Risk Management for Point-of-Care Testing

Point-of-care testing (POCT) is growing in popularity, and with this growth comes an increased chance of errors. Risk management is a way to reduce errors. Originally developed for the manufacturing industry, risk management principles have application for improving the quality of test results in the clinical laboratory. The Clinical and Laboratory Standards Institute (CLSI), EP23-A Laboratory Quality Control based on Risk Management guideline, introduces risk management to the clinical laboratory and describes how to build and implement a quality control plan for a laboratory test. A simple, unit-use blood gas analyzer is utilized as an example for developing a laboratory quality control plan. The US Centers for Medicare and Medicaid Services (CMS) has revised the Clinical and Laboratory Improvement Amendments (CLIA) interpretive guidelines to provide a new quality control option, individualized quality control plans (IQCP), for decreasing the frequency of analyzing liquid controls from two levels each day of testing to manufacturer recommended frequencies in conjunction with a device’s built-in internal control processes and the risk of error when testing with that device. IQCPs have the advantage of allowing laboratories the flexibility to adopt alternative control processes in concert with traditional liquid controls to improve efficiency and cost effectiveness while providing optimal quality POCT results for patient care.