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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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CLIA News and Announcements

  • The Division of Laboratory Systems (DLS) in CDC’s Center for Surveillance, Epidemiology, and Laboratory Services (CSELS) has two new tools now freely available for use by sites that perform testing under a Clinical Laboratory Improvement Amendments (CLIA) Certificate of Waiver or Certificate of Provider-performed Microscopy Procedures. Both tools were developed by DLS as a result of the recommendation and input from the Clinical Laboratory Improvement Advisory Committee (CLIAC).

    • Waived Testing Checklist:

      This self-assessment checklist emphasizes recommended practices for physicians, nurses, medical assistants, pharmacists, and others who perform patient testing under a CLIA Certificate of Waiver. It can be used as a voluntary tool to help assure good testing practices and reliable, high quality test results. Please view the Self Assessment Checklist under Educational Materials here.

      In November 2014, CLIAC emphasized the need to develop a non-punitive and non-regulatory self-assessment checklist-type tool and recommended it for biennial use by all Certificate of Waiver testing sites. The tool could also be used prior to or at the time a site first applies for a CLIA Certificate. Please view past CLIAC meetings here.

    • Provider-Performed Microscopy (PPM) Procedures Booklet:

      This booklet describes recommended practices for physicians, midlevel practitioners (nurse midwife, nurse practitioner, or physician assistant), and dentists who perform patient testing under a CLIA Certificate for PPM procedures. The booklet contains an overview of the regulatory requirements, resources including forms and examples, and an overview with images of common microscopic findings for the nine specific microscopic examinations that may be performed under a Certificate of PPM Procedures. Please view the Provider-Performed Microscopy Procedures booklet under Educational Materials here.

     — 07/18/2016

News and Announcements Archive