Constant improvement in quality and safety of radiology, radiotherapy and nuclear medicine through clinical audit
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.
The updated Euratom legislation as outlined in the Basic Safety Standards Directive (BSSD) 2013/59/Euratom, sets out the EU legal framework for protection of human health against the harmful effects of ionising radiation exposure. The BSSD addresses the field of medical ionising radiation exposure and protection, following on from an earlier Medical Exposure Directive (MED). The BSSD is broad ranging in its requirements and has major implications for European radiological, nuclear medicine and radiotherapy practice.
Key changes in the BSSD compared to MED include:
- Setting out generic safety standards for protection against ionising radiation exposure
- Strengthening the requirements 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 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. Particular quality and safety challenges have been identified in relation to these differing types of medical radiation exposure:
- Diagnostic radiological imaging is the most widespread form of medical application of ionising radiation with in excess of 500 million procedures carried out in the EU annually. The significant rise in the use of computed tomography (CT) over recent decades is a particular subject of concern due to its increased availability, over-utilisation and suboptimal justification and optimisation practices. The rise in high dose interventional radiology and cardiology procedures performed outside of imaging departments (for example in catheter labs or operating theatres) also poses challenges from an occupational protection perspective.
- Nuclear medicine traditionally involved diagnostic procedures and the handling and disposal of short-lived isotopes in specialised departments. The introduction of hybrid technologies in diagnostic nuclear medicine has significantly benefited diagnostic practices; however, it has also introduced computed tomography as an additional source of radiation. The increase in availability and indications for therapeutic nuclear medicine raises challenges around management of longer-lived isotopes, including issues around occupational protection, release of patients after studies, pregnancy and breast feeding and management of hospital radioactive waste.
- Radiotherapy, including external beam radiotherapy and brachytherapy, is an indispensable part of modern cancer treatment, with the ability to benefit up to 50% of patients with the disease. Although radiotherapy accidents are rare, they have the potential for significant harm and may generate negative public attention. High precision, complex and novel techniques together with rapid radiotherapy technology developments require highly skilled staff to prepare and deliver quality and accurate treatment in a safety aware environment.
The Euratom legislation prescribes practice-specific tools for addressing some of the above challenges including referral guidelines and diagnostic reference levels in radiological imaging/interventional techniques, risk assessment and accident learning systems in radiotherapy and criteria for radionuclide release in nuclear medicine.
The clinical audit requirement is a key part of the BSSD, with introduction and integration of effective clinical audit practice within hospital departments essential to support compliance with the BSSD. Clinical audits are part of a continuous, dynamic learning and supportive process where continuous improvement is the goal. Clinical audits can be undertaken at a departmental level, “internal audit”, together with re-audit (to demonstrate continued target compliance or to confirm an improvement in practice if previous targets not achieved). For most radiation protection parameters, a continued programme of clinical audit and re-audit is required to demonstrate maintained compliance.
It is also possible for internal audits to be undertaken with “external direction” – direction supplied by a suitably accredited professional body or society and potentially directed across a number of departments. Setting up an external audit system will depend upon local/national resources and priorities but will occur separately from the regulatory authority. Comprehensive external audit reviews the full patient pathway and is particularly relevant for radiotherapy. Clinical audit is a mandatory component of a quality system, as defined within the BSSD, and is clearly separate from the process of inspection, which likewise is a BSSD requirement, but is undertaken by the radiation protection competent authority.
The European Commission carried out a study on clinical audit in 2007/2008 which revealed quite variable and often absent, or minimal, clinical audit practice in Member States. To improve the situation, the publication „Radiation Protection 159. European Commission Guidelines on Clinical Audit for Medical Radiological Practices (Diagnostic Radiology, Nuclear Medicine and Radiotherapy)“ was published in 2009, the IAEA also produced publications on clinical audit in radiotherapy diagnostic radiology and nuclear medicine. Nevertheless, more recent work carried out in a tender in the BSSD’s pre-transposition period, awarded by the European Commission to a consortium made up by EFOMP, ESR and EFRS, demonstrated that Member States continued to experience difficulties in implementing clinical audit in radiological practices.
The European Commission has other activities ongoing in the arena of medical use of radiation, which are pertinent to the quality and safety framework for medical imaging, such as, for example, the EUCLID project, a European Study on Clinical Diagnostic Reference Levels for X-ray Medical Imaging currently being carried out by the ESR.
In addition, the European Commission DG ENER has decided to embark on developing a Strategic Agenda for Medical, Industrial and Research Applications of Nuclear and Radiation Technology (SAMIRA). As part of the preparation work for the development of the Strategic Agenda, a study has been carried out in order to define the EC’s views on the major issues relating to the use of nuclear and radiation technology outside the nuclear-energy sector. Based on the SAMIRA study, a workshop entitled Addressing Societal Challenges through Advancing the Medical, Industrial and Research Applications of Nuclear and Radiation Technology was organised in March 2018. The study report described the status of non-power applications of nuclear and radiation technology in the EU and related recommendations for EU actions, addressing applications of nuclear and radiation technology, radiology, nuclear medicine applications (including availability and use of medical radioisotopes), and radiotherapy (including proton therapy and molecular-targeted therapy).
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 ESR, EANM 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 specialty (Radiology, Nuclear Medicine and Radiation Oncology) is likely to have different experiences and requirements.
QuADRANT is coordinated by the European Society of Radiology (ESR)
ESR Office Am Gestade 1 | AT – 1010 Vienna
Phone: +43 (1) 533 40 64 -20
E-mail: Monika Hierath, monika [.] hierath [@] myesr [.] org
The project has received funding from the European Commission under Service Contract N° ENER/2019/NUCL/SI2.816093.