ASN notes that the requirements concerning the medical physics organisation and the presence of a medical physicist during the treatments are satisfied in all the centres, even if there may be personnel shortages from time to time. The ASN inspectors observe that the authorisation process is being deployed, but with disparities between the medical and paramedical personnel, given that it is applied mostly for the paramedical staff. Furthermore, the analysis of compliance with regulatory requirements concerning the management of events over the 2019‑2023 period shows that a constant proportion of departments complied with the regulations over the last three years, with significant disparities depending on the requirements concerned (see Graph 2 above): ∙ The detection of adverse events, their reporting (internally or to ASN) and their recording are deemed satisfactory on the whole, with rates varying between 74% and 85% over the period in question but dropping from 2021 to 2023. ∙ The analysis of these adverse events, the defining of corrective actions and building on the lessons learned, after an initial phase of progress followed by stabilisation in 2021 and 2022 at around 75%, is now dropping with 60% of the inspected centres carrying out these steps satisfactorily in 2023. ∙ The improvement in practices resulting from Incident Learning Systems (ILS) and assessing the effectiveness of the corrective actions still represent the weak spot of these events analysis procedures, with the situation being deemed satisfactory in only 29% to 36% of the centres inspected. The results for the 2019-2023 period is stable, but with a degree of progress on this point in 2023 with 49% satisfaction (see Graph 2 above). These approaches must bring together representatives of all the professionals involved in the delivery of treatments. ASN observes greater participation of the radiotherapists in these approaches in the centres inspected in 2023. Furthermore, regular assessment of the corrective actions implemented and updating of the prospective risks analysis on the basis of the lessons learned from the events reported internally, which is obligatory pursuant to the above-mentioned resolution 2021-DC-0708 of 6 April 2021, are vital in order to improve treatment quality and safety. 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 (see box page 218), 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 2023. These investigations reveal that: ∙ The requirements for quality and safety management in radiotherapy departments are satisfied in the majority of cases. Disparities still persist between centres. Thus, the prospective risk analysis is only complete or updated in less than half the inspected centres (44%), mainly due to lack of training or resources, or to a change in the operational quality manager. This incompleteness concerns, for example, the failure to take into account LFE (that of other centres for example, disseminated via the ASN publications – “Patient safety” newsletter and “LFE” sheets) or new practices or the organisation of the centre if there is a change in the technical platform. ∙ The risk management approach is coordinated satisfactorily in 66% of the centres inspected. These are the centres in which management is involved in the approach and has defined a policy with shared, assessable and assessed operational objectives, has allocated the necessary resources, in particular to the operational quality manager and communicated on the results of this policy. Conversely, these procedures stand still or regress when senior management does not sustainably grant sufficient means to the operational quality manager or when s/he does not have sufficient authority to deploy them. The implementation of management reviews and internal audits is also observed but remains highly dependent on an internal dynamic and relies to a large extent on the availability of the persons in charge of quality (operational quality managers and health executives). ASN still observes that the impact of an organisational or technical 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 now obligatory formalisation of the GRAPH Percentage conformity of external-beam radiotherapy facilities in the management of events in 2023 2 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2023 2022 2021 2020 2019 Reporting culture and organisation Analysis, defining corrective actions, building on lessons learned Assessing corrective action effectiveness 216 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
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