安全案例能为患者安全提供什么？一项多地点案例研究。
What can Safety Cases offer for patient safety? A multisite case study.
作者信息
Liberati Elisa Giulia, Martin Graham P, Lamé Guillaume, Waring Justin, Tarrant Carolyn, Willars Janet, Dixon-Woods Mary
机构信息
THIS Institute (The Healthcare Improvement Studies Institute), Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK
THIS Institute (The Healthcare Improvement Studies Institute), Department of Public Health and Primary Care, University of Cambridge, Cambridge, UK.
出版信息
BMJ Qual Saf. 2024 Feb 19;33(3):156-165. doi: 10.1136/bmjqs-2023-016042.
BACKGROUND
The Safety Case is a regulatory technique that requires organisations to demonstrate to regulators that they have systematically identified hazards in their systems and reduced risks to being as low as reasonably practicable. It is used in several high-risk sectors, but only in a very limited way in healthcare. We examined the first documented attempt to apply the Safety Case methodology to clinical pathways.
METHODS
Data are drawn from a mixed-methods evaluation of the Safer Clinical Systems programme. The development of a Safety Case for a defined clinical pathway was a centrepiece of the programme. We base our analysis on 143 interviews covering all aspects of the programme and on analysis of 13 Safety Cases produced by clinical teams.
RESULTS
The principles behind a proactive, systematic approach to identifying and controlling risk that could be curated in a single document were broadly welcomed by participants, but was not straightforward to deliver. Compiling Safety Cases helped teams to identify safety hazards in clinical pathways, some of which had been previously occluded. However, the work of compiling Safety Cases was demanding of scarce skill and resource. Not all problems identified through proactive methods were tractable to the efforts of front-line staff. Some persistent hazards, originating from institutional and organisational vulnerabilities, appeared also to be out of the scope of control of even the board level of organisations. A particular dilemma for organisational senior leadership was whether to prioritise fixing the risks proactively identified in Safety Cases over other pressing issues, including those that had already resulted in harm.
CONCLUSIONS
The Safety Case approach was recognised by those involved in the Safer Clinical Systems programme as having potential value. However, it is also fraught with challenge, highlighting the limitations of efforts to transfer safety management practices to healthcare from other sectors.
背景
安全案例是一种监管技术，要求组织向监管机构证明，他们已系统地识别出其系统中的危害，并将风险降低到合理可行的最低水平。它在多个高风险行业中使用，但在医疗保健领域的应用非常有限。我们研究了首次有记录的将安全案例方法应用于临床路径的尝试。
方法
数据来自对更安全临床系统计划的混合方法评估。为特定临床路径制定安全案例是该计划的核心内容。我们的分析基于涵盖该计划各个方面的143次访谈以及对临床团队制作的13个安全案例的分析。
结果
一种积极主动、系统的方法来识别和控制风险，并可整理在一份文件中的原则受到了参与者的广泛欢迎，但实施起来并不简单。编写安全案例有助于团队识别临床路径中的安全危害，其中一些危害以前被忽视了。然而，编写安全案例的工作需要稀缺的技能和资源。并非所有通过主动方法识别出的问题都能由一线工作人员解决。一些持续存在的危害源于机构和组织的脆弱性，似乎即使是组织的董事会层面也无法控制。组织高层领导面临的一个特殊困境是，是否要优先解决安全案例中主动识别出的风险，而不是其他紧迫问题，包括那些已经造成伤害的问题。
结论
参与更安全临床系统计划的人员认为安全案例方法具有潜在价值。然而，它也充满挑战，凸显了将安全管理实践从其他行业转移到医疗保健领域所做努力的局限性。
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