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Survey & Certification - General Information

Title
SA Responsibilities for 2007 Regarding Cytology PT) under CLIA and Additional Program Information
Memo #
07-04
Posting Date
12/07/2006
Fiscal Year
2007
Summary
This memo provides further guidance for assessing cytology laboratory compliance with CLIA requirements for cytology PT, and updates S and C Memo 05-11 dated 12/16/04 and S and C Memo 06-07 dated 1/23/06. For CY 2007 we are continuing the approach we previously adopted in 2005 and 2006 for the implementation of national PT. This means that laboratories will not fail cytology PT, have deficiencies cited, or have sanctions imposed against their CLIA certificate provided they: 1. Enroll all affected individuals in a Centers for Medicare and Medicaid Services (CMS) approved testing program for the CY 2007 testing cycle, and 2. Ensure that all such individuals are tested in a timely manner within 2007, in accordance with the regulatory protocol. The regulatory protocol under 42 CFR 493.855 identifies the extent to which additional testing, education, or limitations must be put in place with regard to individuals who do not pass the test initially.