Clinical Laboratory
announcements from
Centers for Medicare and Medicaid Services (CMS)
CMS has recently issued two Memos for Clinical Labs:
CMS S&C 18-07-CLIA, Clinical
Laboratory Improvement Amendments of 1988 (CLIA) Proficiency Testing (PT)
Referral Categories, provides Clarification of Proficiency Testing (PT) Referral. The final regulations implementing the Taking Essential Steps for Testing Act (“TEST Act”) include three categories for PT Referral which are based on severity and extent of the violation. For questions, please contact the LabExcellence mailbox at LabExcellence@cms.hhs.gov.
CMS QSO 18-11-CLIA, Clinical
Laboratory Improvement Amendments (CLIA) Release of Request for Information
(RFI),, shares that CMS is seeking public comment and information related to the following areas:
- Personnel requirements: nursing and physical science degrees, competency assessment, laboratory training and experience requirements and documentation;
- Proficiency testing referral: Discretion for Category 1, alternative sanctions imposed for Certificate of Waiver (CoW);
- Histocompatibility; and,
- Compliance and additional fees.
Public comment will be accepted until March 12, 2018. The RFI can be downloaded from the Federal Register at: https://www.federalregister.gov/public-inspection.
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