This incompleteness concerns, for example, the failure to take into account experience feedback (that of other centres for example, disseminated the ASN publications – Patient safety newsletter and Experience feedback sheets) or new practices or the organisation of the centre if there is a change in the technical platform. ∙ More generally, 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. 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 the availability of the operational quality managers. ASN has also noted during its inspections that some centres have initiated peer review procedures in medical physics, particularly when replacing their accelerators. These voluntary initiatives fully converge with the reflections on clinical peer reviews conducted by the Ministry responsible for health (see point 1.3.4). ASN again 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 change management process is not always properly carried out in the centres concerned by recent or ongoing changes. The lessons from the inspections in 2022 effectively show that when a new technique is put in place, the change management procedure is considered satisfactory in only half of the centres, a proportion that remains constant for the 2018‑2022 period. ASN more particularly draws the attention of medical professionals to high-risk situations, such as a relocation combined with an activity extension (new rooms, new machines) which necessitate not only considerable efforts on the part of the personnel in place but also the recruitment and integration of additional personnel made necessary by the new acquisitions. Moreover, ASN observes that the functioning of the centres can be suddenly disrupted further to the buying out of private centres or a mass departure of personnel (radiotherapists or medical physicists). This situation arose in summer 2022 at the Ris-Orangis radiotherapy centre (see box next page). Project mode change management (appointment of a leader, project planning, training of teams, organisation of routine work continuity during project implementation, updating of documents) is not yet well established in the departments. 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. ASN organised a day of discussions with the professionals in Lyon on 25 October 2022 on change management and managing changes in project mode. The centres that have deployed this procedure underline that is a way of improving team dynamics. 2.1.3.3 Significant events in external-beam radiotherapy In 2022, 102 ESRs were reported in radiotherapy under criterion 2.1 (exposure of patients for therapeutic purposes). Among these events, 70 were rated level-1 on the ASN-SFRO scale, i.e. 68% of the total, and three were rated level 2. The latter three concerned: ∙ an error in dose or volume having led to exposure exceeding the planned dose for one of the organs targeted by the treatment as well as a neighbouring organ, and exposure of less than the planned dose for another organ targeted by the radiotherapy treatment; ∙ a fractionation error having resulted in exposure exceeding the planned dose to the organs at risk; ∙ a calibration error that led to six patients receiving an overdose during external-beam radiotherapy treatment. Two ESRs rated level 1 on the ASN‑SFRO scale concerned cohorts of patients as a result of: ∙ a calibration error for more than 5,800 patients. This calibration error resulted from incorrect use of barometric data, leading to GRAPH Breakdown, by ASN regional division, of the number of centres and external-beam radiotherapy accelerators inspected and the number of new licenses or license renewals issued by ASN in 2022 1 0 10 20 30 40 50 60 70 80 90 100 110 Strasbourg Division Paris Division Orléans Division Nantes Division Marseille Division Lyon Division Lille Division Dijon Division Châlons-enChampagne Division Caen Division Bordeaux Division Licensed centres Accelerators New licences or licence renewals 216 ASN Report on the state of nuclear safety and radiation protection in France in 2022 • 07 • Medical uses of ionising radiation 07
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