As in the preceding years, these events always highlight organi– sational weaknesses concerning: ∙ the management of the movement of patients’ medical files; ∙ the validation steps, which are insufficiently explicit; ∙ the keeping of patients’ files in a manner that provides an overall view and gives access to the necessary information at the right time. Variations in practices within a given centre, frequent task interruptions, a high and uncontrolled workload affecting the length of working hours, or the deployment of a new technique or practice, all constitute situations that disrupt work activities and weaken the safety measures defined in the quality management system. It is therefore essential to assess these measures regularly and to draw lessons from the malfunctions that occur. In 2021, ASN published a Patient safety newsletter assessing of 10 years of use of the ASN-SFRO scale for ESRs rated level 2. SUMMARY The inspections carried out in 2021 in nearly a quarter of the radiotherapy departments, and of which the majority were able to be conducted on site despite the constraints associated with the Covid-19 pandemic, confirm that the safety fundamentals are in place: organisation of medical physics, equipment verifications, training in the radiation protection of patients, deployment of quality assurance procedures, recording and analysis of events and production of prospective risk analyses. Nevertheless, the assessment of corrective action effectiveness is struggling to achieve widespread adoption and the prospective risks analyses still remain relatively incomplete and insufficiently updated prior to an organisational or technical change or following experience feedback from events. Although the inspections frequencies have been reduced in response to the progress made by the radiotherapy centres, the departments presenting vulnerabilities or specif ic issues continued to be subject to tighter monitoring in 2021. The occurrence of events such as wrong-side or patient identif ication errors reveals persistent organisational weaknesses and the need to regularly assess practices. The lessons learned from events also illustrate the fact that the calibration of medical devices is a critical step for treatment safety. CALIBRATION : A CRITICAL STEP IN THE RADIOTHERAPY PROCESS On 23 April 2021, the Sainte-Catherine Cancer Institute – Avignon-Provence, situated in Avignon, reported a significant event that occurred in its radiotherapy department, which induced ionising radiation overdoses in several hundred patients. The reported event resulted from errors made when calibrating the photon beams of one of the accelerators in the institute’s radiotherapy department. The consequence of these errors, which were discovered ten months after the incorrect calibration operation, was overdosing during the external-beam radiotherapy sessions performed using this accelerator. A total of 749 patients were concerned by at least one treatment session on this accelerator, including 99 who received a delivered dose that was between 5 and 6.8% higher than the prescribed dose. ASN conducted an inspection of the radiotherapy department in June 2021. In view of the conclusions of this inspection and of the ESR, ASN has decided to re-inspect this centre in the first quarter of 2022. This event concerning several patients was rated level 2+ on the ASN‑SFRO scale of radiotherapy events, graded from 0 to 7 in increasing order of severity. A REVIEW OVER 10 YEARS OF ESRs RATED LEVEL 2 ON THE ASN-SFRO SCALE Since 2008, the ESRs affecting patients during a radiotherapy procedure are rated on the ASN-SFRO scale developed by ASN in collaboration with the SFRO. This scale, dedicated to informing the public, comprises 8 levels: deviations from 0 to 1, incidents from 2 to 3 and accidents from 4 to 7. The severity of the effects is assessed by referring to the international clinical classification used by practitioners (Common Terminology Criteria for Adverse Events –CTCAE grades). A retrospective study spanning 10 years (from 2008 to 2018) was carried out on the follow-up of patients affected by an ESR rated level 2. The data relative to 57 ESRs and 112 patients were collected and analysed by the multidisciplinary working group that produced the ASN bulletin (GT REX). The results of this study show that 30% of the patients have been lost to follow-up and the median follow-up time is less than 2 years, illustrating the fact that follow-up must be improved to ensure better patient care management. Thus, in this bulletin, the GT-REX working group reiterates the regulatory obligation to report an ESR and the moral obligation, further to the ESR, to ensure the long-term follow-up of the patients, beyond the requirements of the INCa (approval criterion No. 18 setting the follow-up time at 5 years). Lastly, the working group issues recommendations concerning the organisation and systematisation of the patient follow-up file. These recommendations concern the creation of a follow-up register and the obligatory items to include in the patient’s file. ASN Report on the state of nuclear safety and radiation protection in France in 2021 213 07 – MEDICAL USES OF IONISING RADIATIONS 08 07 13 04 10 06 12 14 03 09 05 11 02 AP 01
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