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:
- CDC laboratories that perform clinical testing (except clinical trials and basic research) must adhere to CLIA requirements and maintain current certification of CLIA compliance.
- CDC collaborates with the Centers for Medicare & Medicaid Services (CMS) and the Food and Drug Administration (FDA) to implement the CLIA program. CDC focuses on development and evaluation of both regulatory (CLIA) standards and professional and other standards and guidelines for laboratory quality practices, conducts quality improvement research in collaboration with experts in the field, professional organizations, industry, states and other federal agencies, and manages the Clinical Laboratory Improvement Advisory Committee (CLIAC).
for all CDC laboratories that perform clinical testing, including those located in Anchorage, Atlanta, Fort Collins, and San Juan PR.
Specific information about the CLIA program can be accessed from this page, including links to the CLIA law and regulations, the CLIAC web page, CDC CLIA-related publications and educational products, and descriptions of current CLIA research.
CMS CLIA Overview
FDA CLIA Overview