Certified Pulmonary Function Technologist (CPFT) Practice Exam

Which agency oversees the CLIA-88 regulations?

1. Environmental Protection Agency

2. Department of Defense

3. Health and Human Services of the government

4. Food and Drug Administration

The correct answer is: Health and Human Services of the government

The correct choice pertains to the oversight of the CLIA-88 regulations, which stands for the Clinical Laboratory Improvement Amendments of 1988. These amendments were established to ensure the quality and accuracy of laboratory testing in clinical settings. The agency responsible for overseeing CLIA regulations is the Department of Health and Human Services (HHS). Under HHS, the Centers for Medicare & Medicaid Services (CMS) administer the CLIA program, setting standards for laboratory testing to enhance patient safety and healthcare quality. In contrast, the other listed agencies have different mandates and areas of focus. For instance, the Environmental Protection Agency primarily deals with environmental protection and public health issues related to air and water quality. The Department of Defense focuses on national security and military matters, without a direct role in healthcare laboratory regulations. The Food and Drug Administration, while involved in aspects of healthcare regulation, particularly regarding pharmaceuticals and medical devices, does not specifically oversee the CLIA-88 regulations. Thus, the Health and Human Services agency is the appropriate overseer of CLIA-88, emphasizing its critical role in maintaining laboratory standards.