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Title 42 Part 493 → Subpart E → §493.569

Title 42 → Chapter IV → Subchapter G → Part 493 → Subpart E → §493.569

Electronic Code of Federal Regulations e-CFR

Title 42 Part 493 → Subpart E → §493.569

e-CFR data is current as of January 16, 2020

Title 42Chapter IVSubchapter GPart 493Subpart E → §493.569


Title 42: Public Health
PART 493—LABORATORY REQUIREMENTS
Subpart E—Accreditation by a Private, Nonprofit Accreditation Organization or Exemption Under an Approved State Laboratory Program


§493.569   Consequences of a finding of noncompliance as a result of a validation inspection.

(a) Laboratory with a certificate of accreditation. If a validation inspection results in a finding that the accredited laboratory is out of compliance with one or more condition-level requirements, the laboratory is subject to—

(1) The same requirements and survey and enforcement processes applied to laboratories that are not accredited and that are found out of compliance following an inspection under this part; and

(2) Full review by CMS, in accordance with this part; that is, the laboratory is subject to the principal and alternative sanctions in §493.1806.

(b) CLIA-exempt laboratory. If a validation inspection results in a finding that a CLIA-exempt laboratory is out of compliance with one or more condition-level requirements, CMS directs the State to take appropriate enforcement action.