Clinical Laboratory Improvement Amendments (CLIA) of 1988
The Clinical Laboratory Improvement Amendments of 1988 (CLIA) are the regulations for clinical laboratory testing. The regulations are established to ensure that all patient test results are accurate and reliable. CLIA is a federal program governed by the Centers for Medicare & Medicaid Services (CMS); however, the CLIA program is administered at the state level by the Louisiana Department of Health, Health Standard’s Section.
CLIA regulations apply to testing performed in any type of facility with or without a conventional laboratory. CLIA requires all facilities that perform tests on …“materials derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or impairment of, or the assessment of the health of human beings” to comply with the federal regulations. If a facility performs tests for these purposes, it is considered to be a laboratory according to the definition by CLIA, and must obtain and maintain CLIA certification.