493.1800 - Inspection Basis and Frequency

The CLIA provision at 493.1800 establishes the criteria and schedule for inspecting clinical laboratories, detailing which facilities are subject to routine, periodic, or targeted examinations based on risk, complexity, and compliance history. It outlines the inspection frequency, ranging from annual visits for high-risk labs to less frequent reviews for lower-risk sites, ensuring continual adherence to quality and safety standards.