The Clinical Laboratory Improvement Amendments was adopted in 1988 and regulated by the Center for Medicare & Medicaid Services (CMS) to establish quality standards, strengthen Federal oversight of clinical laboratories, and ensure the accuracy and reliability of patient test results. CLIA applies to all laboratories that examine “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.” (42 U.S.C. § 263a(a)). The Division of Clinical Laboratory Improvement & Quality, within the Quality, Safety & Oversight Group, under the Center for Clinical Standards and Quality (CCSQ) has the responsibility for implementing the CLIA Program.
