Use of Risk Assessment Analysis by Failure Mode, Effects, and Criticality to Reduce Door-to-Balloon Time
Use of Risk Assessment Analysis by Failure Mode, Effects, and Criticality to Reduce Door-to-Balloon Time
复制标题
DOI：
10.1016/j.annemergmed.2013.01.023
复制
发表时间：
2013-10-01
影响因子：
6.2
通讯作者：
Holl, Jane L.
中科院分区：
文献类型：
--
作者：
Khare, Rahul K.;Nannicelli, Anna P.;Holl, Jane L.
研究目的：医疗保险和医疗补助服务中心目前认可ST段抬高型心肌梗死患者到急诊室（艾德）就诊的门到球囊时间为90分钟或更短。最近的证据表明，60分钟的门到气球的时间显着降低住院死亡率。我们寻求使用故障模式、影响和危害性分析（FMECA）的主动风险评估方法来评估门到气球的时间过程，调查每个组件故障如何影响系统的性能，并评估每个故障的频率和潜在危害严重度。方法：我们进行了一项由两部分组成的研究：门到球囊时间系统和护理过程的FMECA，以及使用回顾性观察队列设计评价单个机构的门到球囊时间操作数据。FMECA参与者的多学科小组描述了门到球囊时间过程，然后创建了一个全面的地图和表格，列出了所有过程步骤和识别的过程故障，包括其频率、后果和原因。门到气球的时间操作数据进行了评估"开"与"关" hours.Results：五十一个故障点，确定跨4门到气球的时间阶段。在12例高风险失败中，58%发生在ECG和导管室激活之间。总门到气球的时间在上小时有一个中位数时间为55分钟（95%置信区间46至60分钟）相比，77分钟（95%置信区间68至83分钟）在关闭hours.Conclusion：FMECA揭示了明确的潜在延迟和脆弱性，可以解决减少门到气球的时间从90到60分钟。FMECA可以提供对潜在风险的可靠评估，并可以作为重大流程改进和系统重新设计的平台，以适应门到气球的时间。
Study objective: The Centers for Medicare & Medicaid Services currently endorses a door-to-balloon time of 90 minutes or less for patients presenting to the emergency department (ED) with ST-segment elevation myocardial infarction. Recent evidence shows that a door-to-balloon time of 60 minutes significantly decreases inhospital mortality. We seek to use a proactive risk assessment method of failure mode, effects, and criticality analysis (FMECA) to evaluate door-to-balloon time process, to investigate how each component failure may affect the performance of a system, and to evaluate the frequency and the potential severity of harm of each failure.Methods: We conducted a 2-part study: FMECA of the door-to-balloon time system and process of care, and evaluation of a single institution's door-to-balloon time operational data using a retrospective observational cohort design. A multidisciplinary group of FMECA participants described the door-to-balloon time process to then create a comprehensive map and table listing all process steps and identified process failures, including their frequency, consequence, and causes. Door-to-balloon time operational data were assessed by "on" versus "off" hours.Results: Fifty-one failure points were identified across 4 door-to-balloon time phases. Of the 12 high-risk failures, 58% occurred between ECG and catheterization laboratory activation. Total door-to-balloon time during on hours had a median time of 55 minutes (95% confidence interval 46 to 60 minutes) compared with 77 minutes (95% confidence interval 68 to 83 minutes) during off hours.Conclusion: The FMECA revealed clear areas of potential delay and vulnerability that can be addressed to decrease door-to-balloon time from 90 to 60 minutes. FMECAs can provide a robust assessment of potential risks and can serve as the platform for significant process improvement and system redesign for door-to-balloon time.