英美加澳和中国台湾地区医疗风险管理方法与评估工具的比较研究

Comparative Analyses on Methods and Tools for Medical Risk Management and Assessment in the United Kingdom,the United States,Canada,Australia and Taiwan Region

目的比较英美加澳与中国台湾地区医疗风险管理方法与评估工具,为我国医疗风险管理提供决策依据和政策建议。方法计算机检索英美加澳与我国台湾地区政府机构和行业协会或学术团体的官方网站,查找并纳入与医疗风险管理与监测相关的法律、规范性文件、研究报告、综述和评价表格等,而后采用描述性对比分析方法,综合比较上述四国一区医疗风险管理方法与评估工具。结果①共纳入17篇规范性文件,41篇指南,37篇综述和49篇一般信息,共计146篇文献;②英国采用整合风险管理,澳大利亚和台湾采用经典风险识别、分析、评估与控制方法,美国和加拿大采用前瞻性FMEA方法识别与评估临床风险;③在医疗风险评估分级方面,英、澳将医疗风险严重程度分为5级,台湾分为6级;发生频率均分为5级;应对响应均按4级标准。④四国一区RCA分事件对象略有不同,RCA步骤与工具基本一致。结论英美加澳与我国台湾地区主要采取前瞻性风险评估、基于已发生不良事件的风险评估及整合风险管理三种医疗风险管理模式,且评估工具相同;英、澳和我国台湾地区临床医疗风险分级大致相同,但分级定义有差异;四国一区不良事件分析方法与过程基本一致。

Objective To comprehensively compare the methods and tools for medical risk management and assessment in the United Kingdom,the United States,Canada,Australia and Taiwan region（hereafter shortened as ＂four countries and one region＂）,so as to provide evidence and recommendations for medical risk management policy in China.Methods The official websites of the healthcare risk management agencies in these four countries and one region were searched to collect materials concerning healthcare risk management and monitoring,such as laws,regulatory documents,research reports,reviews and evaluation forms,then the descriptive comparative analysis was performed on the methods and tools for risk management.Results a） A total of 146 documents were included in this study,including 2 laws,17 regulatory documents,41 guidelines,37 reviews and 49 documents about general information;b） The United Kingdom applied the integrated risk management;Australia and Taiwan adopted the classical risk management process,including risk identification,risk analysis,risk evaluation and risk control,while the United States and Canada mainly chose the prospective failure mode and effects analysis（FMEA） for clinical risk management;c） The severity of clinical risk was divided into five grades in the United Kingdom and Australia,and six in Taiwan,respectively.The frequency of medical risk was divided into five grades with four grade responses in above two countries and one region;and d） There were almost the same processes and tools about Root Cause Analysis（RCA）,but a little difference in the objects of analysis in these four countries and one region.Conclusion There are three models of risk management with the same assessment tools in these four countries and one region： the prospective risk assessment,the retrospective assessment based on occurred incidents and the integrated risk management.Although the grading of risk is similar,the definition of grading is different in the United Kingdom,Australia and Taiwan.The methods and processes of analyses on the adverse events are almost the same in these four countries and one region.