Which organization establishes standards for laboratory testing?

The Clinical Laboratory Improvement Amendments (CLIA) is the correct answer because it specifically sets the standards for laboratory testing in the United States. Enacted in 1988, CLIA established guidelines that ensure laboratory tests are accurate, reliable, and timely in producing results. These regulations cover a wide range of laboratory activities, including the qualification of personnel, the maintenance of laboratory equipment, and the procedures for quality control. By overseeing laboratory testing standards, CLIA plays a crucial role in protecting public health and ensuring high-quality laboratory services are available to healthcare providers and patients.

Other organizations, while influential in their own right, have different primary roles. The Food and Drug Administration (FDA) focuses on the regulation and approval of medical devices, pharmaceuticals, and food safety, rather than directly establishing laboratory testing standards. The Centers for Disease Control and Prevention (CDC) is primarily concerned with public health issues and disease prevention, providing guidance and support regarding laboratory safety and testing but not setting the standards. The World Health Organization (WHO) works on an international level to promote health, but it does not set standards specifically for laboratory testing similar to CLIA. Therefore, CLIA is the organization that directly establishes and maintains the standards for laboratory testing in the U.S.