Which federal agency administers the CLIA program?

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The correct choice, which is the Centers for Medicare and Medicaid Services (CMS), is responsible for the administration of the Clinical Laboratory Improvement Amendments (CLIA) program. The CLIA program is designed to ensure the quality and accuracy of laboratory testing in order to protect public health. Under this program, CMS establishes standards for laboratory testing, including point-of-care testing, and oversees the certification of laboratories.

CMS performs various roles such as inspecting and approving labs that meet the established standards, thus ensuring that they are capable of providing reliable testing results. The agency's mission aligns directly with its responsibility for regulating laboratory testing and ensuring that patient safety, as well as the integrity of laboratory results, are maintained.

The other federal agencies mentioned do not oversee the CLIA program. The Food and Drug Administration primarily regulates the safety and efficacy of medical devices, including some laboratory tests, but it does not administer the CLIA program. The National Institutes of Health focuses on medical research and funding rather than on the regulation of laboratory practices, while the Environmental Protection Agency deals with environmental health and regulations, not clinical laboratory standards. Thus, the role of CMS is critical and directly linked to the administration of the CLIA program.

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