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Individualized Quality Control Plan (IQCP)

The "Individualized Quality Control Plan” (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) policy currently under development as an alternate QC option allowed by 42CFR493.1250.  The guidance and concepts for IQCP are a formal representation and compilation of many things laboratories already do to ensure quality test results.  IQCP permits the laboratory to customize its QC plan according to test method and use, environment, and personnel competency while providing for equivalent quality testing.   

Refer to the downloads and the related links section below for the following information:

  • Slide presentation, audio recording and written transcript from the CMS IQCP National Call on May 19 2014, file: 2014-05-09-CLIA ;
  • CLIA Individualized Quality Control Plan (IQCP) benefits;
  • Initial Plans and Policy Implementation for Clinical and Laboratory Standards Institute (CLSI) Evaluation Protocol-23 (EP), 'Laboratory Quality Control Based on Risk Management', as Clinical Laboratory Improvement Amendment (CLIA) Quality Control (QC) Policy, file: CMS1253857;
  • Implementing the Individualized Quality Control Plan (IQCP) for Clinical Laboratory Improvement Amendments (CLIA), file: CMS1256877; 
  • Individualized Quality Control Plan (IQCP): A New Quality Control (QC) Option, file: Survey and Cert Letter 13-54;
  • IQCP letter for CLIA certificate of compliance laboratories sent January 30, 2015; 
  • IQCP letter for provider-performed  microscopy procedure laboratories sent January 30, 2015; 
  • CLIA brochure #11 - CLIA Individualized Quality Control Plan Introduction;
  • CLIA brochure #12 - CLIA IQCP, Considerations When Deciding to Develop an IQCP;
  • CLIA brochure #13 - CLIA IQCP, What is an IQCP?;
  • FAQs for IQCP;
  • IQCP workbook - Developing on IQCP, A Step-by-Step Guide; 
  • Audio and written transcript from the IQCP Workbook National Webcast on July 15, 2015; and
  • Video from the IQCP Workbook National Webcast on July 15, 2015.

Any questions about IQCP should be forwarded to