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Individualized Quality Control Plan (IQCP)

The CLIA Individualized Quality Control Plan (IQCP) is a recently developed objective approach to performing quality control (QC) testing. It is an alternate QC option allowed under CMS regulation 42 CFR §493.1250 and applies to non-waived testing. Waived testing is not affected by IQCP.

Participation in IQCP is voluntary, replacing the current Equivalent Quality Control (EQC) procedures already in place for non-waived testing. It’s designed to offer an individualized quality control plan specifically tailored to each individual laboratory rather than a general standardized “one size fits all” plan. Of course, laboratories may elect to follow current CLIA QC regulations directly in order to demonstrate compliance rather than implement IQCP.

The IQCP is composed of three key concepts essential for evaluating good quality control:

Concept Description  
Risk Assessment
(RA)
Risk Assessment is the process of identifying, evaluating and controlling potential sources of error. For IQCP, these sources include risks associated with:
  • the specimen
  • environment
  • reagent
  • test system, and
  • testing personnel

and cover the preanalytic, analytic, and postanalytic phases of the testing process.

 
Quality Control Plan
(QCP)
The Quality Control Plan is a comprehensive strategy for detecting errors and reducing risk. It is intended to proactively address potential risks before they occur. The QCP is based on the risks identified through the Risk Assessment process.  
Quality Assessment
(QA)
Quality Assessment is a method for monitoring the IQCP plan for effectiveness. Identification of failures or risks through QA almost always results in the modification of the IQCP plan, thus improving the overall effectiveness of the lab’s IQCP.  
IQCP Key Points to Consider    
  • IQCP is voluntary for laboratories. The other acceptable option is the CLIA quality control regulations.
  • IQCP = Risk Assessment (RA) + Quality Control Plan (QCP) + Quality Assessment (QA)
  • Risk Assessment (RA) must include the five components (environment, testing system, testing personnel, specimen, and reagents) and entire testing process (pre-analytic, analytic and post-analytic).
  • The manufacturer’s instructions are a good starting point to identify potential errors for the RA.
  • Lab needs to use default QC during the RA study.
  • RA identifies and evaluates potential failures and sources of errors in the testing process.
  • The QCP is a written procedure that outlines steps to prevent or reduce risks and should be supported by data, with ongoing monitoring that is adjusted when necessary. The lab director must approve, sign, and date the QCP.
  • QA program monitors the IQCP for effectiveness.
  • IQCP is available for all specialties except Pathology.
  • After 1/1/16 EQC will no longer be an option. Either the CLIA QC regulations or IQCP must be followed.
  • Other sources for additional information include: