change management process is being increasingly deployed but not always completely in the centres concerned by recent or ongoing changes. The lessons from the inspections in 2023 effectively show that when a new technique is put in place, the change management procedure is considered satisfactory in only half of the centres (50%), a proportion that remains constant for the 2019‑2023 period. Management of the changes in project mode (appointing a coordinator, project planning, training of teams, organisation of the continuity of routine work during project execution, updating documents) is being deployed in the centres to varying extents, and depending on whether the centres have projects planned for the near future or not. 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 context of medical staff shortages, organisational changes due to the reform of the healthcare licences or healthcare facility buy-out operations, ASN urges the decision makers, RNAs and medical professionals to be vigilant regarding the need to assess the impact of these large-scale changes in the work activity of the medical staff, insofar as these projects demand significant investment on the part of the personnel, adding to their existing workload. ASN organised a seminar for radiotherapy stakeholders on 15 March 2023 in Montrouge, which reviewed the quality-safety approaches in radiotherapy since 2008, change management, and the contribution of the LFE initiatives and their improvement (see box above). The lessons from the seminar will be used as inputs to ASN’s reflections for its next radiotherapy inspection programme starting in 2025. 2.1.3.3 Significant events in external-beam radiotherapy In 2023, 88 ESRs were reported in radiotherapy under criterion 2.1 (exposure of patients for therapeutic purposes). Among these events, 37 were rated level 1 on the ASN-SFRO scale, i.e. 42% of the total, and seven were rated level 2. The latter concerned: ∙ four laterality errors (see box next page), of which two involved delivery of the entire or virtually entire treatment to the wrong side (25 sessions out of 28). The other two laterality errors occurred in breast cancer treatments during six sessions out of 15 and 19 out of 33 respectively; the analysis of this type of event can reveal that the safety barriers put in place, such as those for checking that the treatment is delivered to the correct side, have been ineffective, which should lead to the revising of the prospective risks analysis and team reflection to find more robust countermeasures; ∙ a positioning error that resulted in the entire treatment being delivered to the wrong vertebra; ∙ an error linked to an overlap zone not taken into account during the contouring, which resulted in an excess dose being delivered to the organs situated in this zone in a re-irradiation context; ∙ a dose error in treating a breast by Volumetric Modulated Arc Therapy (VMAT), with five treatment sessions more than the prescribed number, resulting in the volume as a whole receiving a total dose that was 20% higher than intended. Two ESRs rated level 1 on the ASN‑SFRO scale concerned cohorts of patients as a result of: ∙ an error when calibrating the patient positioning control system used for external-beam radiotherapy sessions, which caused an offset in the positioning of six patients; ∙ a positioning error that concerned seven patients further to an offset of the treatment isocentre of a repositioning imaging device. The regulatory provisions laying down the quality assurance obligations for the radiotherapy centres were published in 2008. They are part of a set of measures taken by the French authorities further to radiotherapy accidents that occurred in Epinal and Toulouse at the end of the years 2000. On 15 March 2023, ASN brought together the radiotherapy professionals to assess the results of the 15 years of quality initiatives in radiotherapy. Some 250 participants – radiotherapy professionals, representatives of the public health institutions and ASN radiation protection inspectors – asked about how the quality initiatives contribute to the performance of the care system, in a context of greater complexity, fewer resources and major innovations. Invited as a star witness, René Amalberti, director of the Foundation for in Industrial Safety Culture, brought up the current crisis of the healthcare system and questioned the risk of “over-quality” in his opening contribution. The floor was then given to the representatives of the radiotherapy centres to discuss the implementation of the quality assurance systems, the prospective risk analysis, the LFE procedures following adverse events and change management. The seminar also provided the opportunity, in the presence of the Minister responsible for health and the HAS, to discuss the contribution of the clinical peer reviews, the experimentation of which began in 2023, and the methods of evaluating innovative techniques and practices, particularly through the innovation pass. The seminar also confirmed that the main safety fundamentals are in place in the radiotherapy departments and that the quality-safety culture has improved very significantly since 2008. It highlighted the need for the radiotherapy departments to assimilate these procedures and find their own methods of implementation, adapting them to ensure their sustainability. The seminar also brought to light a risk of routinisation and loss of momentum in the continuous improvement initiatives. Several centres have taken measures to give renewed meaning and maintain the interest of the medical professionals in the qualitysafety initiatives. Their testimonial showed the importance of leadership, teamwork and communication, as well as the support of qualiticians and consideration of the actual work situations. The contribution of ASN oversight was also underlined. It enables the centres to re-examine their quality-safety approaches and to find new ways of working that help to maintain the collective dynamic. Lastly, the discussions brought to light the limits of the quality procedures, particularly the tendency to have more and more documents and indicators that are too process-oriented rather than results-oriented. These findings, which are not specific to France, necessitate collective reflection on how to simplify these procedures and on the choice of indicators. ASN will continue its reflections on the quality assurance and risk management procedures, in collaboration with all the radiotherapy stakeholders, in order to develop its future oversight activities. SEMINAR OF THE RADIOTHERAPY STAKEHOLDERS: ASN REVIEWS THE SITUATION OF THE QUALITY-SAFETY APPROACH IN RADIOTHERAPY TO ADAPT ITS OVERSIGHT OF TOMORROW ASN Report on the state of nuclear safety and radiation protection in France in 2023 217 • 07 • Medical uses of ionising radiation 07 05 15 08 11 04 14 06 13 AP 03 10 02 09 12 01
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