Clinical Laboratory Improvement Amendments

Background

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:

• Employment-related drug testing by SAMSHA certified laboratories
• Testing performed for forensic purposes (criminal investigations)
• Research or surveillance testing performed on human specimens in which patient-specific results are not reported (if the results are not used for diagnosis or treatment decisions).

For more information, please refer to CLIA at 42 CFR 493.3.

Responsibilities

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:

• Providing analysis, research, and technical assistance.
• Developing technical standards and laboratory practice guidelines, including standards and guidelines for cytology.
• Conducting laboratory quality improvement studies.
• Monitoring proficiency testing practices.
• Developing and distributing professional information and educational resources.
• Managing the Clinical Laboratory Improvement Advisory Committee (CLIAC).

Laws and regulations

Law

Clinical Laboratory Improvement Amendments (42 USC 263a)1

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.

Regulations

Standards and Certification: Laboratory Requirements (42 CFR 493)1

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.

Interpretive guidelines

CMS Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (Appendix C)

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.

United States code history

Clinical Laboratory Improvement Act of 19672

Clinical Laboratory Improvement Amendments of 19883

Food and Drug Administration Modernization Act of 19974

Taking Essential Steps for Testing Act of 20125

Certificates

Apply for a certificate

Get information about W-9 forms, certificate status, renewal fee coupon, updating certificate information, regulations, and licensure from your state agency.

Training

Free Educational Materials for Public Health and Clinical Laboratories

Download or order free brochures and booklets for waived testing, such as:

• “To Test or Not to Test?”
• “Ready? Set? Test!”
• Provider-Performed Microscopy (PPM)
• Individualized Quality Control Plan (IQCP)

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.

Contacts

Contact LabExcellence@cms.hhs.gov for CLIA-related questions.

Contact CDC-INFO for 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.

Resources

FDA's CLIA test categorization database: Look up tests and analytes.

FDA's Over-the-Counter Database: Search for all FDA-cleared over-the-counter tests.

CMS' CLIA home page

FDA'S CLIA home page

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.