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立体定向放射治疗中用于安全性和效率的失效模式与效应分析的实际应用

Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery.

作者信息

Younge Kelly Cooper, Wang Yizhen, Thompson John, Giovinazzo Julia, Finlay Marisa, Sankreacha Raxa

机构信息

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

Department of Radiation Oncology, University of Michigan, Ann Arbor, Michigan.

出版信息

Int J Radiat Oncol Biol Phys. 2015 Apr 1;91(5):1003-8. doi: 10.1016/j.ijrobp.2014.12.033. Epub 2015 Feb 7.

DOI:10.1016/j.ijrobp.2014.12.033
PMID:25670543
Abstract

PURPOSE

To improve the safety and efficiency of a new stereotactic radiosurgery program with the application of failure mode and effects analysis (FMEA) performed by a multidisciplinary team of health care professionals.

METHODS AND MATERIALS

Representatives included physicists, therapists, dosimetrists, oncologists, and administrators. A detailed process tree was created from an initial high-level process tree to facilitate the identification of possible failure modes. Group members were asked to determine failure modes that they considered to be the highest risk before scoring failure modes. Risk priority numbers (RPNs) were determined by each group member individually and then averaged.

RESULTS

A total of 99 failure modes were identified. The 5 failure modes with an RPN above 150 were further analyzed to attempt to reduce these RPNs. Only 1 of the initial items that the group presumed to be high-risk (magnetic resonance imaging laterality reversed) was ranked in these top 5 items. New process controls were put in place to reduce the severity, occurrence, and detectability scores for all of the top 5 failure modes.

CONCLUSIONS

FMEA is a valuable team activity that can assist in the creation or restructuring of a quality assurance program with the aim of improved safety, quality, and efficiency. Performing the FMEA helped group members to see how they fit into the bigger picture of the program, and it served to reduce biases and preconceived notions about which elements of the program were the riskiest.

摘要

目的

通过由医疗保健专业人员组成的多学科团队应用失效模式与效应分析(FMEA),提高新立体定向放射治疗计划的安全性和效率。

方法和材料

代表包括物理学家、治疗师、剂量师、肿瘤学家和管理人员。从最初的高层次流程树创建了详细的流程树,以促进识别可能的失效模式。要求团队成员在对失效模式进行评分之前确定他们认为风险最高的失效模式。风险优先数(RPN)由每个团队成员单独确定,然后求平均值。

结果

共识别出99种失效模式。对RPN高于150的5种失效模式进行了进一步分析,以试图降低这些RPN。团队最初假定为高风险的项目(磁共振成像左右侧反转)中只有1项位列这前5项之中。实施了新的过程控制,以降低所有前5种失效模式的严重程度、发生率和可检测性得分。

结论

FMEA是一项有价值的团队活动,可协助创建或重组质量保证计划,以提高安全性、质量和效率。进行FMEA有助于团队成员了解他们在计划的整体情况中所扮演的角色,并且有助于减少对计划中哪些元素风险最高的偏见和先入之见。

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