Analyse des risques appliquée au processus pré-analytique d'un laboratoire d’histocompatibilité

Abstract

AbstractIntroduction. Histocompatibility tests have found their place in the transplantation of organs and hematopoietic stem cells, hence the importance of ensuring the reliability of the results. This implies the mastery of the pre-analytical phase which plays a crucial role in the success of subsequent phases. The implementation of a quality management system in medical biology laboratories requires the application of risk analysis to the entire production process. The objective of the study is to identify the failure modes of the pre-analytical phase in the histocompatibility laboratory at the Ibn Sina University Hospital in Rabat.Material and method. We have adopted the failure modes, effects, and criticality analysis (FMECA), combined with the analysis of the causes through the 5M method (Man, Material, Machines, Methods, and Management). This method consists of defining the scope of the study, setting up the working group, describing the analysis process, analysing the process, and setting up an action plan.Results. The pre-analytical phase consists of 7 steps. 38 risks were identified of which 15.8 ٪ have high criticality (C3). Most of these risks concerned sampling step 15 (39.5 ٪), prescription 9 (23.7 ٪), and securing the sample 8 (21 ٪). 43 ٪ of the risks were linked to the human factor.Conclusion. This paper is part of the ISO 9001 certification process for the histocompatibility laboratory of the Ibn Sina University Hospital in Rabat. It made it possible to prioritize the risks in order to define the corrective measures likely to improve the reliability of the results provided.