Klüter Sebastian, Schrenk Oliver, Renkamp Claudia Katharina, Gliessmann Stefan, Kress Melanie, Debus Jürgen, Hörner-Rieber Juliane
Department of Radiation Oncology, Heidelberg University Hospital, Heidelberg, Germany.
Heidelberg Institute of Radiation Oncology (HIRO), National Center for Radiation Oncology (NCRO), Heidelberg, Germany.
Phys Imaging Radiat Oncol. 2021 Jan 22;17:53-57. doi: 10.1016/j.phro.2020.12.005. eCollection 2021 Jan.
The clinical introduction of on-table adaptive radiotherapy with Magnetic Resonance (MR)-guided linear accelerators (Linacs) yields new challenges and potential risks. Since the adapted plan is created within a highly interdisciplinary workflow with the patient in treatment position, time pressure or erroneous communication may lead to various possibly hazardous situations. To identify risks and implement a safe workflow, a proactive risk analysis has been conducted.
A process failure mode, effects and criticality analysis (P-FMECA) was performed within a group of radiation therapy technologists, physicians and physicists together with an external moderator. The workflow for on-table adaptive MR-guided treatments was defined and for each step potentially hazardous situations were identified. The risks were evaluated within the team in order to homogenize risk assessment. The team elaborated and discussed possible mitigation strategies and carried out their implementation.
In total, 89 risks were identified for the entire MR-guided online adaptive workflow. After mitigation, all risks could be minimized to an acceptable level. Overall, the need for a standardized workflow, clear-defined protocols together with the need for checklists to ensure protocol adherence were identified among the most important mitigation measures. Moreover, additional quality assurance processes and automated plan checks were developed.
Despite additional workload and beyond the fulfilment of legal requirements, execution of the P-FMECA within an interdisciplinary team helped all involved occupational groups to develop and foster an open culture of safety and to ensure a consensus for an efficient and safe online adaptive radiotherapy workflow.
磁共振（MR）引导直线加速器（Linac）的术中自适应放射治疗的临床应用带来了新的挑战和潜在风险。由于自适应计划是在患者处于治疗体位的高度跨学科工作流程中制定的，时间压力或错误沟通可能导致各种潜在危险情况。为识别风险并实施安全的工作流程，已进行了前瞻性风险分析。
在一组放射治疗技术人员、医生和物理学家以及一名外部协调员的共同参与下，进行了过程失效模式、影响及危害性分析（P-FMECA）。定义了术中自适应MR引导治疗的工作流程，并识别了每个步骤中的潜在危险情况。团队内部对风险进行了评估，以统一风险评估。团队详细制定并讨论了可能的缓解策略，并予以实施。
在整个MR引导的在线自适应工作流程中，共识别出89项风险。采取缓解措施后，所有风险均可降至可接受水平。总体而言，最重要的缓解措施包括需要标准化工作流程、明确的协议以及确保遵守协议的检查表。此外，还制定了额外的质量保证流程和自动计划检查。
尽管增加了工作量且超出了法律要求的范围，但跨学科团队执行P-FMECA有助于所有相关职业群体培养和促进开放的安全文化，并确保就高效、安全的在线自适应放射治疗工作流程达成共识。
