A FMEA Clinical Laboratory Case Study: How to Make Problems and Improvements Measurable MARIO CAPUNZO, PIERPAOLO CAVALLO, GIOVANNI BOCCIA, LUIGI BRUNETTI, AND SANTE PIZZUTI The authors have experimented the application of the Failure Mode and Effect Analysis (FMEA) technique in a clinical laboratory. FMEA technique allows: a) to evaluate and measure the hazards of a process malfunction, b) to decide where to execute improvement actions, and c) to measure the outcome of those actions. A small sample of analytes has been studied: there have been determined the causes of the possible malfunctions of the analytical process, calculating the risk probability index (RPI), with a value between 1 and 1,000. AQ1 Only for the cases of RPI > 400, improvement actions have been implemented that allowed a reduction of IPR values between 25% to 70% with a costs increment of <1%. FMEA technique can be applied to the processes of a clinical laboratory, even if of small dimensions, and offers a high potential of improvement. Nevertheless, such activity needs a thorough planning because it is complex, even if the laboratory already operates an ISO 9000 Quality Management System. BACKGROUND Failure Mode and Effect Analysis (FMEA), together with other techniques, such as Fault Tree Analysis and Event Tree Analysis, is one of the process risk evaluation techniques that can be used to identify AQ2 and measure the malfunction hazards of a process (1). FMEA is based on a preliminary study of safety and functionality of a component, part, product, or productive phase, developed taking into account its possible failure modes, the effects, the critical points, and the causes that have generated them. FMEA is based on a preliminary study of safety and functionality of a component, part, product, or productive phase, developed taking into account its possible failure modes, the effects, the critical points, and the causes that have generated them. The FMEA target is to measure the risk probability of any possible failure or nonconformity (NC), by an index, called risk probability index (RPI), that is the product of: A the ‘‘severity index’’ (SI), from 1 to 10 A the ‘‘probability index’’ (PI), from 1 to 10 A the ‘‘detectability index’’ from 1 to 10. The RPI can go from a minimum of 1 (1 1 1) to a maximum of 1,000 (10 10 10). In general, the improvement interventions start from the NC/failures with RPI > 400, and for each intervention it is possible to evaluate the RPI reduction, expected and actual, and the cost for RPI unit reduction. We have evaluated an experimental application of the FMEA method to some analytical processes of a clinical laboratory. January/February 2004 1 Mario Capunzo, M.D., is a Professor of Hygiene and Director of the Laboratory of Hygiene and Occupational Medicine at the University of Salerno, Italy. His research interests focus on the epidemiology and diagnostics of occupational illnesses, and on infectious diseases prevention. Pierpaolo Cavallo, M.D., is a Contract Professor at the University of Salerno, Italy. He works as Director of Ippocratica Diagnostica Research Center, Salerno, Italy, and is a Quality Management Systems Lead Auditor registered by IRCA (UK). His research interests include quality management systems in health organizations, health economics, and quantitative management methods development. Giovanni Boccia, M.D., is a Specialist in Hygiene and Preventive Medicine and a coworker of the Laboratory of Hygiene and Occupational Medicine at the University of Salerno, Italy. His research interests focus on the epidemiology and diagnostics of occupational diseases. Luigi Brunetti, Biologist, is the Chief Technician of the Laboratory of Hygiene and Occupational Medicine at the University of Salerno, Italy. His research interests focus on laboratory diagnostics of occupational illnesses and quality improvement. Sante Pizzuti, Chemist, is the Director of the Chemical Laboratory at Ippocratica Diagnostica Research Center, Salerno, Italy, where he is attending the ISO 17025 accreditation process. His research interests focus on laboratory organization and quality improvement. Copyright # 2004 by Clinical Laboratory Management Association Inc.