Resources for Food and Drug Administration (FDA)

CMS Initiatives to Improve Quality of laboratory testing under the CLIA Program

CMS

In the wake of reports of inaccurate results from Pap smears intended to detect cervical cancer, Congress enacted the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to ensure the accuracy and reliability of all laboratory testing. This legislation, for the first time, extended Federal regulation to all laboratories – hospital, independent, and physician office laboratories, etc. – that perform testing on human specimens for the purpose of diagnosing or treating a disease, illness, or assessment of the health of human beings. Among the tests commonly performed in laboratories regulated under CLIA are tests on blood, urine and other samples to detect cancer, HIV, diabetes, and multiple other diseases.

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