In 1988, Congress passed The Clinical Laboratory Improvement Amendments (CLIA) in order to establish quality standards for all laboratory testing to ensure accuracy, reliability, and timeliness of laboratory results regardless of where the patient's specimen was tested.
The CLIA regulations are based on the complexity of the test method; the more complicated the method, the more stringent the requirements. Three categories of tests have been established: waived, moderate (which includes the sub-category of provider-performed microscopy), and high complexity.
CLIA stipulates the quality standards for proficiency testing, patient management, quality control, personnel qualifications, and quality assurance for those laboratories performing moderate and/or high complexity testing. Those laboratories performing only waived testing must enroll in CLIA and are required to follow the manufacturer's instructions for those testing methods performed.
The Centers for Medicare and Medicaid Services (CMS) is charged with laboratory registration; fee collection; surveys; surveyor guidelines and training; enforcement; and approval of proficiency testing providers, as well as accrediting organizations and exempt states.
The Centers for Disease Control and Prevention (CDC) is responsible for CLIA studies, convening the CLIA Committee, and providing scientific and technical support and consultation to the Centers for Medicare and Medicaid Services.
It is the responsibility of the Food and Drug Administration (FDA) to categorize new test methodologies.