Poder Joel, Brown Ryan, Howie Andrew, Yuen Johnson, Ralston Anna, Schreiber Kristine, Bece Andrej, Bucci Joseph
St George Hospital Cancer Care Centre, Kogarah, NSW, Australia; Centre of Medical Radiation Physics, University of Wollongong, NSW, Australia.
St George Hospital Cancer Care Centre, Kogarah, NSW, Australia.
Brachytherapy. 2018 Sep-Oct;17(5):788-793. doi: 10.1016/j.brachy.2018.05.005. Epub 2018 Jun 21.
The purpose of this study was to apply a risk-based approach to the development of a quality management (QM) program for ultrasound-based high-dose-rate (HDR) prostate brachytherapy (pBT) treatment planning and delivery.
A QM program was developed by a multidisciplinary team, using both an in-house risk-and-benefit balance impact template (RABBIT) tool and a failure modes and effect analysis (FMEA). FMEA scores were determined by three physicists, one radiation therapist and two radiation oncologists who were familiar with the protocol. The QM program produced by both risk-based techniques was then compared and consolidated.
The RABBIT tool identified 26 potential risks during the treatment planning and delivery process. During the FMEA, a total of 35 potential failure modes were identified from the seven major processes in ultrasound-based HDR pBT. For the 35 potential failure modes, risk priority number scores ranged from 14 to 267. The highest ranked failure mode was identified to be mislabeling/connection of the transfer tubes/catheters. From the risks analyses, a comprehensive QM program was developed.
Both the RABBIT tool and process mapping and FMEA were shown to be valuable tools in developing a QM program for ultrasound-based HDR pBT treatments. A considerable number of the potential failure modes identified in both tools were related to human or procedural errors, highlighting the importance of checklists and protocols in delivering a safe and effective ultrasound-based HDR pBT treatment.
本研究的目的是应用基于风险的方法来制定质量管理（QM）计划，用于基于超声的高剂量率（HDR）前列腺近距离放射治疗（pBT）的治疗计划和实施。
一个多学科团队开发了一个质量管理计划，使用内部的风险与效益平衡影响模板（RABBIT）工具和失效模式与效应分析（FMEA）。FMEA评分由三位熟悉该方案的物理学家、一位放射治疗师和两位放射肿瘤学家确定。然后对两种基于风险的技术产生的质量管理计划进行比较和整合。
RABBIT工具在治疗计划和实施过程中识别出26个潜在风险。在FMEA过程中，从基于超声的HDR pBT的七个主要过程中总共识别出35个潜在失效模式。对于这35个潜在失效模式，风险优先数评分范围为14至267。排名最高的失效模式被确定为输送管/导管的标记错误/连接错误。通过风险分析，制定了一个全面的质量管理计划。
RABBIT工具以及流程映射和FMEA在为基于超声的HDR pBT治疗制定质量管理计划方面均被证明是有价值的工具。两种工具中识别出的相当数量的潜在失效模式与人为或程序错误有关，突出了检查表和方案在提供安全有效的基于超声的HDR pBT治疗中的重要性。
