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CFR > Title 42 - Public Health > CHAPTER IV—CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER G—STANDARDS AND CERTIFICATION (parts 482 to 498) > PART 493—LABORATORY REQUIREMENTS > SUBPART E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program (§493.551 to §493.575) > 493.567—Refusal to cooperate with validation inspection.

CFR

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.
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