Genetic Testing and the Clinical Laboratory Improvement Amendments of 1988: Present and Future (Clinical Chemistry Forum‪)‬

Laboratory practice in the United States is regulated in many ways. The Food and Drug Administration (FDA), [1] through the Medical Devices Amendment, controls new devices and attempts to insure their safety and efficacy. The Health Care Financing Administration (HCFA), through Medicare, controls reimbursement for laboratory tests, as do insurance companies. The Joint Commission for Accreditation of Health Care Organizations accredits hospitals, and thereby laboratory practice in hospitals. There is state and local legislation related to laboratory performance and the qualifications of practitioners. The ethics of clinical laboratory performance is essentially the responsibility of professional societies and consumer groups. The topic of this presentation is the role of CLIA '88, which regulates all laboratory practice in the United States, in genetic testing. CLIA regulations are mandated for a test performed on a specimen derived from the human body and whose analytical result is used in diagnosis or the management of a patient. History of CLIA