ASN Report 2017

281 ASN report on the state of nuclear safety and radiation protection in France in 2017 Chapter 09  - Medical uses of ionising radiation In 2017, ASN published Patient safety bulletin No. 11, and event analysis sheets No. 3 and No. 4 concerning an error in setting treatment table density parameters and a problem of beam asymmetry linked to premature target degradation. 5.3.4 Synthesis and prospects In radiotherapy in 2017, although the safety fundamentals are in place (equipment verifications, medical staff training, quality and risk management policy), ASN still observes significant disparities between centres. The quality procedures struggle to achieve continuity over the long term, and sometimes even regress due, for example, to lack of assessment or the departure of the person with operational responsibility for quality. Moreover, the risk analyses remain relatively theoretical and are insufficiently deployed prior to organisational or technical changes. ASN underlines that the long-term involvement of all medical professionals – and radiation oncologists in particular – in the management of treatment quality and risks is necessary in order to improve treatment safety. ASN also observes that the radiotherapy centres belonging to a given group and inspected over a certain period of time show the same shortcomings and little sharing of experience feedback, highlighting the fact that there is no real policy of quality and risk management in the healthcare groups. Given the diversity of situations encountered, the centres displaying vulnerabilities or particular risks will continue to be subject to particular scrutiny in 2018. 5.4 Radiation protection situation in brachytherapy Twenty brachytherapy centres were inspected in 2016 (31% of the centres). In 2017, 23 centres were inspected. 5.4.1 Worker radiation protection The occupational radiation protection measures deployed in 2016 by the brachytherapy departments were considered satisfactory, but various points can still be improved: ཛྷ ཛྷ All the inspected centres had a designated RPE-O dedicated to this activity; their duties were defined but their means were insufficient in three of the centres inspected. ཛྷ ཛྷ All the inspected centres had carried out working environment analyses but in six of the centres they did not cover all the jobs. ཛྷ ཛྷ The risk assessment was effectively carried out in all the centres but in three of them it was not consistent with the delimitation of regulated areas. ཛྷ ཛྷ The majority of the centres inspected had drawn up the technical programme of internal and external radiation protection controls. However, the internal technical controls were either not exhaustive or were not carried out at the required frequency in six centres. 5.4.2 Radiation protection of patients The treatment quality and safety management system The results of the inspections carried out in 2016 showed that the majority of the brachytherapy units had deployed a quality approach assisted by the external-beam radiotherapy FOCUS Making the patient a partner in treatment safety The analysis of events notified to ASN shows that patient vigilance can help to detect errors and mitigate their consequences. Furthermore, having a good understanding of the treatment protocol contributes to the delivery of safer and more effective treatments. This issue of the patient safety bulletin aims to echo the ongoing reflections on the role of patients as actors in their own treatment safety. Three themes promoting involvement of the patients are developed: building a relationship of confidence, improving the clarity and the observance of instructions and explanations, and encouraging cooperation. These recommendations are the result of a reflection by the working group on experience feedback analysis, with two ergonomics specialists. FOCUS Overdose in contact radiotherapy Among the three level-2 ESRs notified to ASN in 2017, one ESR associated with a large radiation overdose in contact radiotherapy occurred in the Bordeaux university hospital. In this particular case, for the treatment of cutaneous lesions, the patient was prescribed a total ionising radiation dose of 40 Gy to be delivered by contact radiotherapy in ten sessions of 4 Gy each. The treatment time applied during eight sessions was 2.69 minutes instead of the 0.96 minutes necessary to the deliver the prescribed dose to the patient. The error was detected at the 9th session and the treatment was stopped. IRSN made a retrospective assessment of the dose effectively received by the patient. The event was caused by an error in the manual entry of the irradiation time into the software controlling the device. This event occurred in a situation where the medical staff were overstretched. Following this event, improvement measures were put in place, comprising systematic verification of the treatment parameters by a medical physicist prior to the first treatment session in all cases, and setting up of the equipment in the treatment room by the radiotherapist and the radiographer during a “practice run” session with no dose delivery.