Pathology Laboratory Policies and Procedures for Releasing Diagnostic Tissue for Cancer Research.

CONTEXT.­: The Surveillance, Epidemiology, and End Results (SEER) cancer registry program is currently evaluating the use of archival, diagnostic, formalin-fixed, paraffin-embedded (FFPE) tissue obtained through SEER cancer registries, functioning as honest brokers for deidentified tissue and associated data. To determine the feasibility of this potential program, laboratory policies for sharing tissue for research needed to be assessed. OBJECTIVE.­: To understand the willingness of pathology laboratories to share archival diagnostic tissue for cancer research and related policies. DESIGN.­: Seven SEER registries administered a 27-item questionnaire to pathology laboratories within their respective registry catchment areas. Only laboratories that processed diagnostic FFPE specimens and completed the questionnaire were included in the analysis. RESULTS.­: Of the 153 responding laboratories, 127 (83%) responded that they process FFPE specimens. Most (n = 88; 69%) were willing to share tissue specimens for research, which was not associated with the number of blocks processed per year by the laboratories. Most laboratories retained the specimens for at least 10 years. Institutional regulatory policies on sharing deidentified tissue varied considerably, ranging from requiring a full Institutional Review Board review to considering such use exempt from Institutional Review Board review, and 43% (55 of 127) of the laboratories did not know their terms for sharing tissue for research. CONCLUSIONS.­: This project indicated a general willingness of pathology laboratories to participate in research by sharing FFPE tissue. Given the variability of research policies across laboratories, it is critical for each SEER registry to work with laboratories in their catchment area to understand such policies and state legislation regulating tissue retention and guardianship.

Evaluating the Use of LAST 2-Tiered Nomenclature and Its Impact on Reporting Cervical Lesions in a Population-Based Cancer Registry.

BACKGROUND: Since 2012, the Lower Anogenital Squamous Terminology (LAST) Project recommended a 2-tiered nomenclature, low-grade and high-grade squamous intraepithelial lesion (LSIL and HSIL), to replace the 3-tiered cervical intraepithelial neoplasia (CIN) system for HPV-associated lesions. Prior to 2019, preinvasive cervical lesions classified as CIN3, severe dysplasia, carcinoma in situ (CIS), and adenocarcinoma in situ (AIS) were considered reportable to the Louisiana Tumor Registry for a CIN3 project funded by the Centers for Disease Control and Prevention (CDC); but lesions classified exclusively as high-grade/HSIL based on the 2-tiered system were not considered reportable. Due to the terminology changes, we wanted to know whether pre-2019 reportable criteria need to be modified to capture all reportable precancerous cervical cases diagnosed in 2019 forward. OBJECTIVES: To evaluate the utilization of LAST 2-tiered classification, low-grade and high-grade squamous intraepithelial lesion, and p16 immunohistochemistry (IHC) testing on cervical biopsy/surgical specimens, assess the search criteria needed to identify high-grade lesions for the CDC-funded CIN3 project, and assess the impact of underreporting cervical lesions caused by terminology changes. METHODS: An equal number of abnormal/precancerous and normal cervical findings from biopsy pathology reports received in 2015 were randomly selected by an artificial intelligence (AI) search engine developed by Artificial Intelligence in Medicine Inc (AIM) using pre2019 search criteria. Selected pathology reports were reflagged for the reportability by AIM audit software based on 2019 search criteria and manually reviewed for the use of reportable terms including CIN3, severe dysplasia, CIS, AIS, highgrade/HSIL terminology, and CIN2 or CIN2-3 with positive p16 IHC testing. Cohen's kappa statistic was used to assess the agreement between AIM auto-coding and manual review. Positive predictive values (PPV) and sensitivity tests were computed to evaluate the reportable terms. RESULTS: Six out of 9 surveyed laboratories used 2-tiered terminology on cervical biopsy pathology reports and 7 performed p16 IHC tests. Of 1,974 randomly selected reports from 5 laboratories, 987 were flagged as precancer by AI using pre-2019 search criteria. After adding the high-grade/HSIL term into pre-2019 search criteria, precancerous reports increased by 29%. After manual review, 41.6% of these cases were reportable precancerous cervical cases with a PPV of 0.65 (95% CI, 0.62-0.67) and 13.6% had p16 IHC performed. CONCLUSIONS: Both the 2-tiered and 3-tiered nomenclature are needed to ensure complete identification of all reportable high-grade cervical lesions.