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评估基于 Web 的定制临床决策支持系统在电子健康记录中的安全性:案例研究。

Assessing the Safety of Custom Web-Based Clinical Decision Support Systems in Electronic Health Records: A Case Study.

机构信息

Department of Biomedical and Health Informatics, Children's Hospital of Philadelphia, Philadelphia, Pennsylvania, United States.

Department of Pediatrics, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania, United States.

出版信息

Appl Clin Inform. 2019 Mar;10(2):237-246. doi: 10.1055/s-0039-1683985. Epub 2019 Apr 3.

DOI:10.1055/s-0039-1683985
PMID:30943572
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6447398/
Abstract

BACKGROUND

With the widespread adoption of vendor-supplied electronic health record (EHR) systems, clinical decision support (CDS) customization efforts beyond those anticipated by the vendor may require the use of technologies external to the EHR such as web services. Pursuing such customizations, however, is not without risk. Validating the expected behavior of a customized CDS system in the high-volume, complex environment of the live EHR is a challenging problem.

OBJECTIVE

This article identifies technology failures that impacted clinical care related to web service-based advanced custom CDS systems embedded in the complex sociotechnical context of a production EHR.

METHODS

In an academic health system's primary care network, we performed an inventory of incidents between January 1, 2008 and December 31, 2016 related to a customized CDS system and performed a targeted review of changes in the CDS source code. Additional feedback on the root cause of individual incidents was obtained through interviews with members of the CDS project teams.

RESULTS

We identified five CDS malfunctions that impaired clinical workflow. The mechanisms for these failures are mapped to four characteristics of well-behaved applications: (1) system integrity; (2) data integrity; (3) reliability; and (4) scalability. Over the 9-year period, two malfunctions of the customized CDS significantly impaired clinical workflow for a total of 5 hours. Lesser impacts-loss of individual features with straightforward workarounds-arose from three malfunctions, which affected users on 53 days.

DISCUSSION

Advanced customization of EHRs for the purpose of CDS can present significant risks to clinical workflow.

CONCLUSION

This case study highlights that advanced customization of CDS within a commercial EHR may support care for complex patient populations, but ongoing monitoring and support is required to ensure its safe use.

摘要

背景

随着供应商提供的电子健康记录 (EHR) 系统的广泛采用,超出供应商预期的临床决策支持 (CDS) 定制工作可能需要使用 EHR 之外的技术,如 Web 服务。然而,进行这种定制并非没有风险。在 EHR 的高容量、复杂环境中验证定制 CDS 系统的预期行为是一个具有挑战性的问题。

目的

本文确定了影响与嵌入生产 EHR 复杂社会技术环境中的基于 Web 服务的高级定制 CDS 系统相关的临床护理的技术故障。

方法

在一个学术医疗系统的初级保健网络中,我们对 2008 年 1 月 1 日至 2016 年 12 月 31 日期间与定制 CDS 系统相关的事件进行了清查,并对 CDS 源代码的更改进行了针对性审查。通过对 CDS 项目团队成员的访谈,获得了对个别事件根本原因的额外反馈。

结果

我们确定了五个影响临床工作流程的 CDS 故障。这些故障的机制映射到行为良好的应用程序的四个特征上:(1)系统完整性;(2)数据完整性;(3)可靠性;(4)可扩展性。在 9 年期间,定制 CDS 的两次故障总共对临床工作流程造成了 5 小时的严重影响。由于三次故障,个别功能丧失且具有简单的解决方法,对用户的影响持续了 53 天。

讨论

出于 CDS 的目的对 EHR 进行高级定制可能会对临床工作流程带来重大风险。

结论

本案例研究强调,在商业 EHR 中对 CDS 进行高级定制可以支持对复杂患者群体的护理,但需要进行持续监测和支持,以确保其安全使用。

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