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

• DOI: 10.1016/j.radonc.2017.02.016
• Publication Date: 2017-03-25T23:45:16Z
• Authors: Julian Malicki; Ritva Bly; Mireille Bulot; Jean-Luc Godet; Andreas Jahnen; Marco Krengli; Philippe Maingon; Carlos Prieto Martin; Kamila Przybylska; Agnieszka Skrobała; Marc Valero; Hannu Jarvinen
• Keywords: ACCIRAD; Adverse error-event; Events reporting; Near miss; Risk management; Hematology; Oncology; Radiology; Nuclear Medicine and Imaging; Adverse error-event; 610; Risk Assessment; 03 medical and health sciences; 0302 clinical medicine; Nuclear Medicine and Imaging; 616; Near mi; Humans; Radiation Injuries; Events reporting; Risk Management; Radiotherapy; ACCIRAD; Hematology; 3. Good health; Europe; Risk management; Oncology; Health Care Surveys; Practice Guidelines as Topic; Patient Safety; Radiology

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