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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

  • On May 15, 2015, CDC's Division of Laboratory Systems in CSELS/OPHSS in conjunction with Centers for Medicare & Medicaid Services (CMS), Division of Laboratory Services launched a new step-by-step instructional workbook to assist laboratories with meeting CLIA quality control requirements. The Individualized Quality Control Plan (IQCP) is a new QC option to meet CLIA regulations based on an assessment of the risk of errors or failures in the testing process and the laboratory's plan to reduce or mitigate those risks. IQCP might be considered when the manufacturer's instructions for frequency of QC testing are less stringent than the CLIA regulations. This workbook is designed to assist laboratory staff in developing an Individualized Quality Control Plan (IQCP) for tests that they perform. "Developing an IQCP: A Step-By-Step Guide" is now available on this website.  IQCP is currently in an education and transition period until the end of 2015 and it becomes effective as of January 1, 2016.  More information can be found on the CMS CLIA website at:

     — 08/25/2015

News and Announcements Archive