Code of Federal Regulations Title 42. Public Health § 42.493.569 Consequences of a finding of noncompliance as a result of a validation inspection

(a) Laboratory with a certificate of accreditation. If a validation inspection results in a finding that the accredited laboratory is out of compliance with one or more condition-level requirements, the laboratory is subject to—

(b) CLIA–exempt laboratory. If a validation inspection results in a finding that a CLIA–exempt laboratory is out of compliance with one or more condition-level requirements, CMS directs the State to take appropriate enforcement action.