4. Monitoring of PAP test with Cervical Biopsy Correlations

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1 Page 1 of 6 1. For cases of an HSIL Pap test with a discordant biopsy report where only the biopsy report is available, what action do you take? (check all that apply) Paper correlation without review of any slides 6 19% Correlate the Pap and biopsy results but only review the Pap slide 19 59% Attempt to obtain the biopsy slides from another laboratory 8 25% Hold the correlation until the slides are available and then review all slides and correlate 8 25% Other, please specify 5 16% Not sure It depends, we always do the paper review, but we pull slides as the pathologist determines it should be done. N/A we actually would do nothing None, we do not have the needed materials to correlate 2. In your opinion, is it useful to track the percent of HSIL or greater Pap tests for which you receive a follow-up biopsy in your laboratory? Yes 24 75% No 8 25% Unsure 0 0% % 3. For what percent of HSIL or greater Pap tests do you receive a follow-up biopsy or biopsy result? 0% 0 0% 1-25% 1 3% 26-50% 6 20% 51-75% 5 17% 76-99% 18 60% 100% 0 0% %

2 4. If you obtain additional levels of cervical biopsies during correlation, what are the usual reasons? (check all that apply) To correct orientation problems 7 24% To expose a biopsy edge or potential lesion deeper in the block 19 66% Cellular changes suggest dysplasia but are not conclusive 14 48% Low grade dysplasia, want to exclude higher grade dysplasia 9 31% Policy requirement on all discrepancies 2 7% Pap findings are very convincing for the Pap diagnosis 9 31% Ancillary stains 9 31% Not applicable additional levels not obtained 7 24% 5. Would your laboratory be able to implement a policy requiring the following... Top number is the count of respondents selecting the option. Bottom % is percent of the total respondents selecting the option. Recuts/levels of biopsy slides when they do not initially correlate with the previous cytology Second pathologist review of biopsy slides when they do not initially correlate with the previous cytology diagnosis Second pathologist review of the previous cytology slides when the biopsy does not correlate with the previous cytology diagnosis Correlation between the incident Pap and the biopsy Yes No Not Applicable % 18% 0% % 21% 0% % 21% 0% % 7% 0% 6. If you answered "no" to any of the above, please explain why. Sometimes we have only one pathologist so it would be impossible to have a policy requiring a second pathologist. I answered yes to the above, because we would be able to implement, but for most w would not want to -- to much work and I don't believe most would be worthwhile. Only 1 pathologist on site. The lab would have the ability to institute the above, but do not believe the pathologists would institute it Recuts would be expensive Time contraints We already have such a policy in place. time constraints, different faculty, way system set up is signout by different sections and faculty. usually done retrospectively or by clinician request or by colposcopy conference. amendums are made when disagreements found, reviewed with original pathologist (pap or biopsy) as necessary.

3 Page 2 of 6 7. When performing RETROSPECTIVE cytology-histology correlation for quality assurance purposes, how often are cervical biopsy SLIDES unavailable to you for comparison with Pap tests? Always 0 0% Usually 3 11% Sometimes 12 44% Rarely 9 33% Never 3 11% 8. Which of the following scenarios is most descriptive of your cytologic- histologic correlation component of quality assurance (QA) for your laboratory? Cytologic-histologic correlation is initiated because of an abnormal Pap test 5 19% Cytologic-histologic correlation is initiated because of a cervical biopsy 9 33% Cytologic-histologic correlation is bidirectional (ie, cytologic histologic correlation is initiated by either Pap test or cervical biopsy and are integrated) 13 48% We do not perform cytologic-histologic correlation 0 0% 9. How are histology-cytology correlations performed in your laboratory? (check all that apply) By reviewing available glass slides for both biopsy and cytology for ALL cases, concordant and discordant 5 19% By reviewing available glass slides for both the biopsy and cytology in discordant cases 20 77% By annotating the concordant and discordant cases without any cytology or biopsy slide review 0 0% By annotating the concordance statistics, but reviewing only cytology slides of discordant cases 4 15% By annotating the concordance statistics, but reviewing only the biopsy slides of discordant cases 0 0% Other, please specify 2 8% Always annotating concorance and disconcordant cases, glass slides pulled at the discretion of the pathologist. Often the pathologist will request Pap slides to be pulled at the time the corresponding tissue is being interpreted. correlations requested by clinician to see if cells are explained by biopsy or not (such as agc, lsil, hsil cannot be excluded), etc

4 10. For quality assurance purposes, when is the optimal time to perform cytologic-histologic correlation? Prospectively, during sign-out 16 59% Retrospective 8 30% Other, please specify 3 11% Both- they serve different purposes ideally prospective but not possible in our current system; best for patient care purposes Both 11. Should cytology-histology correlation between Pap tests and cervical biopsies be standardized among laboratories? Yes 14 50% No 5 18% Unsure 9 32% % 12. If yes, at what levels should they be standardized? (check all that apply) Time frame limit from abnormal Pap test to cervical biopsy 9 50% Acceptable discrepancy rate between Pap test and biopsy results 11 61% Type of statistics for all laboratories to maintain 13 72% Frequency of the cytology-histology monitor, ie, monthly, quarterly, annual or combination of time periods (monthly and annually) 7 39% Acceptable actions for discrepancies and statistical outcomes 12 67% Other, please specify 1 6% Definition of discordance 13. In your opinion, should pathologists provide recommendations in the biopsy report when a cytology diagnosis was "positive" and the biopsy diagnosis "negative"? Yes 13 48% No 6 22% Unsure 8 30% 14. Would you support the development of standard comments for follow-up recommendations that would accompany biopsy diagnoses when a cytology diagnoses was "positive" and the biopsy report and the biopsy diagnosis "negative"? Yes 16 62% No 1 4% Unsure 9 35% %

5 Page 3 of What are the barriers to performing correlation statistical metrics in your laboratory? (check all that apply) No dedicated QA personnel 11 44% Don t understand how to perform statistical analysis 4 16% Don t do anything with the data tabulated 5 20% Difficult to obtain necessary data from LIS or other LIS limitation(s) 12 48% Too complicated 6 24% Uncertain how to improve the metric 7 28% Numbers of correlation are too low 3 12% Too many individuals doing correlations 3 12% No good system to compile data and/or analyze data 8 32% Unable to access all biopsy slides 8 32% No barriers, can perform correlation statistical metrics 5 20% Other, please specify 2 8% we do it- much of it is manual- dedicated individuals the above table does not make any sense for correlations

6 Page 4 of In your opinion, when a Pap test is negative/ NILM and the biopsy is HSIL, should the review of the Pap test be reported in the surgical pathology report for that biopsy? Yes 14 52% No 11 41% Unsure 2 7% 17. If yes, what should be reported? (check all that apply) Only a statement that there is a discrepancy between the Pap test and the biopsy 2 12% Only the result of the review of the Pap test 0 0% Only a statement that the Pap test was reviewed, but not the result of the review 6 38% The results of the Pap test review and who reviewed it 6 38% A statement summarizing any additional measures taken on the biopsy to resolve the discrepancy, eg, additional levels, re-orientation in the block, second pathologist review 8 50% Other, please specify 2 12% A statement indicating that there is an inherent false negative rate in Pap tests that can be caused by a variety of factors, not necessarily a lab discrepancy

7 Page 5 of Should laboratories be mandated to rescreen NILM Pap tests when prompted by an HSIL or greater CERVICAL BIOPSY in the same manner required by CLIA 88 in regards to the 5 year retrospective rescreening of Pap tests for a current HSIL Pap result? Yes 17 63% No 7 26% Unsure 3 11% 19. If yes, what should the laboratory do with the results of retrospective rescreening of NILM Pap tests prompted by an HSIL or greater cervical biopsy? Issue an amended cytology report if rescreen yields abnormal result 3 13% Call clinician if rescreen yields abnormal results 0 0% Document the finding in QA report as part of QM plan 5 22% Review the misinterpreted Pap test with the original cytotechnologist(s) 3 13% Review of the misinterpreted Pap test(s) and cervical biopsies by laboratory staff for in-house education 11 48% Other, please specify 1 4% If an error occurred review slide with CT and/or pathologist. If no error document review in QA report %

8 Page 6 of Does your LIS include applications for the collection of correlation data? Yes, the correlation data is collected automatically without any manual data entry 1 4% Yes, the correlation data is collected by a report generator but some of the correlation is done manually 14 52% No, the correlation data must be manually collected and entered in the LIS 4 15% No, the LIS does not provide collection of or accept manual entry of correlation data 7 26% Unsure 1 4% 21. Does your LIS include applications for the reporting of correlation data? Yes 5 19% No 16 59% Unsure 6 22% 22. Does your LIS provide patient tracking functions? Yes 7 26% No, but patient tracking is performed manually 13 48% No, and there is no follow-up tracking 1 4% Unsure 6 22% 23. If yes, which patient tracking functions does your LIS provide? Tracks repeat Paps and/or biopsies on each patient. Letters asking for follow-up of patients not having any type of Pap repeat or biopsy sent to this lab. Pap tests and cervical biopsies not in same LIS system. Therefore all abnormal Paps tracked in one LIS and queried in the other LIS system manually. traks hgsil and prints out follow up letters. must manually check for follow up information. Not well connected. Is very cumbersome Searches Our LIS claims to have all of these functions, but NONE of them work and nothing has been done to change this for the last 19 years. Knowing this we still went with the same vendor 2 years ago and NONE of it still works!

9 24. Does your LIS include an automated application that allows for the inquiry of the patient s caregiver for patient status as well as discontinuation of follow up activity? (Patient status includes biopsy/treatment performed elsewhere, patient transferred to another caregiver, and patient lost to follow up.) Yes 4 15% No 16 59% Unsure 7 26%