CMSInformationalSupplementOnCytologyProficiencyTesting 
Medicare, Medicaid, and CLIA Programs: Statutory and Regulatory Requirements Related to Laboratory Participation in Proficiency Testing and the Availability of Proficiency Testing Programs in Cytology
The current requirements for cytology proficiency testing are found in the CLIA regulations at 42 CFR Part 493, published February 28, 1992 and effective, September 1,1992. Click here for 42 CFR Part 493.
Implementation of cytology proficiency testing has taken an extended period of time due to the absence of qualified national proficiency testing organizations, an insufficient number of referenced cytology testing materials, and significant technical difficulties. There are three CMS-approved cytology proficiency testing programs. for 2006. The approval of national cytology PT programs demonstrates CMS’ continued dedication and commitment to improve one of the principal issues on women’s health; that is, accurate and reliable Pap smear results. With the initiation of cytology proficiency testing on a national basis, CMS has implemented every provision of the CLIA law. We will continue to add inquiries to this Informational Supplement, as necessary.
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