Patient safety and risk management in medical laboratories: theory and practical application

Ada Aita, Andrea Padoan, Giorgia Antonelli, Laura Sciacovelli, Mario Plebani


Patient safety, defined by the Institute of Medicine (IOM) as “the prevention of harm to patients”, is the ultimate goal of medical laboratory services. Although it has been demonstrated that the error rate in medical laboratories is very low compared to the billions of tests daily performed, and that most of these errors rarely become unfavourable events, adverse outcome may occur and may also become the object of daily news. Risk management principles should therefore be considered as integral parts of laboratory in assuring quality and safety, so that they have become actual requirements (4.14.6) of International Organization for Standardization (ISO) 15189:2012, the international standard for accreditation of medical laboratories. Risk is no longer thought in negative sense, but becomes a tool to identify improvement opportunities and preventing negative outcomes. ISO/TS 22367 and some Clinical and Laboratory Standards Institute (CLSI) guidelines (i.e., EP18-A2 and EP23-A) introduce risk management principles and they can be used for driving application of ISO 15189 as a system for reducing laboratory error and improving patient safety. Laboratory goals, organization within which the laboratory operates along with available resources, are all key elements for selecting the technique to be used for risk assessment. However, although different approaches have been suggested, failure modes and effects analysis (FMEA) is the most commonly applied. There are currently few reports on active use of risk management tools in medical laboratories. Some of these are limited to risk identification and estimation steps, whilst others report corrective measures without verifying their effectiveness. Risk management, however, is a process consisting of three main phases (i.e., risk identification, estimation and control), and should hence embrace all its phases to achieve its goal, that is ensuring patient safety. This paper summarizes the principles of risk management process applied to clinical laboratory and discusses some practical applications available in the literature.