Which organization enforces compliance with laboratory tests standards?

The Centers for Medicare & Medicaid Services (CMS) is the organization responsible for enforcing compliance with laboratory test standards in the United States. CMS administers and implements the Clinical Laboratory Improvement Amendments (CLIA), which set quality standards for laboratory testing to ensure the accuracy, reliability, and timeliness of patient test results.

Under CLIA, all laboratory testing performed on humans for health assessment or to diagnose, prevent, or treat disease operates under regulations that CMS oversees. This includes inspections of laboratories, proficiency testing, and ensuring that laboratories comply with standards regarding staff qualifications and quality control measures.

In contrast, while other organizations like the CDC, FDA, and HHS may have roles in public health and healthcare regulations, they do not specifically enforce laboratory test standards as their primary focus. The CDC is primarily involved in public health and disease control; the FDA regulates the safety and efficacy of medical devices and drugs; the HHS oversees various health programs and policies but does not enforce laboratory standards directly. Thus, the role of CMS as the enforcer of laboratory test standards makes it the correct answer.