Cytology PT FollowUp

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2005-2007 Testing Follow-Up? (Excerpt from 12/08/06 Letter to State Agencies)

Letter Summary

Purpose: This memo provides further guidance for assessing cytology laboratory compliance with CLIA requirements for cytology PT, and updates S&C Memo #05-11 dated 12/16/04 and S&C Memo #06-07 dated 1/23/06.

2007 Approach: 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 & 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.

Choices for 2007 Testing Cycle: The State of Maryland, the American Society for Clinical Pathology (ASCP) and the College of American Pathologists (CAP) have been approved by CMS as cytology PT providers for 2007. (Note: the ASCP acquired the Midwest Institute for Medical Education (MIME) in February 2006. MIME was the only national cytology PT provider in 2005)
Current Developments: CMS and the Centers for Disease Control and Prevention (CDC) received recommendations from a workgroup under the auspices of the Secretary’s Clinical Laboratory Improvement Advisory Committee (CLIAC) to refine the cytology PT standards to address issues of concern and optimize proficiency tests. CMS and CDC are currently in the process of developing a new regulation. We expect to publish the proposed rule in 2007.

The CLIA Web site at: http://www.cms.hhs.gov/clia includes current cytology PT performance data and policies, as well as responses to issues of concern.

Attached Files

 Letter to State Agencies-December 2006
 CMS Letter to Lab Directors-Mar 2006