Our efforts of dealing with incidents in Department of Clinical Laboratory at Tohoku Medical and Pharmaceutical Hospital: Application example of ISO 15189

Abstract

To avoid medical incidents and to improve the quality of medical care in healthcare settings, excellent and intense safety management has been required. ISO 15189 (ISO) is an international standard known as an organizational management tool for clinical laboratories, and it has been reported to improve quality assurance and safety management. We analyzed the number of incidents from 2017 to 2022, categorized by standard requirements of ISO. As a result, the years and numbers of incident cases were as follows: 2017, 27; 2018, 30; 2019, 14; 2020, 15; 2021, 6; 2022, 8. We found that the numbers were markedly reduced after 2019 when our laboratory acquired ISO in January of this year. We found that more than 80% of the incidents arose from “5.4 pre-examination processes” (42%), “5.5 examination processes” (39%), and “5.8 reporting of results” (14%), and the proportions have mostly remained unchanged throughout this period. Moreover, we introduce two documents with our original tips in ISO, which may reduce the number of incidents. One is “Flow chart to get to the roots of the problems about procedures”, and the other is “Improvement and prevention plans/reports”. Through these two documents, relevant divisions can easily and quickly identify the cause, plan, and perform corrective actions, and share the results with the entire clinical laboratory. Moreover, we consider that our quality managers play an important role in reducing the number of incidents, since they always carefully check, assess, and provide directions for corrective actions.