ASN Report 2017

237 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 08  - Regional overview of nuclear safety and radiation protection ILE-DE-FRANCE facility, will be examined at the same time as the next periodic safety review which is to be submitted before 31st July 2018. To conclude, ASN expects to a see lasting improvements at CIS bio international. The operating rigour, the safety culture, optimisation of the organisational structure and the staff, the monitoring of operations, the cross-functionality of the organisation, and compliance with the baseline requirements of the facility and of the resolutions and regulations must all be improved. 1.2 Radiation protection in the medical field External radiotherapy and brachytherapy ASN carried out 13 inspections in external-beam radiotherapy departments and 7 in brachytherapy departments in the Ile-de- France region in 2017. One inspection was carried out in 2017 further to an ESR (Significant Radiation Protection Event) in 2016 involving a laterality (wrong-side) error and rated level 2 on the ASN-SFRO scale. This inspection provided a better understanding of the succession of steps that led to the event, and allowed the quality of the analysis, the relevance of the corrective measures implemented and the methods of assessing these measures to be reviewed. ASN considers that the departments have on the whole progressed. Most of them now have a complete documentary baseline and have deployed computerised tracking of the patient care pathway, thereby improving treatment safety. One department found to have organisational vulnerabilities in 2017 will be subject to tightened monitoring in 2018. The inspections in 2017 focused mainly on the practical implementation of these procedures and the involvement of all the players in the culture of risk management. Further progress is required in taking SOHFs into account, particularly through experience feedback from adverse events. Furthermore, the renewal of equipment and the implementation of new treatment techniques can create tensions in the organisational setups, which can foster the occurrence of errors. The two brachytherapy departments displaying shortcomings in the application of the regulations have implemented the majority of the corrective actions needed to meet the demands formulated in 2016. In 2017, ASN inspected the brachytherapy departments in order to have a complete view of the way worker and patient radiation protection is applied and of the safety of transport operations. Fluoroscopy-guided interventional practices ASN performed 37 inspections in the area of fluoroscopy-guided interventional practices in Ile-de-France in 2017. Three significant radiation protection events rated level 2 on the INES scale involving exceeding of the regulatory maximumdose at the extremities for workers performing fluoroscopy-guided interventional procedures were reported at the end of 2017. The centres concerned will undergo a specific inspection at the beginning of 2018, conducted by a radiologist expert designated by the French Professional College of Radiology (G4) for one and an IRSN expert for the other, in order to better understand the practices of the centres that reported the events. In view of the observed shortcomings in the wearing of extremity dosimeters by the workers in many centres, ASN wonders whether other similar cases might have gone undetected. The inspections performed in 2017 confirmed the major radiation protection implications for patients and workers during interventions involving ionising radiation. ASN observed that radiation protection was better integrated in the medical specialities of interventional cardiology and neuroradiology, where procedures are carried out in dedicated rooms with professionals who are more aware of the risks than in specialities in which the practitioners carry out interventional procedures in operating theatres. ASN observes a lack of involvement of the medical physicists in the operating theatre and insufficient presence in the field. Five significant radiation protection events that occurred during interventional procedures were reported to the Paris division. Three concerned workers, one concerned a patient and one concerned the theft of a decommissioned mobile surgical C-arm unit. Nuclear medicine ASN carried out 12 inspections in nuclear medicine departments in Ile-de-France in 2017. ASN found that the design or layout of the ventilation systems in several departments did not fully meet regulatory requirements. Twenty significant radiation protection events were reported by nuclear medicine departments. Twelve events involved errors in the preparation or administration of radionuclides to patients, leading to either administration of the wrong radiopharmaceutical or an error in the administered activity. One event concerned the potential external exposure of patients and workers in a conventional room through which passed a pipe carrying contaminated liquid effluents from the nuclear medicine department. 1.3 Radiation protection in the industrial and research sectors Industrial radiography ASN continued its oversight of industrial radiography activities and users of gamma radiography in particular, performing 11 inspections in Ile-de-France in 2017. Six of these inspections were unannounced and carried out under worksite conditions. One inspection was carried out as a follow-up to an ESR rated level 1 on the INES scale in which workers performing on-site gamma radiography work were exposed to a dose to the extremities exceeding one quarter of the regulatory annual limit. This inspection more specifically allowed an assessment of the extent to which social, organisation and human factors contributed to the incident. Universities and laboratories or research centres ASN carried out 14 inspections in research facilities in the Ile-de-France region in 2017. Particular attention was paid