ASN Report 2018

In addition to the verifications performed, the ability of the centre to deploy a risk management procedure was again investigated, with the following findings: ∙ ∙ 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. Thus, the prospective risk analysis - which is mandatory - is only available in half of the inspected centres. ∙ ∙ 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 operational quality manager. Furthermore, the involvement of all the professionals, especially the medical professionals, remains an essential prerequisite for the risk management procedures to produce concrete improvements in the safety of practices. Lastly, ASN notes again in 2018 that the technical, organisational or human changes are not sufficiently anticipated. The impact a change can have on the operators’ activity is not analysed, despite the fact that these changes can weaken the existing lines of defence.  GRAND EST REGION  Placing the Private Radiotherapy Centre of Metz (CPRM) under tightened surveillance The inspections conducted by ASN in 2016 and 2017, accompanied by IRSN representatives, in the CPRM and in the radiotherapy centres of the U2R group which is affiliated to it, revealed persistent deviations in the management of the quality assurance system and in the risk analysis approach, and questions concerning the utilisation of an internally developed software used as a single support for the administration of the entire patient care pathway. An expert assessment and inspection mission was carried out on 23 and 24 April 2018, coordinated by the Grand Est Regional Health Agency (ARS) and ASN, in collaboration with the ANSM, in order to assess the medical practices of the centre and the control of risks for the patients, in the presence of two experts. Concluding that there was no immediate risk for the treatment of patients, but confirming an extremely conflictual relational situation that was starting to have a significant impact on the functioning of the centre and ultimately representing a risk for treatment safety, ASN decided to place the CPRM under tightened surveillance. This tightened surveillance may be relaxed once the following points can be confirmed: ཛྷ ཛྷ a quality management system has been reinstated; ཛྷ ཛྷ an appropriate and consistent risks analysis has been carried out and presented; ཛྷ ཛྷ observable collegiality has been restored in the analysis and decision-making authorities addressing the issues relating to radiation protection and patient safety; ཛྷ ཛྷ a continuity plan has been put in place for the subcontracted functions, capable of guaranteeing the sustainability, robustness and conformity of functioning of the corresponding activities. Percentage of conformity of the facilities concerning the management of events giving rise to corrective actions in 2018 0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100% Culture and organisation of reporting Analysis, definition of corrective actions, capitalisation Evaluation of the effectiveness of corrective actions Diagram 6 210  ASN report on the state of nuclear safety and radiation protection in France in 2018 07 – MEDICAL USES OF IONISING RADIATION