BACKGROUNDThe Bethesda System for reporting the results of cervical cytology was developed as a uniform system of terminology that would provide clear guidance for clinical management.

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The American Cancer Society (ACS) has developed guidelines for the use of the prophylactic human papillomavirus (HPV) vaccine for the prevention of cervical intraepithelial neoplasia and cervical cancer. These recommendations are based on a formal review of the available evidence. They address the use of prophylactic HPV vaccines, including who should be vaccinated and at what age, as well as a summary of policy and implementation issues.

In 2011, the American Cancer Society, the American Society for Colposcopy and Cervical Pathology, and the American Society for Clinical Pathology updated screening guidelines for the early detection of cervical cancer and its precursors. Recommended screening strategies were cytology or cotesting (cytology in combination with high-risk human papillomavirus [hrHPV] testing). These guidelines also addressed the use of hrHPV testing alone as a primary screening approach, which was not recommended for use at that time. There is now a growing body of evidence for screening with primary hrHPV testing, including a prospective U.S.-based registration study. Thirteen experts, including representatives from the Society of Gynecologic Oncology, the American Society for Colposcopy and Cervical Pathology, the American College of Obstetricians and Gynecologists, the American Cancer Society, the American Society of Cytopathology, the College of American Pathologists, and the American Society for Clinical Pathology, convened to provide interim guidance for primary hrHPV screening. This guidance panel was specifically triggered by an application to the U.S. Food and Drug Administration (FDA) for a currently marketed HPV test to be labeled for the additional indication of primary cervical cancer screening. Guidance was based on literature review and review of data from the FDA registration study, supplemented by expert opinion. This document aims to provide information for health care providers who are interested in primary hrHPV testing and an overview of the potential advantages and disadvantages of this strategy for screening as well as to highlight areas in need of further investigation.

The Bethesda System recognizes "Atypical Squamous Cells of Undetermined Significance" (ASCUS) as a category of epithelial cell abnormality. Neither the acceptable rate of ASCUS nor the clinical follow-up are well defined. This study focused on interlaboratory comparison and quality assurance methods for evaluating the rate and outcome of ASCUS. Data was collected from questionnaire surveys from the College of American Pathologists Interlaboratory PAP Program and the four authors' laboratories. Most PAP laboratories (82.5%) limit the use of "atypia" terminology to abnormalities of undetermined significance. According to PAP data, the median rate of ASCUS in 1992 was 2.9%, with 10% of laboratories reporting rates greater than 9.0%. The median squamous intraepithelial lesion (SIL) rate was 2.2%, with a median ASCUS/SIL ration of 1.3. The authors' laboratories (university, independent, and hospital) revealed ASCUS rates of 1.6-9.0%, while SIL rates were 2.1-9.0%. The ASCUS/SIL ratio was less variable, 0.8-2.7. Follow-up of ASCUS patients in the authors' laboratories showed 10.3-43% with SIL, but less than 6% with high grade SIL. The ratio ASCUS/SIL may serve as a useful laboratory monitor. Peer review and follow-up studies of ASCUS serve to validate laboratory criteria and consequent clinical follow-up. Communication with clinicians is vital in ensuring optimal patient care.