Abstracts ASN Report 2019

א ِ ב ِ « א ƏƳǣƏɎǣȒȇ ȵȸȒɎƺƬɎǣȒȇ Ȓǔ ȸƏƳǣȒɎǝƺȸƏȵɵ 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 ĶłŀŃňĿņłŅŌ ĵŌ ŅĸņłĿňŇļłŁ ӅӃӃӋі іӃӄӃӆׇłĹ ӄׇ ňĿŌ ӅӃӃӋє Since 2016, these inspections have included verifications of the adequacy of the human resources, and in particular the presence of the medical physicist and internal organisation procedures for tracking and analysing adverse events –or malfunctions– recorded by the radiotherapy centres. The presence of a medical physicist during the treatments was ĶłŁĹļŅŀĸķ ļŁ ĴĿŀłņŇ ӌӃՌ łĹ ŇĻĸ ļŁņŃĸĶŇĸķ ĶĸŁŇŅĸņє ŀĸķļĶĴĿ ŃĻŌņļĶņ łŅĺĴŁļņĴŇļłŁ ŃĿĴŁ ļņ ĴĿņł ĴʼnĴļĿĴĵĿĸ ļŁ ĴĵłňŇ ӌӃՌ łĹ ŇĻĸ centres. The assessment shows that the detection of adverse events, their reporting (internally or to ASN) and their recording are deemed satisfactory on the whole. On the other hand, the analysis of these adverse events is only satisfactory on the whole in 46% łĹ ŇĻĸ ļŁņŃĸĶŇĸķ ĶĸŁŇŅĸņё ŊĻļĶĻ ŅĸŃŅĸņĸŁŇņ Ĵ ŅĸĺŅĸņņļłŁ łĹ ӅӋՌ ŊļŇĻ ŅĸņŃĸĶŇ Ňł ӅӃӄӋѓ Ҋ The analysis of the causes of events is still too succinct, often not going beyond the immediate causes. Ҋ Similarly, the analyses of recurrent events are still poorly developed, even though they should constitute alert signals for the centre. The improvement in practices through experience feedback and the assessment of the effectiveness of the corrective actions were deemed satisfactory in only 27% of the centres inspected, ŊĻļĶĻ ļņ ņŇĴĵĿĸ ŊļŇĻ ŅĸņŃĸĶŇ Ňł ӅӃӄӋׇĴŁķ ĻĴķ ķŅłŃŃĸķ ĵŌ ӄӃՌ with respect to 2017. Although the majority of these procedures involve representatives of all the medical professionals who contribute to the treatment process, some of the personnel –the physicians in particular– do not involve themselves, which reduces the effectiveness of the procedures. In order to achieve real continued improvement in treatment quality and safety, further progress must be made in the monitoring and evaluation of the corrective actions put in place, in the involvement of all the personnel and in the utilisation of experience feedback to assess and enrich the prospective risk ĴŁĴĿŌņļņё ŅĸńňļŅĸķ ĵŌ ŇĻĸ ĴĵłʼnĸŀĸŁŇļłŁĸķ ŅĸņłĿňŇļłŁ ӅӃӃӋі іӃӄӃӆׇłĹ ӄׇ ňĿŌ ӅӃӃӋє In addition to the verifications performed, the ability of a centre to deploy a risk management procedure was again subject to ņŃĸĶļĹļĶ ļŁʼnĸņŇļĺĴŇļłŁņ ļŁ ӅӃӄӋє Ļĸņĸ ļŁʼnĸņŇļĺĴŇļłŁņ ŅĸʼnĸĴĿ ŇĻĴŇѓ Ҋ Although the requirements for the management of quality and safety in radiotherapy departments set by the abovementioned resolution are satisfied on the whole, there are still disparities between centres. The prospective risk analysis for example, which is mandatory, is only available and complete in half of the inspected centres. Ҋ More generally, further to the inspections carried out since 2016, ASN considers that implementation of the risk management procedure is only satisfactory on the whole in half of the inspected centres. These are the centres in which management has defined a policy with shared, assessable and assessed operational objectives, has communicated on the results of this policy and allocated the necessary resources, particularly to the łŃĸŅĴŇļłŁĴĿ ńňĴĿļŇŌ ŀĴŁĴĺĸŅє ňŅŇĻĸŅŀłŅĸё ŇĻĸ ļŁʼnłĿʼnĸŀĸŁŇ łĹ ĴĿĿ the professionals, especially the medical professionals, remains an essential prerequisite for the risk management procedures to produce concrete improvements in the safety of practices. ĴņŇĿŌё ŁłŇĸņ ĴĺĴļŁ ļŁ ӅӃӄӌׇŇĻĴŇ ŇĻĸ ŇĸĶĻŁļĶĴĿё łŅĺĴŁļņĴŇļłŁĴĿ or human changes are not sufficiently anticipated. The impact a change can have on the operators’ activity is not always analysed, despite the fact that these changes can weaken the existing lines of defence. The lessons learned from the inspections carried out ļŁ ӅӃӄӌׇņĻłŊ ŇĻĴŇё ŊĻĸŁ Ĵ ŁĸŊ ŇĸĶĻŁļńňĸ ļņ ķĸŃĿłŌĸķё ļŁ łŁĿŌ ӇӃՌ of the cases do the centres have adequate command of project management, and in only 25% of the cases do they have adequate command of the installation of the new equipment. א ِ ב ِ ב ³ǣǕȇǣǔǣƬƏȇɎ ƺɮƺȇɎɀ ǣȇ ƺɴɎƺȸȇƏǼ ٮ ƫƺƏȅ ȸƏƳǣȒɎǝƺȸƏȵɵ Ł ӅӃӄӌё ӄӇӈׇņļĺŁļĹļĶĴŁŇ ĸʼnĸŁŇņ ĶłŁĶĸŅŁļŁĺ ŅĴķļłŇĻĸŅĴŃŌ ŊĸŅĸ reported. In the last few years, ASN has noted a significant reduction in the ESRs reported by radiotherapy departments. Ł ĸĹĹĸĶŇё ņłŀĸ ӅӃӃׇ ņ ŊĸŅĸ ŅĸŃłŅŇĸķ ŃĸŅ ŌĸĴŅ ļŁ ӅӃӄӇׇĴŁķ 2015. This phenomenon must be analysed with the assistance of the radiotherapy professionals to find out the reasons for this ķŅłŃ ļŁ ŁňŀĵĸŅņє Ļļņ ķŅłŃ ņŇĴĵļĿļņĸķ ļŁ ӅӃӄӌё ŊļŇĻ ŇĻĸ ŁňŀĵĸŅ łĹ ŅĸŃłŅŇĸķ ĸʼnĸŁŇņ ĸńňļʼnĴĿĸŁŇ Ňł ŇĻĸ ӅӃӄӋׇĹļĺňŅĸє łņŇ łĹ ŇĻĸ ĸʼnĸŁŇņ ŅĸŃłŅŇĸķ ļŁ ӅӃӄӌׇĶłŁĶĸŅŁ ŃĴŇļĸŁŇ ŅĴķļĴŇļłŁ protection, and the majority of them are not expected to have any clinical consequences. ɖɮƺȸǕȇƺ ٫ «ǝȕȇƺ ٮ Ǽȵƺɀ !ȒȅȵǼǣƏȇƬƺ ȇȒɎǣƬƺ ɀƺȸɮƺƳ Ȓȇ Ɏǝƺ nɖƬǣƺȇ zƺɖɯǣȸɎǝ !ƏȇƬƺȸȒǼȒǕɵ XȇɀɎǣɎɖɎƺ ٢X!nz٣ ǣȇ ³ƏǣȇɎ ٮ ¨ȸǣƺɀɎ ٮ ƺȇ ٮ hƏȸƺɿ ٢nȒǣȸƺ département ٣ 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 Ȓǔ ژ Ɏǝǣɀ ǣȇɀɎǣɎɖɎƺً ȅƏǣȇǼɵ Ȓȇ ƏƬƬȒɖȇɎ Ȓǔ ȸƺǼƏɎǣȒȇƏǼ ƳǣǔǔǣƬɖǼɎǣƺɀ within the radiotherapy department. This has resulted ǣȇ ژ Ɏǝƺ ǣȇɀɎǣɎɖɎƺ ɖȇƳƺȸǕȒǣȇǕ ǔȒɖȸ ǣȇɀȵƺƬɎǣȒȇɀ ǣȇ ɎɯȒ ɵƺƏȸɀِ (ɖȸǣȇǕ Ɏǝƺ ǼƏɀɎ ǣȇɀȵƺƬɎǣȒȇ ƬƏȸȸǣƺƳ ȒɖɎ Ȓȇ ژח ƏȇƳ ׏׎ ژ hɖǼɵ אژ ׎׏ ח ً Ɏǝƺ ³z ǣȇɀȵƺƬɎȒȸɀ ǔȒɖȇƳ Ɏǝƺ ȅƺƳǣƬƏǼ ȵǝɵɀǣƬɀ unit to be in a very vulnerable situation. They noted that responsibilities were not adequately defined, foremost among these being the verification and validation channels, and the division of roles between the medical physics service provider and the personnel of the medical physics unit. The work of the outside service providers, found to be highly fragmented, is a risk factor (by increasing the number of points of contact between professionals) which must also be taken into account. ASN considers that the ICLN’s responses following this inspection were not satisfactory and would not reduce the risks for patients: ASN therefore gave ICLN formal notice to comply with certain regulatory provisions concerning organisation, human resources and risk management. The person responsible for nuclear activities was notified Ȓǔ Ɏǝƺɀƺ ȵȸȒɮǣɀǣȒȇɀ Ȓȇ ׏ (ژז ƺƬƺȅƫƺȸ א ׎׏ ח ِ ³z ɯǣǼǼ ɮƺȸǣǔɵ ǣȇ אژ ׎ א ׎ ژ Ɏǝƺ ƏƬɎǣȒȇɀ ɎƏǸƺȇ ƫɵ Ɏǝƺ X!nz ɎȒ ƬȒȅȵǼɵ ɯǣɎǝ Ɏǝǣɀ ژ ȇȒɎǣƬƺِ ASN Report on the state of nuclear safety and radiation protection in France in 2019 207 ׎ ٲ ו MEDICAL USES OF IONISING RADIATION 07