University of California Davis Medical Center, Sacramento, CA, USA.
Int J Radiat Oncol Biol Phys. 2012 Jul 15;83(4):1324-9. doi: 10.1016/j.ijrobp.2011.09.019. Epub 2011 Dec 22.
To improve the quality and safety of our practice of stereotactic body radiation therapy (SBRT), we analyzed the process following the failure mode and effects analysis (FMEA) method.
The FMEA was performed by a multidisciplinary team. For each step in the SBRT delivery process, a potential failure occurrence was derived and three factors were assessed: the probability of each occurrence, the severity if the event occurs, and the probability of detection by the treatment team. A rank of 1 to 10 was assigned to each factor, and then the multiplied ranks yielded the relative risks (risk priority numbers). The failure modes with the highest risk priority numbers were then considered to implement process improvement measures.
A total of 28 occurrences were derived, of which nine events scored with significantly high risk priority numbers. The risk priority numbers of the highest ranked events ranged from 20 to 80. These included transcription errors of the stereotactic coordinates and machine failures.
Several areas of our SBRT delivery were reconsidered in terms of process improvement, and safety measures, including treatment checklists and a surgical time-out, were added for our practice of gantry-based image-guided SBRT. This study serves as a guide for other users of SBRT to perform FMEA of their own practice.
为了提高立体定向体部放射治疗（SBRT）实践的质量和安全性，我们采用失效模式和影响分析（FMEA）方法对该流程进行了分析。
FMEA 由多学科团队执行。对于 SBRT 治疗过程中的每一步骤，我们都推导出了潜在的失效发生情况，并评估了三个因素：每个发生的概率、事件发生的严重程度以及治疗团队的检测概率。每个因素都被赋予 1 到 10 的等级，然后相乘的等级得出相对风险（风险优先数）。然后，考虑实施流程改进措施的失效模式，这些模式具有最高的风险优先数。
总共推导出 28 种失效情况，其中 9 种失效情况的风险优先数显著较高。风险优先数最高的失效事件排名从 20 到 80 不等。这些失效事件包括立体定向坐标的转录错误和机器故障。
我们对 SBRT 治疗的几个方面进行了重新考虑，包括添加治疗核对表和手术暂停等安全措施，以改进基于龙门的图像引导 SBRT 的治疗流程。本研究为其他 SBRT 用户执行自身实践的 FMEA 提供了指导。
