부산대학교 도서관

Introduction: the Failure Mode Effects And Criticality Analysis (FMECA) is a proactive risk management tool that involves the analysis of a predefined process and the multidisciplinary identification of preventable defects/errors in order to prioritise the changes to be implemented. The Regional Centre for Health Risk Management and Patient Safety of Regione Lombardia (Italy) has drawn up together with the Regional Reference Centre for the Quality of Laboratory Medicine Services, an FMECA model for the management of the process of swabs for the detection of the SARS-CoV-2 virus during the recent pandemic. Methods: the application of FMECA involves several procedural steps, the first of which is the establishment of a multi-disciplinary and multi-professional team. For each process in the FMECA model, the working group identified, by means of a qualitative analysis, the frequency of occurrence, the severity of the effects and their detectability as well. Results: the working group found 118 different possible criticalities (items) in the entire process: 9 belonged to the Request Generation Phase, 35 to the pre-Analytical phase, 46 to the Analytical phase and 28 to the post-Analytical phase. The analysis of the Risk Index (RI), revealed that 81% of the items presented an acceptable risk, subject only to periodic monitoring, while 19% presented a low RI for which planned corrective measures were developed. Discussion: the working group considered the proactive approach useful in intercepting errors before they occur by identifying potentially dangerous situations. The FMECA model made it possible to act proactively on the threats inherent in laboratory processes, stimulating reflection in the identification of improvement actions, ensuring awareness of daily processes and increasing the spread of a preventive risk culture. [ABSTRACT FROM AUTHOR]