Individualized Quality Control Plan (IQCP)
The "Individualized Quality Control Plan” (IQCP) is the Clinical Laboratory Improvement Amendments (CLIA) Quality Control (QC) procedure for 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.
The IQCP procedure is located in the guidance for §493.1256(d) found in the State Operations Manual, Appendix C - Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services (PDF). Refer to the downloads and the related links sections below for the State Operations Manual and additional educational information.
Any questions about IQCP should be forwarded to LabExcellence@cms.hhs.gov.
FAQs for IQCP - Revised August 2016 (PDF)
IQCP Workbook - Developing an IQCP, A Step-by-Step Guide – 5/15/2015 (PDF)
som107ap_c_lab - Rev. 166, 02-03-17 (PDF)
CLIA Brochure - CLIA Individualized Quality Control Plan Introduction – July 2013 (PDF)
CLIA Brochure - CLIA IQCP, Considerations When Deciding to Develop an IQCP - November 2014 (PDF)
CLIA Brochure - CLIA IQCP, What is an IQCP? - November 2014 (PDF)