Clinical Laboratory Improvement Amendments (CLIA)

Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The objective of the CLIA program is to ensure quality laboratory testing covering approximately 189,000 laboratory entities. The Division of Laboratory Services, within the Survey and Certification Group, under the Center for Medicaid and State Operations (CMSO) has the responsibility for implementing the CLIA Program.

The Center for Medicare and Medicaid Services (CMS) assumes primary responsibility for financial management operations of the CLIA program, although the categorization of commercially marketed in vitro diagnostic tests under CLIA is now the responsibility of the FDA.