{"data":{"id":"us/42-cfr-493.1780","jurisdiction":"us","citation":"42 CFR 493.1780","heading":"Standard: Inspection of CLIA-exempt laboratories or laboratories requesting or issued a certificate of accreditation.","body":"(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.\n(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.\n(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:\n(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.\n(2) A CLIA-exempt laboratory is subject to appropriate enforcement actions under the approved State licensure program.\n(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.","path":["Title 42—Public Health","CHAPTER IV—CENTERS FOR MEDICARE \u0026 MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER G—STANDARDS AND CERTIFICATION","PART 493—LABORATORY REQUIREMENTS","Subpart Q—Inspection"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-42.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:26:11Z","sha256":"647d0081abf25e497e210a5e29db9da83855f435f28283ef5858fc44e29d3852","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-493.1777","next":"us/42-cfr-493.1800"},"notice":"GroundRules: Original legal text. Not legal advice."}