493.1780—Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
(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.
[63 FR 26738, May 14, 1998]