Teixeira Flavia C, de Almeida Carlos E, Saiful Huq M
CNEN-Comissao Nacional de Energia Nuclear, Rio de Janeiro, RJ 22290-901, Brazil and LCR/UERJ-Laboratorio de Ciencias Radiologicas/Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.
LCR/UERJ-Laboratorio de Ciencias Radiologicas/Universidade do Estado do Rio de Janeiro, Rio de Janeiro, RJ 20550-013, Brazil.
Med Phys. 2016 Jan;43(1):171. doi: 10.1118/1.4938065.
The goal of this study was to evaluate the safety and quality management program for stereotactic radiosurgery (SRS) treatment processes at three radiotherapy centers in Brazil by using three industrial engineering tools (1) process mapping, (2) failure modes and effects analysis (FMEA), and (3) fault tree analysis.
The recommendations of Task Group 100 of American Association of Physicists in Medicine were followed to apply the three tools described above to create a process tree for SRS procedure for each radiotherapy center and then FMEA was performed. Failure modes were identified for all process steps and values of risk priority number (RPN) were calculated from O, S, and D (RPN = O × S × D) values assigned by a professional team responsible for patient care.
The subprocess treatment planning was presented with the highest number of failure modes for all centers. The total number of failure modes were 135, 104, and 131 for centers I, II, and III, respectively. The highest RPN value for each center is as follows: center I (204), center II (372), and center III (370). Failure modes with RPN ≥ 100: center I (22), center II (115), and center III (110). Failure modes characterized by S ≥ 7, represented 68% of the failure modes for center III, 62% for center II, and 45% for center I. Failure modes with RPNs values ≥100 and S ≥ 7, D ≥ 5, and O ≥ 5 were considered as high priority in this study.
The results of the present study show that the safety risk profiles for the same stereotactic radiotherapy process are different at three radiotherapy centers in Brazil. Although this is the same treatment process, this present study showed that the risk priority is different and it will lead to implementation of different safety interventions among the centers. Therefore, the current practice of applying universal device-centric QA is not adequate to address all possible failures in clinical processes at different radiotherapy centers. Integrated approaches to device-centric and process specific quality management program specific to each radiotherapy center are the key to a safe quality management program.
本研究的目的是通过使用三种工业工程工具（1）流程映射、（2）失效模式与效应分析（FMEA）和（3）故障树分析，评估巴西三个放疗中心立体定向放射外科（SRS）治疗过程的安全与质量管理计划。
遵循美国医学物理师协会第100任务组的建议，应用上述三种工具为每个放疗中心创建SRS程序的流程树，然后进行FMEA。识别所有流程步骤的失效模式，并由负责患者护理的专业团队分配O、S和D值（RPN = O×S×D）来计算风险优先数（RPN）的值。
所有中心的子流程治疗计划出现的失效模式数量最多。中心I、II和III的失效模式总数分别为135、104和131。每个中心的最高RPN值如下：中心I（204）、中心II（372）和中心III（370）。RPN≥100的失效模式：中心I（22）、中心II（115）和中心III（110）。以S≥7为特征的失效模式，在中心III的失效模式中占68%，在中心II中占62%，在中心I中占45%。在本研究中，RPN值≥100且S≥7、D≥5和O≥5的失效模式被视为高优先级。
本研究结果表明，巴西三个放疗中心相同的立体定向放射治疗过程的安全风险概况不同。虽然这是相同的治疗过程，但本研究表明风险优先级不同，这将导致各中心实施不同的安全干预措施。因此，当前应用通用的以设备为中心的质量保证方法不足以解决不同放疗中心临床过程中的所有可能故障。针对每个放疗中心的以设备为中心和特定于流程的质量管理计划的综合方法是安全质量管理计划的关键。
