Clinical laboratories must maintain accreditation through regularly scheduled inspections. The inspection process aims to ensure that CLIA regulations are followed.
Laboratories are usually inspected by organizations deemed by CMS to perform CLIA inspections. These organizations include CAP, COLA, TJC, and others. Hospital blood banks are inspected by AABB. In some cases, CLIA may send its own inspectors to examine a laboratory.
The inspectors view current policies and procedures, personnel qualification documentation, testing operations, and more to check for compliance. If a deficiency is found, the inspector or agency may devise a corrective plan. If multiple deficiencies are found, that section of the laboratory or, in extreme cases, the entire laboratory may be prevented from performing diagnostic testing until the issues are resolved and re-evaluated.
