What is required before performing any diagnostic tests?

Before performing any diagnostic tests, having a CLIA (Clinical Laboratory Improvement Amendments) certificate is essential. This certificate ensures that the laboratory conducting the tests meets specific federal standards for accuracy, reliability, and timeliness of patient test results. Laboratories that perform testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease must be certified under CLIA, which regulates all laboratory testing performed on humans in the United States.

While a medical license is necessary for healthcare providers to practice medicine, and various forms of accreditation might be needed for specific healthcare facilities or specialties, the CLIA certification specifically pertains to laboratory testing and is a regulatory requirement that must be met before conducting diagnostic tests in most settings. Written consent from patients is often required for certain procedures or tests but is not universally required for all diagnostic testing in the way that CLIA certification is. Therefore, the requirement of a CLIA certificate is a foundational aspect of ensuring that diagnostic tests are performed according to established safety and quality standards.