The Laboratory Compliance section inspects facilities performing clinical, substances of abuse and health screen testing for compliance with state and federal law. This section also inspects blood transfusion services for the Food and Drug Administration for compliance with their regulations.
Oregon contracts with the Centers for Medicare and Medicaid Services (CMS) to perform inspections and monitor compliance of clinical laboratories to the Clinical Laboratory Improvement Amendments (CLIA) program. In addition, Oregon issues Health Screen Testing (HST) permits, Substance of Abuse (SOA) screening licenses, and SOA registrations in compliance with Oregon Administrative Rules.
Laboratory Compliance oversees for CMS clinical laboratory testing performed within the state for the purpose of diagnosis and treatment or assessment of health of humans in all facility types. The performance of even a single test requires certification. Exempt from regulation are tests performed in federal government laboratories and pure research and home testing when performed by the patient.
Oregon still has clinical laboratory licensure laws under OAR 333-024-0005 through 333-024-0400. A laboratory having the federally mandated CLIA certificate does not need a separate clinical laboratory license from the Oregon Health Authority. Laboratories must meet the more stringent requirements of Oregon state law, CLIA regulations or private accreditation organization standards.
Laboratory Compliance is part of the Oregon State Public Health Laboratory in the Center for Public Health Practice. View the complete OSPHL staff directory or search the Public Health Program Directory to see all programs in the Oregon Public Health Division.