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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:

  • 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;
  • CLIA brochure #11 - CLIA Individualized Quality Control Plan Introduction; and
  • IQCP announcement letter for CLIA certificate of compliance and provider-performed  microscopy procedure laboratories.

Any questions about IQCP should be forwarded to IQCP@cms.hhs.gov.