[Primary role of public health management centers in patient safety]

Objectives　In 2023, the Kobe City Public Health Management Center (KCPHMC) conducted an extraordinary on-site inspection based on the Medical Care Act and provided administrative guidance after a whistleblower report regarding Hospital A. However, owing to repeated legal violations, the KCPHMC eventually issued an improvement measure. In this study, we evaluated the various steps of the interventions implemented by the KCPHMC to establish a patient safety management system (PSMS), clarified the role of a public health management center, and identified the remaining unresolved issues.Methods　A factual overview is provided based on the relevant documents in this case. Subsequently, the KCPHMC-induced interventions were divided into four verification items, including the processes of extraordinary on-site inspections under the Medical Care Act, fact-finding and guidance, evaluation of improvements, and decision making, and analyzed retrospectively. We evaluated the validity of the inspection methods following the detection of the case and its legitimacy, the impact of the identification of root causes and providing guidance, and the utility of the methods used by KCPHMC to evaluate improvements and the decision-making processes.Results　The application of Article 25(2) of the Medical Care Act for on-site inspections was found to be valid. The process-from the selection of investigation targets and fact-finding processes for the determination of legal violations to the issuance of an improvement order-was appropriate. Identifying the organizational background as the root cause led to fundamental improvements. In addition to the guidance of the KCPHMC, expert advice regarding the PSMS enabled Hospital A to incorporate advanced measures into the improvement plans. The check system to evaluate PSMS improvement, using improvement-verification tables that were cross-verified by the KCPHMC and Hospital A, promoted PSMS activities and the establishment of a PSMS culture. As the concern strongly affected the regional medical system, discussions and policy decisions were made by departments other than the KCPHMC in Kobe City, depending on the nature of the case.Conclusions　In case of a dysfunctional PSMS, the hospital faces difficulties in self-correction. KCPHMC-instituted interventions, including extraordinary inspections, fact-finding, improvement orders, root-cause analysis, formulation of fundamental improvement plans, and subsequent evaluations, were crucial for the reconstruction of the PSMS. In such cases, where there is a potential threat to citizens' lives and an impact on the regional medical system, proactive intervention by the health center is important. Simultaneously, we noticed a shortage of expertise and human resources in this process. Further knowledge regarding effective interventions and guidance by health centers is required.