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

Sicurezza in sala operatoria: utilizzo della tecnica FMEA/FMECA nel percorso diagnostico pre-analitico del campione biologico dalle sale operatorie ai laboratori

[Safety in the operating room: use of the FMEA/FMECA proactive analysis technique in the pre-analytical diagnostic pathway of the biological sample from the operating room to laboratories]The inaccurate management of biological samples is one of the errors that can occur in the operating room: it can lead to a loss, incorrect labeling or storage of the sample, causing serious consequences for the patient. Proactive analysis of this high-risk process can reduce the possibility of this type of errors, improving patient safety and reliability of activities. A risk analysis technique employing proactive logic is the Failure and Effects Analysis/ Failure Mode, Effects, and Criticality Analysis (FMEA/FMECA).This paper describes an inter-professional and inter-facility project in which the FMEA / FMECA has been applied to the biological sample path from the operating room to the destination laboratories in two healthcare facilities in Bologna: the University Hospital S. Orsola Malpighi (AOU BO) and the Rizzoli Orthopedic Institute (IRCCS IOR). The aim of the project was to improve the safety and the reliability of the routine and urgent diagnostic procedure in these healthcare facilities.Two different working groups, belonging to the two healthcare facilities and composed of operating room doctors and nurses, have implemented the methodological steps of the FMEA/FMECA technique.At the end of the analysis process, 16 failure mode (FM) were identified at the AOU BO and 21 at the IRCCS IOR. Each FM was assigned a risk priority index (RPI) and the main causes and improvement actions to be planned were identified.Interventions were therefore undertaken to improve the safety and reliability of the riskiest welfare practices.A re-evaluation of the RPIs at 6 months-1 year from the improvement interventions will be carried out.The FMEA / FMECA technique gave the opportunity to the professionals involved to approach the adverse event through a new approach, which is the proactive method of risk analysis, using methods and tools for the improvement of patient safety that are independent, at least in part, from the study of the adverse event or near miss, representing an important step towards a real culture of security