Ford Eric C, Smith Koren, Terezakis Stephanie, Croog Victoria, Gollamudi Smitha, Gage Irene, Keck Jordie, DeWeese Theodore, Sibley Greg
Department of Radiation Oncology and Molecular Radiation Sciences, Johns Hopkins University, Baltimore, MD 21287.
Med Phys. 2014 Jun;41(6):061709. doi: 10.1118/1.4875687.
Explore the feasibility and impact of a streamlined failure mode and effects analysis (FMEA) using a structured process that is designed to minimize staff effort.
FMEA for the external beam process was conducted at an affiliate radiation oncology center that treats approximately 60 patients per day. A structured FMEA process was developed which included clearly defined roles and goals for each phase. A core group of seven people was identified and a facilitator was chosen to lead the effort. Failure modes were identified and scored according to the FMEA formalism. A risk priority number,RPN, was calculated and used to rank failure modes. Failure modes with RPN > 150 received safety improvement interventions. Staff effort was carefully tracked throughout the project.
Fifty-two failure modes were identified, 22 collected during meetings, and 30 from take-home worksheets. The four top-ranked failure modes were: delay in film check, missing pacemaker protocol/consent, critical structures not contoured, and pregnant patient simulated without the team's knowledge of the pregnancy. These four failure modes had RPN > 150 and received safety interventions. The FMEA was completed in one month in four 1-h meetings. A total of 55 staff hours were required and, additionally, 20 h by the facilitator.
Streamlined FMEA provides a means of accomplishing a relatively large-scale analysis with modest effort. One potential value of FMEA is that it potentially provides a means of measuring the impact of quality improvement efforts through a reduction in risk scores. Future study of this possibility is needed.
采用一种旨在尽量减少员工工作量的结构化流程，探索简化的失效模式与效应分析（FMEA）的可行性及影响。
在一家每天治疗约60名患者的附属放射肿瘤中心，对外照射流程进行FMEA。开发了一种结构化的FMEA流程，其中包括为每个阶段明确界定的角色和目标。确定了一个由七人组成的核心小组，并挑选了一名协调人来领导这项工作。根据FMEA形式确定失效模式并进行评分。计算风险优先数（RPN），并用于对失效模式进行排序。RPN>150的失效模式接受安全改进干预措施。在整个项目过程中仔细跟踪员工的工作量。
确定了52种失效模式，其中22种在会议期间收集，30种来自带回家填写的工作表。排名前四的失效模式为：胶片检查延迟、起搏器方案/同意书缺失、关键结构未勾画以及在团队不知情的情况下模拟怀孕患者。这四种失效模式的RPN>150，并接受了安全干预措施。FMEA在一个月内通过四次1小时的会议完成。总共需要55个员工工时，此外，协调人还需要20小时。
简化的FMEA提供了一种用适度工作量完成相对大规模分析的方法。FMEA的一个潜在价值在于，它有可能通过降低风险评分提供一种衡量质量改进工作影响的方法。需要对这种可能性进行进一步研究。
