The Clinical Laboratory Improvement Amendments (CLIA) program is a federal regulatory program that establishes quality standards for laboratory testing. Laboratories that perform testing on human specimens for the diagnosis, prevention, or treatment of disease are required to be CLIA-certified. However, there are some laboratories that may qualify for a CLIA waiver.
A CLIA waiver is a type of certification that allows certain laboratories to perform testing with a reduced level of regulatory oversight. To qualify for a CLIA waiver, a laboratory must meet certain criteria, such as: