{"data":{"id":"us/42-cfr-493.567","jurisdiction":"us","citation":"42 CFR 493.567","heading":"Refusal to cooperate with validation inspection.","body":"(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—\n(i) Is subject to full review by CMS or a CMS agent, in accordance with this part; and\n(ii) May be subject to suspension, revocation, or limitation of its certificate of accreditation under this part.\n(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:\n(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.\n(ii) The laboratory withdraws any prior refusal to allow a validation inspection.\n(iii) CMS finds that the laboratory meets all the condition-level requirements.\n(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.","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 E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program"],"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":"7c4df957958d23efecd068c9d46274dbf50eb9cbe21a74ce5a1f4d3086246411","source_id":"us-cfr","stale":true,"prev":"us/42-cfr-493.565","next":"us/42-cfr-493.569"},"notice":"GroundRules: Original legal text. Not legal advice."}