失效模式与效应分析在治疗前特定患者的计划剂量验证流程中的应用研究

Application of Failure Modes and Effects Analysis for Patient-Specific Quality Assurance

目的使用基于AAPM TG-100号报告的失效模式及效应分析(Failure Mode and Effects Analysis,FMEA)方法确定治疗前特定患者的计划剂量验证流程中的高危失效模式,提升现有的质量管理措施。方法组织风险评估小组确定治疗前特定患者的计划验证各环节并建立流程图。小组对每个失效模式的发生率、严重性以及探测率进行评估,三者之积为风险优先值(Risk Priority Number,RPN)。将RPN在前20%的失效模式作为高危失效模式进行下一步分析。结果本中心治疗前特定患者的计划剂量验证流程由8个主步骤,28个支步骤组成。全流程共有61个失效模式,通过制定改善措施优化了其中被确定的12个高危失效模式。结论针对治疗前特定患者的计划剂量验证流程使用FMEA方法能有效提升剂量验证结果的准确性与可靠性,最终达到提升放射治疗安全性的目的。

Objective To determine potential failure modes(FMs)with high-risk during patient-specific quality assurance(PSQA)by using failure mode and effects analysis(FMEA),to improve current quality management program based on the AAPM TG-100 report.Methods A risk ranking team was formed to determine the workflow and every FM of PSQA,and constructed the process map.The team evaluated occurrence(O),severity(S)and detectability(D)of every FM,and the product of O,S and D was risk priority number(RPN).The failure modes with 20%highest RPN were defined as high-risk FMs for furthermore analyzed.Results The PSQA process consisted of 8 major steps and 28 sub-steps.61 FMs were listed and 12 of them were defined as high-risk FMs to be made improvement strategies.Conclusion The application of FMEA for PSQA workflow can effectively enhance the accuracy and validity of PSQA results.It can ultimately improve the safety of radiotherapy.