The CLIA Program sets standards and issues certificates for clinical laboratory testing. CLIA defines a clinical laboratory as any facility which performs laboratory testing on specimens derived from humans for the purpose of providing information (1) for the diagnosis, prevention, or treatment of disease or impairment, and (2) for the assessment of health. An objective of the CLIA is to ensure the accuracy, reliability and timeliness of test results regardless of where the test was performed.
Under CLIA, tests that meet risk, error and complexity requirements are issued a CLIA certificate of waiver. In November 2007, The CLIA waiver provisions were revised by Congress to make it clear that tests approved by the FDA for home use automatically qualify for CLIA waiver.
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