Mazeron R, Aguini N, Rivin Del Campo E, Dumas I, Gensse M-C, Brusadin G, Lefkopoulos D, Deutsch E, Haie-Meder C
Radiation Oncology, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
Quality and risk Assessment, Gustave-Roussy Cancer Campus Grand Paris, 114, rue Édouard-Vaillant, 97805 Villejuif cedex, France.
Cancer Radiother. 2015 Apr;19(2):89-97. doi: 10.1016/j.canrad.2014.11.002. Epub 2015 Jan 16.
To report the application of the global risk analysis (GRA) in the pulsed-dose rate (PDR) brachytherapy workflow.
Analyses were led by a multidisciplinary working group established within the unit with the guidance of a quality engineer. First, a mapping of hazardous situations was developed as a result of interactions between the patient workflow for a treatment using PDR brachytherapy split into 51 sub-phases with a comprehensive list of the hazards that he/she faces (44). Interactions, when relevant, were sorted by level of priority: to be treated immediately, secondarily (the group is not entitled to treat the situation), or later (safe situation). Secondly, for each high priority dangerous situation, scenarios were developed to anticipate their potential consequences. Criticality was assessed, using likelihood and severity scales and a matrix, which allocated risks into categories: acceptable (C1), tolerable under control (C2) and unacceptable (C3). Then, corrective actions were proposed and planned when relevant, after assessment of their feasibility with a scale of effort. Finally, the criticality of the scenarios was reevaluated, taking into account the implementation of these actions, leading to a residual risk mapping, which could trigger additional proposals of actions.
Two thousand one hundred and eighty-four potential interactions between the list of hazards and the workflow were analyzed. Mapping of dangerous situations identified 213 relevant interactions, from which 61 were considered with high priority. One hundred and twenty-six scenarios were generated: 68 with a low criticality (74.3%), 58 with an intermediate score (25.7%). No scenario with the highest criticality was individualized. Twenty-one corrective actions were planned. Mapping of residual risk resulted in the disappearance of most C2 risks, leaving 5 C2 scenarios (4%), for which four monitoring indicators were implemented in addition to the corrected actions decided on.
The implementation of the GRA appeared feasible, and led to implement 21 corrective actions, based on scenarios and not on incidents.
报告全球风险分析（GRA）在脉冲剂量率（PDR）近距离放射治疗工作流程中的应用。
分析工作由在质量工程师指导下于本单位内成立的多学科工作组主导。首先，绘制了危险情况图，这是通过将使用PDR近距离放射治疗的患者工作流程划分为51个子阶段，并列出患者所面临的危害（44项）而产生的相互作用结果。相关的相互作用按优先级排序：需立即处理、其次处理（该组无权处理该情况）或稍后处理（安全情况）。其次，针对每个高优先级危险情况，制定了情景以预测其潜在后果。使用可能性和严重程度量表及矩阵评估关键性，将风险分为几类：可接受（C1）、在控制下可容忍（C2）和不可接受（C3）。然后，在通过努力程度量表评估其可行性后，针对相关情况提出并规划纠正措施。最后，考虑到这些措施的实施情况，重新评估情景的关键性，从而得出残余风险图，这可能会引发更多行动建议。
分析了危害清单与工作流程之间的2184种潜在相互作用。危险情况图确定了213种相关相互作用，其中61种被视为高优先级。生成了126个情景：68个关键性较低（74.3%），58个得分中等（25.7%）。未确定关键性最高的情景。规划了21项纠正措施。残余风险图显示大多数C2风险消失，仅剩下5个C2情景（4%），针对这些情景，除了已决定的纠正措施外，还实施了4个监测指标。
GRA的实施似乎可行，并基于情景而非事件实施了21项纠正措施。
