US · guidance
CMS SOM App. C, Tag D3009
§493.1101 Standard: Facilities
(c)The laboratory must be in compliance with applicable Federal, State, and local
laboratory requirements.
Interpretive Guidelines §493.1101(c)
The laboratory must possess a current license issued by the State (or local government, if
such licensing exists. If a State (https://www.cms.gov/regulations-and-
guidance/legislation/clia/downloads/cliasa.pdf) or local government removes a
laboratory’s license and the right to operate within the State or locality, Centers for
Medicare & Medicaid Services (CMS) may take an action to revoke the Clinical
Laboratory Improvement Amendments (CLIA) certificate.
History
Rev. 233; Issued: 09-12-25; Effective: 09-12-25; Implementation: 09-12-25
Provenance
- Source
- cms.gov
- Retrieved
- 2026-07-22
- Edition
- som-2026-07-22
- Content hash
e072ce125f4735f24260921c8e5c651a9ab4ff59337040f07c8322a21a632630
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