A laboratory holding a certificate of waiver or a PPM certificate is not subject to biennial inspection but may be inspected at any time during its hours of operation to determine whether its testing poses an imminent and serious risk to public health, to evaluate a public complaint, to determine whether it tests beyond the scope of its certificate, or to collect information on the appropriateness of waived and PPM categorisation, and must comply with the basic inspection requirements. A laboratory issued a registration certificate must permit an initial inspection, at any time during its hours of operation, before CMS issues a certificate of compliance, and is then inspected biennially or as often as CMS decides from its compliance history, with the inspection sample able to include PPM testing. CLIA-exempt laboratories and laboratories that have requested or hold a certificate of accreditation may receive validation inspections and complaint inspections at any time during operating hours; where such an inspection finds noncompliance with one or more condition-level requirements, an accredited laboratory is subject to full CMS review under Subpart E and section 488.11 and a CLIA-exempt laboratory to enforcement under the approved State licensure program. Every laboratory must comply with the basic inspection requirements of section 493.1773.
The graph holds this control, the 0 it maps to, and the evidence behind each claim, over MCP and REST.