reserved. 4 Background: Prospective Rescreen

5. CLIA 88 – Sec 493.1274 (c)3 o Patients with current HSIL+ must have their negative cases, if available, from the prior 5 years reviewed o If significant discrepancies are found, which affect current patient care, an amended report must be issued © 2011 College of American Pathologists. All rights reserved. 5 Background: Retrospective Rescreen

6. CLIA 88 – Sec 493.1274 (c)4,5,6 and (d) o Records of all rescreening results must be documented o There must be an annual statistical evaluation of the number of reviews of any negative cases reclassified as LSIL+ o These reviews are compared as individuals against the laboratories’ overall statistics, and are one of the elements used to determine workload limits © 2011 College of American Pathologists. All rights reserved. 6 Background: Results of Reviews

7. CYP.07478 : 10% Rescreen – same as CLIA and clarifies that slides screened by MD certified in AP and qualified as a technical director do not need to be rescreened Otherwise, essentially reiterates CLIA regulations © 2011 College of American Pathologists. All rights reserved. 7 Background: CAP Checklist

8. How are high risk cases selected for prospective rescreen? Clinical information95.4% Prior abnormal Pap (ASC → HSIL)82.7 → 95.0% Prior abnormal Bx (CIN1 → CIN3)80.5 → 85.1% Prior +hrHPV61.2% Provider/patient location9.8% Age7.4% © 2011 College of American Pathologists. All rights reserved. 8 Survey Results: Prospective Rescreen

9. Total Negative Cases Rescreened (n=509) % Cases% Labs 0 0.6% 1-90.6% 10-2067.4% 21-3015.7% 31-50 7.5% > 50% 8.3% ** A minority of labs (<15%) limit their rescreen to the CLIA mandated 10% © 2011 College of American Pathologists. All rights reserved. 9 Survey Results: Prospective Rescreen

10. © 2011 College of American Pathologists. All rights reserved. 10

11. % High Risk in NILM Cases Rescreened % Cases% Labs 02.6% 1-1051.7% 11-2018.0% >2027.8% Majority of labs (72%) include <20% high risk cases in their prospective rescreen © 2011 College of American Pathologists. All rights reserved. 11 Survey Results: Prospective Rescreen

12. © 2011 College of American Pathologists. All rights reserved. 12

13. What percentage of rescreens should be high risk cases (n=47)? % HR Cases %Respondents 1-10%34% 11-20%13% 21-30%6% 31-40%2% 41-50%13% > 50%30% Survey Results: Prospective Rescreen © 2011 College of American Pathologists. All rights reserved. 13

14. Survey Results: Prospective Rescreen How are patients removed from the high risk category? (n=468) o Never removed 43.4% o Negative Pap test diagnoses 36.5% o Specified time interval 29.7% − 5 years 52.1% − 3 years 20.8% Majority of respondents (71%) favor removal of patients from “high risk” category (n=45) © 2011 College of American Pathologists. All rights reserved. 14

15. Does the laboratory track the total number of prospective rescreen cases for each individual cytotechnologist? (Required by CLIA and CAP LAP) (n=512) Yes84.8% No 15.2% If No, why not? (Results from online questions) “Why would I need that information?” “No easy way to do this” “Small lab. Single cytotechnologist” “Smears read off site” © 2011 College of American Pathologists. All rights reserved. 15 Survey Results: Prospective Rescreen

16. Does the laboratory track the number of lesions identified by prospective rescreen? (Required by CLIA and CAP LAP) (n=513) Yes78.6% No 21.4% If No, why not? (Results from online questions) “Never occurred to us to do this. Few lesions are ever identified” “What do you mean by “lesions”? We track the number of false negatives” © 2011 College of American Pathologists. All rights reserved. 16 Survey Results: Prospective Rescreen

17. Upgrade rates from NILM to ECA that are actively monitored (n=425) o ASCUS/ASCH − Labs: 53.4 – 54.8% − CT’s: 73.9 – 77.9% o LSIL, HSIL, AGC, SCC, ADC − Labs: 57.6 – 69.2% − CT’s: 81.2 – 95.3% © 2011 College of American Pathologists. All rights reserved. 17

18. 1.Smaller labs are more likely to only use a random sample for selection of cases for rescreen (P=0.001) 2.Larger labs are more likely to use prior abnormal cytology and biopsy results to identify high risk patients (P=0.001) 3.Larger labs are more likely to track the number of cases rescreened (P=0.001) 4.Larger labs are more likely to track the number of lesions identified (P=0.001) © 2011 College of American Pathologists. All rights reserved. 18 Survey Results: Prospective Rescreen - Lab Volume Analysis

19. Justification: Survey, Literature and Expert Consensus 1.10% rescreen by itself, especially without the addition of HR cases, is a very poor QA measure. Currently, the majority of labs (>85%) rescreen more than the CLIA mandate. 2.Maximizing the number of high risk cases increases the power of this QA measure. 3.The best way to maximize HR cases is to use multiple measures to identify them and to remove patients who no longer meet HR criteria. Statement: Prospective Rescreen © 2011 College of American Pathologists. All rights reserved. 19

20. Statement: Prospective Rescreen 4.Readily identifiable high risk patients: data should be extracted from the LIS or paper requisition in a timely manner prior to sign-out, allowing identification of patients for prospective rescreening. Suggested factors may include: o Prior high grade cytology o Recent CIN 2+ biopsy o Recent hrHPV positivity o No screening in past 5 years o Current unsatisfactory Pap test o Current clinical designation as high risk o Other parameters at discretion of laboratory © 2011 College of American Pathologists. All rights reserved. 20

21. Justification: Survey, Literature and Expert Consensus 5.If the information is available prior to sign out, positive hrHPV NILM cases from a HPV DNA Pap test should be prospectively rescreened. 6.Most labs do not have enough HR cases in their prospective rescreen population. Labs should include all readily identifiable HR cases in addition to randomly selected cases. 7.Labs, especially small labs, must be educated on the requirements for tracking the results of prospective rescreening. Statement: Prospective Rescreen © 2011 College of American Pathologists. All rights reserved. 21

22. 21.Laboratories should make an effort to maximize the number of high risk cases in their prospective rescreens and multiple measures should be used to identify these patients. a.Yes98.61% b.No1.39% Question © 2011 College of American Pathologists. All rights reserved. 22

23. 22.Should all readily identifiable high risk cases be included in the prospective rescreen? a.Yes89.39% b.No10.61% Question © 2011 College of American Pathologists. All rights reserved. 23

24. 23. If the number of high risk cases is maximized, what is an adequate minimum percentage of cases to rescreen? a.10%42.86% b.15%0% c.20 – 30%35.71% d.31 – 40%7.14% e.>40%14.29% Question © 2011 College of American Pathologists. All rights reserved. 24

25. 24. Should patients be removed from the high risk category? a.No13.11% b.Yes, after consecutive negative Paps over a specified time interval19.67% c.Yes, after consecutive negative Paps and negative hrHPV tests over a specified time interval44.26% d.Yes, 3 years from last identified criterion for high risk status21.31% Question © 2011 College of American Pathologists. All rights reserved. 25

26. 25. Should NILM Paps from patients with concurrent positive hrHPV results be rescreened prior to sign-out? a.Yes84.48% b.No15.52% Question © 2011 College of American Pathologists. All rights reserved. 26

27. How many years back are previous negative Paps chosen for retrospective rescreen based on a current HSIL+ Pap? 1-4 years0.6% 5 years96.2% All available years2.5% © 2011 College of American Pathologists. All rights reserved. 27 Survey Results: Retrospective Rescreen

28. Which diagnostic categories other than HSIL+ or AIS+ prompt a retrospective review of NILM Paps? None71.4% AGC15.0% LSIL8.6% ASC-US6.8% ASC-H2.3% © 2011 College of American Pathologists. All rights reserved. 28 Survey Results: Retrospective Rescreen

29. Which Pap tests are routinely reviewed for retrospective rescreen? o All available Pap tests – 32.6% o NILM only – 34.3% o NILM, UNSAT – 30.4% o LSIL – 1.2% o NILM, UNSAT, LSIL – 1.2% o NILM, LSIL – 0.4% © 2011 College of American Pathologists. All rights reserved. 29

30. Survey Results: Retrospective Rescreen Which review diagnoses should be monitored as part of this review? o ASC-US – 56% o ASC-H – 91% o LSIL – 91% o HSIL – 98% o AGC – 80% o AIS – 93% o Carcinoma/other malignancy – 96% © 2011 College of American Pathologists. All rights reserved. 30

31. Does the laboratory monitor how often a previous Pap test is upgraded based on retrospective review? (Required by CLIA and CAP LAP) (n=518) Yes76.6% No 23.4% © 2011 College of American Pathologists. All rights reserved. 31 Survey Results: Retrospective Rescreen

32. Monitoring of upgrade rates (375 labs) o For NILM to HSIL+ Laboratory72.0% Cytotechnologist82.7% Pathologist37.3% o For ASC-US to HSIL+ Laboratory27.5% Cytotechnologist35.7% Pathologist18.1% © 2011 College of American Pathologists. All rights reserved. 32 Survey Results: Retrospective Rescreen

33. 1.Very Small labs are more likely to retain NILM slides for 10 or more years (P=0.004) 2.Smaller labs are more likely to use a less significant diagnosis (ASC-LSIL) to initiate a retrospective review (P=0.001 to 0.026) 3.Smaller labs are more likely to review all available Paps (P=0.001) 4.Both smaller and larger labs are likely to include UNSAT Paps in their retrospective review (P=0.098) 5.Larger labs are more likely to track how often tests are upgraded (P=0.03) © 2011 College of American Pathologists. All rights reserved. 33 Survey Results Retrospective Rescreen: Lab Volume Analysis

34. Justification: Survey, Literature and Expert Consensus 1.Most labs use this monitor 2.The number of upgraded cases is low (similar to prospective review) 3.Review of UNSAT Paps in addition to NILM Paps should be included in retrospective review 4.Retrospective review based on surgical biopsy results when possible is suggested Statement: Retrospective Rescreen © 2011 College of American Pathologists. All rights reserved. 34

35. Justification: Survey, Literature and Expert Consensus 5.The monitoring of upgrade rates are very low for pathologists (37.3% for NILM to HSIL+) 6.Labs, especially small labs, must be educated on the requirements for tracking the results of retrospective rescreening Statement: Retrospective Rescreen © 2011 College of American Pathologists. All rights reserved. 35

36. 26.Because the number of upgraded cases in retrospective review is low, should all diagnoses less than the initiating diagnosis be reviewed (for example, an LSIL with a follow up CIN 2+ biopsy)? a.Yes19.72% b.No78.87% c.Other1.41 Question © 2011 College of American Pathologists. All rights reserved. 36

37. 27.To maximize the power of this measure, should retrospective review based on surgical biopsy results, when possible, be performed? a.Yes87.14% b.No12.86% Question © 2011 College of American Pathologists. All rights reserved. 37

38. Question © 2011 College of American Pathologists. All rights reserved. 28.Should pathologists be included when monitoring upgrade rates in a retrospective review? a.Yes86.15% b.No13.85% 38

39. Statement: Prospective and Retrospective Rescreen 1.Both CTs and pathologists should get feedback on upgrade/review diagnoses 2.It is important to monitor ASCUS/ASCH upgrades from NILM for CTs, pathologists and the laboratory 3.It is helpful to categorize review diagnoses into major and minor changes to stratify significance 4.A major barrier to implementation of enhanced/additional quality measures is limited LIS functionality © 2011 College of American Pathologists. All rights reserved. 39

40. 29.For both prospective and retrospective reviews, should upgraded diagnoses from NILM to ASC-US/ASC-H be tracked? a.Yes63.77% b.No36.23% Question © 2011 College of American Pathologists. All rights reserved. 40

41. 30.Is it helpful to categorize review diagnoses into major and minor changes to stratify significance? a.Yes72.73% b.No25.76% c.Other1.52% Question © 2011 College of American Pathologists. All rights reserved. 41 © 2011 College of American Pathologists. All rights reserved.