---
kind: "section"
citation: "42 C.F.R. § 493.1780"
title: "42"
number: "493.1780"
heading: "Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation."
url: "https://uscodex.org/cfr/42/493.1780"
---

# §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](/cfr/42/subpartE.md) of this part and [§ 488.11](/cfr/42/488.11.md) 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](/cfr/42/493.1773.md).

## Notes

### Amendments

[63 FR 26738, May 14, 1998]

### Source

Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.

### Authority

Authority: 42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17).

### Source

Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.

### Amendments

[63 FR 26738, May 14, 1998]