The Clinical Laboratory Improvement Amendments of 1988 (CLIA) established quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. A laboratory is defined as any facility that performs laboratory testing on specimens derived from humans for the purpose of providing information for the diagnosis, prevention, treatment of disease, or impairment of, or assessment of health. CMS is charged with the implementation of CLIA, including laboratory registration, fee collection, certificate generation, surveys, surveyor guidelines development and training, enforcement, financial management and finally, approvals of proficiency testing providers, accrediting organizations and exempt states. The Food and Drug Administration is responsible for test categorization. The Centers for Disease Control and Prevention is responsible for the CLIA studies, convening the Clinical Laboratory Improvement Amendments Committee (CLIAC) and provides scientific and technical support to CMS.
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