Risk Management in Clinical Laboratory: from Theory to Practice

Abstract

Abstract Clinical laboratory tests ensure approximately 70% of the medical decisions, so that the time until the release of the results and its accuracy are critical for the diagnosis and the efficiency of the treatment [1]. Risk management involves both the anticipation of what could happen erroneous and the assessment of errors’ frequency as well as the consequences or the severity of the effects caused by it, and finally to decide what can be done in order to reduce the risk to an acceptable clinical level. For this reason, organizations should not see the risk management as a compliance issue, but as an integral part of the decision-making process. EP23-A is a guideline of CLSI that introduces the risk management principles in the clinical laboratory and encourages the laboratories to develop plans of risk management which are addressed to the risks of each laboratory. EP18-A2 proposes 2 techniques for identifying and controlling the errors in the laboratory: FMEA (Failure Mode and Effects Analysis) and FRACAS (Failure Reporting, Analysis and Corrective Action System). The European Committee of Experts and Management of Safety and Quality in Health Care proposed to use the quality indicators to identify the critical stages of each process, thus being possible to assess continuously the medical processes with the aim of identifying the errors when they occur. This review summarizes the principles of the risk management in the clinical laboratory, thus it can achieve its aims to report valid, accurate and reliable test results