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Overview

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. CDC, in partnership with CMS and FDA, supports 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)

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Regulatory

CLIA Law & Regulations

View Clinical Laboratory Improvement Amendments of 1988 and the regulations applicable to all U.S. clinical laboratories

CLIA History

Search and view historical regulations and announcements related to CLIA

CLIAC

Visit CLIA’s Federal Advisory Committee website for information on the Committee and their meetings

 

Resources

Laboratory Search

Look up demographic information on CLIA-certified clinical laboratories

Test Complexities

Learn how laboratory tests are evaluated by the FDA and how the CLIA regulations apply to different groups of tests

Links

Access laboratory related organizations and resources

CLIA News and Announcements

  • Help CDC and APHL to understand how laboratories throughout the United States use proficiency testing (PT) beyond meeting requirements and how you perceive its value.

    Results from the survey will be compiled and shared anonymously as a summary document used in learning tools, presentations at professional conferences and potentially published in a professional journal in the field of laboratory science.

    Please visit www.surveymonkey.com/s/aphl to begin your survey or email ptsurvey@aphl.org to request a paper copy.

    Survey will be open through November 2013. — 10/04/2013
  • Educational materials on good laboratory practices for waived testing are available on the CDC’s website. Materials include an online training module, two booklets, a poster, and a postcard. — 05/20/2013

News and Announcements Archive

 
Contact Us:
  • Centers for Disease Control and Prevention,
    Division of Laboratory Programs, Standards, and Services
    1600 Clifton Road
    Mailstop F-11
    Atlanta, GA 30333, USA
  • CLIA Direct Line:
    404-498-2290
  • CLIA@cdc.gov
USA.gov: The U.S. Government's Official Web PortalDepartment of Health and Human Services
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