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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

  • The Clinical Laboratory Improvement Advisory Committee (CLIAC) is a Federal Advisory Committee managed by CDC that provides scientific and technical advice to HHS regarding clinical laboratory quality, laboratory medicine practices, and possible revision of the CLIA standards.

    The fall CLIAC meeting was held November 4-5, 2014 in Atlanta, GA.  At the conclusion of the two day meeting, the following recommendations were made by the Committee.

    • Recommend that: HHS should facilitate the development of a non-punitive and non-regulatory self-assessment checklist-type tool and recommend it for biennial use by all Certificate of Waiver testing sites. It could also be used prior to or at the time a site first applies for a CLIA Certificate.
    • Recommend that: CMS should revisit the A19 request to open up the CLIA law to allow changes to the waived testing requirements and provide a description of the details of the A19 request at the next CLIAC meeting.
    • Recommend that:  CMS should explore:
    • Regulatory changes or guidance(s) that would allow virtual crossmatching to replace physical crossmatching as a pre-requisite for organ transplant;
    • Appropriate criteria and decision algorithms, based on the Virtual Crossmatch Workgroup input provided to CLIAC, under which virtual crossmatching would be an appropriate substitute for physical crossmatching. The determination of appropriate criteria and decision algorithms should involve a process that includes an open comment period.

    To learn more about CLIAC, or to view the meeting summary that includes the complete recommendations and presentations, go to http://wwwn.cdc.gov/cliac/.

     — 02/03/2015

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
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