背景:质子治疗是眼部黑色素瘤的有效治疗方法,和其他眼部肿瘤。马萨诸塞州总医院专门用于眼部治疗的固定水平光束线最初于2002年投入使用,其中大部分设备都是安全功能,和实践可以追溯到1970年代哈佛回旋加速器的早期实施。
目的:描述对最长的连续运行质子治疗计划之一的安全性环境进行重新评估和增强的经验。
方法:在运行的多年中,已经引入了质量控制方面的一些增强措施,正如这份手稿中所描述的,更好地将实践与不断发展的质子治疗标准和现代医院的要求保持一致。我们重点介绍了故障模式和影响分析(FMEA)的设计和结果,以及随后采取的措施来减轻与高风险相关的模式。FMEA的调查结果为新软件应用程序提供了规范,这有助于改善治疗工作流程和眼部治疗的图像指导方面的管理。
结果:描述了11种风险最高的失效模式。随着图像引导放射治疗(IGRT)新应用的临床推广,其中六个得到了缓解。其他人通过任务自动化来解决,更广泛地引入清单,并加强了由工作人员主导的预处理超时。
结论:在对我们专用眼光束线的安全系统进行现代化改造的整个任务中,FMEA被证明是征求员工关于安全和工作流程问题的意见的有效工具,帮助识别与故障风险升高相关的步骤。随着新的IGRT应用的临床引入,风险降低了,它集成了因其在风险缓解中的作用而广受认可的质量管理工具:数据传输和工作流程步骤的自动化,并引入检查表和冗余交叉检查。
BACKGROUND: Proton therapy is an effective treatment for ocular melanoma, and other tumors of the eye. The fixed horizontal beamline dedicated to ocular treatments at Massachusetts General Hospital was originally commissioned in 2002, with much of the equipment, safety features, and practices dating back to an earlier implementation at Harvard Cyclotron in the 1970s.
OBJECTIVE: To describe the experience of reevaluation and enhancement of the safety environment for one of the longest continuously operating proton therapy programs.
METHODS: Several enhancements in quality control had been introduced throughout the years of operation, as described in this manuscript, to better align the practice with the evolving standards of proton therapy and the demands of a modern hospital. We spotlight the design and results of the failure mode and effect analysis (FMEA), and subsequent actions introduced to mitigate the modes associated with elevated risk. The findings of the FMEA informed the specifications for the new software application, which facilitated the improved management of the treatment workflow and the image-guidance aspects of ocular treatments.
RESULTS: Eleven failure modes identified as having the highest risk are described. Six of these were mitigated with the clinical roll-out of a new application for image-guided radiation therapy (IGRT). Others were addressed through task automation, the broader introduction of checklists, and enhancements in pre-treatment staff-led time-out.
CONCLUSIONS: Throughout the task of modernizing the safety system of our dedicated ocular beamline, FMEA proved to be an effective instrument in soliciting inputs from the staff about safety and workflow concerns, helping to identify steps associated with elevated failure risks. Risks were reduced with the clinical introduction of a new IGRT application, which integrates quality management tools widely recognized for their role in risk mitigation: automation of the data transfer and workflow steps, and with the introduction of checklists and redundancy cross-checks.