故障模式和效应分析与故障树分析方法在调强放射治疗计划设计流程中的应用  

Application of failure mode and effects analysis and fault tree analysis to IMRT planning

作　　者：丁寿亮 胡江[1] 张俊 顾慧宽 王艺璇 刘懿梅 黄晓延[1] Ding Shouliang;Hu Jiang;Zhang Jun;Gu Huikuan;Wang Yixuan;Liu Yimei;Huang Xiaoyan(Department of Radiation Oncology, Sun Yat-Sen University Cancer Center, State Key Laboratory of Oncology in South China, Collaborative Innovation Center for Cancer Medicine, Guangzhou 510060, China)

机构地区：[1]中山大学肿瘤防治中心放疗科华南肿瘤学国家重点实验室肿瘤医学协同创新中心,广州510060

出　　处：《中华放射医学与防护杂志》2019年第9期673-679,共7页Chinese Journal of Radiological Medicine and Protection

摘　　要：目的运用故障模式和效应分析(failuremodesandeffectsanalysis,FMEA)与故障树分析(failuretreeanalysis,FTA)对调强放射治疗(intensitymodulatedradiotherapy,IMRT)计划设计流程进行风险评估,优化和完善质量管理方案.方法对运用Eclipse计划系统设计IMRT计划的工作流程建立流程图.根据流程图进行FMEA分析,对每个故障模型(failuremodes,FM)进行定量评估得出O、S、D值,相乘得到风险优先系数(riskprioritynumber,RPN).然后按照是否执行质量管理措施(qualitymanagement,QM)分为两组进行评估,并按照RPN值大小排序.最后对排序靠前的高危步骤进行FTA分析.结果研究得出IMRT计划设计流程图,可分为10个主过程,33个子过程.FMEA分析后得出47个FM模型,未执行QM评估组中FM模型的RPN值范围为13.2~271.8,其中有27个FM模型RPN≥80,18个FM模型S≥8.执行QM评估组FM模型RPN值范围为11.2~158.4,其中有11个FM模型RPN≥80.对执行QM评估组(101.17±66.34)和未执行QM评估组(59.54±35.64)的RPN值比较差异有统计学意义(t=8.501,P<0.05).RPN值排序前25%的FM模型为处方剂量定义错误、计算参数设置错误、影像导入错误、计划评估确认错误等.最后对定义处方剂量和导入影像这两个高危步骤进行FTA分析.结论FMEA和FTA分析方法具有可操作性和实用性,能够系统全面地分析IMRT计划设计流程中存在的潜在故障和风险,可帮助建立和优化放射治疗中的质量管理规范.Objective To investigate IMRT planning process using the combined application of failure modes and effects analysis (FMEA) and fault tree analysis (FTA) by reference to the report of Task Group 100 of the AAPM, and stablish and optimize the quality. Methods A multidisciplinary team detailed the process mapping of IMRT planning using Eclipse TPS. The team evaluated the potential failure modes (FMs) of every process step. The evaluation was divided into two groups according to whether quality management (QM) was considered. For every FM, occurrence (O), severity (S) and detectability (D) by consensus were evaluated, and the product of O, S and D yielded the risk priority number (RPN), which permitted the ranking of the FMs. Finally, FTA was used to determine the root factors contributing to the riskiest failure modes. Results The IMRT plan process consisted of 10 major sub-processes and 33 steps, which amounted to 47 failure modes. For the group without quality management, the RPN of FMs was between 13.2-271.8, 27 of which had RPN ≥ 80, and 18 FMs had S ≥ 8. For the group with quality management, the RPN of FMs was between 11.2-158.4, 11 of which had RPN ≥ 80. The difference of RPN between the two groups was statistically significant (RPN of the group without QM=101.17±66.34, RPN of the group with QM=59.54±35.64, t=8.501, P < 0.05). Finally, FTA was used to determine the root factors contributing to the FMs, i.e., prescription dose definition and importing images. Conclusions The FMEA and FTA methods are operable and practical, which can systematically and comprehensively analyze the potential failures and risks existing in the process of IMRT plan. And the FMEA and FTA can contribute to establish and optimize the quality management program in radiotherapy.

关 键 词：调强放射治疗 故障模式和效应分析 故障树分析 质量管理 

分 类 号：R730.55[医药卫生—肿瘤]