Risk Management in the Clinical Laboratory

Abstract

Clinical laboratory tests play an integral role in medical decision-making and as such must be reliable and accurate. Unfortunately, no laboratory tests or devices are foolproof and er- rors can occur at pre-analytical, analytical and post-analytical phases of testing. Evaluating possible conditions that could lead to errors and outlining the necessary steps to detect and prevent errors before they cause patient harm is therefore an important part of laboratory testing. This can be achieved through the practice of risk management. EP23-A is a new guideline from the CLSI that introduces risk management principles to the clinical labora- tory. This guideline borrows concepts from the manufacturing industry and encourages laboratories to develop risk management plans that address the specific risks inherent to each lab. Once the risks have been identified, the laboratory must implement control pro- cesses and continuously monitor and modify them to make certain that risk is maintained at a clinically acceptable level. This review summarizes the principles of risk management in the clinical laboratory and describes various quality control activities employed by the laboratory to achieve the goal of reporting valid, accurate and reliable test results.