ASN moreover observes a rise in numbers of stereotactic treatments in radiotherapy departments across the country, with an increase in extra-cranial stereotactic indications (lung, liver, spine, bones, ENT). This activity presents radiation protection risks and requires skills of a high standard and greater control of the doses delivered. It also takes up more medical and medical physics time and requires work organisation adaptations. Furthermore, the reform of care licensing (see point 1.3.3) is likely to lead to changes in the porting of nuclear activity licences (for radiosurgery for example), and organisational changes. ASN will be extremely attentive to the impact of these changes on radiation protection, and in particular to the adequacy of the planned resources for implementing treatments of this type. The safety of radiotherapy treatments has been a priority area of ASN oversight since 2007 on account of the high doses delivered to the patient. Since 2019, the four-yearly inspection programmes have placed the emphasis on the ability of the centres to deploy a risk management approach. Skills management, the implementation of new techniques or practices and the mastery of the equipment are also examined in depth, depending on the centres. ASN has continued its graded inspection approach: ∙ by reducing, in the light of the progress made in the control of treatment safety, the average frequency of inspections, which since 2020 has been reduced to once every four years (instead of the previous three-yearly frequency), enabling all the centres to be inspected every four years; ∙ by maintaining a higher frequency for the centres presenting vulnerabilities or risks, particularly for some centres having necessitated tightened inspections. ASN conducted 68 inspections in 2023, representing 39% of the French centres. Out of the 68 inspections, ten were conducted in combined mode, that is to say both on site and remotely. Two inspections were unannounced (see box previous page). By analysing documents and general points at their desk, inspectors can devote more time when on site to visiting the facility and interviewing the personnel. In addition to the routine inspections, commissioning inspections carried out following the introduction of new services, change of site further to a relocation and the acquisition of new machines, and inspections carried out following an ESR are counted in these 68 inspections. ASN observes that in addition to the existing difficulty in recruiting radiographers and medical physicists, it is now difficult to recruit radiotherapists, whatever the region. This lack of personnel has impacts on the activity, the organisational set-ups and the medical staff (reduction in treatment slots, overstretched personnel, tensions in the teams, etc.). Holding interviews with the medical and paramedical teams and medical physicists during the inspections can bring to light situations of tension and malfunctioning, which are sources of risks for the patients despite a formalised reference framework. Holding interviews with senior management enables these conflictual situations to be discussed with a view to helping the department identify technical, human and organisational lines for improvement. These inspections focusing on Human and Organisational Factors (HOFs) are conducted regularly by ASN in the area of radiotherapy and are extending increasingly to other medical fields (see box below); they sometimes detect situations representing a risk for patient safety that would not be found during a conventional inspection. 2.1.3.1 Radiation protection of external-beam radiotherapy professionals When the radiotherapy facilities are designed in accordance with the rules in force, the radiation protection risks for the medical staff are limited due to the protection provided by the facility. The results of the inspections conducted in 2023 reveal no difficulties in this sector: ∙ radiation protection advisors have been designated in all the centres inspected; ∙ all the radiation protection technical controls have been carried out at the required regulatory frequency. 2.1.3.2 Radiation protection of radiotherapy patients The assessment of the radiation protection of radiotherapy patients is based on the inspections focusing on implementation of the treatment quality and safety management system, made compulsory by ASN resolution 2021-DC-0708 of 6 April 2021. Since 2016, in the course of its inspections ASN verifies the adequacy of the human resources, and in particular the presence of the medical physicist and the internal organisation procedures for tracking and analysing adverse events – or malfunctions – recorded by the radiotherapy centres. The inspections that include an HOF approach are increasing in the medical sector in order firstly to better consider the context of the healthcare facilities and their actual organisational set-ups that could create difficulties for application of the regulations, and secondly to question adaptive safety. This is because the radiation protection of workers and patients is not based solely on the defining of regulatory requirements, or on them being broken down into standards, baseline requirements, protocols and organisation memos (normative safety). It is also ensured by a set of regulations applied on a daily basis by the healthcare personnel (adaptive safety) because the work conditions and actual organisational set-ups are usually different to those defined and envisaged by management. The risks do not arise only from deviations from the regulations; they are also linked to the actual work conditions. “Invoking human error to hastily in the event of a malfunction or even an accident, is often a shortcut that does not foster prevention. The question is rather to ask what were the organisational conditions that led to the malfunction or accident. Considered as one of the three pillars of safety, the human and organisational factors approach consists in identifying the conditions that foster safe behaviour at all levels of the organisation” (Institute for an Industrial Safety Culture – ICSI). HOFs are being taken into account in inspections progressively. They are currently taken into account in inspections further to an ESR or when events are repeated in a given department, or when situations of internal conflict that could affect patient safety have been reported to ASN. But this type of inspection can also be implemented in the case of a significant technical and/or organisational change. ASN ADAPTS ITS OVERSIGHT TO TAKE BETTER ACCOUNT OF THE HUMAN AND ORGANISATIONAL FACTORS IN ITS INSPECTIONS ASN Report on the state of nuclear safety and radiation protection in France in 2023 215 • 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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