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患者安全管理系统及相关活动对促进院内自愿报告和强制性国家级报告的影响:一项横断面研究。

Patient safety management systems and activities related to promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues: A cross-sectional study.

机构信息

Toho University School of Medicine, Tokyo, Japan.

Hitachinaka General Hospital, Ibaraki, Japan.

出版信息

PLoS One. 2021 Jul 28;16(7):e0255329. doi: 10.1371/journal.pone.0255329. eCollection 2021.

Abstract

Both voluntary in-hospital reporting and mandatory national-level reporting systems for patient safety issues need to work well to develop a patient safety learning system that is effective in preventing the recurrence of adverse events. Some of the hospital systems and activities may increase voluntary in-hospital reporting and mandatory national-level reporting. This study aimed to identify the hospital systems and activities that increase voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues. An anonymous mail survey of hospitals in Japan was conducted in 2017. The hospitals were selected by stratified random sampling according to number of beds. The survey examined the annual number of reported events in the voluntary in-hospital reporting system for patient safety and experience of reporting unexpected patient deaths possibly due to medical interventions to the mandatory national-level reporting system in the last 2 years. The relationship of the answer to the questions with the patient safety management systems and activities at each hospital was analyzed. The response rate was 18.8% (603/3,215). The number of in-hospital reports per bed was positively related to identifying events by referring complaints or questions of patients or family members, using root cause analysis for analyzing reported events, and developing manuals or case studies based on reported events, and negatively related to the unification and standardization of medical devices and equipment. The experience with mandatory national-level reporting of serious adverse events was positively related to identifying problematic cases by a person in charge of patient safety management from the in-hospital reporting system of complications and accidental symptoms. Enhanced feedback for reporters may promote voluntary in-hospital reporting of minor cases with low litigation risks. Developing an in-hospital mechanism that examines all serious complications and accidental symptoms may promote mandatory national-level reporting of serious adverse events with high litigation risks.

摘要

自愿院内报告和强制性国家级报告系统都需要良好运行,以建立一个有效的患者安全学习系统,防止不良事件再次发生。一些医院系统和活动可能会增加自愿院内报告和强制性国家级报告。本研究旨在确定增加自愿院内报告和强制性国家级报告的医院系统和活动。2017 年,对日本的医院进行了匿名邮件调查。医院根据病床数量进行分层随机抽样选择。调查检查了自愿院内报告系统中报告的患者安全事件的年度数量,以及过去 2 年向强制性国家级报告系统报告可能因医疗干预导致的意外患者死亡的经验。分析了回答这些问题与每家医院的患者安全管理系统和活动之间的关系。回应率为 18.8%(603/3,215)。每床住院报告数量与通过参考患者或家属的投诉或问题来识别事件、使用根本原因分析来分析报告事件、根据报告事件制定手册或案例研究以及医疗器械和设备的统一和标准化呈正相关。强制性国家级严重不良事件报告的经验与从并发症和意外症状院内报告系统中由患者安全管理负责人识别有问题的病例呈正相关。为报告人提供增强反馈可能会促进低诉讼风险的轻微病例的自愿院内报告。建立一个审查所有严重并发症和意外症状的院内机制可能会促进高诉讼风险的严重不良事件的强制性国家级报告。

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