Failure Mode, Effects, and Criticality Analysis (FMECA) per l’elaborazione del “protocollo di convalida” del processo di controllo della sterilità delle unità di emocomponenti: esperienza della Fondazione Policlinico Universitario A. Gemelli IRCCS, Roma

[Autom. eng. transl.] Introduction Risk management tools in the healthcare sector are increasingly used. Among these, especially proactive ones, capable of identifying the potential weaknesses of the system to develop corrective measures before the occurrence of an adverse event, are a valid tool for process governance. The purpose of this study is the validation of an FMECA to identify and quantify situations at risk of microbiological contamination in the process of collection and production of blood component units for clinical use, in a logic of continuous quality improvement. Materials and methods The Blood Transfusion Service of the facility under study produces approximately 27,000 units of blood components each year, including those for transfusion and plasma intended for the pharmaceutical industry. In addition to the regular self-control activities carried out by the Service, the Complex Hospital Hygiene Operative Unit carries out sterility tests for process control. A working group consisting of specialist and training medical hygienists, blood transfusionists and biologists has been set up to develop an FMECA model through a shared assignment of scores with three parameters (score 1-10 for each parameter, according to the scales proposed by the National Blood Center): Probability of the event happening; Failure detection; Severity of the consequences. The product of these three values represents the Risk Priority Index (IPR). For the purposes of programming the sterility tests, activities with IPR> 100 or with a Severity value greater than 8 were considered relevant. For each possible failure, the corrective action to be taken was planned. Results The FMECA was broken down into four main macrophases: collection of whole blood or blood components; red blood cells; plasma; platelet concentrates. A total of 13 phases and 26 sub-phases were analyzed: out of a total of 43 error modes, 19% were assessed as relevant. The disinfection activity of the skin in the collection phase, with the failure modes of "non-disinfection" and "disinfection not according to the procedure", obtained the highest IPR (162). In 100% of the activities considered relevant, the cause was human error, so corrective actions are represented by training interventions and verification of knowledge of procedures. Conclusions There is no evidence in the literature on the application of proactive risk management tools in blood transfusion. From our analysis the activities with the highest risk of contamination are the inspection and disinfection of the skin. The use of risk analysis methods such as FMECA allows the process control on the production of blood components to be programmed more effectively and efficiently.