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Amendments to CLIA's Proficiency Testing Provisions Passed by Congress

The Senate approved the previously House-passed Taking Essential Steps for Testing Act  (also known as the “TEST Act”) this week, clearing the way for President Obama's signature and enactment.  The legislation, which amends a provision of the Clinical Laboratory Improvement Amendments (CLIA), makes clear that the Centers for Medicare & Medicaid Services (CMS) has the authority to impose intermediate sanctions instead of revoking the CLIA certificate of a laboratory that has referred a proficiency testing sample to another laboratory.  The TEST Act was introduced by Rep. Michael Grimm (R-NY), and it quickly gained wide bipartisan support.  According to the American Clinical Laboratory Association, “[t]he bill grants [CMS] much-needed discretion so that clinical laboratories will not have their CLIA certificates revoked for the unintentional referral of proficiency testing samples to other laboratories.”   The legislation also received support from the College of American Pathologists.

 

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Author

Karen S. Lovitch

Member / Chair, Health Law Practice

Karen S. Lovitch is a Mintz attorney who represents health care companies in regulatory, transactional, and operational matters. She advises them on health care regulations such as the Stark Law and the Clinical Laboratory Improvement Amendments of 1988.