compared with 38% in 2020 (see Graph 2). In order to be effective, these approaches must bring together representatives of all the professionals involved in the delivery of treatments. The lack of availability of personnel, especially medical, limits their effectiveness. In order for there to be real continuous improvement in treatment quality and safety, it is necessary to regularly assess the corrective actions put in place, to involve all the personnel and to use the lessons learned to review the prospective risk analysis, which is mandatory pursuant to the abovementioned ASN resolution 2021-DC-0708 of 6 April 2021. In effect, the only way of testing the long-term robustness of the measures taken is to assess the corrective actions. The addition of check points, for example, can constitute a “false security” if they cannot be implemented by the professionals for various reasons. Moreover, the analysis of events can reveal that the safety barriers in place have not been effective, like those for ascertaining that the treatment has been delivered to the correct side, which should lead to a review of the prospective risk analysis and a team reflection to find more effective protection measures. The ability of a centre to deploy a risk management procedure was again subject to specific investigations in 2021. These investigations reveal that: ∙ Although the requirements for quality and safety management in radiotherapy departments are satisfied in the majority of cases, there are still disparities between centres. Thus, the prospective risk analysis –which is mandatory– is only complete or updated in half the inspected centres, mainly due to lack of training or resources, or to a change in the operational quality manager. This incompleteness concerns, for example, the residual unassessed risks after applying corrective actions, or the lack of integration of experience feedback (from other centres, for example, disseminated through the ASN publications –Patient safety newsletters and experience feedback sheets). ∙ More generally, further to the inspections carried out since 2016, ASN considers that the risk management procedure is only implemented satisfactorily in half of the inspected centres. These are the centres in which management has defined a policy with shared, assessable and assessed operational objectives, has communicated on the results of this policy and allocated the necessary resources, in particular, to the operational quality manager. ASN notes that the impact of a change on the operators’ activity is not always analysed, yet these changes are potential sources of disruption, particularly in the organisation of treatments and work practices and can weaken the existing lines of defence. It is vital in this respect to call into question the prospective risk analysis in order to supplement it, if necessary, from the moment new work processes are put in place or to verify that the existing defence barriers are still appropriate. The lessons learned from the inspections carried out in 2021 effectively show that, when a new technique is deployed, the centres have an adequate command of change management in 74% of the cases and the installation of new equipment in 66% of the cases. ASN nevertheless notes that deployment of these procedures is progressing, since the figures for 2020 and 2019 were 58% and 40% respectively for the deployment of a new technique, and 69% and 25% respectively for the installation of new equipment. In view of the difficulties found during inspections or when exam– ining ESRs, ASN asked IRSN in 2018 to draw up recommendations to help the radiotherapy centres embrace equipment and/or technical changes. In October 2021, in partnership with the radiotherapy professionals, IRSN published a Guide to embracing technical or equipment changes in radiotherapy. 2.1.3.3 Significant events in external-beam radiotherapy In 2021, 97 ESRs were reported in radiotherapy under criterion 2.1 (exposure of patients for therapeutic purposes). Among these events, 55 were rated level-1 on the ASN-SFRO scale, i.e. 57% of the total, and four were rated level 2. The four level-2 events concern one wrong-side error, one patient identification error and two excess doses, one of which was due to a calibration error. Most of the events reported in 2021 concern patient radiation protection, and the majority of them are not expected to have any clinical consequences. GRAPH Percentage of conformity of the facilities concerning the management of events giving rise to corrective actions in 2021 2 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Reporting culture and organisation Analysis, defining corrective actions, building on lessons learned Assessing corrective action effectiveness 212 ASN Report on the state of nuclear safety and radiation protection in France in 2021 07 – MEDICAL USES OF IONISING RADIATIONS
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