The European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom is an extremely important piece of legislation and became effective in EU Member States as of February 2018. European Member States are required to transpose its requirements into national legislation and individual radiology departments and imaging facilities (involving the use of ionising radiation) must comply, providing evidence of this during any inspections by authorised external agencies. As mentioned earlier, undertaking clinical audit “in accordance with national procedures” is mandated within the Directive with clinical audit processes also subject to inspection as part of evaluation of BSSD compliance. Although not directly inspected per se, regulatory audit (and re-audit) to ensure compliance with specific BSSD requirements is clearly good practice for radiology departments and other departments with imaging facilities (involving the use of ionising radiation). Comprehensive explanation of clinical and regulatory audit processes, the differences between them and their role in radiation protection is provided in recent European Commission and Heads of the European Radiological Protection Competent Authorities (HERCA) publications [3, 6].
The 2021 BSSD uptake survey was, as in 2018, directed to the ESR EuroSafe Imaging Star Network. The survey response rate (61%, 78/128 departments) was good and comparable to the 2018 survey (64%, 66/103), making significant response bias unlikely. The co-operation of a large number of radiology departments in completing survey returns during difficult times is acknowledged and appreciated. These departments, by virtue of their involvement in the EuroSafe Imaging Star initiative and their wide geographic distribution, are likely to be representative of wider European radiological practice and these departments also have access to relevant ESR radiation protection and audit-related initiatives and publications.
The 2021 survey was distributed as a follow-up survey, following the 2018 pilot-formal standards/targets were again not included. As noted previously in 2018, all BSSD requirements covered in the survey are fixed and compulsory with a target of 100%. The need for regulatory audit and re-audit is not an BSSD requirement, but embedding effective processes of regulatory audit has clear benefits for radiology departments as documented earlier and can be considered good-practice.
Some general observations can be made on evaluation of the survey results: -
Supporting processes of clinical audit are required by the BSSD and would be subject to formal inspection. The survey only briefly touched on clinical audit, with the opening question relating to departmental presence of a clinical audit infrastructure to support BSSD implementation. There was a reduction in positive responses to this question when compared to 2018 (47/70.15% in 2021, 54/81.82% in 2018), noting a higher % of departments answering “in development” in 2021 (10.61% vs 19.40%).
In terms of implementation of specific BSSD parameters a mixed picture of both improvement and deterioration in compliance emerges. A significant improvement in compliance is evident between the two surveys in relation to the survey question relating to the BSSD dose limits and occupational exposure to the eye (2018 57.63%, 2021 80%).
A similar mixed pattern of responses is present in relation to those questions referring to having a process in place to audit regulatory requirements. Quite marked improvement is seen since 2018 in those questions relating to dose limits to eye/skin for apprentices/students, with significant worsening in compliance identified for having a written protocol in place and training documented where justification is delegated to non-radiologists.
In most cases an improvement since 2018 is present for questions covering regular re-audit of compliance with BSSD requirements (noting a relatively low yes/no response rate for this section in 2021).
An additional important finding is the higher proportion of “skipped” responses provided in the 2021 survey compared to 2018. The increased tendency for “skipping” is a constant finding throughout the 2021 results and is particularly in evidence in relation to the audit/re-audit questions. The reasons for this are unclear – however the BSSD requirements covered in this survey are of relevance to most radiology departments and it is likely that in a proportion of “skipped” responses this actually translates into a failure of implementation. If this were to be the case then clearly this would have an adverse effect on reported departmental compliance in 2021 and comparisons with 2018 would be affected.
As was mentioned in the 2019 paper reporting the results of the 2018 survey  caution should be applied when drawing conclusions from survey data in terms of accuracy and generalisability. The work in progress observed in the departmental responses from 2018 has not materialised uniformly and the overall impression from the 2021 survey is that of persistently variable compliance amongst European radiology departments in terms of BSSD implementation, despite a number of ESR (and other organisation) radiation protection and audit related initiatives.
The most obvious explanation for the 2021 survey findings is the COVID-19 pandemic. Since early 2020 COVID-19 has caused significant problems for European (and worldwide) healthcare systems. Radiology departments and their staff have been at the forefront of dealing with these patients, radiology staff often becoming patients themselves. Radiology staff may have been redeployed to other areas, staff working offsite will have reduced availability and face-to-face meetings, audit sessions etc. will have been cancelled. It is easy to see how this crisis will have diverted attention and resources away from the more mundane and everyday aspects of radiology departmental practice and procedure. A proportion of departments may have overestimated their ability to implement necessary infrastructure and process changes when questioned in 2018 and COVID subsequently required re-allocation of available resources.
Embedding effective processes of clinical audit, radiation protection and clinical audit in medical radiological practices (those involving exposure to ionising radiation) are key priorities for the European Commission, other European and international agencies and also the professional societies. A number of key ESR initiatives were either in place prior to the 2018 survey or introduced subsequently. However, the potential benefits of these initiatives are likely to have been disrupted by the COVID-19 pandemic before they had time to influence radiology practice at departmental level. The ESR published Esperanto – A Guide to Clinical Audit and Clinical Audit Tool, in 2017 [7, 8]. An enhanced version 2 of Esperanto was launched at the European Congress of Radiology (ECR) in 2019. Esperanto is designed to support radiology departments in developing an effective programme of clinical audit, one that also supports BSSD compliance. Esperanto is in 2 sections, an initial guide explaining the principles and definitions of clinical audit and its relationship to radiation protection and the BSSD, the second section containing a series of audit templates for departmental use and adaptation as appropriate. The templates have a focus on regulatory audit but there is a clinical audit section in addition. Esperanto is currently under further development, with the launch of version 3 planned for ECR in 2022. The new version will have expanded sections covering clinical audit and also current best practices and guidances. Overall its emphasis will shift towards clinical audit in the template section, although regulatory audit templates will be maintained. New templates covering non-radiation protection related clinical audit and also clinical audits which specifically support BSSD compliance will be introduced. An updated ESR application process for membership of the EuroSafe Imaging Star Network is currently in preparation, this will include an increased emphasis on demonstration of compliance with BSSD requirements. Alongside Esperanto, ECR features bespoke sessions covering and promoting clinical audit with guidance on best practice and explanation of core principles. The EuroSafe Imaging Call for Action, 2018  is a keynote ESR flagship campaign promoting and strengthening quality and safety in medical imaging and clinical audit is an important component.
It is also appropriate to mention the QuADRANT initiative at this juncture . In 2019 the European Commission (EC) put out at tender No ENER/D3/2019–231-2 “Constant improvement in quality and safety of radiology, radiotherapy and nuclear medicine through clinical audit”. The ESR, as lead of a consortium also involving the European Association of Nuclear Medicine (EANM) and European Society of Radiotherapy and Oncology (ESTRO), was awarded the tender. The acronym QuADRANT was adopted (Quality Improvement Through Clinical Audit in Diagnostic (including Interventional) Radiology, Radiotherapy and Nuclear Medicine including Therapies). QuADRANT has core aims: -
To review the status of implementation of clinical audits in the Member States.
To identify good practices in Member States and available guidance and resources for clinical audits at national, European and international level.
To provide further guidance and recommendations on improving the implementation and integration of clinical audits into national healthcare systems.
To identify the potential for further co-ordinated EU action on quality and safety of radiology, radiotherapy and nuclear medicine.
QuADRANT commenced in January 2020 and will run over 30 months, the project includes two conferences and a main survey on European clinical audit practice, process and infrastructure and involving key players in European healthcare and clinical audit. This is a very important piece of work, looking to create a roadmap of clinical audit best practice with an emphasis on clinical audit in support of radiation protection.
Importantly, also in 2021, the European Commission announced the action plan for the SAMIRA (Strategic Agenda for Medical Ionising Radiation Applications) initiative . One of the three major elements of SAMIRA is the European Initiative on Quality and Safety of medical applications of ionising radiation, designed to ensure that diagnostic and therapeutic uses of ionising radiation in European Member States conform to the highest standards. SAMIRA will support the incorporation of clinical audit practices into Member States’ healthcare systems. One action planned under SAMIRA involves seeking to improve justification of imaging use of ionising radiation, in line with European Council conclusions on this topic published in 2015  Clinical audit will play a significant part in implementing this improvement. The ESR welcomes the SAMIRA Action Plan, and looks forward to collaborating with the European Commission and other stakeholders in bringing it to fruition.
The previous publication covering the 2018 BSSD uptake survey  did highlight the need for collaboration between relevant European agencies, national governmental bodies and national professional societies to facilitate improved BSSD uptake across Europe amongst European radiology departments. The ESR has undertaken additional surveys (pre-COVID-19) evaluating both the current state of clinical audit practice amongst European National Radiological Societies and also obtaining feedback on Esperanto from European radiology departments [12, 13]. These surveys demonstrated marked variability in clinical audit infrastructures, BSSD compliance and awareness of ESR-related audit initiatives. 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 ESR and other specialist and healthcare bodies to facilitate necessary change.