Clinical Laboratory Improvement Amendments (CLIA)
What is CLIA?
The Clinical Laboratory Improvement Amendments (CLIA) are federal requirements established to ensure the accuracy, reliability and timeliness of laboratory test results. CLIA regulations apply to all facilities in the United States that perform laboratory testing on human specimens for health assessment or the diagnosis, prevention, or treatment of disease. All laboratories, including those at CDC, that perform this type of testing must meet the requirements specified by CLIA.
What are CDC’s responsibilities under CLIA?
CDC has two separate and distinct responsibilities related to CLIA:Related Sites
CMS CLIA Overview
FDA CLIA Overview