What regulatory body oversees laboratory standards and practices in the United States?

The Clinical Laboratory Improvement Amendments (CLIA) is the correct answer because it specifically addresses the standards and practices that govern laboratory testing in the United States. Enacted in 1988, CLIA establishes quality standards for laboratory testing to ensure accurate and reliable results that are critical for patient care. This regulatory framework applies to all laboratories that perform tests on human specimens, regardless of their ownership or the type of testing they conduct.

In contrast, while the Food and Drug Administration (FDA) oversees the approval and regulation of medical devices and diagnostics, including some laboratory tests, it does not directly manage laboratory practices themselves. The Centers for Disease Control and Prevention (CDC) focuses primarily on public health issues, disease prevention, and disease surveillance rather than regulating laboratory standards. The National Institutes of Health (NIH) primarily funds and conducts medical research and does not have a direct role in overseeing laboratory practices. Thus, CLIA is the distinct regulatory body specifically dedicated to laboratory standards.