ASCP Phlebotomy Technician Certification Practice Exam 2025 - Free Phlebotomy Practice Questions and Study Guide

Question: 1 / 400

Which federal agency enforces CLIA regulations?

Department of Health and Human Services

Centers for Disease Control and Prevention

Centers for Medicare and Medicaid Services

The Centers for Medicare and Medicaid Services (CMS) is the federal agency responsible for enforcing the Clinical Laboratory Improvement Amendments (CLIA) regulations. CLIA was enacted to ensure the quality and accuracy of laboratory testing that affects patient care, and CMS oversees all laboratory testing under those amendments. They establish standards and regulations for laboratories, monitor compliance, and can impose penalties for non-compliance.

The other options refer to agencies with different responsibilities. For example, the Department of Health and Human Services oversees multiple health-related agencies but does not enforce CLIA regulations directly. The Centers for Disease Control and Prevention focuses primarily on public health and disease prevention but does not enforce laboratory standards. The Food and Drug Administration is responsible for regulating food safety and pharmaceuticals, rather than the oversight of laboratory testing under CLIA.

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Food and Drug Administration

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