CLIA and Associated Federal Agencies

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The page below is a sample from the LabCE course Inspection Preparation, Process, and Corrective Action. Access the complete course and earn ASCLS P.A.C.E.-approved continuing education credits by subscribing online.

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CLIA and Associated Federal Agencies

The clinical laboratory is under the oversight of the Clinical Laboratory Improvement Amendment (CLIA). CLIA publishes quality standards and requires that each laboratory performing CLIA-regulated tests must be certified by the Secretary of the United States Department of Health and Human Services (DHHS). In conjunction with the Centers for Disease Control and Prevention (CDC) and the US Food and Drug Administration (FDA), the Centers for Medicare and Medicaid Services (CMS) administers the CLIA laboratory certification program for the Secretary.

CMS, FDA, and CDC are responsible for enforcing CLIA regulations.
Laboratory accreditation agencies exist for voluntary oversight of the laboratory in its entirety or specific laboratory departments. These agencies may be selected for oversight in addition to CLIA.