Tips for Optimizing Individualized Quality Control Plan Effectiveness

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Nine months after the Individualized Quality Control Plan (IQCP) replaced EQC (Equivalent Quality Control) as the only federally approved alternative quality control option, COLA Resources Inc.,® (CRI) is offering tips to help labs get the most out of the new risk management process.

“It is not enough to simply have IQCP plans in place,” said James Liggins, CEO of CRI, the educational subsidiary of COLA. “As with any quality control program, labs must also constantly monitor their plans in the context of their unique requirements, especially in the constantly changing lab testing environment.”

IQCP allows labs to consider all possible sources of errors unique to their individual laboratory, and to develop quality control plans customized for their testing workflow process, while maintaining compliance with applicable regulations.

Because any changes in testing protocol, instrumentation, reagents, test location, and even personnel can affect the quality of lab work, Liggins said that lab managers should implement a series of protocols to ensure that their IQCPs continue to manage risk effectively. These include:

  • Establishing a review system to monitor each IQCP. Reviews should be performed semi-annually during the first year, then annually, with additional reviews conducted when changes are made in package insert instructions
  • Monitoring each required component of IQCP by reviewing reports and documentation that your plan uses to prevent errors and ensure accurate results
  • Creating additional monitors, unique to each test system, that reveal how many times a particular error occurs. If there is a testing process failure, the lab should investigate its cause and impact on patient care, and make appropriate modifications to their Quality Control plan.
  • Maintaining documentation that all required reviews have been completed

“Ultimately, the best test for determining if your lab’s IQCP plans are working is to look back and assess whether systematic errors have been caught before results were released; quality issues were the same or lower than in the previous review; and quality control failures were analyzed and addressed,” said Liggins.

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