Basic Safety Standards Directive Research Articles

Clinical audit in European radiology: current status and recommendations for improvement endorsed by the European Society of Radiology (ESR)

Clinical audit is an important quality improvement activity and has significant benefits for patients in terms of enhanced care, safety, experience and outcomes. Clinical audit in support of radiation protection is mandated within the European Council Basic Safety Standards Directive (BSSD), 2013/59/Euratom. The European Society of Radiology (ESR) has recognised clinical audit as an area of particular importance in the delivery of safe and effective health care. The ESR, alongside other European organisations and professional bodies, has developed a range of clinical audit-related initiatives to support European radiology departments in developing a clinical audit infrastructure and fulfilling their legal obligations. However, work by the European Commission, the ESR and other agencies has demonstrated a persisting variability in clinical audit uptake and implementation across Europe and a lack of awareness of the BSSD clinical audit requirements. In recognition of these findings, the European Commission supported the QuADRANT project, led by the ESR and in partnership with ESTRO (European Association of Radiotherapy and Oncology) and EANM (European Association of Nuclear Medicine). QuADRANT was a 30-month project which completed in Summer 2022, aiming to provide an overview of the status of European clinical audit and identifying barriers and challenges to clinical audit uptake and implementation. This paper summarises the current position of European radiological clinical audit and considers the barriers and challenges that exist. Reference is made to the QuADRANT project, and a range of potential solutions are suggested to enhance radiological clinical audit across Europe.

Attitudes to radiation safety and cholangiogram interpretation in endoscopic retrograde cholangiopancreatography (ERCP): a UK survey

BackgroundFluoroscopy during endoscopic retrograde cholangiopancreatography (ERCP) exposes staff and patients to potentially harmful ionizing radiation. We performed a UK survey to explore trainee and trainer attitudes to radiation protection and...

Radiological assessment of bauxite residue processing to enable zero-waste valorisation and regulatory compliance

In this work, the presence of natural radionuclides in bauxite residue subjected to a neutralisation-leaching process and smelting-leaching process was investigated. The radionuclide concentrations of radium-226, radium-228 and thorium-228 were compared with the concentration of the same radionuclides in the untreated bauxite residue. It was found that neutralisation of bauxite residue at relatively high temperatures (120–150 °C) and high pressure (PCO2 = 30 bar) did not change the initial concentration of radionuclides. In fact, the concentration of radionuclides after an intensive neutralisation process remained below 500 Bq kg−1. The separation of iron from the rare-earth elements by reductive smelting permitted a significant decrease of iron concentration in the pregnant leach solution obtained after high pressure acid leaching. However, the radionuclide concentration in the slag was increased 1.5 times with respect to the initial concentration, although it did not exceed 800 Bq kg−1. Further processing of the slags by high pressure acid leaching led to the dissolution of several base metals, while a portion of the radionuclides remained unreacted in the solid fraction. Thus, a concentration of thorium-228 > 1000 Bq kg−1 was only observed after leaching a calcium oxide-based slag with hydrochloric acid. Meanwhile, in the leach liquors, the concentration of radionuclides was <100 Bq L−1. Nevertheless, based on analytical estimations using conservative assumptions, the solid residues and leach liquors produced by acid leaching in the current study are unlikely to exceed the exposure limit of 1 mSv set by the European Basic Safety Standards Directive. It should be noted that the current results are based on a specific bauxite residue studied in this work, and caution should be used in the application to other situations. The described radiological assessment of bauxite residue processing can ensure the necessary regulatory compliance and facilitate zero-waste valorisation.

A European survey on the regulatory status for the estimation of the effective dose and the equivalent dose to the lens of the eye when radiation protection garments are used

Following the proposal of the ICRP for the reduction of the dose limit for the lens of the eye, which has been adopted by the International Atomic Energy Agency and the European Council, concerns have been raised about the implementation of proper dose monitoring methods as defined in national regulations, and about the harmonisation between European countries. The European Radiation Dosimetry Group organised a survey at the end of 2017, through a web questionnaire, regarding national dose monitoring regulations. The questions were related to: double dosimetry, algorithms for the estimation of the effective dose, methodology for the determination of the equivalent dose to the lens of the eye and structure of the national dose registry. The results showed that more than 50% of the countries that responded to the survey have legal requirements about the number and the position of dosemeters used for estimation of the effective dose when radiation protection garments are used. However, in only five out of 26 countries are there nationally approved algorithms for the estimation of the effective dose. In 14 out of 26 countries there is a legal requirement to estimate the dose to the lens of the eye. All of the responding countries use some kind of national database for storing individual monitoring data but in only 12 out of 26 countries are the estimated effective dose values stored. The personal dose equivalent at depth 3 mm is stored in the registry of only seven out of 26 countries. From the survey, performed just before the implementation of the European Basic Safety Standards Directive, it is concluded that national occupational exposure frameworks require intensive and immediate work under the coordination of the competent authorities to bring them into line with the latest basic safety standards and achieve harmonisation between European countries.

I250] Implementing clincial imaging guidelines

Clinical imaging guidelines are the most practical format to provide referring doctors with guidance on appropriate imaging based on clinical indications. But, while they have been available for decades, guidelines are hardly used in clinical practice, and study after study shows that medical imaging is utilised inappropriately to a significant degree. The best way to increase the use of guidelines in clinical practice without significantly disrupting or delaying the referral workflow are clinical decision support (CDS) systems. Implementing guidelines through integrated CDS has several benefits compared to text-based guidelines or stand-alone, static applications. The guidelines can be updated continuously, and updates can be deployed to users in very short intervals. Updating comprehensive guidelines is an extensive process, and for entire guideline sets, updated editions are often only released every five years or less. Integrated CDS provides users with guideline-based recommendations within their native workflow, so they do not have to use a different system, or even open a separate browser window. Anonymous patient parameters like patient age and sex are automatically sent to the order entry system so that users need only select the reason for exam. Implementation not only depends on technical aspects and a streamlined user experience, there are other factors to consider. In Europe, the availability of referral guidelines is a requirement for EU member states according to the Basic Safety Standards Directive (2013/59/Euratom). This directive is a welcome driver to increase the adoption and use of referral guidelines in clinical practice. While this applies across the EU, the healthcare systems, utilisation of medical imaging, and incentives at work are very different, requiring a tailored strategy for promoting the implementation of guidelines in each country. This is why the ESR’s EuroSafe Imaging campaign has established a working group to promote the implementation of guidelines through clinical decision support this year. Working with national radiology societies, radiation protection campaigns, national authorities and other stakeholders, the group’s purpose is to identify strategies for maximising the adoption of evidence-based guidelines, and their application in clinical practice.

Spanish experience on the design of radon surveys based on the use of geogenic information

One of the requirements of the recently approved EU-BSS (European Basic Safety Standards Directive, EURATOM, 2013) is the design and implementation of national radon action plans in the member states (Annex XVIII). Such plans require radon surveys. The analysis of indoor radon data is supported by the existing knowledge about geogenic radiation. With this aim, we used the terrestrial gamma dose rate data from the MARNA project. In addition, we considered other criterion regarding the surface of Spain, population, permeability of rocks, uranium and radium contain in soils because currently no data are available related to soil radon gas concentration and permeability in Spain. Given that, a Spanish radon map was produced which will be part of the European Indoor Radon Map and a component of the European Atlas of Natural Radiation. The map indicates geographical areas with high probability of finding high indoor radon concentrations. This information will support legislation regarding prevention of radon entry both in dwellings and workplaces. In addition, the map will serve as a tool for the development of strategies at all levels: individual dwellings, local, regional and national administration.

The gabbro and serpentinized peridotite of Bonassola (Bracco-Levanto ophiolite, Italy) – An extremely low natural radiation area to improve in situ gamma spectrometry

Outcrops of dunite, serpentinized peridotite and clinopyroxene-rich coarse gabbro around Bonassola (Bracco-Levanto ophiolite, NW Italy) have been analyzed for natural radionuclides using γ-spectrometry. The very low activity concentrations of natural radionuclides in the dunite outcrop (< 9.0 Bq kg -1 226 Ra; < 3.5 Bq kg -1 228 Ac and < 25 Bq kg -1 40 K) indicate that this site is characterised by a very low natural radiation for both cosmic (being at sea level) and terrestrial contributions. Before starting a field radiometric survey it is important to assess the local background, i.e. the g radiation that does not originate from rock, in order to correct the measurements for the local background. Contrary to the general practice regarding the background radiation in γ-spectrometry measurements, the investigated mafic-ultramafic outcrops has been used to estimate the detection limits for in situ measurement of 238 U, 232 Th and 40 K using sodium iodine (NaI) scintillator detectors. These results have proved useful to quantify the minimum detectable amount of activity (MDA) of 238 U, 232 Th and 40 K for the NaI detector; the MDA points at sub ppm levels for 238 U and 232 Th and 0.01 wt% K 2 O. This study also permits to assess the radiological risk of dimension stones that are petrographically similar to the serpentinized ultramafics occurring in the Bracco-Levanto ofiolite. The comparison of the activity concentration index I, defined by the EU Basic Safety Standards Directive and depending on the activity concentrations of 226 Ra, 232 Th and 40 K, with other stones used as building material, indicates that the Bonassola mafic-ultramafic rocks provide a negligible contribution to the indoor gamma radiation dose.

Modernisation and consolidation of the European radiation protection legislation: the new Euratom Basic Safety Standards Directive.

With the publication of new basic safety standards for the protection against the dangers arising from exposure to ionising radiation, foreseen in Article 2 and Article 30 of the Euratom Treaty, the European Commission modernises and consolidates the European radiation protection legislation. A revision of the Basic Safety Standards was needed in order (1) to take account of the scientific and technological progress since 1996 and (2) to consolidate the existing set of Euratom radiation protection legislation, merging five Directives and upgrading a recommendation to become legally binding. The new Directive offers in a single coherent document basics safety standards for radiation protection, which take account of the most recent advances in science and technology, cover all relevant radiation sources, including natural radiation sources, integrate protection of workers, members of the public, patients and the environment, cover all exposure situations, planned, existing, emergency, and harmonise numerical values with international standards. After the publication of the Directive in the beginning of 2014, Member States have 4 y to transpose the Directive into national legislation and to implement the requirements therein.

The new Basic Safety Standards Directive and its implications for environmental monitoring

Monitoring of levels of radioactivity in the environment is enshrined in Chapter 3 of the Euratom Treaty, in particular its Articles 35 and 36. These requirements in primary law have had an important impact on the importance of monitoring in Europe but have not been worked out in much detail in secondary legislation. The consolidation and revision of the Basic Safety Standards Directive was an opportunity for doing so. The requirements in Directive 96/29/Euratom had remained rather general. Now, more specific text is introduced on the establishment of discharge authorisations for radioactive effluents, and on monitoring these discharges. Requirements on estimation of public exposures and on environmental monitoring programmes have largely been copied from the old basic safety standards (BSS), however. The main novelty of the new BSS is the introduction of exposure situations, as defined by the ICRP in Publication 103 (2007). Environmental monitoring as part of the management of an emergency exposure situation is now addressed more clearly. As for existing exposure situations, indoor exposure to radon requires extensive surveys of indoor air or soil concentrations, and precise requirements are made on the management of residues from industries processing naturally occurring radioactive materials (NORM) as well as on the monitoring of building materials. Although the BSS do not address specific monitoring issues, studies have been undertaken on effluents from hospitals and on long-term management of uranium mining areas.The proposal for the new Basic Safety Standards Directive is examined in the light of experience of the accident at Fukushima Dai-ichi Nuclear Power Plant disabled by the terrible tsunami on 11 March 2011. The arrangements for information exchange in a normal situation and in an emergency exposure situation need to be looked at from this perspective as well as from the perspective of smaller incidents such as the release of 131I in Hungary in autumn 2011.Finally, an important novelty in the Euratom BSS is the inclusion of monitoring for the protection of non-human species in the environment, in line with ICRP Publications 103 and 108. These requirements are still under legal scrutiny in terms of the scope of the Euratom Treaty. The issue is very important also for the role of the Euratom legal framework in different EC policies, such as laid down in the Marine Waters Framework Directive or concluded under the OSPAR Convention (North-East Atlantic).

EU Basic Safety Standards and European response to the Fukushima accident

The European Basic Safety Standards Directive (EU, 1996) contains a chapter on intervention, which, to a large extent, is dedicated to emergency planning and response, but without detailed requirements. A new Directive will consolidate all existing Directives and thus broaden the scope to all exposure situations and categories of exposure, including the protection of the environment. This new text follows the situation-based approach recommended by ICRP (ICRP, 2007). The requirements for emergency preparedness have been worked out in more detail, and the use of reference levels for emergency response is highlighted. The accident in Fukushima prompted reflection on the Euratom legal framework, including the Basic Safety Standards, the arrangements for the early exchange of information (ECURIE) and legislation on the nuclear safety of nuclear installations. A “stress test” of EU nuclear power plants has been undertaken, which includes on-site emergency response. The results of this exercise will allow the Commission to report, by the end of 2012, to the EP and the Council, and to propose new legislation as appropriate. This may extend to the harmonisation of off-site emergency response and communication arrangements among Member States. Meanwhile, an informal coordination mechanism is being set up with the Heads of European Radiation Protection Competent Authorities (HERCA). With regard to the legislation on maximum permitted levels in food, there will be further reflection on the consistency between the controls in place after Chernobyl and after Fukushima, as well as their consistency with the values for the placing on the market of food and feed in the EU in the event of a future accident.

Criteria for acceptability of medical radiological equipment in Euratom legislation

The treaty establishing the European Atomic Energy Community ('Euratom Treaty') is binding primary law for 27 member states of the European Union (EU) with about 500 million inhabitants. Council Directive 96/29/Euratom is a secondary EU law establishing the Basic Safety Standards (BSS) for protection of the health of workers and the general public. The BSS Directive is supplemented by other binding instruments, medical exposure being regulated under Council Directive 97/43/Euratom ('Medical Exposures Directive', MED). MED, Article 8 (3), stipulates that the EU member states shall adopt criteria of acceptability for medical radiological equipment in order to indicate when action is necessary, including taking the equipment out of service. A few years ago, the European Commission ('the Commission', EC) started a revision of the Euratom BSS encompassing, among others, a codification of similar legal acts including MED. The draft legal proposal contains a number of changes on medical exposure and, while no amendments have been made on the criteria for acceptability, some of them (e.g. those concerning the requirements for equipment in use and the involvement of the medical physics expert) may have a direct influence in this area. The Commission submitted the revised Directive to the Council of the European Union in September 2011; the adoption depends on the procedures in the Council. In order to facilitate the implementation of MED, Article 8 (3), in 1997 the Commission published 'Radiation Protection 91: Criteria for acceptability of radiological (including radiotherapy) and nuclear medicine installations'; an update of RP 91 was launched in 2007 and planned for publication in early 2012 (as RP 162).

WE‐A‐211‐03: IOMP: Guidance on Education and Training Requirements for Medical Physicists

Purpose: To present the IOMP recommendations on the roles and responsibilities of medical physicists and the corresponding basic requirements for education and training (E&amp;T). Special focus will be given to the development of E&amp;T efforts in Asian‐Pacific countries and Europe. Methods: In line with its mission, IOMP is publishing new Policy Statements on “Role and Responsibilities of the Medical Physicist” and “Basic Requirements for Education and Training of Medical Physicists”. IOMP is also proposing a new Model Curriculum that is already available on‐line at http://emerald2.eu/mep_11.html. This e‐book includes 39 papers, various e‐Learning and Open source materials, International Education/Training projects and University courses from 27 countries. This first volume is including a strong participation of Asian‐Pacific countries, represented at AFOMP. Also AFOMP developed “Policy Statement No. 3: recommendations for the education and training of medical physicists in AFOMP countries” in 2011. At the European level we must refer the Medical Physics Expert European Project. The main objectives of the European Commission project ‘Guidelines on Medical Physics Expert’ are to provide for improved implementation of the provisions relating to the Medical Physics Expert (MPE) as it was defined in the Council Directive 97/43/EURATOM, known as the Medical Exposures Directive, (MED) and the recently proposed recast Basic Safety Standards (BSS) Directive. This includes harmonization of the mission statement, education and training of the MPE among the Member States of the European Union. Results: In all of these initiatives the expected results point to the identification of gaps in education contents, identification of minimum education and training requirements and definitions of required knowledge, skills and competences in Medical Physics. Conclusions: It is certainly a role of IOMP to contribute to the guidance on the harmonization of the different educational pathways and approaches all over the world.

Revision of the Euratom Basic Safety Standards Directive--current status

The European Commission is currently developing a revised Euratom Basic Safety Standards (BSS) Directive covering two major objectives: the consolidation of existing Euratom Radiation Protection legislation and the revision of the Euratom BSS. The consolidation will merge the following five Directives into one single Directive: the BSS Directive, the Medical Exposures Directive, the Public Information Directive, the Outside Workers Directive and the Directive on the Control of high-activity sealed radioactive sources and orphan sources. The revision of the Euratom BSS will take account of the latest recommendations by the International Commission on Radiological Protection and shall improve clarity of the requirements where appropriate. It is planned to introduce more binding requirements on natural radiation sources, on criteria for exemption and clearance, and on the cooperation between Member States for emergency planning and response. The provisions for regulatory control of planned exposure situations foresee a graded approach commensurate to the magnitude and likelihood of exposures from a practice. Finally, the new BSS shall take account of recent scientific developments. One additional goal is to achieve greater harmonisation between the Euratom BSS and the international BSS. While the requirements on the protection of workers, apprentices and students remain nearly unchanged, the revised BSS will clarify the roles and responsibilities of services and experts involved in technical and practical aspects of radiation protection, such as the occupational health services, the dosimetry services, the radiation protection expert and the medical physics expert. The requirements in the BSS on individual monitoring of category A workers remain unchanged, but the existing guidance on individual monitoring was revised and updated--the technical recommendations for monitoring individuals occupationally exposed to external radiation are published by the European Commission. This paper summarises the current status of the revision of the Euratom BSS Directive.

Analysis of the contribution of natural sources of radiation to the total dose received by workers

People working with ionising radiation are receiving radiation coming from artificial and natural sources. In Spain, as in many other countries, there is a serious control by the national authorities, Spanish Nuclear Safety Council, of the dose the workers receive from artificial sources. However, until the publication of the European Basic Safety Standards Directive, 96/29/EURATOM, the old criteria referring to the “above natural background” were widely used. This directive was incorporated to the Spanish legislation in July 2001 (BOE 178); in its Title VII it recommends to evaluate the dose coming from natural sources and take it into account for establishing the safety criteria. It is noteworthy to assess the natural doses received at homes and the dose received by workers of radioactive installations subject to regulations, and to compare the two results. The social and economical implications of the results derived can be important in the practical application of the recommendations included in the above-mentioned BOE 178 Directive.

Regulatory aspects of radiation protection

The paper introduces the projects launched by the European Community to foster prospects in dosimetry, radiation protection and best use of equipment in the medical field. These projects are put in perspective with the European legal framework for radiation protection, in particular, the Basic Safety Standards Directive, the Medical Exposures Directive and the Directive on High-Activity Sealed Sources. A summary is given of the overall mission statements of the commission services in the field of radiation protection, including the field of research, and how they relate to other actions in the overall health policy of the EU. In conclusion, a number of priority areas for future work in the medical field are highlighted.

Radiation protection aspects of the cosmic radiation exposure of aircraft crew.

Aircraft crew and frequent flyers are exposed to elevated levels of cosmic radiation of galactic and solar origin and secondary radiation produced in the atmosphere, the aircraft structure and its contents. Following recommendations of the International Commission on Radiological Protection in Publication 60, the European Union introduced a revised Basic Safety Standards Directive, which included exposure to natural sources of ionising radiation, including cosmic radiation, as occupational exposure. The revised Directive has been incorporated into laws and regulations in the European Union Member States. Where the assessment of the occupational exposure of aircraft crew is necessary, the preferred approach to monitoring is by the recording of staff flying times and calculated route doses. Route doses are to be validated by measurements. This paper gives the general background, and considers the radiation protection aspects of the cosmic radiation exposure of aircraft crew, with the focus on the situation in Europe.

SRP Meeting: The Radioactive Substances Act and Exemption Orders London, 16 January 2001

SRP Meeting: The Radioactive Substances Act and Exemption Orders London, 16 January 2001

Radon in workplaces / Radon an Arbeitsplätzen

The EU Member States have to implement the new Basic Safety Standards Directive (BSS) by May 2000. The Title VII of the Directive applies in particular to radon in workplaces. The Member States are required to identify workplaces which may be of concern, to set up appropriate means for monitoring radon exposures in the identified workplaces and, as necessary, to apply all or part of the system of radiological protection for practices or interventions. The BSS provisions on natural radiation are based on the ICRP 1990 recommendations. These recommendations were considered in the Finnish radiation legislation already in 1992, which resulted in establishing controls on radon in all types qf workplaces. In this paper issues are discussed on the practical implementation of the BSS concerning occupational exposures to radon basing on the Finnish experiences in monitoring radon in workplaces during the past seven years.

Development of revised Ionising Radiations Regulations

New standards in ICRP60 led to the revision of the 1980 European Basic Safety Standards Directive, which in turn has created the necessity to revise the Ionising Radiations Regulations 1985. Proposals from the Health and Safety Commission (HSC) for revised regulations are currently out for public consultation in a formal Consultative Document. This article describes some of the background to the proposals in the Consultative Document, key influences on the revision process and the methods used to develop the proposals so that they are broadly acceptable to stakeholders. Some of the changes proposed are structural in nature, such as integration of the provisions of the Outside Workers Regulations. Others are of a legal nature and include: new proposals for justification, prior authorisation and risk assessment; two options for the dose limitation system; and significant changes to the means of recognising the competence of the Radiation Protection Adviser. Following the current public consultation, final proposals need to be drawn up, approved by HSC and cleared through the European Commission under procedures required by the Euratom Treaty. If all goes according to plan, the revised regulations should be on the Statute Book about the middle of next year, with most provisions coming into force on 1 January 2000.

The European Directive on health protection of individuals against the dangers of ionising radiation in relation to medical exposures (97/43/EURATOM)

On 30 June 1997 the Council of Ministers approved the Directive on the Health Protection of Individuals in relation to Medical Exposures (MED) (97/43/EURATOM). This MED must be implemented in national law no later than 13 May 2000, repealing at that time Directive 84/466/EURATOM, the so-called `Patient Directive'. It complements the Basic Safety Standards Directive of 1996 (96/29/EURATOM) as regards medical exposures, which comes into force at the same date. The MED considerably extends the scope of application from exposures of patients to all exposures directly or indirectly related to medical uses of ionising radiation. The MED reaffirms the objectives of the 1984 Directive - to aim at optimum diagnostic efficacy at reasonable dose to the patient and to reduce the number of unnecessary and inadequate exposures - but also strengthens most of its requirements as a result of the experience gained with its implementation and, at the same time, adds new provisions considered important taking into account scientific and technical evolution in the radiological field. In particular those exposures where there is no direct health benefit for the person undergoing the exposure and exposures at great risk are given special attention. With the aim of facilitating the implementation of the MED in national legislation the European Commission, with the help of the group of experts established under article 31 of the EURATOM Treaty, will produce technical guidelines with further explanation on some of the requirements of the MED.