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Radiotherapy errors spark investigations and reform

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.

The process of radiation therapy planning and delivery is increasing in complexity, and errors that occur can have serious repercussions for patients. Many radiation therapy departments use incident learning systems (ILSs) to report, analyze, and learn from errors. The success of an ILS relies on a nonpunitive workplace culture in which practitioners are comfortable reporting errors. This study examines the error reporting culture of radiation therapists and dosimetrists in Canada and the United States.

A survey assessing perceptions regarding communication among staff, comfort in error reporting, and associated obstacles was mailed to a national sample of 1,500 radiation therapists and 528 dosimetrists in the United States. A similar survey was sent electronically to 1,500 Canadian radiation therapists, and the results from both surveys were compared and summarized using descriptive statistics.

The quality of communication between radiation therapists and physicians, physicists, and administrators is good in both countries, but there are differences between the three groups, with administrators ranked lowest. There was better perceived communication between radiation therapists, physicians, and physicists in the US cohort. Both cohorts felt they had opportunities to speak to physicians, physicists, and administrators, but the US cohort felt they had better opportunities than the Canadians. Most respondents felt there was a system for reporting errors in their departments, but this was higher in the Canadian group (88% in the United States, 98% in Canada). The majority of respondents felt that they were encouraged and felt comfortable to report errors in the clinic, and this result was significantly higher in the Canadian group. The majority of respondents felt that they had not been reprimanded for reporting an error; more people reported knowing of other staff being reprimanded rather than themselves. The largest obstacles to error reporting in both cohorts were fear of reprimand, poor communication, and hierarchy.

The majority of staff in both countries feel that communication in their department is good and that there are adequate systems for error reporting. However, a number of respondents felt that they, or a colleague, had been reprimanded in the past, and there are still perceived barriers to the use of an ILS. There is still work to do on improving positive perceptions of error reporting and departmental communication.

Le processus de planification et d'administration des traitements de radiothérapie devient de plus en plus complexe et les erreurs qui surviennent peuvent avoir de graves conséquences pour les patients. De nombreux services de radiothérapie utilisent un système de rapports sur les incidents (SRI) pour signaler les erreurs, les analyser et en tirer des enseignements. Le succès d'un SRI repose sur une culture non punitive dans le milieu de travail, dans laquelle les praticiens n'hésitent pas à signaler les erreurs. Cette étude examine la culture de signalement des erreurs chez les radiothérapeutes et dosimétristes au Canada et aux États-Unis.

Un sondage visant à évaluer les perceptions concernant les communications entre les membres du personnel, l'aisance face au signalement des erreurs et les obstacles connexes a été distribué par la poste à un échantillon national de 1 500 radiothérapeutes. Les résultats des deux sondages ont été comparés et résumés à l'aide de la statistique descriptive.

La qualité des communications entre les radiothérapeutes, les médecins, les physiciens et les administrateurs est bonne dans les deux pays, mais il existe des différences entre les trois groupes, les administrateurs se classant les plus bas. Les communications entre les radiothérapeutes, les médecins et les physiciens sont perçues comme meilleures au sein de la cohorte américaine. Les deux cohortes croient avoir la possibilité de discuter avec les médecins, les physiciens et les administrateurs, mais les répondants américains croient avoir de meilleures possibilités de communication que les Canadiens. La plupart des répondants pensent qu'un système de signalement des erreurs existe dans leur service, et cette proportion est plus élevée au Canada (98 %) qu'aux États-Unis (88 %). La majorité des répondants se sent encouragée à signaler les erreurs et à l'aise de le faire, un résultat significativement plus élevé chez les répondants canadiens. La majorité des répondants dit ne pas avoir été réprimandée pour avoir signalé une erreur; un nombre plus élevé de répondants disent connaître d'autres employés ayant reçu une réprimande qu'eux-mêmes. Dans les deux cohortes, les principaux obstacles au signalement des erreurs sont la crainte des réprimandes, les mauvaises communications et la hiérarchie.

Dans les deux pays, la majorité des membres du personnel croit que la communication est bonne dans leur service et qu'un système adéquat est en place pour le signalement des erreurs. Cependant, un certain nombre de répondants croit qu'eux-mêmes ou des collègues ont été réprimandés dans le passé pour avoir signalé une erreur et qu'il existe toujours des obstacles à l'utilisation d'un SRI. Il reste du travail à faire pour améliorer la perception positive du signalement des erreurs et les communications au sein des services.

The Radiation Oncology Safety Information System (ROSIS) was established in 2001. The aim of ROSIS is to collate and share information on incidents and near-incidents in radiotherapy, and to learn from these incidents in the context of departmental infrastructure and procedures.

A voluntary web-based cross-organisational and international reporting and learning system was developed (cf. the www.rosis.info website). Data is collected via online Department Description and Incident Report Forms. A total of 101 departments, and 1074 incident reports are reviewed.

The ROSIS departments represent about 150,000 patients, 343 megavoltage (MV) units, and 114 brachytherapy units. On average, there are 437 patients per MV unit, 281 per radiation oncologist, 387 per physicist and 353 per radiation therapy technologist (RT/RTT). Only 14 departments have a completely networked system of electronic data transfer, while 10 departments have no electronic data transfer. On average seven quality assurance (QA) or quality control (QC) methods are used at each department. A total of 1074 ROSIS reports are analysed; 97.7% relate to external beam radiation treatment and 50% resulted in incorrect irradiation. Many incidents arise during pre-treatment but are not detected until later in the treatment process. Where an incident is not detected prior to treatment, an average of 22% of the prescribed treatment fractions were delivered incorrectly. The most commonly reported detection methods were “found at time of patient treatment” and during “chart-check”.

While the majority of the incidents that reported to this international cross-organisational reporting system are of minor dosimetric consequence, they affect on average more than 20% of the patient’s treatment fractions. Nonetheless, defence-in-depth is apparent in departments registered with ROSIS. This indicates a need for further evaluation of the effectiveness of quality controls.

La radioterapia (RT) es un proceso complejo que utiliza altas dosis de radiación con finalidad terapéutica. La notificación y el análisis de incidentes, además de ser un requisito legal en RT, aporta información que ayuda a mejorar la seguridad de los pacientes. En este trabajo se describe nuestra experiencia tras 9 años utilizando un sistema local de notificación y aprendizaje de incidentes (SNAI) específico en RT.

El centro dispone de 4 aceleradores lineales que tratan a un total 1.900 pacientes anualmente. La primera acción que se llevó a cabo para abordar la seguridad de los pacientes fue la constitución de un grupo multidisciplinar de seguridad en RT (GSRT). Se decidió utilizar una metodología basada en la notificación de incidentes. Para ello se implementó un SNAI local adaptando el sistema de registro de incidentes ROSEIS, utilizado y consolidado por la Sociedad Europea Radioterapia Oncológica (ESTRO). Todos los incidentes donde algún paciente recibió alguna sesión de RT incorrecta se consideraron eventos adversos (EA) y fueron analizados. Finalmente, a través de una encuesta, se valoró la opinión de los profesionales con relación al SNAI y al funcionamiento del grupo de seguridad.

Desde junio del 2009 hasta octubre del 2018 se registraron 1.708 incidentes. Se observó un aumento de notificaciones a lo largo de los años. Un 2,5% de los incidentes reportados fueron EA, el resto fueron sucesos que no tuvieron impacto en el paciente. En la fase de administración del tratamiento, se detectaron el 55% de los incidentes, siendo los técnicos de RT los profesionales que más registraron. La mayoría de los casos provenían de fallos organizativos relacionados son la comunicación o protocolos de trabajo. Se implementaron acciones de mejora dirigidas a reducir la frecuencia de EA y facilitar su detección temprana. Las acciones realizadas fueron básicamente; redacción y revisión de protocolos y circuitos, implantación de listas de verificación y acciones formativas.

Un 85% de los trabajadores encuestados valoraron positivamente la incorporación del SNAI y el funcionamiento del grupo de seguridad. Sin embargo, un 15% de los profesionales consideraron que la metodología empleada en el análisis de incidentes no fue totalmente objetiva y tenía carácter punitivo.

Se ha abordado la seguridad del paciente que recibe RT a partir de una metodología basada en la implementación de un SNAI local. El análisis de los incidentes notificados ha promovido diversas acciones dirigidas a mejorar la seguridad de los pacientes que reciben RT. La metodología empleada ha sido bien valorada por los trabajadores y ha ayudado a introducir la cultura de la seguridad en la mayoría de profesionales implicados. Además, el SNAI local facilita dar cumplimiento a la normativa europea en cuanto a la obligación de registrar incidentes en RT.

Radiation therapy (RT) is a complex process that employs high-dose radiation for therapeutic purposes. Incident reporting and analysis, in addition to being a legal requirement in RT, provides information that helps to improve patient safety. This paper describes our experiences over a 9 year period in which a local incident reporting and learning system (SNAI) specific to RT was employed.

The center has 4 lineal accelerators that treat a total of 1900 patients annually. The first action taken with a view to improving patient safety was the implementation of a multidisciplinary RT safety group (GSRT), who decided to employing a methodology based on incident reporting. For this purpose, a local SNAI was implemented, adapting the ROSEIS incident reporting system used and consolidated by the European Society of Radiation Oncology Therapy (ESTRO). All incidents in which patients received an incorrect RT session were considered adverse events (AE) and were thus analyzed. Finally, the opinion of the professionals involved in relation to the SNAI and the functioning of the safety group was evaluated by means of a survey.

From June 2009 to October 2018, 1708 incidents were recorded, with an increasing incidence observed over time. Approximately 2.5% of the incidents reported were AE. The remainders were events that did not affect the patient. As many as 55% of incidents were detected in the treatment administration phase. Radiotherapy technicians were the professionals who reported more incidents. The majority of recorded cases originated from procedural shortcomings relating to communication or work protocols. Implemented remedial actions were aimed at reducing the frequency of AE and facilitating its early detection. Actions employed were essentially: drafting and revision of protocols and circuits, implementation of checklists, and training actions.

Of the workers surveyed, 85% positively valued the incorporation of the SNAI and the existence of a safety group. However, 15% of the professionals considered that the methodology used in the analysis of incidents was not totally objective i.e punitive in nature.

The safety of the patient receiving RT has been approached from a methodology based on a local SNAI. The analysis of reported incidents has promoted various actions aimed at improving the safety of patients receiving RT. The methodology used has been well received by the workers and has helped to introduce a culture of patient safety for the majority of professionals involved. Furthermore, the local SNAI facilitates compliance with European regulations regarding the obligation to record incidents in RT.