Every medical laboratory needs to maintain a quality management system to provide accurate, consistent test results. Transitioning to an Individualized Quality Control Plan (IQCP) is expected to be a major area of focus for laboratories in 2015.
The CLIA Individualized Quality Control Plan (IQCP), a risk-based, objective approach to performing quality control testing was introduced by the Center for Medicare and Medicaid Services (CMS) in 2013 to replace the Equivalent Quality Control (EQC) procedure.
As compared to EQC’s standardized approach intended to minimize the amount of external QC required and laboratory costs, the IQCP addresses the risks involved in QC testing by taking into account all the possible sources of error specific to each individual laboratory, and is used to develop a customized QC plan that can change with changing technologies. The transitional period to the IQCP started January 1, 2014, will run through January 1, 2016.
Factors impacting the development of an IQCP include regulatory/accreditation requirements, manufacturer/product information, and the individual facility setting. The IQCP has three main elements: assessment of risk, development of a quality control plan (QCP), and ongoing quality assessment (QA). The risks assessed must include those associated with the specimen, environment, reagent, test system, and testing personnel covering the preanalytic, analytic, and postanalytic phases. The QCP covers all control procedures and is intended to address potential risks before they happen and cause failures. QA is a strategy to evaluate the effectiveness or performance of the QCP through ongoing laboratory monitoring and assessment of documentation generated via the QCP.
By 2016, the current daily minimum quality control (QC) or implementation of an IQCP will be required for CLIA QC compliance. But IQCP is not mandatory. A lab can elect to follow current CLIA QC regulations directly in order to demonstrate compliance. This is a feasible option for labs with fewer instruments where QC testing can pose a big cost burden. On the other hand, labs with a lot of medical laboratory equipment may find that the savings from implementing an IQCP would outweigh the costs of implementation.