La tecnica di analisi proattiva FMEA/FMECA per la gestione del rischio clinico in diagnostica di laboratorio

[FMEA/FMECA proactive analysis technique for clinical risk management in laboratory diagnostics] At the IRCCS Rizzoli Orthopaedic Institute of Bologna the FMEA/FMECA technique has been used for several years in the laboratory diagnostics setting for the analysis of processes, the proactive identification of possible mistakes and the implementation of improvement actions. In five laboratories of the Institute, current critical processes have been mapped to identify priority risks. Therefore, the intervention priorities have been defined, the improvement plans implemented and the efficacy in reducing the risks evaluated. The results were assessed by calculating the index of improvement (IM), as the ratio between the value of the Risk Priority Number (RPN) obtained by an evaluation before ( ex-ante ) and after ( ex-post ) the improvement actions. In all analyzed diagnostic processes initial values RPN were reduced and all IM showed values > 1. In addition, as result of risk analysis, 75 improvement actions were implemented, divided into: training/information (18,7%), organizational changes (53,3%), acquisition/maintenance of equipment and technologies (10,7%), revision and elaboration of procedures/protocols (16%), structural adjustments (1,3%). The technique FMEA/FMECA has proven to be useful to identify critical and high-risk processes proactively and to implement improvement actions according to priorities.