To enroll in the CLIA program, what are laboratories required to do first?

Laboratories must register and complete an application to enroll in the Clinical Laboratory Improvement Amendments (CLIA) program. The application process is essential as it provides the necessary information about the laboratory's operations, including the types of tests performed and the laboratory's personnel. This step allows the Centers for Medicare & Medicaid Services (CMS) to evaluate the laboratory's compliance with CLIA regulations and to assign the appropriate certification based on the complexity of testing performed.

Submitting an application is crucial because it initiates the formal enrollment process, enabling laboratories to achieve certification that proves they meet quality standards for laboratory testing. Following this process, laboratories may need to undergo inspections and pay associated fees, but the foundational requirement is to submit the application for enrollment first.