The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease.
Exceptions to the CLIA regulations exist for certain testing, including:
For more information, please refer to CLIA at 42 CFR 493.3.
CDC partners with Centers for Medical and Medicaid Services (CMS) and the Food and Drug Administration (FDA). Together they support the CLIA program and clinical laboratory quality.
CDC’s responsibilities for the national CLIA program include:
The CLIA statute is an amendment to the Public Health Services Act. In this Act, Congress revised the federal program for certification and oversight of clinical laboratory testing. Two subsequent amendments were made after 1988. The law continues to be cited as CLIA ’88 as named in legislation.
The section of the federal regulations titled "Standards and Certification: Laboratory Requirements" is issued by CMS. It's purpose is to enact the CLIA law passed by Congress (see below).
CLIA regulations establish quality standards for laboratory testing performed on specimens from humans, such as blood, body fluid, and tissue. This is done for the purpose of diagnosis, prevention, or treatment of disease, or assessment of health. The final CLIA regulations were published in 1992, phased in through 1994, and amended in 1993, 1995, and 2003.
Visit CLIA Documents to search and view the Federal Register Notices and former editions of the Code of Federal Regulations. It is published each October.
The interpretive guidelines to the CLIA regulations are published in the CMS State Operations Manual (SOM). The SOM is used by state offices to administer various federal programs. This includes clinical laboratory certification under the CLIA regulations. They are enforced by CMS. It is also a source of guidance to laboratories for interpreting the CLIA regulations.
Get information about W-9 forms, certificate status, renewal fee coupon, updating certificate information, regulations, and licensure from your state agency .
Download or order free brochures and booklets for waived testing, such as:
Ready? Set? Test!
This free, on-demand eLearning course is available through CDC’s Laboratory Training website. You can find many more free trainings, including ones that offer P.A.C.E.® credit.
For CLIA-related questions please contact:
CDC-INFO: CDC’s national contact center and publications
Pay your CLIA laboratory user fee online or mail your payment to the address on the coupon by U.S. Postal Service only.
CDC does not issue CLIA certificates or process fee payments. Please contact your state agency for assistance.
FDA's Over-the-Counter Database : Search for all FDA-cleared over-the-counter tests.
Clinical Laboratory Improvement Advisory Committee (CLIAC)
CLIAC, managed by CDC, provides the Department of Health and Human Services (HHS) with scientific and technical advice and guidance. It is related to clinical laboratory quality improvement and laboratory medicine practice.