Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons.

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.

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.

Lessons learned from events notified to the French Nuclear Safety Authority during the period 2007-13 in the medical field.

The analysis of events is crucial for accident prevention. In 2007, ASN set up a system for the notification of radiation protection events. The majority of them concern the exposure of patients undergoing therapeutic or diagnostic procedures and, to a lesser extent, occupational exposures and the management of radioactive effluents. The most significant events concern interventional radiological procedures and nuclear medicine, in which there are exceedances of mandatory dose limits and staff contaminations, respectively. Deterministic effects in patients were observed following interventional procedures and in nuclear medicine. Many events involve leakage of radioactive effluents and highlight the need to improve the monitoring and maintenance of radioactive effluent facilities. The causes are mainly of organisational and human origin. The lessons learned emphasise the importance of the role of medical physicists and radiation protection officers and the need to implement quality and risk management measures and to conduct clinical audits.

Medical physics personnel for medical imaging: requirements, conditions of involvement and staffing levels-French recommendations.

The French regulations concerning the involvement of medical physicists in medical imaging procedures are relatively vague. In May 2013, the ASN and the SFPM issued recommendations regarding Medical Physics Personnel for Medical Imaging: Requirements, Conditions of Involvement and Staffing Levels. In these recommendations, the various areas of activity of medical physicists in radiology and nuclear medicine have been identified and described, and the time required to perform each task has been evaluated. Criteria for defining medical physics staffing levels are thus proposed. These criteria are defined according to the technical platform, the procedures and techniques practised on it, the number of patients treated and the number of persons in the medical and paramedical teams requiring periodic training. The result of this work is an aid available to each medical establishment to determine their own needs in terms of medical physics.

Patient safety in external beam radiotherapy - guidelines on risk assessment and analysis of adverse error-events and near misses: introducing the ACCIRAD project.

In 2011 the European Commission launched a tender to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy. This tender was awarded to a consortium of 6 institutions, including the ESTRO, in late 2011. The project, denominated "ACCIRAD", recently finished the data collection phase. Data were collected by surveys administered in 38 European countries. Results indicate non-uniform implementation of event registration and classification, as well as incomplete or zero implementation of risk assessment and events analysis. Based on the survey results and analysis thereof, project leaders are currently drafting proposed guidelines entitled "Guidelines for patient safety in external beam radiotherapy - Guidelines on risk assessment and analysis of adverse-error events and near misses". The present article describes the aims and current status of the project, including results of the surveys.