ASN Report 2017

280 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 09  - Medical uses of ionising radiation The improvement in practices through experience feedback and the assessment of the effectiveness of the corrective actions were deemed satisfactory in only 36% of the centres inspected. Although the majority of these procedures brought together representatives of all the professional categories, not all the members of personnel are involved, particularly the physicians, which limits their effectiveness. In order to achieve effective continuous improvement in treatment quality and safety, progress was required in the monitoring and evaluation of the corrective actions put in place, in the involvement of all the personnel and in the utilisation of the experience feedback to assess and enrich the prospective risk analysis. The risks analysis The prospective risk analysis was available in 92% of the centres. For 95% of them this analysis resulted from the work of a multi-professional group which had been set up in 89% of the inspected centres. However, in 44% of the centres it had not been updated, and in 51% of them it had not been assessed. Consequently, the overall situation was satisfactory in only half the inspected centres and these centres had not yet fully embraced the prospective risk management approach. More generally, on completion of the inspections carried out in 2016, ASN had considered that the management of the risk management procedure was on the whole satisfactory in only half of the inspected centres. These were the centres whose management had defined a policy with shared, assessable and assessed operational objectives, had communicated on the results of this policy and allocated the necessary resources, particularly to the operational quality manager. Furthermore, the involvement of all the professionals, especially the medical professionals, remains an essential prerequisite for the risk management procedures to produce concrete improvements in the safety of practices. In 2017, ASN inspected more specifically the risk management policies of the Amethyst and U2R groups, each of which manages four radiotherapy centres. The inspections carried out over time in the different centres managed by the same group have effectively led to similar findings revealing the absence of pooling and of a group-level risk management policy. These groups are currently organising themselves to deploy a coordinated risk management policy. The implementation of new techniques Seventy percent of the centres inspected in 2016 were implementing a new technique or using a new item of equipment. ASN considered that the new technique or the equipment was adequately mastered in 79% and 86% of these centres respectively. The training needs for the personnel concerned had been defined in 96% of the cases and they had all been trained in the new technique in 98% of the cases. The operating procedures associated with the new technique or the use of the equipment had been established in 96% of the centres. Nevertheless, the analysis of the impact of the new technique - particularly on staff numbers, and the adequacy of the means for the new needs, could be improved in 30% of the centres inspected. Moreover, the risk analysis prior to deployment of the new technique had been carried out in only 77% of the centres. More generally, ASN observes that the impacts of the technical, organisational or human changes on the activity of the operators are not sufficiently analysed, despite the fact that they can weaken the existing lines of defence. In 2017, in partnership with IRSN, health sector institutions and radiotherapy professionals, ASN launched the IMRTH project (Impact of a modification in radiotherapy), which aims to give centres the means to identify the impact of a change on the work activity and take the necessary measures to protect the activity. The work carried out in 2017 will continue in 2018 with an experiment conducted with two radiotherapy centres which have technical or organisational changes scheduled. Hypofractionated treatments The analysis of events notified to ASN in 2016 had underlined the high potential risks of hypofractionated treatments. ASN had inspected 17 centres performing this type of treatment, examining more specifically the robustness of the defence barriers formed by the validation of the prescription, the verification of patient identity and the check of patient positioning. The inspections revealed that although the verifications and checks are written into the quality procedures and subject to a degree of traceability, they should nevertheless be set out in greater detail, indicating the types of verifications/ checks performed, the stage in the process at which they are performed, the person performing them and the cross- check methods. 5.3.3 Notified events in external-beam radiotherapy 146 radiotherapy events were notified in 2017, and they almost exclusively concerned patient exposure. The large majority of ESRs (97%) had no clinical consequences for the patients. Sixty-five percent of the events were rated level 1 on the ASN-SFRO scale in 2016. Nevertheless, three ESRs in radiotherapy rated level 2 were notified in 2017. They involved two cases of excess doses after overlaps between two treatments and one excess dose in contact radiotherapy. As in preceding years, these events highlight the organisational weaknesses in managing the movements of patients’ files, in validation steps that are not sufficiently explicit and in the upkeep of patients’ files to ensure an overall view and access to the necessary information at the right time. Variations in practices within the same centre, frequent task interruptions, a heavy and uncontrolled workload with, among other things, an impact on treatment ranges or the deployment of a new technique or practice, constitute situations which can foster errors. In  2016 and  2017, ASN observed a distinct reduction in ESRs notified by the radiotherapy departments in France as a whole. Indeed, since 2008, some 240 ESRs per year were being notified. While this drop may be partly due to a loss of momentum in the feedback procedures, it seems more likely that it reflects a reluctance of the centres to declare minor events (rated ≤1 on the ASN-SFRO scale), which very often represent no real risk with regard to the safety of practices.