---
kind: "section"
citation: "42 C.F.R. § 493.567"
title: "42"
number: "493.567"
heading: "Refusal to cooperate with validation inspection."
url: "https://uscodex.org/cfr/42/493.567"
---

# §493.567. Refusal to cooperate with validation inspection.

- (a) **Laboratory with a certificate of accreditation.**
  - (1) A laboratory with a certificate of accreditation that refuses to cooperate with a validation inspection by failing to comply with the requirements in [§ 493.565](/cfr/42/493.565.md)—
    - (i) Is subject to full review by CMS or a CMS agent, in accordance with this part; and
    - (ii) May be subject to suspension, revocation, or limitation of its certificate of accreditation under this part.
  - (2) A laboratory with a certificate of accreditation is again deemed to meet the condition-level requirements by virtue of its accreditation when the following conditions exist:
    - (i) The laboratory withdraws any prior refusal to authorize its accreditation organization to release a copy of the laboratory's current accreditation inspection, PT results, or notification of any adverse actions resulting from PT failure.
    - (ii) **The laboratory withdraws any prior refusal to allow a validation inspection.**
    - (iii) **CMS finds that the laboratory meets all the condition-level requirements.**
- (b) **CLIA-exempt laboratory.** If a CLIA-exempt laboratory fails to comply with the requirements specified in [§ 493.565](/cfr/42/493.565.md), CMS notifies the State of the laboratory's failure to meet the requirements.

## 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.