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Code of Federal Regulations Title 42. Public Health § 42.493.1780 Standard:  Inspection of CLIA–exempt laboratories or laboratories requesting or issued a certificate of accreditation

Current as of October 02, 2022 | Updated by FindLaw Staff

(a) Validation inspection. CMS or a CMS agent may conduct a validation inspection of any accredited or CLIA–exempt laboratory at any time during its hours of operation.

(b) Complaint inspection. CMS or a CMS agent may conduct a complaint inspection of a CLIA–exempt laboratory or a laboratory requesting or issued a certificate of accreditation at any time during its hours of operation upon receiving a complaint applicable to the requirements of this part.

(c) Noncompliance determination. If a validation or complaint inspection results in a finding that the laboratory is not in compliance with one or more condition-level requirements, the following actions occur:

(1) A laboratory issued a certificate of accreditation is subject to a full review by CMS, in accordance with subpart E of this part and § 488.11 of this chapter.

(2) A CLIA–exempt laboratory is subject to appropriate enforcement actions under the approved State licensure program.

(d) Compliance with basic inspection requirements. CLIA–exempt laboratories and laboratories requesting or issued a certificate of accreditation must comply with the basic inspection requirements in § 493.1773.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 42. Public Health § 42.493.1780 Standard:  Inspection of CLIA–exempt laboratories or laboratories requesting or issued a certificate of accreditation - last updated October 02, 2022 | https://codes.findlaw.com/cfr/title-42-public-health/cfr-sect-42-493-1780/

Read this complete Code of Federal Regulations Title 42. Public Health § 42.493.1780 Standard:  Inspection of CLIA–exempt laboratories or laboratories requesting or issued a certificate of accreditation on Westlaw

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