The Centers for Medicare and Medicaid Services (CMS) or its approved accreditation organizations routinely survey laboratories performing cytology testing biennially. In addition to these surveys, the Clinical Laboratory Improvement Amendment (CLIA) statute requires that individuals performing cytology examinations be tested for their proficiency. Specifically, at Section 353(f)(4)(B)(iv) of the statute, the Secretary is required to perform a "periodic confirmation and evaluation of the proficiency of individuals involved in screening or interpreting cytological preparations, including announced and unannounced on-site proficiency testing of such individuals, with such testing to take place, to the extent practicable, under normal working conditions."
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.