ASN Report 2020

Enforcement measures and tightened monitoring of centres: improvements observed by ASN The measures ASN has taken in terms of enforcement (compliance notices) and tightened monitoring of certain radiotherapy centres have brought significant improvements in their situation. Below are three examples of centres faced with organisational malfunctions in preceding years. Improvement of the situation of the Lucien Neuwirth Cancerology Institute The Lucien Neuwirth Cancerology Institute (ICLN), situated in Saint‑Priest‑en‑Jarez (Loire département ), is a public institution specialised in fighting cancer and which exercises external-beam radiotherapy and brachytherapy activities. Since 2017, ASN has put in place tightened monitoring of this institute, mainly on account of relational difficulties within the radiotherapy department. This monitoring has resulted in the institute undergoing four inspections in two years. The responses obtained further to the inspection of 9 and 10 July 2019 led ASN to give ICLN formal notice on 18 December 2019 to comply with certain regulatory provisions concerning the organisation of human resources and risk management. The ICLN, represented by its Director and the head of the external-beam radiotherapy department, presented its action plan in response to this compliance notice to ASN General Management on 10 February 2020, and undertook to reduce its activity pending the recruitment and dispensing of the training necessary to acquire the required skills. These provisions were taken up in the licensing decision issued to ICLN in June 2020, the main purpose of which was to transfer responsibility for the nuclear activity from the head of the radiotherapy department to the institute as a legal entity, and to restrict certain activities. ASN continued its tightened monitoring of the site throughout 2020. The observed improvements enabled the ICLN to gradually resume normal activity in July 2020. An inspection carried out on 28 and 29 September 2020 showed the inspectors that the requirements set in the compliance notice had been satisfied. More generally, improvements have been noted in patient radiation protection, in the organisation of medical physics with appropriate personnel numbers and skills, and effective implementation of the quality approach. Lastly, working relations between the medical staff have improved thanks to collective involvement of all the professions of the radiotherapy department. ASN will continue to monitor the ICLN in 2021, in order to accompany it in the next phases, particularly the resumption of certain treatments that present greater risks for the patients in the event of an implementation error. Improvement in the situation of the Peuplier Hospital radiotherapy centre Further to organisational malfunctions observed during inspections between March and October 2019, the head of external-beam radiotherapy activities at the private Peuplier Hospital of the Ramsay Santé Group, Paris 13th district, was served formal notice on 10 February 2020 to comply with certain regulatory requirements. The measures adopted by the centre to meet the requirements were transmitted to ASN on the set dates and their effective application was checked during a new inspection by ASN on 21 and 22 September 2020, in parallel with a control visit by the Île-de-France Regional Health Agency (ARS). This inspection revealed a distinct improvement in the situation of the centre. More specifically, the organisation of the medical and medical physics teams, the work of the radiographers and the physicians’ assistants have been reorganised. Functions essential for the smooth functioning of the centre and for assisting professionals have been filled by persons involved who have undergone an induction process (deputy director, head radiographer, operational quality manager and quality and risk assistant). Bodies responsible for governance, quality management, consultation and communication have been put in place or revamped, and the associated decisions communicated to the persons concerned. The adverse events internal reporting and analysis system is functioning again, thereby contributing to the continuous improvement of treatment safety. Lastly, activity resumption was organised gradually and as appropriate for the available staff. Lifting of the ASN compliance notice was based on all these points. ASN will check in 2021 that the new organisation is maintained in a situation of more intense activity. Follow-ups to the tightened monitoring of the Metz private radiotherapy centre The technical platform of the Private Radiotherapy Centre of Metz (CPRM) was taken over in May 2019 by Calimetz, a subsidiary of Elsan, a private group of clinics, giving rise to the Private Radiotherapy Institute of Metz (IPRM). The IPRM therefore now holds the license issued by ASN and is responsible for the management of patient and worker radiation protection. Some of the radiotherapist physicians from the CPRM are continuing their medical activity at the IPRM as independent private practitioners. With this resumption of activity, the new persons in charge have implemented a governance plan that provides for setting up a local management structure, taking control of the quality process and the risk analysis approach, and the overhaul of the information technology resources. Lastly, the centre’s organisation has been reviewed and support functions reintroduced internally. Given this context of significant change, ASN maintained its tightened monitoring of the IPRM’s activity in 2019 and 2020, based on regular interchanges and inspections conducted at least annually. ASN’s monitoring has confirmed the robustness of the IPRM’s approach, which should ultimately meet the conditions needed to lift the tightened monitoring applied to the centre since 2018. Although particular vigilance is required given the interpersonal relationships, still marked by the past conflicts, and the prospect of the new projects envisaged by the IPRM, such as the implementation of stereotactic techniques, ASN no longer sees any sources of concern for health care safety that would necessitate placing the centre under tightened monitoring. 216 ASN Report on the state of nuclear safety and radiation protection in France in 2020 07 – MEDICAL USES OF IONISING RADIATION