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According to the Clinical Laboratory Improvement Amendments 1988 regulations, 5-year retrospective review (5YRR) of normal Papanicolaou tests in patients with a newly diagnosed high grade squamous intraepithelial lesion or above (HSIL+) is mandatory. Since this mandate has been in place, a multitude of changes have taken place in the screening and management guidelines of cervical cancer. The aim of this study is to assess the role of this mandate in our laboratory and to investigate the lessons learned. The cytopathology electronic database and institutional quality assurance records at Loyola University Medical Center were searched from January 2009 to December 2019 to identify all Papanicolaou tests diagnosed as new "HSIL and above" (HSIL+). Major discrepancy (2+) was defined as initial negative diagnosis changed to HSIL+. A total of 153,083 Papanicolaou tests were performed during this period; out of these, 1452 (0.94%) were diagnosed as HSIL+. A total of 695 HSIL+ Papanicolaou tests had a negative prior Papanicolaou and in 615 of 695 there was agreement with the initial negative diagnosis. In 61 Papanicolaou tests, the initial diagnosis was changed from negative and they were reclassified on review as 3 HSIL, 9 ASC-H, 7 AGC, and 42 ASCUS or LSIL. Major discrepancy rate was calculated as 3 of 695 (0.43%). None required an amended report. It is important to revisit the 5YRR as a method of implementing the quality indicators in gynecologic cytology so that the process retains its value without overburdening cytology laboratories and personnel. • Five year retrospective review (5YRR) is an integral part of gynecologic cytology quality assurance practices as mandated by CLIA and this requirement has remained largely unchanged for the last 3 decades. • Since this mandate has been in place, a multitude of changes have taken place in the screening and management guidelines of cervical cancer, including the latest 2019 ASCCP guidelines, availability of HPV vaccination, the utilization of HPV cotesting, and primary HPV testing. • The aim of this study is to assess the role of this mandate in our laboratory and to investigate the lessons learned. • We retrospectively searched for cases diagnosed as HSIL and above (HSIL+). The prior negative Papanicolaou tests within previous 5 years for the same patients were re-reviewed where available. • Major discrepancy was defined as a prior negative Papanicolaou test that was reclassified HSIL+ on review. • Out of 153,083 Papanicolaou tests 1452 were diagnosed as HSIL+. Out of these, 695 HSIL+ Papanicolaou tests had a negative prior Papanicolaou result. • On review, 61 Papanicolaou tests originally reported as negative were reclassified as follows: 3 HSIL, 9 ASC-H, 7 AGC, and 42 ASCUS or LSIL. Major discrepancy rate was calculated as 3 of 695 (0.43%). • None required an amended report. • The time, money, and the resources that are needed to perform these reviews could be significantly decreased without sacrificing the benefits of the quality assurance practices. • With the advent of newer testing modalities, clinical guidelines, and management strategies in cervical cancer screening, we believe it is time now to revisit the 5YRR rule. [ABSTRACT FROM AUTHOR]

BACKGROUND. The Bethesda 2001 (B2001) classification system raised the thresholdfor reporting atypical squamous cells. The category of Atypical SquamousCells of Undetermined Significance (ASCUS)-favor reactive has been eliminatedwith a recommendation for cytologists to judiciously downgrade those Papanicolaou(Pap) tests that would formerly have been in this category to Negative forIntraepithelial Lesion or Malignancy (NILM). The effect of this change on sensitivityand specificity of the Pap test is not yet known.METHODS. A total of 535 consecutive SurePath Pap tests interpreted as ASCUSduring a period from March 1 through December 31, 2001, with follow-up polymerasechain reaction(PCR)-based human papilloma virus (HPV) testing, wereindependently reviewed by 3 pathologists and 1 cytotechnologist who reinterpretedthese tests according to Bethesda 2001 criteria. Follow-up HPV and biopsyresults were compiled for a 5-year period.RESULTS. By consensus of the 4 observers, 169 (32%) of the ASCUS cases weredowngraded to NILM. These cases showed a lower rate of underlying high-riskHPV infection (11% vs 30%) and cervical intraepithelial neoplasia of grades 2 to 3(CIN 2/3) (5% vs 10%) on follow-up than those tests that were reinterpreted asASCUS or higher. Nine women with follow-up CIN 2/3 would have had the Paptest interpreted as NILM instead of ASCUS under Bethesda 2001 (20% of all CIN2/3 found). Individual reviewers downgraded 29% to 42% Pap tests to NILMincluding those of 5 to 10 women with follow-up CIN 2/3.CONCLUSIONS. The ASCUS threshold established by B2001 prevents a sizeablesubset of women from having follow-up for ASC. However, as a consequence, afew women with CIN 2/3 are downgraded to NILM. The cost savings thusachieved must be weighed against the lost opportunities to detect CIN 2/3. [ABSTRACT FROM AUTHOR]

The article discusses the specificity and sensitivity of liquid-based Papanicolaou (Pap) smear test before endometrial carcinoma or histologic endometrial hyperplasia diagnosis. Results from liquid-based Pap smear tests of 272 women were analyzed as performed within 6 months preceeding histologic diagnosis of hyperplasia or endometrial carcinoma. Conclusions indicated that benign-appearing endometrial cells (BEAMC) reporting in women can lead to marginal increase in sensitivity.

An abstract of the article "Reprocessing SurePath™ Liquid-Based Pap Test (LBPT): An Experience with 966 Cases," by Ramona A. Evans, Lizette Miller, Maren Gregerson, Klint Kjeldahl, H. Evin Gulbahce, and Stefan E. Pambuccian is presented.

An abstract of the article "Unsatisfactory Liquid-Based Papanicolaou Test (LBPT): Causes and Significance," by Mariam Alsharif, Dan M. McKeon, H. Evin Gulbahce, Kat Savik, and Stefan E. Pambuccian is presented.

An abstract of the article "Size Criteria for Atypical Squamous Cells of Undetermined Significance (ACS-US) and Low Grade Squamous Intraepithelial Lesion in Liquid-Based Papanicolaou Tests (LBPT): Bethesda Or Sheffield?," by Gabriela M. Oprea-Ilies, H. Evin Gulbahce, Kay Savik, Edward B. Stelow, Dan M. Mckeon, and Stefan E. Pambuccian is presented.

Context.-The use of p16 in cervical biopsies improves the accuracy of cervical intraepithelial neoplasia (CIN) diagnosis and grading and decreases its interpathologist variability. Objective.-To determine the impact of the frequency of use of p16 immunostains in cervical biopsies on pathologists' diagnoses of CIN grade 1 and grade 2 or above (CIN1 and CIN2+) and on cytohistologic correlations. Design.-We identified all cervical biopsy specimens with cytologic correlations subjected or not to p16 staining from January 1, 2005, to September 30, 2010; calculated each pathologist's percentage of p16 use; and correlated it with their major cytohistologic discrepancy rates, CIN2+ diagnoses, and CIN1/CIN2+ ratios. Results.-During the study period, each of the 23 pathologists interpreted 59 to 1811 (mean, 518) of 11 850 cervical biopsy specimens, used p16 for 0% to 21.31% (mean, 10.14%) of these, had CIN2+ detection rates of 9.5% to 24.1% (mean, 18.9%), and CIN1/CIN2+ ratios of 0.7 to 4.5 (mean, 1.5). Compared to the 12 ''low users'' of p16,who used p16 fewer times than the institution's mean for p16 use, the 11 ''high users'' of p16 diagnosed more biopsies (8391 versus 3459), had a lower rate of major cytohistologic discrepancies (12.62% versus 14.92%, P , .001), a higher rate of CIN2+ diagnoses (19.9% versus 16.4%, P , .001), a lower range of CIN2+ rates (15.0%-23.1% versus 9.5%- 24.1%), and lower CIN1/CIN2+ ratios (1.2 versus 2.3). Conclusions.-We found a high intrainstitutional variability of p16 use in cervical biopsies, CIN2+ rates, and CIN1/CIN2+ ratios. Use of p16 for greater than 10% of cervical biopsies was associated with improved cytohistologic correlation rates and with lower variability in the frequencies of histologic diagnoses. [ABSTRACT FROM AUTHOR]