Clinical Laboratory Improvement Amendments (CLIA)
Medical (clinical) laboratories are registered through the Certification Program under the Clinical Laboratory Improvement Amendments (CLIA) federal regulation to ensure quality laboratory testing. All labs that perform testing on human specimens for diagnosis, treatment or health assessment in the United States must hold the appropriate CLIA certificate. The CLIA regulations set standards for personnel, records, quality control and quality assurance. The greater the complexity of a test, the greater the requirements.