Analysis of Incident/Accident Reports in the Department of Clinical Laboratory at Tohoku Medical and Pharmaceutical University Hospital: Effect of ISO 15189 Implementation on Medical Safety

Objective: Managing the safety and security of medical treatment information is critical for every clinical department in a hospital, and improving safety and security management is increasingly emphasized. Our laboratory, the Department of Clinical Laboratory, Tohoku Medical and Pharmaceutical Hospital, acquired ISO 15189 accreditation in January 2019. We sought to assess the effect of ISO 15189 quality management on medical safety by analyzing incidents and accidents before 2017 and from ISO 15189 acquisition until 2022.<br> Methods: We assessed the classification of incident severity, the medical services in which incidents occurred, the specific laboratory test steps in which incidents occurred, the variety and number of recurrences, and the medical services in which recurrent incidents were observed.<br> Results: No accidents above level 3b were observed over the study period, and the total number of incidents decreased significantly after 2020. Level 1 incidents in particular decreased notably after 2021. Incidents that occurred during the night shift/day duty dramatically decreased after 2019 (2017–2018, 21 cases; 2019–2022, 10 cases, p < 0.001). The proportions of incidents by laboratory test step remained unchanged. The number of recurrent incidents was highest in 2018 (12 cases) and then gradually decreased (2019, eight cases; 2020, five cases; and 2021, one case). No recurrent cases were observed after 2022. <br> Conclusions: Implementing a quality management system that meets ISO 15189 standards is associated with fewer incidents, especially in night shift/day duty services. Reducing recurrent incidents may require additional time, even with the application of ISO 15189 systems.