---
kind: "section"
citation: "42 C.F.R. § 493.569"
title: "42"
number: "493.569"
heading: "Consequences of a finding of noncompliance as a result of a validation inspection."
url: "https://uscodex.org/cfr/42/493.569"
---

# §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—
  - (1) The same requirements and survey and enforcement processes applied to laboratories that are not accredited and that are found out of compliance following an inspection under this part; and
  - (2) Full review by CMS, in accordance with this part; that is, the laboratory is subject to the principal and alternative sanctions in [§ 493.1806](/cfr/42/493.1806.md).
- (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.

## Notes

### Source

Source: 63 FR 26732, May 14, 1998, 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.