effective than in the preceding two years, with 77% of the departments presenting a good medical physics organisation in 2023 compared with 83% in 2021 and 2022 (see Graph 7 previous page). However, for some services inspected in 2023, the Medical Physics Organisation Plan (POPM) was incomplete and the medical physics organisation described in the POPM was considered inadequate. Lastly, following the publication of two ASN resolutions 2019‑DC‑0660 and 2021-DC-0708, laying down the quality assurance obligations in medical imaging and for therapeutic procedures respectively, ASN notes a strong commitment and significant investment on the part of the medical departments in the deployment of the QMS. ASN observes that the authorisation process is being deployed, but there are still disparities between the medical and paramedical personnel, given that it is applied mostly for the paramedical staff. Although the events notification culture is present in a large proportion of the inspected departments, it must be improved or be reinforced, as ASN observed that some centres had not reported ESRs. 2.3.3.3 Protection of the public and the environment Compliance with the requirements concerning protection of the general public and the environment was checked in all the inspected centres. More than 90% of the departments inspected over the 2019‑2023 period (96% in 2023) have a dedicated and protected deliveries area (see Graph 8 above), that complies with the requirements of ASN resolution 2014-DC-0463 of 23 October 2014. About 20% the departments inspected each year (21% in 2023) have difficulties in meeting the regulatory limits set for the activity concentration of effluents discharged after letting the effluents decay (10 becquerels per litre – Bq/L - for contaminated effluents after storage, or 100 Bq/L for effluents from the rooms of patients treated with iodine-131 (see Graph 8 above). Improvements have been observed these last three years in the verification of the storage tank leak detectors in the retention trays and in the formalising of checks, with more than 80% complying with the regulations (87% in 2023). The inspections have also revealed that the EWMPs do not always contain all the required elements, such as the discharge agreement signed with the manager of the public wastewater drainage network, and the setting of a maximum permissible value at the outlet of the centre. Alongside this, over the last three years ASN has observed an improvement in performance of the non-contamination checks at the end of therapeutic procedures when the procedures are performed outside the nuclear medicine departments, which are performed satisfactorily by more than 90% of the inspected departments (93% in 2023). ASN notes that the RNAs have difficulties in implementing the new regulations concerning the verifications to be carried out under the Public Health Code which are applicable since 1 January 2023. The main difficulty is linked to the definition of the requirements (scope of the verification action) of the Order, for the approved organisations and healthcare centres alike. 2.3.3.4 Significant events in nuclear medicine Out of the 61 departments inspected, most of them have a system for recording adverse events. For the majority of events reported to ASN, the proposed action plan is appropriate but shortcomings are sometimes observed in the analysis of their root causes. On the other hand, several inspected departments had not reported certain ESRs to ASN, primarily due to the personnel’s lack of awareness of events reporting. Altogether, 201 ESRs were reported in 2023, a figure that is slightly higher than in 2022 and which has been increasing on the whole over the last few years (40% since 2019 – see point 2.7). As in the preceding years, the majority of the reported events (71%) concern patients (see Graph 10). Most of the reported events have no expected clinical consequences, in view of the activities injected. ASN notes that deployment of the nuclear medicine activity, particular when new medical devices are purchased, changes the organisational arrangements and the work activity and can be a source of ESRs if it is not managed properly. This was ASN’s finding during an inspection in 2023 after a centre reported two events that occurred in its PET sector in a period of ten days. It was found that the significant increase in the department’s activity with the acquisition of a fourth PET scanner, without recruiting additional personnel, combined with the introduction of a barcode system to make the RPD preparation and injection process safer but requiring accustomisation, with personnel who could be assigned to several different sectors, were factors contributing to these events. GRAPH Development of nuclear medicine department compliance with protection of the public and the environment (2019-2023) 8 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% 2023 2022 2021 2020 2019 Regular verification of operation of tank alarms Contamination checks performed at end of therapeutic procedures outside the department Compliance with the regulatory effluent discharge values Source deliveries reception room protected, dedicated and locked ASN Report on the state of nuclear safety and radiation protection in France in 2023 227 • 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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