Lee Yongsook C, Kim Yongbok, Huynh Jason Wei-Yeong, Hamilton Russell J
Department of Radiation Oncology, The University of Arizona, Tucson, AZ.
Department of Radiation Oncology, The University of Arizona, Tucson, AZ.
Brachytherapy. 2017 Nov-Dec;16(6):1265-1279. doi: 10.1016/j.brachy.2017.07.005. Epub 2017 Aug 18.
The aim of the study was to identify potential failure modes (FMs) having a high risk and to improve our current quality management (QM) program in Collaborative Ocular Melanoma Study (COMS) ocular brachytherapy by undertaking a failure modes and effects analysis (FMEA) and a fault tree analysis (FTA).
Process mapping and FMEA were performed for COMS ocular brachytherapy. For all FMs identified in FMEA, risk priority numbers (RPNs) were determined by assigning and multiplying occurrence, severity, and lack of detectability values, each ranging from 1 to 10. FTA was performed for the major process that had the highest ranked FM.
Twelve major processes, 121 sub-process steps, 188 potential FMs, and 209 possible causes were identified. For 188 FMs, RPN scores ranged from 1.0 to 236.1. The plaque assembly process had the highest ranked FM. The majority of FMs were attributable to human failure (85.6%), and medical physicist-related failures were the most numerous (58.9% of all causes). After FMEA, additional QM methods were included for the top 10 FMs and 6 FMs with severity values > 9.0. As a result, for these 16 FMs and the 5 major processes involved, quality control steps were increased from 8 (50%) to 15 (93.8%), and major processes having quality assurance steps were increased from 2 to 4.
To reduce high risk in current clinical practice, we proposed QM methods. They mainly include a check or verification of procedures/steps and the use of checklists for both ophthalmology and radiation oncology staff, and intraoperative ultrasound-guided plaque positioning for ophthalmology staff.
本研究旨在通过进行失效模式与效应分析（FMEA）和故障树分析（FTA），识别具有高风险的潜在失效模式（FM），并改进协作性眼部黑色素瘤研究（COMS）眼内近距离放射治疗中当前的质量管理（QM）程序。
对COMS眼内近距离放射治疗进行流程映射和FMEA。对于FMEA中识别出的所有FM，通过赋予并相乘发生度、严重度和不可探测度值来确定风险优先数（RPN），每个值范围为1至10。对具有排名最高FM的主要流程进行FTA。
识别出12个主要流程、121个子流程步骤、188个潜在FM和209个可能原因。对于188个FM，RPN分数范围为1.0至236.1。模板组装流程具有排名最高的FM。大多数FM归因于人为失误（85.6%），与医学物理师相关的失误数量最多（占所有原因的58.9%）。FMEA后，针对排名前10的FM和严重度值>9.0的6个FM纳入了额外的QM方法。结果，对于这16个FM和所涉及的5个主要流程，质量控制步骤从8个（50%）增加到15个（93.8%），具有质量保证步骤的主要流程从2个增加到4个。
为降低当前临床实践中的高风险，我们提出了QM方法。它们主要包括对眼科和放射肿瘤学工作人员的程序/步骤进行检查或验证以及使用检查表，以及为眼科工作人员提供术中超声引导模板定位。
