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Current as of January 02, 2025 | Updated by Findlaw Staff
(a) Laboratory with a certificate of accreditation.
(1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation inspection by failing to comply with the requirements in § 493.565—
(i) Is subject to full review by CMS or a CMS agent, in accordance with this part; and
(ii) May be subject to suspension, revocation, or limitation of its certificate of accreditation under this part.
(2) A laboratory with a certificate of accreditation is again deemed to meet the condition-level requirements by virtue of its accreditation when the following conditions exist:
(i) The laboratory withdraws any prior refusal to authorize its accreditation organization to release a copy of the laboratory's current accreditation inspection, PT results, or notification of any adverse actions resulting from PT failure.
(ii) The laboratory withdraws any prior refusal to allow a validation inspection.
(iii) CMS finds that the laboratory meets all the condition-level requirements.
(b) CLIA–exempt laboratory. If a CLIA–exempt laboratory fails to comply with the requirements specified in § 493.565, CMS notifies the State of the laboratory's failure to meet the requirements.
Cite this article: FindLaw.com - Code of Federal Regulations Title 42. Public Health § 42.493.567 Refusal to cooperate with validation inspection - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-42-public-health/cfr-sect-42-493-567/
FindLaw Codes may not reflect the most recent version of the law in your jurisdiction. Please verify the status of the code you are researching with the state legislature before relying on it for your legal needs.
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