(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 Sec. 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.