42 CFR § 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.
---
identifier: "/us/cfr/t42/s493.1780"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "42 CFR § 493.1780 - Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation."
title_number: 42
title_name: "Public Health"
section_number: "493.1780"
section_name: "Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation."
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: "2026-03-24"
last_updated: "2026-03-24"
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"
---
# 493.1780 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]