∙The risk management approach is coordinated satisfactorily in 59% 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 procedures to formalise the change management process are being increasingly deployed. They are deemed satisfactory in slightly over half the centres (53%) inspected in 2024, whereas over the 2021-2023 period they were satisfactory in 40% of the centres. To help them to better adopt material and/or technical changes, IRSN has published, in partnership with the radiotherapy professionals and at the request of ASN, a Guide to the adoption of a material or physical change in radiotherapy. In a persistent context of medical staff shortages, organisational changes due to the reform of the healthcare licences or healthcare facility buy-out operations, ASN continues to urge the decision makers, RNAs and medical professionals to be vigilant regarding the need to assess the impact of these changes insofar as these projects demand significant investment on the part of the personnel, adding to their existing workload. 2.1.3.3 Significant events in external-beam radiotherapy In 2024, 95 ESRs were notified in radiotherapy. The majority of the events concern patient radiation protection, with 79 ESRs notified under criterion 2.1 (exposure of patients for therapeutic purposes). Most of the events have no expected clinical consequences. Among these events, 45 were rated level 1 on the ASN-SFRO scale, i.e. 57% of the total, and five were rated level 2. One ESR was rated level 4. The level-2 ESRs concern: ∙three cases of laterality errors (see box previous page), all three concerning treatment of a breast cancer; in one case, the entire treatment was delivered to the wrong side in 20 sessions; in the other two cases, the treatment was delivered to the wrong side for 8 of the 25 planned sessions and 6 of the 15 planned sessions respectively; ∙a dose protraction / fractionation error in a treatment of a cancer of the right breast using the Vmat technique that induced a 20% excess dose to the target volume; ∙an error linked to the failure to take into account the overlapping of treatment plans, which occurred in the treatment of a patient undergoing stereotactic treatment on three locations simultaneously. Two of the above-mentioned ESRs were notified by the same centre in the space of one month and triggered an ASN inspection (see boxes previous page and below). The ESR of level 4 on the ASN‑SFRO scale occurred in 2023 but was notified in 2024. It resulted from the failure to take into account, in the medical prescription, a previous treatment delivered in 2013 to the same anatomical area and which led to over-irradiation of the pelvic region and exceeding of the dose constraint to the rectum (see box below). In addition, two ESRs rated level 1 on the ASN‑SFRO scale concern cohorts of patients and are linked to: ∙a contouring error concerning 127 patients: absence of contouring at the junction between the spinal cord and the cerebral trunk over several anatomical sections; ∙a positioning error that concerned 6 patients following the non-functioning of automatic KV repositioning of the table on three accelerators. As in the preceding years, these events highlight organisational weaknesses concerning: ∙the keeping of the patients’ medical files, which provide an overall picture and give access to the required information at the right time; the earlier the error is committed in the treatment process (e.g. wrong side), particularly in the initial consultation and prescription elaboration phase, the less the laterality information is called into question in the subsequent stages of the patient care pathway; it is therefore essential to test the barriers in place at these stages of the process; ∙validation steps in which the parameters to verify are not sufficiently explicit (what check? At what stage of the process? By which operator?); ∙the management of the patients’ medical file movements which, if it is not optimised, creates constraints on the work Significant radiation protection event rated level 4 on the ASN-SFRO scale ASN was informed on 20 June 2024 of an ESR that occurred during external-beam radiotherapy treatment of a patient with a relapse of a cancer of the pelvic region. The treatment, which was delivered in summer 2023, did not take into account a previous treatment of the same anatomical region by external-beam radiotherapy in 2013. A complete treatment (i.e. 38 sessions of 2 grays – Gy) was thus delivered in 2023, leading to over-irradiation of the organs at risk given the radiotherapy treatment of 2013. Several months after the end of the treatment, major lesions necessitating surgical treatment appeared, revealing the over-irradiation. This ESR was rated level 4 on the ASN-SFRO scale in view of the appearance of serious late effects in the patient with a major deterioration in quality of life. An incident notification was published on the ASN website on 12 July 2024. ASN pointed out that these re-irradiation situations represent high risks, particularly when the treated areas are identical or adjacent to those treated previously. In effect, if each treatment is subject to planning with the aim of preserving the healthy tissues around the tumour, said to be “at risk”, by limiting their irradiation as much as possible, the accumulation of several treatments on a given zone can lead to significant irradiation of these organs at risk. Consequently, the radiotherapy treatment prescription and planning must take account of any previous treatments and the cumulative effect of the irradiations in order not to deliver excessive cumulative doses to the organs at risk. ASN has drawn the attention of the medical professionals and all the radiotherapy centres to this growing problem and the need to put safety barriers in place and to assess them regularly. These particular risks led ASN to devote a “Patient safety” bulletin to prior radiotherapy treatments in June 2020. This bulletin underlines the significant clinical risks associated with the treatment of patients who have received several radiotherapy treatments in the course of their life and identifies areas for improvement. An inspection conducted by ASN on 23 August 2024 gave a better understanding of the occurrence context of this ESR, notably through consultation of the information recorded in the patient’s medical file (follow-up consultation report, nuclear medicine report, date of validation, etc.) and of the quality unit’s analysis. The established action plan was examined and considered on the whole appropriate to counter the observed deficiencies. The inspectors observe that the delivery of an external-beam radiotherapy treatment without a formal decision in a multidisciplinary consultation meeting (obligatory under Article R. 6123-91-1 of the Public Health Code) and the absence of any record of follow-up consultations during the two months of the treatment (obligatory under Article R. 6123-93 of the Public Health Code) constitute major nonconformities in the medical organisation of the centre. Furthermore, the event was not notified until 20 June 2024 which is considered too late, given that the medical reports of December 2023 mention radiation-induced symptoms. 222 ASN Report on the state of nuclear safety and radiation protection in France in 2024 Medical uses of ionising radiation
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