42 CFR § 493.567 - Refusal to cooperate with validation inspection.
---
identifier: "/us/cfr/t42/s493.567"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.567 - Refusal to cooperate with validation inspection."
title_number: 42
title_name: "Public Health"
section_number: "493.567"
section_name: "Refusal to cooperate with validation inspection."
chapter_name: "CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "G"
subchapter_name: "STANDARDS AND CERTIFICATION"
part_number: "493"
part_name: "LABORATORY REQUIREMENTS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "42 U.S.C. 263a, 1302, 1395x(e), 1395x(s)(3) and (s)(17)."
regulatory_source: "55 FR 9576, Mar. 14, 1990, unless otherwise noted."
cfr_part: "493"
---
# 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—
(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, CMS notifies the State of the laboratory's failure to meet the requirements.