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

cap.org v. 1

Gynecologic Consensus ConferenceWorking Group 2: Prospective and Retrospective ReviewJune 4, 2011

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

Background: Definitions• Prospective rescreen

oReview, 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

oReview of NILM+ Pap tests that have been signed out – an example is NILM slides from the preceding 5 years in patients with current HSIL+


• CLIA 88 – Sec 493.1274 (c)1oMandates at least 10% of cases

screened by a cytotechnologist be rescreened prior to sign-out

oMust be randomly selected and include cases at high risk


Background: Prospective Rescreen

• CLIA 88 – Sec 493.1274 (c)3oPatients 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


Background: Retrospective Rescreen

• CLIA 88 – Sec 493.1274 (c)4,5,6 and (d)oRecords of all rescreening results must be

documentedoThere must be an annual statistical

evaluation of the number of reviews of any negative cases reclassified as LSIL+

oThese reviews are compared as individuals against the laboratories’ overall statistics, and are one of the elements used to determine workload limits


Background: Results of Reviews

• 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


Background: CAP Checklist

• How are high risk cases selected for prospective rescreen?

Clinical information 95.4%Prior abnormal Pap (ASC → HSIL) 82.7 → 95.0%Prior abnormal Bx (CIN1 → CIN3) 80.5 → 85.1%Prior +hrHPV61.2%Provider/patient location 9.8%Age 7.4%


Survey Results: Prospective Rescreen

• Total Negative Cases Rescreened (n=509)

% Cases% Labs0 0.6%1-9 0.6%10-2067.4%21-30 15.7%31-50 7.5%> 50% 8.3%

** A minority of labs (<15%) limit their rescreen to the CLIA mandated 10%





• % High Risk in NILM Cases Rescreened

% Cases% Labs 0 2.6%1-1051.7%11-20 18.0%>20 27.8%

• Majority of labs (72%) include <20% high risk cases in their prospective rescreen





• What percentage of rescreens should be high risk cases (n=47)?

% HR Cases %Respondents1-10% 34%11-20% 13%21-30% 6%31-40% 2%41-50% 13%> 50% 30%



Survey Results: Prospective Rescreen• How are patients removed from the high

risk category? (n=468)oNever removed 43.4%oNegative Pap test diagnoses 36.5%oSpecified 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)


• Does the laboratory track the total number of prospective rescreen cases for each individual cytotechnologist? (Required by CLIA and CAP LAP) (n=512)Yes 84.8%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”



• Does the laboratory track the number of lesions identified by prospective rescreen? (Required by CLIA and CAP LAP) (n=513)Yes 78.6%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”



Survey Results: Prospective Rescreen• Upgrade rates from NILM to ECA

that are actively monitored (n=425)oASCUS/ASCH

−Labs: 53.4 – 54.8%−CT’s: 73.9 – 77.9%

oLSIL, HSIL, AGC, SCC, ADC−Labs: 57.6 – 69.2%−CT’s: 81.2 – 95.3%


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)


Survey Results: Prospective Rescreen - Lab Volume Analysis

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


Statement: Prospective Rescreen4. 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 cytologyo Recent CIN 2+ biopsyo Recent hrHPV positivityo No screening in past 5 yearso Current unsatisfactory Pap testo Current clinical designation as high risko Other parameters at discretion of

laboratory© 2011 College of American Pathologists. All rights reserved. 20


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


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. Yes 98.61%b. No 1.39%

Question


22.Should all readily identifiable high risk cases be included in the prospective rescreen?a. Yes 89.39%b. No 10.61%

Question


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


24. Should patients be removed from the high risk category?a. No

13.11%b. Yes, after consecutive negative

Paps over a specified time interval 19.67%

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 status

21.31%

Question


25. Should NILM Paps from patients with concurrent positive hrHPV results be rescreened prior to sign-out?a. Yes 84.48%b. No 15.52%

Question


• How many years back are previous negative Paps chosen for retrospective rescreen based on a current HSIL+ Pap?

1-4 years 0.6%5 years 96.2%All available years 2.5%


Survey Results: Retrospective Rescreen

• Which diagnostic categories other than HSIL+ or AIS+ prompt a retrospective review of NILM Paps?

None 71.4%AGC 15.0%LSIL 8.6%ASC-US 6.8%ASC-H 2.3%




• 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%



• 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%


• Does the laboratory monitor how often a previous Pap test is upgraded based on retrospective review? (Required by CLIA and CAP LAP) (n=518)

Yes 76.6%No 23.4%



• Monitoring of upgrade rates (375 labs)oFor NILM to HSIL+

Laboratory 72.0%Cytotechnologist 82.7%Pathologist 37.3%

oFor ASC-US to HSIL+Laboratory 27.5%Cytotechnologist 35.7%Pathologist 18.1%



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)


Survey Results Retrospective Rescreen: Lab Volume Analysis


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



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


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. Yes 19.72%

b. No 78.87%c. Other 1.41

Question


27.To maximize the power of this measure, should retrospective review based on surgical biopsy results, when possible, be performed?a. Yes 87.14%b. No 12.86%

Question


Question

© 2011 College of American Pathologists. All rights reserved.

28.Should pathologists be included when monitoring upgrade rates in a retrospective review?a. Yes 86.15%b. No 13.85%

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Statement: Prospective and Retrospective Rescreen1. Both CTs and pathologists should get

feedback on upgrade/review diagnoses2. 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


29.For both prospective and retrospective reviews, should upgraded diagnoses from NILM to ASC-US/ASC-H be tracked?a. Yes 63.77%b. No 36.23%

Question


30. Is it helpful to categorize review diagnoses into major and minor changes to stratify significance?a. Yes 72.73%b. No 25.76%c. Other 1.52%

Question

© 2011 College of American Pathologists. All rights reserved. 41© 2011 College of American Pathologists. All rights reserved.

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