The Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulate laboratory testing. CLIA requires that clinical laboratories are certified by the Centers for Medicare and Medicaid Services (CMS) before they can accept human samples for diagnostic testing.
Generally, CLIA regulations establish quality standards for laboratory testing performed on human specimens, such as blood, body fluids, and tissue, to diagnose, prevent, treat, or assess disease or health.
A laboratory must be CLIA-certified and meet the applicable regulatory requirements before conducting clinical diagnostic or serological SARS-CoV-2 testing.
The lab’s CLIA certification must correspond to the highest level of complexity of the tests performed. The more complicated the test, the more stringent the specific CLIA quality standards and requirements for personnel qualifications and responsibilities are.
