Abstract

The recently implemented European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom lays down core radiation protection standards for European radiology departments, including a mandatory requirement for supporting processes of clinical audit. A repeat survey on behalf of the European Society of Radiology (ESR) was undertaken in February 2021, involving the ESR EuroSafe Imaging Star department network, to re-assess compliance with selected key BSSD requirements following an initial survey in 2018 where variable compliance was demonstrated. 61% (78/128) of eligible departments participated and overall the survey results revealed a mixed picture in terms of implementation of BSSD requirements when compared to the 2018 survey with both improvement and deterioration observed. This pattern was seen also in relation to supporting processes of regulatory audit and re-audit. Higher levels of “skipping” of responses were also observed in 2021. These findings were unexpected in light of the interventions in relation to audit (clinical and regulatory) and radiation protection undertaken by the ESR and other organisations in recent years, but can reasonably be explained by the onset of the COVID-19 pandemic, with consequent significant disruption of radiology services. The 2021 survey results do serve to highlight again the need for co-ordinated intervention involving relevant European bodies, organisations and governmental agencies to address the important issues raised by this survey. The European Commission clinical audit and radiation protection initiatives, QuADRANT, led by the ESR, and SAMIRA will act as important drivers for improvement in patient safety, experience and outcomes across Europe.

Highlights

  • This paper describes the results of a follow-up survey amongst European radiology departments, following an original survey in 2018, which has demonstrated variable compliance with Basic Safety Standards Directive (BSSD) implementation and supporting audit processes

  • The European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom [1], laying down the requirements for protection from the dangers associated with medical ionising radiation exposure, was adopted by the Council of the European Union (EU) in 2013, for transposition into the national legislation of EU Member States by February 2018

  • A core requirement for improving clinical audit uptake and BSSD compliance in European radiology departments will be establishing functional national infrastructures across all Member States, with the National Radiological Society networks well placed alongside the European Society of Radiology (ESR) and other specialist and healthcare bodies to facilitate necessary change. This re-survey of EuroSafe Imaging Star Departments evaluating BSSD uptake and supporting audit processes has demonstrated a mixed pattern of improvement and deterioration, with reduced compliance in many areas, since the previous 2018 survey

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Summary

Introduction

The European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom [1], laying down the requirements for protection from the dangers associated with medical ionising radiation exposure, was adopted by the Council of the European Union (EU) in 2013, for transposition into the national legislation of EU Member States by February 2018. The BSSD highlights the need for radiology departments to carry out clinical audit “in accordance with national procedures”, thereby allowing a degree of flexibility according to national resources and audit infrastructures, but making clear that supporting clinical audit activity is mandatory and a legal requirement. The ESR considers it important for radiology departments to develop effective regulatory audit processes – to ensure and improve patient safety, to confirm that departments are complying with BSSD requirements and to give confidence that departments can satisfy the relevant competent authority during inspections. In order to ascertain European radiology departmental compliance with BSSD requirements the ESR undertook a survey, distributed to all departments within the EuroSafe Imaging Star Network, in late 2018 [4]. The emphasis on implementation of specific BSSD requirements and supporting departmental regulatory audit to ensure continuing compliance was deliberate and felt to be the most immediate priority at the time for European radiology departments. A brief and general question on supporting clinical audit infrastructure was included

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