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Title 42 Part 493 → Subpart Q → §493.1780

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart Q → §493.1780

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart Q → §493.1780

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart Q → §493.1780


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart Q—Inspection


§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]