Governance model for managing risk associate to M.E.I.R. in Europe. Italian and Irish experiences.

Medical exposure to ionising radiation (MEIR) inherently has associated risks that must be effectively managed to minimise their possible occurrence. In this context, risk management in the wider context of clinical governance has contributed to taking under control multiple variables (organisational, individual, and technical) that can influence the occurrence of adverse events. Therefore, there is a global priority to establish a governance model for risk management related to MEIR to fully respect radioprotection principles. To address this purpose, the European Union enacted the European Directive 2013/59/Euratom, transposing indications from the International Commission on Radiological Protection. This model defines a common theoretical governance model across three levels for managing MEIR risks for the establishment of uniform basic safety standards against the dangers arising from ionising radiation. Different competent authorities among European countries have resulted due to the freedom of Member States to adopt a governance model that better fits with their national legislations and organisation of healthcare systems. Currently, there is a dearth of literature summarising and comparing outputs and outcomes generated by the different national governance models for MEIR risk management. However, there is a lack of assessment of the results obtained by different national governance models for MEIR risk management and the benchmark of their performance as required by the European Directive 2013/59/Euratom. This study was designed to address these knowledge gaps by evaluating the different modalities of transposition of the European Directive 2013/59/Euratom that characterise the national governance model for MEIR risk management by comparing the European Competent Authorities for MEIR (CAs-MEIR). Located at the second level of the MEIR risk management governance model proposed by the European Directive, CAs-MEIR is a strategic decision-making junction between practice and legislation designated by Member States as having legal authority for the purposes of this Directive. Italy and Ireland were chosen as compelling country case studies for various reasons, especially for the implementation of CAs-MEIR with extremely different organisational assets. A qualitative approach deemed most appropriate for investigating and comparing the organisational assets of the Irish and the Italian CAs-MEIR was adopted for this cross-country analysis. An extensive literature review was extended beyond the canonical biomedical databases to include grey literature from relevant sectors to develop the theoretical framework. Country case studies for cross-country analysis were described, investigated, and compared through a narrative review of national laws regarding the risk management of MEIR, participative observation within national CA-MEIR (only in Ireland), desk analysis of the documentation made available by these organisations, and in-depth semi-structured interviews were conducted. The different governance and organisational models on which the two national CAs-MEIR were articulated necessitated the use of an explorative approach for each country case study involving both top-down and bottom-up perspectives through interviews with top management and professionals. SWOT analysis was employed to collect results of the CAs-MEIR self-assessment and internal proposals for improvement. The Irish governance model for MEIR risk management was efficient and effective in line with that proposed by the European Directive, implementing all functions outlined in the S.I. 256/2018 for the achievement of purposes set by the European Directive. The Irish governance model for MEIR supported the European network of CAs-MEIR, aiming to ensure the efficient implementation of the basic safety standards for protection against ionising radiation throughout Europe. By contrast, the Italian governance model for MEIR risk management consisting of only two governance levels deviated from the reference governance model for MEIR risk management proposed by the European Directive. The peculiarity of the Italian governance model is the establishment of a support network for CA-MEIR composed of institutions that assist CA-MEIR in performing its regulatory functions. Formally, the Italian CA-MEIR performed all its tasks but there are significant inefficiencies due to the proliferation of actions, some of which are similar without clear responsibility for each entity contributing to MEIR risk management in Italy. Mutual learning among the Irish and the Italian CAs-MEIR is possible especially about: a. implementation of internal mechanisms of continuous improvement of the performance. The enforcement of the governance and organisational model was identified as the first step to guarantee the operativity of the CA-MEIR at a national level. b. the minimum degree of flexibility within guidance and methodological tools to prevent paralysis or excessive elongation of processes, especially in low complexity and/or low-risk scenarios. c. mutual help between European CAs-MEIR, sharing experiences, tools, and solutions, with the necessary national adaptations. These exchanges should prevent the replication of mistakes, enabling the faster and more effective implementation of solutions already tested in similar realities. d. empowerment of the collaborative European network to ensure that the decisions made in this context have a broader impact in each country. This should sustain the creation of a common initiative for working together to choose indices for European benchmarking of the CAs-MEIR in each Member State. It would facilitate the benchmarking of results achieved by different Member States, aiming to ensure consistent levels of quality, safety and control to citizens living in Europe in compliance with European Directive 2013/59/Euratom. European countries have implemented different organisational models for CAs-MEIR as demonstrated in Ireland and Italy. From the comparison of these country case studies, it was evident that national CAs-MEIR prioritised the consolidation of their roles in their respective country for ongoing and future improvement of their performance. However, there is a common awareness and willingness to make the European working group more operational and impactful in national decision-making processes in the near future. These findings were generalisable to all European States, as each CA-MEIR must operate in compliance with the European Directive 2013/59/Euratom, performing all functions attributed to them.