Individualized Quality Control Plan (IQCP)

Welcome to LabUniversity’s Individualized Quality Control Plan (IQCP) Program. For healthcare professionals with key roles in providing effective and quality-driven laboratory medicine, the debate over laboratory procedures for Quality Control (QC) is familiar. Questions often include: How is QC defined? What guidelines should be followed for when and how QC should be performed? Do the physician’s office laboratory and hospital laboratory have similar QC requirements?

Whether performing QC in the physician’s office laboratory, the hospital laboratory, or any other clinical laboratory, effective QC offers patients and healthcare providers reassurance that test results obtained on patient specimens are accurate. With continual technology advances in laboratory diagnostics, not only have laboratory QC procedures evolved, so has the approach laboratorians take in developing an overall QC Plan. With the 2004 adoption by the Centers for Medicare & Medicaid Services (CMS) of Equivalent Quality Control (EQC) as an alternative form of QC, laboratories were able to decrease the frequency of testing external controls after performing a successful standardized qualifying study.

Even though many labs implemented EQC without difficulty, there were a number of potential errors which could lead to inaccurate results that were not detected by the test system’s internal controls or by the EQC qualifying studies. Consequently, regulators and healthcare professionals began considering potential errors that may not have been addressed in the EQC process. As a result, CMS initiated the development of a new alternative QC option, known as the “Individualized Quality Control Plan” (IQCP). The goal: to allow healthcare professionals to utilize risk assessment to identify, assess and mitigate potential errors that could occur in their laboratories, during all phases of specimen testing, in order to provide the most effective QC for the test.

The Education and Transition period for this new alternative QC policy began January 1, 2014, and ended on January 1, 2016. As of this end date, EQC is no longer an acceptable QC option and laboratories must perform the CLIA requirement for QC (usually 2 levels each day of testing) or implement the alternative QC option IQCP.

Individualized Quality Control Plan (IQCP) is effective QC that allows laboratories to consider all of the possible sources of errors unique to their individual laboratory, so they can develop a QC plan that is customized for their testing workflow process, while maintaining compliance with the applicable regulations.

In the years since the publication of the final CLIA regulations, the frequency with which laboratories have been required to perform external QC and other quality checks has been widely discussed. A comprehensive approach to QC, which complies with regulations while meeting the needs of the majority of the laboratory community, has emerged in the form of IQCP.

IQCP is quality control based on Risk Management. Risk management is the sequential process of risk identification, risk assessment and risk mitigation.

The process of risk management includes:

• Identifying potential sources of errors;
• Evaluating the errors to determine their impact on patient test results;
• Controlling the errors in such a way that any remaining risk is acceptable.

The cornerstone of IQCP is identifying, evaluating, and controlling potential sources of error relevant to the individual laboratory. Performing a Risk Assessment will facilitate the development of an IQCP to implement targeted quality control measures.

 

A key contributor to the development of an effective Individualized Quality Control Plan (IQCP) is education. For some healthcare professionals, risk management is a well-known and commonly used process; however, for others, this may be an area where knowledge is limited. Our Educational program is designed to educate and strengthen IQCP core competency by offering an array of tools to help develop an effective IQCP.