1.4 The risks and oversight priorities In order to establish its oversight priorities, ASN has classified the nuclear-based medical activities according to the risks for the patients, the personnel, the public and the environment. This classification takes particular account of the doses delivered or administered to the patients, individually or collectively, the fitting out of the premises and the conditions of use of sources of ionising radiation by the medical professionals, the production of waste and effluents contaminated by radionuclides, the source security risks (high activity sealed sources), lessons learned from significant events reported to ASN and the radiation protection situation in the institutions exercising these activities. On the basis of this classification (see point 1.3.3, Table 1), ASN considers that its oversight must focus in priority on externalbeam radiotherapy, brachytherapy, nuclear medicine and FGIPs. The inspection frequencies have been adapted and enable all the radiation-risk activities to be inspected over a period of 3 to 5 years, depending on the sectors. As from 2018, ASN defined a list of systematic inspection points concerning the radiation protection of workers, patients and the public, the management of sources, waste and effluents, and the security of sources. These inspections, associated with indicators, enable regional and national assessments to be carried out and the developments to be measured over time. Some indicators are common to all the inspected activities, such as the organisation of worker radiation protection and of medical physics, and training in radiation protection of workers and patients. Others are specific to a given activity, such as the management of waste and effluents in nuclear medicine or the security of sources in brachytherapy. These indicators serve in particular as the basis for assessing the radiation protection situation in the medical sector (see point 2). These systematic checks are complemented by investigations on specific themes defined in an annual or multi-annual framework and adapted to the particular situations encountered in the inspections. The main themes chosen in 2022 were: ∙ in radiotherapy and brachytherapy: risk management, management of skills and training, mastery of the equipment and the security of high-activity sealed sources; ∙ in nuclear medicine: the experience feedback process for reported internal or external events (ESRs); ∙ in FGIPs: implementation of the optimisation approach. For the routine inspections, ASN has defined an inspection frequency per inspected nuclear activity (Table 2) based on a graded approach to the radiation protection risks. These frequencies are increased when vulnerabilities that could have an impact on radiation protection are identified (difficulties linked to human resources, technical or organisational changes, quality management or insufficient control of risks – lateness in formalising practises, absence of risk assessments, lack of risk culture – particular risks associated with certain techniques, etc.). This can lead ASN to place certain centres under tightened surveillance, when significant persistent malfunctions have been found, and to inspect them at least annually. THE SETTING UP OF CLINICAL PEER REVIEWS In order to transpose Council Directive 2013/59/Euratom of 5 December 2013, the work on setting up clinical peer reviews, which began following publication of the Directive, was relaunched in 2022 by the Ministry responsible for health, which is coordinating drafting of the texts. The ongoing work aims to determine the procedures for conducting these audits (recruiting auditors, training, funding, etc.) and to draw up the baselines on which the auditors can found their work. Work on imaging and radiotherapy is in progress, with contributions from the national professional councils of radiologists and radiotherapists. ASN is involved in the discussions on these two themes. Several institutions are involved in the procedure (General Health DIrectorate – DGS, General Healthcare Directorate – DGOS, HAS, INCa, ASN), as the successful implementation of these clinical peer reviews is partly dependent on them fitting in well with the existing systems, such as HAS certification and ASN oversight. ASN encourages an approach that is graded according to the radiation protection risks by focusing the clinical peer reviews on the areas of radiotherapy, therapeutic nuclear medicine, FGIPs and computed tomography, the latter being the technique that makes by far the greatest contribution to exposure of the French population. ASN will ensure compliance with the framework of the directive, and: ■ provide input for the procedure based on European work (QUADRANT project and EU‑JUST‑CT project); ■ participate actively on the steering committee that the Ministry responsible for health wishes to set up to evaluate the system and propose guidelines concerning any necessary changes; ■ target these audits on clinical practices; ■ link the system with the two ASN resolutions on the quality assurance obligations (ASN resolution 2019‑DC‑0660 of 15 January 2019 in medical imaging – nuclear medicine for diagnostic purposes, dental and conventional radiology, computed tomography and FGIPs, and ASN resolution 2021-DC-0708 of 6 April 2021 for therapeutic procedures (radiotherapy, radiosurgery and nuclear medicine for therapeutic purposes), being careful to maintain what has been achieved (formalising of change management, of subcontracted operations and of specific work task qualifications in particular); ■ promote an approach graded according to the risks, prioritising putting in place computed tomography audits targeting implementation of the principle of justification and when deploying new radiotherapy techniques and practices. Holding clinical peer reviews should improve the justification of procedures, which is why ASN is making it a priority action (justification/clinical peer reviews) of the National plan for controlling imaging doses. ASN cannot act alone on this subject because its scope of competence only enables it to verify implementation of the principles of justification during its inspections in a “quality management system process” approach (formalisation of the process, recording of the elements of proof of the justification process). This why ASN will endeavour to continue mobilising all the institutional players and learned societies on the subject of clinical audits, in particular through the framework agreements it has signed with these entities. Alongside this work, ASN will continue its field inspection activity to monitor the deployment and the impact of the clinical peer reviews. 212 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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