Trends in the use of cervical cancer screening tests in a large medical claims database, United States, 2013-2019.

OBJECTIVE: To examine trends in the use of cervical cancer screening tests during 2013-2019 among commercially insured women. METHODS: The study population included women of all ages with continuous enrollment each year in the IBM MarketScan commercial or Medicare supplemental databases and without known history of cervical cancer or precancer (range = 6.9-9.8 million women per year). Annual cervical cancer screening test use was examined by three modalities: cytology alone, cytology plus HPV testing (cotesting), and HPV testing alone. Trends were assessed using 2-sided Poisson regression. RESULTS: Use of cytology alone decreased from 34.2% in 2013 to 26.4% in 2019 among women aged 21-29 years (P < .0001). Among women aged 30-64 years, use of cytology alone decreased from 18.9% in 2013 to 8.6% in 2019 (P < .0001), whereas cotesting use increased from 14.9% in 2013 to 19.3% in 2019 (P < .0001). Annual test use for HPV testing alone was below 0.5% in all age groups throughout the study period. Annually, 8.7%-13.6% of women aged 18-20 years received cervical cancer screening. There were persistent differences in screening test use by metropolitan residence and census regions despite similar temporal trends. CONCLUSIONS: Temporal changes in the use of cervical cancer screening tests among commercially insured women track changes in clinical guidelines. Screening test use among individuals younger than 21 years shows that many young women are inappropriately screened for cervical cancer.

Good laboratory practices for molecular genetic testing for heritable diseases and conditions.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations, laboratory testing is categorized as waived (from routine regulatory oversight) or nonwaived based on the complexity of the tests; tests of moderate and high complexity are nonwaived tests. Laboratories that perform molecular genetic testing are subject to the general CLIA quality systems requirements for nonwaived testing and the CLIA personnel requirements for tests of high complexity. Although many laboratories that perform molecular genetic testing comply with applicable regulatory requirements and adhere to professional practice guidelines,specific guidelines for quality assurance are needed to ensure the quality of test performance. To enhance the oversight of genetic testing under the CLIA framework,CDC and the Centers for Medicare & Medicaid Services (CMS) have taken practical steps to address the quality management concerns in molecular genetic testing,including working with the Clinical Laboratory Improvement Advisory Committee (CLIAC). This report provides CLIAC recommendations for good laboratory practices for ensuring the quality of molecular genetic testing for heritable diseases and conditions. The recommended practices address the total testing process (including the preanalytic,analytic,and postanalytic phases),laboratory responsibilities regarding authorized persons,confidentiality of patient information,personnel competency,considerations before introducing molecular genetic testing or offering new molecular genetic tests,and the quality management system approach to molecular genetic testing. These recommendations are intended for laboratories that perform molecular genetic testing for heritable diseases and conditions and for medical and public health professionals who evaluate laboratory practices and policies to improve the quality of molecular genetic laboratory services. This report also is intended to be a resource for users of laboratory services to aid in their use of molecular genetic tests and test results in health assessment and care. Improvements in the quality and use of genetic laboratory services should improve the quality of health care and health outcomes for patients and families of patients.

Comparison of cytology proficiency testing: glass slides vs. virtual slides.

OBJECTIVE: To compare proficiency testing in gynecologic cytology using glass slides vs. virtual slides. STUDY DESIGN: To compare performance, a sample of 111 individuals (pathologists = 52, cytotechnologists = 59) from participating in-state laboratories were administered 2 proficiency tests. The annual test of the Maryland Cytology Proficiency Testing Program (MCPTP) was administered to individuals in their laboratories following normal work practice (i.e., using microscopes and equipment with which they were familiar). The other test was CytoView II (Centers for Disease Control and Prevention, Atlanta, Georgia, U.S.A.), a computer-based test composed of virtual slides captured from the MCPTP's glass slides, which test administration personnel transported to the individual's laboratory and administered using 1 of 2 laptop computers. ANOVA was used to compare the performance on the 2 tests and the effect of various potential confounding variables. The slides were evaluated by comparing the performance average for each glass slide to that of the matching virtual slides. All data analysis was performed at the 95% confidence interval. RESULTS: The mean score of the individuals (n = 111) on the MCPTP test was 99.2% (SD = 2.2, range = 90-100%). The mean score of the individuals (n = 111) on CytoView II was 96.8% (SD = 5.8, range = 70-100%). No individual scored < 90% on the glass slide test (pass rate = 100%). Eight individuals (pathologists = 3, cytotechnologists = 5) scored < 90% on the CytoView II (pass rate = 93.8%). Comparison of an individual's performance on the 2 tests demonstrated a significant difference. When virtual slides that did not attain a 90% consensus were excluded from the scoring, a comparison of individual pass rate for the glass slide test (100%) and computer-based test (99.1%) did not demonstrate significant difference. CONCLUSION: Each slide (glass or virtual) must be field validated by cytotechnologists and pathologists. If field validation and Clinical Laboratory Improvement Amendment referencing of virtual slides are comparable to those of glass slides, computer-based testing can be equivalent.