of 5 July 2021, entered into effect in July 2021. It repeals the resolution of 23 August 2011 (2021-DC-0238) and updates the qualifications required for physicians and dental surgeons who perform procedures using ionising radiation for medical purposes or research involving humans, and for the physicians appointed to coordinate a medical nuclear activity or who apply for a license or registration as a natural person. The quality assurance obligations – To control the doses delivered to patients and thereby contribute to improved treatment safety, the obligations of heads of nuclear activities with regard to quality assurance for all medical activities involving ionising radiation are now governed by two ASN resolutions: ∙ resolution 2019-DC-0660 of 15 January 2019 in medical imaging, that is to say in nuclear medicine for diagnostic purposes, in dental and conventional radiography, in computed tomography and for FGIPs; ∙ resolution 2021-DC-0708 of 6 April 2021 for therapeutic procedures, that is to say external-beam radiotherapy, in– cluding contact therapy and intraoperative radiotherapy, brachytherapy, nuclear medicine for therapeutic purposes (ITR) and radiosurgery. These resolutions oblige the head of the nuclear activity, with requirements proportionate to the radiation protection risks, to formalise the processes, procedures and work instructions associated with the operational implementation of the two general principles of radiation protection, namely justification for the procedures and dose optimisation, and those concerning the lessons learned from the events, the training of professionals and, for therapeutic procedures, the prospective risk analysis. ASN resolution 2021-DC-0708 of 6 April 2021, which entered into effect on 17 August 2021, repeals resolution 2008-DC-0103 of 1 July 2008 relative to quality assurance obligations in radiotherapy. It updates and steps up the quality assurance requirements, particularly in the event of an organisational or technical change or the outsourcing of services. Training in patient radiation protection – The obligations for continuous training in patient radiation protection are set in Articles L. 1333‑19, R. 1333‑68 and R. 1333‑69 of the Public Health Code. The system as a whole was revised in ASN resolution 2017-DC-0585 of 8 January 2015 amended, further to discussions with all the National Professional Councils (CNP) concerned in order to clarify and reinforce the teaching objectives concerning justification, to integrate new players and to foster links with the other continuous training instruments. Since this resolution entered into application, some twenty professional guides have been produced by the learned societies, validated by ASN and put on line. To monitor the practical implementation of this new framework, a qualitative and quantitative assessment was initiated at the end of 2021, involving all the players. An inventory of the training offerings will be drawn up to identify the main players (health facilities, learned societies, continuous training organisations). For the guide for radiotherapy professionals and the guide for radiographers, a specific assessment shall be conducted on the number and content of the training course offerings in these two areas. This assessment will focus on compliance with the regulations, the organisation of the training courses, their teaching methods and the level of satisfaction of the professionals who have followed the courses. This work will be presented in 2022 to the committee that monitors the national plan for controlling imaging doses. 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 external- beam 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 2021 were: ∙ in radiotherapy and brachytherapy: risk management, man– agement 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. 208 ASN Report on the state of nuclear safety and radiation protection in France in 2021 07 – MEDICAL USES OF IONISING RADIATIONS
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