Most of the events reported in 2023 concern patient radiation protection, and the majority of them are not expected to have any clinical consequences. As in the preceding years, these events always highlight organisational weaknesses concerning: ∙ the keeping of the patients’ medical files, which provide an overall picture and give access to the required information at the right time; the earlier the error is committed in the treatment process (e.g. wrong side), particularly in the initial consultation and prescription elaboration phase, the less the laterality information is called into question in the subsequent stages of the patient care pathway; it is therefore essential to test the barriers in place at these stages of the process; ∙ validation steps in which the parameters to verify are not sufficiently explicit (What check? At what stage of the process? By which operator?); ∙ the management of the patients’ medical file movements which, if it is not optimised, creates constraints on the work activity of the medical staff, fostering the overlooking of certain verification steps. As a general rule, variations in practices within a given centre, frequent task interruptions, a high and uncontrolled workload with, among other things, an impact on the length of working hours, the deployment of a new technique or practice that is not fully mastered, constitute situations that disrupt work activities and weaken the safety measures defined in the Quality Management System (QMS). It is therefore essential to assess these measures regularly and to draw lessons from the malfunctions that occur. In 2023, ASN published a “Patient Safety” bulletin devoted to the prospective risk analysis procedure. The aim of this bulletin is to bring out a common vision of the patient care and treatment process, anticipate the potential risks and define and improve the safety measures needed to control them. For example, treatment interruptions further to a machine failure, a technical fault or maintenance work, disrupt the team’s organisation and are sources of potential risks for the patient, without necessarily resulting in an ESR. This bulletin examines not only the risk factors for the patient during a treatment interruption, but also the safeguarding factors. The multidisciplinary group behind the “Patient Safety” bulletin has tested the EPECT method, recently developed by IRSN, on a scenario combining different cases of treatment interruption. ASN notes a significant drop in ESR notifications in radiotherapy since 2015 (see point 2.7, Graph 14 page 237), and of about 35% since 2019. This drop can probably be partly attributed to the setting up of organisations that have rendered treatment preparation smoother and safer (complete dematerialisation with lists of “record and verify” tasks, harmonisation of medical protocols, contour delineation assistance software, automatic application of dosimetry shifts, monitoring of preparation times, etc.), and the integration of lessons learned from events. The setting up of audits to assess the performance of the radiotherapy treatment process (auditing of files, tracking times), observance of the identity monitoring rules or the effectiveness of an improvement measure can also explain this drop in ESR reporting, even if these procedures are still far from being widely implemented. Nevertheless, the ASN inspectors also observe, as in 2022, a decrease in the number of adverse events recorded internally and analysed (fewer meetings of Experience Feedback Committees – CREX) and superficial analyses of the events with little exploration of their root causes. The inspectors also note a lack of integration of the lessons learned from the events reported at national level. Four of the seven ESRs reported in 2023 and rated level 2 on the ASN-SFRO were laterality errors (right-left reversal). In a first case, the laterality error occurred during the preparation for treatment of a breast cancer by external-beam radiotherapy, resulting in the left breast being contoured as the zone to treat instead of the right breast. A treatment plan was thus defined with a total of 28 sessions and a planned dose of 2.25 grays (Gy) at each session. One of the factors that contributed to this laterality error is the presence of conflicting information in the initial medical consultation report. The subsequent steps, including the contouring and the various validations, failed to identify this error, which was not detected until the end of the 25th treatment session. In the second case, which also concerned a breast cancer treatment, six external-beam radiotherapy sessions (out of the 15 scheduled) were delivered to the wrong breast. The analysis of the causes revealed a failure to perform the laterality check (by all the medical staff): during the contouring and validation of the dosimetry by the physician, when entering the prescription and during the double check of the file by the physicist and during preparation of the file and delivery of the treatment sessions by the radiographers. A history of radiotherapy treatment on both breasts which figured in the patient’s medical file could have fostered the confusion. In the third case, the laterality error resulted in delivery of the entire stereotactic radiotherapy treatment to a nodular lesion on the left lung instead of the lesion on the right lung as was planned. The event was due to a prescription error, which led to the treating of an existing nodular lesion but contralateral to the intended lesion, whereas the diagnostic information and the conclusions of the multidisciplinary consultation meeting prior to the treatment indicated the correct localisation. The event was detected during an imaging examination to prepare for the patient’s post-treatment follow-up consultation in the radiotherapy department. In the fourth case, the laterality error occurred during the treatment of an oropharyngeal cancer and was detected after 19 treatment sessions out of the 33 scheduled. The 19 sessions were carried out on the healthy pharyngeal side instead of the affected side. The in-depth analysis of the causes revealed the absence of laterality verification rules and the need for better communication between the various persons involved. ASN draws the attention of the radiotherapy professionals to the need to evaluate the robustness of the safety barriers put in place to guard against laterality errors, which form the subject of several ESR notifications each year. ASN points out that the “Patient safety – Paving the way for progress – Laterality errors” bulletin of May 2014 enables the centres to ponder on the risk situations and effective prevention and detection measures. This bulletin proposes keys for avoiding these laterality errors, recommendations from two centres that have conducted an in-depth analysis further to such an event, and the testimony of the ARS of Bretagne on its prevention action implemented jointly with the Eugène Marquis Centre (Rennes). SIGNIFICANT EVENTS RESULTING FROM LATERALITY ERRORS 218 ASN Report on the state of nuclear safety and radiation protection in France in 2023 • 07 • Medical uses of ionising radiation
RkJQdWJsaXNoZXIy NjQ0NzU=