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Patient safety in external beam radiotherapy, results of the ACCIRAD project: Current status of proactive risk assessment, reactive analysis of events, and reporting and learning systems in Europe

      Abstract

      Purpose

      To describe the current status of implementation of European directives for risk management in radiotherapy and to assess variability in risk management in the following areas: 1) in-country regulatory framework; 2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems.

      Material and Methods

      The original data were collected as part of the ACCIRAD project through two online surveys.

      Results

      Risk assessment criteria are closely associated with quality assurance programs. Only 9/32 responding countries (28%) with national regulations reported clear “requirements” for proactive risk assessment and/or reactive risk analysis, with wide variability in assessment methods. Reporting of adverse error events is mandatory in most (70%) but not all surveyed countries.

      Conclusions

      Most European countries have taken steps to implement European directives designed to reduce the probability and magnitude of accidents in radiotherapy. Variability between countries is substantial in terms of legal frameworks, tools used to conduct proactive risk assessment and reactive analysis of events, and in the reporting and learning systems utilized. These findings underscore the need for greater harmonisation in common terminology, classification and reporting practices across Europe to improve patient safety and to enable more reliable inter-country comparisons.

      Keywords

      Modern radiotherapy has an excellent long-term safety record. Nevertheless, accidental unintended radiation exposure to patients or hospital staff is an ever-present risk. To minimize this risk, the European Commission (EC) has published guidelines and established regulations to ensure radiation protection. A general requirement designed to reduce the probability and magnitude of accidents in radiotherapy related to accidental or unintended exposures was established in 1997 by European Council directive 97/43/EURATOM (Medical Exposure Directive, or MED directive) [
      • Teunen D.
      The european directive on health protection of individuals against the dangers of ionising radiation in relation to medical exposures (97/43/EURATOM).
      ], now reinforced with an additional specific requirement on risk assessment in the new European Council Directive 2013/59/Euratom Basic Safety Standards (BSS) [], which replaced five earlier directives, including the MED directive. While there are some differences between the earlier (1997) MED directive and the more recent (2013) Euratom directive, both of these require that member states take measures to minimize the probability and magnitude of accidental or unintended exposures of individuals subject to medical exposure. The Euratom directive is more specific, calling for the inclusion (within a quality assurance programme) of an assessment of the risk of accidental or unintended exposures and for implementation of a system for record keeping and analysis of such events.
      In the year 2011, the EC commissioned a project (denominated “ACCIRAD”) to assess implementation among European Union (EU) member states of the requirements stipulated in the MED Directive. The specific objectives of the ACCIRAD project were (1) to verify implementation of the MED requirements designed to reduce the probability and magnitude of accidents and (2) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT). Initial results of the ACCIRAD surveys were published in 2014 [
      • Malicki J.
      • Bly R.
      • Bulot M.
      • Godet J.L.
      • Jahnen A.
      • Krengli M.
      • et al.
      Patient safety in external beam radiotherapy – guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.
      ] and full results in 2015 (EC Radiation Protection [RP]-181) [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ]. The present paper describes the current status of implementation of risk management in the EU. The data presented here are based primarily on RP-181 but also include updated information from two recent studies [
      • Vilaragut J.J.
      • Duménigo C.
      • Delgado J.M.
      • Morales J.
      • McDonnell J.D.
      • Ferro R.
      • et al.
      Prevention of accidental exposure in radiotherapy: the risk matrix approach.
      ,

      International Atomic Energy Agency. Aplicación del método de la matriz de riesgo a la radioterapia. IAEA-TECDOC 1685 Series. Vienna: IAEA, 2012.

      ].
      The present document has two aims: (1) to report the current status of implementation of European directives for risk management in radiotherapy; and (2) to describe variability in risk management approaches among EU countries. The results are organized into four sections: (1) in-country regulatory framework; (2) proactive risk assessment; (3) reactive analysis of events; and (4) reporting and learning systems.

      Materials and methods

      The methods have been previously described in detail elsewhere [
      • Malicki J.
      • Bly R.
      • Bulot M.
      • Godet J.L.
      • Jahnen A.
      • Krengli M.
      • et al.
      Patient safety in external beam radiotherapy – guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.
      ,

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ]. Briefly, two online surveys were conducted to collect baseline data. The first survey (conducted online from March to May 2012) gathered country-specific data on national regulations and systems implemented to comply with Article 11 of the MED Directive. A second, more comprehensive survey (available online from August to October, 2012) was administered to gather detailed information from countries with national reporting systems; data were collected on national risk management systems for EBRT, and on approaches to classifying, recording, and reporting adverse events or near misses. The ACCIRAD recommendations (RP-181) [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ] were approved by the EC and endorsed by the European Society for Radiotherapy & Oncology (ESTRO).

      Results

      In-country legal framework: regulations/guidelines

      Of the 38 countries surveyed, 32 provided responses about national regulations governing risk management in radiotherapy. Ten countries reported “requirements” for proactive risk assessment and/or reactive risk analysis (Table 1). While the European directives do not explicitly require proactive risk assessment for patients, this is nevertheless mandatory in some countries (the BSS, not yet implemented in all European countries at the time of the survey, only refers to “a study of the risk of accidental or unintended exposures”). Depending on the country, proactive risk assessment is governed either by national authorities (regulations/guidelines) or national professional societies. Note that although the countries included in this survey were located in Europe, many are not EU members and thus not subject to EU regulations. Nevertheless, given the value and relevance of such data for the scientific community, we have included data for all the countries that responded because this provides more comprehensive information about risk management practices in greater Europe.
      Table 1The ten countries that reported having national regulations or guidelines for (a) proactive risk assessment, (b) reactive analysis of events and/or (c) reporting and learning systems.
      Risk management categoryCountry
      FranceIrelandUKNetherlandsSpainSlovakiaDenmarkItalyPolandFinland
      Proactive Risk Assessment for patientsYesNo
      Reactive analysis of eventsMandatory (no defined methodology: recommendations only)
      Reporting and learning systemsYes

      Proactive risk assessment

      Many countries have regulations or guidelines in place to govern proactive risk assessment (Table 1); however, even where this is mandatory, no specific methodology is usually required.
      In general, requirements for risk assessment are closely linked to quality assurance (QA) management. In Finland, for example, although no explicit requirements for proactive risk assessment exist, error prevention principles are included in requirements for QA programmes [

      Safety in radiotherapy, Safety Guide ST 2.1, Radiation and Nuclear Safety Authority (STUK); available from: http://plus.edilex.fi/stuklex/en/lainsaadanto/saannosto/ST2-1.

      ].

      Reactive analysis of events

      In most countries—even those in which reactive analysis of events is mandatory—no specific methodology is required. However, reactive analysis of events is closely related to QA, with mandatory recording at the hospital and/or local/national levels. In the Netherlands, France, and UK, reactive analysis is governed by general radiation protection regulations [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ,

      Mazeron R, Aguini N, Deutsch É. [Risk analysis in radiation therapy: state of the art]. Cancer Radiothérapie; 17:308–16; 332.

      , ]. Finland, Spain and France have—in addition to general regulations—specific requirements for radiotherapy [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ]. In the UK and Ireland, non-binding guidelines are available for radiotherapy-specific reactive analysis of events [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ,
      • Rahn D.A.
      • Kim G.-Y.
      • Mundt A.J.
      • Pawlicki T.
      A real-time safety and quality reporting system: assessment of clinical data and staff participation.
      ].

      Reporting of adverse error-events

      Adverse events are defined as events that result in unintended harm to the patient by an act of commission or omission. The term “adverse event” could be understood to encompass all types of adverse effects (including treatment-related side-effects and human or machine errors) that negatively affect the patient. To avoid confusion, the term “adverse error-event” is used in this paper, and defined as any adverse event caused by human and/or organizational failures or machine malfunction. Treatment-related side effects are excluded from this definition.
      For reporting of adverse error-events, most countries (69%, including all 10 of the countries listed in Table 1) have legislative requirements. However, in 44% of the countries surveyed, these requirements form part of general requirements. By contrast, radiotherapy-specific criteria exist in only 25% of the countries surveyed.

      Proactive risk assessment

      Brief overview

      A proactive risk assessment should be conducted when changes in practice, equipment, or procedures are undertaken. Several methods are available to assess proactive risk, including Fault Tree Analysis (FTA) and Event Tree Analysis (ETA). Both of these methods, known as the “defence in depth approach”, account for barrier failures. FTA is a deductive (top down) qualitative method used to assess the extent to which a fault or basic event can propagate through the system to the ultimate event. ETA, by contrast, is an inductive (bottom up) method for identifying propagation of an initiator (failure, incident, etc.) and its potential to trigger undesirable events.
      Other commonly-used inductive proactive risk assessment methods include Failure Mode and Effect Analysis (FMEA) and Preliminary Hazard or Risk Analysis (PHA/PRA). In FMEA, potential failures of system “components” are identified and then potential consequences are evaluated. FMEA analysis should be conducted by a multidisciplinary working group led by a risk manager (or other team leader) to determine the impact of potential hazards. This method can be used to identify single failures and to identify possible preventive, corrective and detective measures (i.e., barriers). PHA (or PRA) is an inductive approach widely used in industry. More details about these methods are provided in the Technical Supplement to RP 181 (http://ec.europa.eu/energy/sites/ener/files/documents/AnnexeGuidelinesRP181.pdf) and in the papers by Huq et al. [
      • Huq M.S.
      • Fraass B.A.
      • Dunscombe P.B.
      • Gibbons J.P.
      • Ibbott G.S.
      • Medin P.M.
      • et al.
      A method for evaluating quality assurance needs in radiation therapy.
      ,
      • Huq M.S.
      • Fraass B.A.
      • Dunscombe P.B.
      • Gibbons J.P.
      • Ibbott G.S.
      • Mundt A.J.
      • et al.
      The report of Task Group 100 of the AAPM: application of risk analysis methods to radiation therapy quality management.
      ] and Ford et al. [
      • Ford E.C.
      • Gaudette R.
      • Myers L.
      • Vanderver B.
      • Engineer L.
      • Zellars R.
      • et al.
      Evaluation of safety in a radiation oncology setting using failure mode and effects analysis.
      ].

      Proactive risk assessment methods in use in selected European countries

      Methods specific to EBRT

      Two risk assessment methods have been specifically-designed for radiotherapy: Failure mode, effects and criticality analysis (FMECA) in France [

      ASN. Guide de l’ASN n°4 : Guide d’auto-évaluation des risques encourus par les patients en radiothérapie externe. Available at: https://professionnels.asn.fr/Les-Guides-de-l-ASN/Guide-de-l-ASN-n-4-Auto-evaluation-des-risques-encourus-par-les-patients-en-radiotherapie-externe. Last accessed, 25 January, 2017.

      ], and the Risk Matrix approach (RMA) developed by the Ibero-American Forum of Radiological and Nuclear Regulatory Agencies (FORO) [

      International Atomic Energy Agency. Aplicación del método de la matriz de riesgo a la radioterapia. IAEA-TECDOC 1685 Series. Vienna: IAEA, 2012.

      ,
      • Torres A.
      • Montes de Oca J.
      Nuevo algoritmo para análisis de riesgo en radioterapia.
      ].

      France: FMECA

      Due to adverse events that occurred in the year 2005 in France [
      • Derreumaux S.
      • Etard C.
      • Huet C.
      • Trompier F.
      • Clairand I.
      • Bottollier-depois J.F.
      • et al.
      Lessons from recent accidents in radiation therapy in France.
      ,
      • Furlow B.
      Radiotherapy errors spark investigations and reform.
      ], the ASN devised (non-mandatory) radiotherapy-specific risk assessment guidelines []. A multidisciplinary working group, including experts from the French Nuclear Safety Authority, investigated risks arising from abnormalities in the treatment planning and delivery of radiotherapy. The work was based on the FMECA (similar to FMEA), which prioritizes preventive measures. The severity assessment of failure modes was inspired by the CTCAE and the RTOG Toxicity Criteria. However, unlike those criteria (defined for specific cancer localizations), the severity assessment table applies to all organs. This method applies failure mode analysis to three main lines/pathways: patients; equipment; and human/organizational factors. This method also includes a probability scale to assess the likelihood of occurrence. The FMECA method in France was developed to be applied to standard radiotherapy process but adapted by users according to the specificities of their activity.

      Spain – FORO: risk matrix methodology

      The RMA (used in Spain) is a semi-quantitative method consisting of a scale to evaluate event probability and severity to define risk acceptability criteria [

      International Atomic Energy Agency. Aplicación del método de la matriz de riesgo a la radioterapia. IAEA-TECDOC 1685 Series. Vienna: IAEA, 2012.

      ]. Since a simple failure does not necessarily lead to patient harm, the RMA focuses on determining the probability of harmful events. This method assesses barriers that could halt propagation of the initiating event, and seeks to identify opportunities to strengthen existing barriers or add new ones.
      The RMA methodology involves three main steps: (1) identification of hazards/barriers with a proven methodology (e.g., FMEA or PRA); (2) screening (risk matrix) to sort events by risk level; and (3) second screening to identify high risk events. The risk-matrix must be created first. Both the risk matrix itself and a comprehensive list of hazards and barriers are freely available, including a software tool [
      • Paz A.
      • Godinez V.
      • López R.
      ] (http://www.foroiberam.org/sevrra). Probability levels for total failure are ranked as high (no barriers), medium (1–2 barriers), low (3 barriers), and very low (≥4 barriers).

      FINLAND: FMECA and risk matrix

      In Finland, a multidisciplinary team of professionals from national radiotherapy centres in co-operation with the STUK has developed national guidelines using a spreadsheet (available at http://www.stuk.fi/web/en/frontpage). This team used the ACCIRAD guidelines to establish a national approach for proactive risk assessment using FMECA to identify failures, and a risk matrix to evaluate event likelihood and severity. Similar methods were recently applied in other countries to assess various radiotherapy procedures [
      • Cantone M.C.
      • Ciocca M.
      • Dionisi F.
      • Fossati P.
      • Lorentini S.
      • Krengli M.
      • et al.
      Application of failure mode and effects analysis to treatment planning in scanned proton beam radiotherapy.
      ,
      • Masini L.
      • Donis L.
      • Loi G.
      • Mones E.
      • Molina E.
      • Bolchini C.
      • et al.
      Application of failure mode and effects analysis to intracranial stereotactic radiation surgery by linear accelerator.
      ,
      • Younge K.C.
      • Wang Y.
      • Thompson J.
      • Giovinazzo J.
      • Finlay M.
      • Sankreacha R.
      Practical implementation of failure mode and effects analysis for safety and efficiency in stereotactic radiosurgery.
      ].

      Other methods: process analysis

      The adverse error-event process starts with an ‘‘initiating event’’ (equipment failure or human error) which could potentially lead to undesirable consequences if safety measures fail to halt propagation.
      Process analysis is used to identify the safety level of each step by verifying “robustness” under risk situations. This is the method recommended by the “Haute Autorité de Santé” in France, which requires a detailed description (using mapping tools) of all steps. Risk situations are identified through preliminary studies (e.g., FMEA or PRA) or by expert input (e.g., feedback from operating experience). For each risk situation, the possible causes are identified to verify existing safety barriers and consequences. An initial assessment identifies each step's safety level, without regard to severity (summarized in the risk table). “Critical points” are defined as situations not covered by existing safety barriers but with the potential for severe consequences. The results are used to select specific process improvements after analysis with FMEA or other tools.

      Comparison of the various proactive risk assessment methods

      Table 2 compares existing proactive risk assessment methods, colour coded in descending order of complexity. Although FMEA and FMECA are similar in many aspects, the difference between the two is that when an additional step is added to FMEA to evaluate the criticality of each failure mode, the method is known as FMECA. In the case of France, the FMECA model, although quite comprehensive, is easy to apply because it provides a fully adaptable model with guidelines and completed tables.
      Table 2Comparison of six proactive methods of risk assessment. Methods are colour coded from least complex to apply (green) to most complex (orange).
      *FTA indicates Fault Tree Analysis; FMECA, Failure mode, effects and criticality analysis; PRA, Preliminary Risk Analysis; ETA, Event Tree Analysis.

      Reactive analysis of events

      Brief overview

      Reactive analysis of events is closely linked to event recording and reporting (section IV). When an error in the treatment process is detected, the standard response is as follows: (1) local recording and reporting within the radiotherapy department accompanied by a rapid analysis of the causes and consequences with implementation of “immediate” corrective actions; (2) detailed analysis of the event, including identification of underlying causes and proposed preventive measures; (3) final event reporting, including external reporting and learning systems.
      Regardless of the method used to perform the reactive analysis, only adverse error-events that meet pre-defined severity criteria and “sentinel” events (i.e., unexpected adverse events involving death or serious harm to a patient) need to be fully analysed. A multidisciplinary investigation team trained in events analysis performs the investigation, including structured interviews with witnesses and relevant stakeholders. The team must be independent from those directly involved in the event.
      The analysis must answer the following questions: (1) What happened? (2) Why did it happen? and (3) What can we learn from what happened and what needs to change?

      General methods

      Numerous general methods are available: Root Cause Analysis (RCA); Association of Litigation and Risk Management (ALARM); Causal Tree Analysis (CTA); and the ORION method. See RP-181 [

      European Commission (2015). Radiation Protection N° 181. General guidelines on risk management in external beam radiotherapy.

      ] for details.

      Radiotherapy-specific methods

      The primary radiotherapy-specific method for reactive analysis of events is the Human Factor Analysis and Classification System (HFACS) [
      • Portaluri D.M.
      • Fucilli F.I.M.
      • Gianicolo E.A.L.
      • Tramacere F.
      • Francavilla M.C.
      • De Tommaso C.
      • et al.
      Collection and evaluation of incidents in a radiotherapy department.
      ], a detailed event analysis method for identifying both latent and active failures. HFACS provides a highly practical framework to identify failures.

      Comparison of different methods for reactive analysis of events

      Differences between available methods are chiefly related to the nature of the causes identified and the practical support provided to conduct the analysis. Root cause identification can be performed with RCA (including “5 whys” and Ishikawa diagram), ALARM, HFACS, and ORION. Tables and/or checklists to support the analysis are available for ALARM, HFACS and ORION. HFACS describes failure levels and identification of root causes. In Italy, a detailed version of HFACS has been developed specifically for radiotherapy [
      • Portaluri D.M.
      • Fucilli F.I.M.
      • Gianicolo E.A.L.
      • Tramacere F.
      • Francavilla M.C.
      • De Tommaso C.
      • et al.
      Collection and evaluation of incidents in a radiotherapy department.
      ]. The use of a causal tree (included in both CTA and ORION methods) is particularly valuable because it enables identification of causal relationships among events. However, these methods are not suitable for identifying overall system faults or influencing factors.
      The various methods are compared in Table 3, which is colour coded in descending order of complexity.
      Table 3Comparison of reactive methods for analysis of events. Methods are colour coded from least complex (green) to most complex (orange).
      *HFACS indicates Human Factor Analysis and Classification System; ALARM, Association of Litigation and Risk Management.

      Reactive analysis of events: methods used in selected European countries

      In most countries, reactive analysis of events is mandatory although no defined methodology is usually required and any method described in Table 3 can be used.

      Events reporting and learning systems

      Brief overview

      A comprehensive reporting and learning system should include the following: detailed description of the event; how the event was discovered; severity of consequences and how these were managed; analysis of causes; corrective actions implemented; and recommendations for preventing future recurrences. In addition, the system should clearly state which events are reportable.
      In many countries reporting is mandatory (to ensure public accountability) while in others the systems are voluntary at various levels (i.e., departmental, institutional, regional, national, and international). The most common failure of mandatory reporting systems is the lack of adequate resources to fully analyse the reports and share the lessons learnt. Ideally, information from both mandatory and voluntary systems should be combined into a central reporting system to guarantee effective sharing and learning.
      Importantly, nearly 70% of countries have legislative requirements in place to govern reporting of adverse error-events, although these form part of more general regulations in 44% of countries (see RP-181).

      Methods currently in use in selected European countries

      Numerous reporting and learning systems are available (Table 4).
      Table 4Reporting and learning systems used in Europe.
      General systemsRT-specific systems
      International systemsICPS (WHO)AIMS (International)ROSIS
      RT RISK PROFILE (WHO)
      SAFRON (IAEA)
      National or other systemsSiNASP (SPAIN)ASN-ANSM (France)
      DPSD (Denmark)RCR (UK)
      ICHT/NRLS (UK)PRISMA-RT (Netherlands)
      SWISS ROSIS (Switzerland)
      DPSD indicates, Danish Patient Safety Database; NRLS, National Reporting and Learning System; ROSIS, Radiation Oncology Safety Information System; SAFRON, Safety in Radiation Oncology; IAEA, International Atomic Energy Association; SiNASP, Sistema de Notificación y Aprendizaje para la Seguridad del Paciente. ICPS, International Classification of Patient Safety. RCR, Royal College of Radiologists; WHO, World Health Organization; ASN-ANSM, French Health Authority; ICHT/NRLS, Imperial College Healthcare Trust/National Reporting and Learning System (NRLS).
      In Europe, the two main radiation oncology-specific international systems are ROSIS and SAFRON. ROSIS, established in 2001 under the auspices of the ESTRO, provides an international voluntary incident and near-incident reporting system. In addition, ROSIS has a supporting website and, importantly, runs an annual teaching course on patient safety.
      Table 5 provides an overview of the characteristics and features of the principal systems used in Europe. As Table 4, Table 5 clearly illustrate, the characteristics are highly variable.
      Table 5Overview of the principal patient safety systems used in Europe.
      Name of system (Organization), web addressNATIONAL SYSTEMSINTERNATIONAL SYSTEM
      Vigie radiothérapie (ASN/ANSM) http://vigie-radiotherapie.fr/ICHT/NRSL (Imperial College Healthcare NHS Trust /National Reporting and learning System) http://www.nrls.npsa.nhs.uk/Prevention, Recovery and Information System for Monitoring and Analyses in RadioTherapy (PRISMA-RT) http://www.prisma-rt.nlSAFRON (IAEA) https://rpop.iaea.org/safron/
      Local/ExternalExternalExternalExternalLocal and External
      Geographical rangeFrance, Monaco, OthersUnited KingdomNetherlandsInternational
      RT specificYesNo, but RT incidents have trigger codeYesYes
      VoluntaryMandatoryYesYesYes
      ConfidentialityDepending on the scale of the event the name of the Department and Hospital are revealed.ConfidentialUnknownConfidential
      Reportable eventsCriterion 2.1 (ASN guide ASN/DEU/03)All radiotherapy errors including Adverse events, Incidents and Near misses and othersNear incidentsAny event, called generically incidents and divided into 6
      Classification and definitionsReporting criteria in the ASN Guide ASN/DEU/03. Criterion 2.1 is for radiotherapy.Terminology and Classification of the severity and type of incident according to what is defined in the document “Towards Safer Radiotherapy”For root cause classification the Eindhovens-Classification Model (ECM) is used. For this purpose, 21 different codes are defined each divided into 4 categories: human, technical, organization or patient related.Process steps for EBRT are grouped into 4 levels based on the WHO “Radiotherapy Risk Profile”, and the radiotherapy pathway outlined in “Towards Safer Radiotherapy” (UK)
      Number of reports in the databaseClose to 300 events reported in the period 2007–2008. In 2009, 131 events were reported.4 million patient safety incident reports, 4,209 reports specific to radiotherapy (30 May 2012)UnknownMore than 1150 reports (March 2013)
      FeedbackDetailed analysis of the causes of Significant Event Reports (SER) and a description of the planned or implemented corrective action.Analysis of the incident report carried out by HPA (Health Protection Agency)UnknownFeatured incident reports and documents
      Information on safer radiotherapy at http://www.hpa.org.uk/radiotherapyRegistered participants automatically receive summary reports and news alerts
      Presentations and articles.
      Alerts are sent electronically to radiotherapy stakeholders

      Discussion

      The present document describes the current status of implementation of risk management programs for radiotherapy, as required in the European Council directives. This article provides a comprehensive overview of the situation in the EU with regards to the main areas of risk management, demonstrating wide variability among countries. Based on the results of the ACCIRAD project, it is clear that greater efforts are needed to harmonise risk management processes in the EU, particularly with regard to developing common terminology and reporting practices. As we have shown, risk assessment criteria are closely associated with QA programs. This is an important finding as it suggests that countries that have implemented QA guidelines or regulations are more likely to have some type of rules or recommendations for proactive risk assessment and/or reactive analysis of events.

      Legal framework

      In terms of the legal framework, only 9 of the 32 countries that responded to our survey and provided responses about national regulations (France, Ireland, UK, Netherlands, Spain, Denmark, Italy, Poland, and Finland) had clear “requirements” for proactive risk assessment and/or reactive risk analysis. Moreover, these requirements were highly variable: in some cases they were established by national authorities as regulations or guidelines, while in others they were recommendations from professional societies.

      Proactive risk assessment

      There are two proactive risk assessment methods specifically designed for radiotherapy, the FMECA developed in France and the RMA in Spain.

      Reactive analysis of events

      Numerous general methods are used within the EU to perform reactive analysis of events, including RCA (Denmark, Ireland, Netherlands), ALARM (Slovakia), CTA (Spain, Netherlands, Slovakia), and ORION (France). The main radiotherapy-specific method is the HFACS. Many countries have established regulations to govern proactive risk assessment and reactive analysis of events. However, even when such risk management methods are mandatory, no specific methodology is established. General radiation protection regulations in the Netherlands, France and the UK govern reactive analysis of events. In Finland, Spain and France, there are specific requirements for radiotherapy. In the UK and Ireland, non-binding guidelines for reactive analysis of events specific to radiotherapy have been published.

      Reporting and learning systems

      Although reporting is mandatory in more than two-thirds of countries, the specific requirements vary in terms of the types of events that must be reported and the follow-up actions required. Less than half of the countries surveyed had legislative requirements governing reporting of near misses, and these were specific to radiotherapy in a small percentage of (1 out of 6) cases. In addition to mandatory reporting, many countries also have voluntary systems. Clearly, it would be preferable to combine the data collected in mandatory and voluntary reporting and learning systems into a central reporting system. This would make the data more widely and easily accessible, thus ensuring more effective sharing of lessons learnt to further improve safety.
      Although most countries require reporting of adverse error-events, nearly one-third do not require such reporting. This is an important issue that should be addressed in the near future given the importance of learning from adverse events.

      Conclusions

      The present report demonstrates that many—though not all—EU countries have taken steps to implement the European directive requirements designed to reduce the probability and magnitude of accidents in radiotherapy. However, variability between countries is substantial, not only in terms of legal frameworks, but also with regards to the tools used for proactive risk assessment, reactive analysis of events, and reporting and learning systems.
      Considering that the ACCIRAD project was completed only recently (at the end of the year 2014), it is understandable that it will take time before each country approves legislation to comply with the European directives. Nevertheless, the large variability among European countries in terms of risk management systems underscores the urgent need for greater harmonization across Europe to improve patient safety and enable more reliable inter-country comparisons. It is worth emphasizing that the main aim of harmonization is not necessarily to implement specific risk management methodologies, as many different approaches may be effective, but rather to harmonize common terminology, classification and reporting practices. Indeed, the current variability in risk management approaches may actually be beneficial in the long-term in that it could help to identify the most effective approaches to risk management.
      Given the importance of the recommendations described in the current report and in RP-181, the ESTRO has recently proposed incorporating these findings and knowledge into the dedicated teaching courses that they offer to help train radiation oncologists, physicists, and quality managers in implementing risk assessment and management programs. This same program will also include training in the most appropriate procedures for improving QA programmes at European radiation oncology departments.

      Conflict of interest

      None declared.

      Acknowledgements

      We wish to thank Bradley Londres for his invaluable assistance in editing and improving the present document. Financial support for this writing assistance was paid for by the Greater Poland Cancer Centre using EC grant “ACCIRAD”.

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