“Constant improvement in quality and safety of radiology, radiotherapy and nuclear medicine through clinical audit”

(project accepted under call for tenders N° ENER/D3/2019-231-2)

The proposed 30-month European Commission tender project QuADRANT started in January 2020 and is led by the European Society of Radiology (ESR) together with the European Association of Nuclear Medicine (EANM) and the European SocieTy for Radiotherapy and Oncology (ESTRO) as consortium partners.

13th and 14th January 2022 : QuADRANT WP4 workshop

Work package 4 is responsible for preparing and organising a workshop, to discuss with representatives of Member States the need for further coordinated EU action on quality and safety of radiology, radiotherapy and nuclear medicine.
Consult here the programme, and click here to register for the workshop

QuADRANT workshop report
Read here the workshop report of workpackage 2: “Constant improvement in quality and safety of radiology, radiotherapy and nuclear medicine through clinical audit”

QuADRANT WP2 report

Aim

QuADRANT aims to promote constant improvement in quality and safety of radiology, radiotherapy and nuclear medicine through the implementation of clinical audit as part of Member States’ healthcare systems. More specifically, the project will
a) review the status of implementation of clinical audits in the Member States;
b) identify good practices in Member States and available guidance and resources for clinical audits, at national, European and international level;
c) provide further guidance and recommendations on improving the implementation and integration of clinical audits into national healthcare systems;
d) identify potential for further coordinated EU action on quality and safety of radiology, radiotherapy and nuclear medicine.

Background

The updated Euratom legislation as outlined in the Basic Safety Standards (BSS) Directive 2013/59/Euratom, following on from an earlier directive, addresses the field of medical ionising radiation exposure and protection. The BSSD is broad ranging in its requirements and has major implications for European radiological, nuclear medicine and radiotherapy practice.

Key areas include:

• Setting out generic safety standards for protection against ionising radiation exposure
• Emphasising the need for justification and optimisation of medical exposure
• Introducing/strengthening patient information requirements
• Reinforcing/strengthening the requirements for recording and reporting doses relating to radiological procedures, also including accidental or inadvertent exposures, and for the setting up of Diagnostic Reference Levels (DRLs)

Importantly the BSSD, like its predecessor Directive, also specifically mandates carrying out clinical audit “in accordance with national procedures”, making clinical audit in support of implementation of BSSD requirements a legal necessity. Clinical audit is a well-established tool within modern healthcare and a key component of effective clinical governance, which can be used to improve patient care, safety, experience and outcomes. Clinical audit is defined within the BSSD as “a systematic examination or review of medical radiological procedures that seeks to improve the quality and outcome of patient care through structural review, whereby medical radiological practices, procedures and results are examined against agreed standards for medical radiological procedures, with modifications of practices, where appropriate and the application of new standards if necessary.” The term “medical radiological practices” also encompasses hybrid imaging, interventional cardiology procedures, nuclear medicine and radiotherapy techniques.

Why QuADRANT?

All three consortium partners work collaboratively with other organisations, including national and specialist societies and via their memberships, to promote and enhance BSSD compliance, and support clinical audit practice.

A pan-European study is timely to evaluate current levels of BSSD compliance and the development of supporting clinical audit processes, to understand why clinical audit’s use is so limited, and how to improve its broader implementation and to foster its full integration into existing audit programmes in healthcare. The study involving not only professional and national societies who may be responsible for external coordination of audit, but also other auditing organisations, competent authorities and health authorities. The EANM, ESR and ESTRO are well-placed to direct this undertaking using their knowledge and expertise in this field and their extensive professional networks; each associated medical speciality (Nuclear Medicine, Radiology, Radiation Oncology) is likely to have different experiences and requirements.

Learn more about QuADRANT.

The project has received funding from the European Commission under Service Contract N° ENER/2019/NUCL/SI2.816093.

Under the aegis of the European Cancer Organisation, and led by Prof Yolande Lievens, a working group on value based healthcare has been established, focusing on the applicability of existing value frameworks in the pharmaceutical sector towards non-systemic oncology treatment (e.g. radiation oncology and surgery). ESTRO experts are involved.

As a result, an article has been published “Towards an evidence-informed value scale for surgical and radiation oncology: a multi-stakeholder perspective” in which the case for improving health system understanding of the value of non-systemic oncology treatment is made with reference to scales for this purpose developed for systemic treatment. More information here.

 - Medical Applications of Radiation – Learning from Incidents and Near Misses

SAMIRA Study on Reporting and Learning from Patient-Related Incidents and Near Misses in Radiotherapy, Interventional Cardiology, Nuclear Medicine and Interventional and Diagnostic Radiology
 

The 24-month MARLIN project, started 1^st January 2023, will support the implementation of Council Directive 2013/59/Euratom and provide a comprehensive description of the current status of incident reporting. It is important that the use of ionising radiation in the diagnosis and treatment of diseases is carefully monitored and measures are taken to minimise both the frequency and harm caused by accidental or unintended exposures to patients, according to the relevant articles of the Basic Safety Standards Directive (BSSD). The use of incident learning systems (ILSs), anonymous notification systems where incidents and near misses can be investigated and possible flaws in a process can be identified and rectified, will be studied with regard to their compliance with the BSSD and other regulatory requirements and their role in improving patient safety.

This tender is led jointly by the European Institute for Biomedical Imaging Research (EIBIR), the European Society for Radiotherapy and Oncology (ESTRO) and the European Federation of Organisations for Medical Physics (EFOMP).
 

ESTRO experts are involved in the following work packages:
ESTRO experts will co-lead WP1, lead WP2, WP3, WP4 and co-lead WP5. The ESTRO Experts are:

• Dr. Carlos Prieto, Madrid/ES

• Dr. Nicolas Pourel, Avignon/FR

• Maeve Kearney, MPH, B.Sc (Hons), Dublin/IE

• Gianfranco Brusadin MSc, Paris/FR

WP1 - Survey on the implementation of the European legal requirements on reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine and interventional and diagnostic radiology.

WP2 - General and practice-specific guidelines on reporting and learning from patient-related incidents and near missies in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology.

WP3 - Carry out consultations and agree on consensus European guidelines.

WP4 - Project workshop.

WP5 - Project management, coordination, and dissemination.

Aim

The project aims to improve the reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology. The project will meet the following specific objectives:

a) Collect and analyse up-to-date information on the implementation of Council Directive 2013/59/Euratom requirements for reporting and learning from patient-related incidents and near misses in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology.

b) Develop best-practice consensus guidelines on the implementation of the above Directive in radiotherapy, interventional cardiology, nuclear medicine, and interventional and diagnostic radiology.

c) Discuss the results of the work with representatives of Member States and relevant stakeholders, with the view of stimulating further national and EU wide level efforts in this area.

For further information about MARLIN, you may also visit the website of EIBIR through the link here

EU-REST European Union Radiation, Education, Staffing & Training

The 24-month European Commission tender project EU-REST started in September 2022 and will last until 31 August 2024. It is intended to answer the invitation to tender addressing Call HADEA/2022/OP/0003 for a service contract regarding analysis on workforce availability, education and training needs for the quality and safety of medical applications involving ionising radiation in the EU. The action contributes to the implementation of the Europe’s Beating Cancer Plan and is also part of the actions of the Strategic Agenda for Medical Ionising Radiation Applications (SAMIRA) Action Plan.

This tender is proposed jointly by the European Society of Radiology (ESR), the European Federation of Organisations for Medical Physics (EFOMP), the European Federation of Radiographer Societies (EFRS) and the European Society for Radiotherapy and Oncology (ESTRO).

Aim

The project aims to provide an analysis of workforce availability, education, and training needs to ensure quality and safety aspects of medical applications involving ionising radiation in the EU. In addition, it foresees the development of staffing and education and training guidelines for key professional groups involved in ensuring radiation safety and quality of medical radiation applications in the EU member states.

The project will meet the following specific objectives:

• Collect and analyse data on workforce availability, education, and training needs to ensure quality and safety aspects of medical applications involving ionising radiation, as well as related stakeholder mapping.
• Draft guidelines for staffing and education andtraining for medical and other professionals involved in medical radiation applications in Member States and related stakeholder consultation.
• Develop conclusions and recommendations.

ESTRO and its experts are involved with Working Packages (WP) 1, 2 & 3.
The ESTRO Experts are:

Yavuz Anacak, radiation oncologist, Izmir/TR
Nuria Jornet, medical physicist, Barcelona/ES
Michelle Leech, radiation therapist, Dublin/IE
Mary Coffey, radiation therapist, Dublin/IE
Cristina Garibaldi, medical physicist, Milan/IT
Pedro Lara, radiation oncologist, Las Palmas/ES

WP1
Data collection and analysis on workforce availability, education and training needs involving ionising radiation.

WP1 aims to collect up-to-date data on staffing, education and training of the key professional groups involved in ensuring radiation safety and quality of medical radiation applications in Member States. The collected data will cover the areas of radiology, radiotherapy, nuclear medicine and other medical practices independently utilising ionising radiation, from an educational and training standpoint, with an emphasis on procedures delivering high(er) radiation doses to patients and/or staff.

ESTRO Experts involved:
Yavuz Anacak, radiation oncologist, Izmir/TR
Nuria Jornet, medical physicist, Barcelona/ES
Michelle Leech, radiation therapist, Dublin/IE

WP 2 - Drafting guidelines for staffing and education/training.

This work package will use the information collected in WP1 to form the basis of guidelines for staffing and education and training. A series of guidelines will be required covering the three disciplines: radiology, nuclear medicine and radiotherapy. The guidelines will focus on staff activities and associated workforce requirements as well as the education and training needs of all disciplines with respect to the roles and responsibilities associated with each. Following their drafting, the guidelines will undergo external peer review and stakeholder consultation. The training in radiation protection will be assessed. In particular it will be monitored whether the training is included in the specialization training, or it is with an independent registration.

ESTRO Experts:
Mary Coffey, radiation therapist, Dublin/IE (Lead)
Yavuz Anacak, radiation oncologist, Izmir/TR
Cristina Garibaldi, medical physicist, Milan/IT

Nuria Jornet, medical physicist, Barcelona/ES

WP 3 - Conclusions and recommendations on the EU workforce availability.

The objective of WP3 is to provide the conclusions and recommendations on the EU workforce availability, education and training needs for the quality and safety of medical applications involving ionising radiation, for Medical Doctors, Radiographers & Radiation Therapists, Medical Physicists and other health professionals using ionising radiation.

The conclusions and recommendations will be based on the deliverables from WP1 and WP2, a literature review, and the outputs from a stakeholder consultation process made through an online survey.

ESTRO Experts:
Yavuz Anacak, radiation oncologist, Izmir/TR
Pedro Lara, radiation oncologist, Las Palmas/ES
Michelle Leech, radiation therapist, Dublin/IE

WP4 - Project management, Coordination and Dissemination

This WP will ensure the overall coordination of the project and monitor implementation of the proposed workplan. WP4 will also be responsible for the dissemination activities in alignment with the European Commission.