Risk management, quality and safety in ESTRO.

ESTRO has a long history in promoting the highest quality radiotherapy for all patients. This is clearly stated in their vision for radiation oncology and cancer care for the 2020 horizon “All patients are entitled to access healthcare systems that enable the highest quality radiotherapy with a safe healthcare environment……” and broken down in vision 1.1. “Optimised individualized patient care will be achieved by integrating new clinical and preclinical evidence from biology, functional and anatomic imaging, and the use of novel systemic agents together with the delivery of high-precision radiation therapy in a safety-aware environment.”1

ESTRO’s role in promoting quality dates from the 1990s with two key publications on the implementation of a quality system in a radiotherapy department. The first was a physics booklet – Recommendations for a Quality Assurance Programme in External Radiotherapy produced by the French Society of Radiation and Oncology in collaboration with the French Society of Hospital Physicists (1995) followed in 1998 by the more detailed Practical Guidelines for the Implementation of a Quality System in Radiotherapy which was a publication resulting from a project of the ESTRO Quality Assurance Committee sponsored by Europe Against Cancer. These two publications were used extensively by radiotherapy departments resulting in both higher quality and also an increased awareness of the importance of quality assurance and quality control in treatment preparation and delivery.

EU projects

ESTRO participated in a range of EU projects in the area of quality and safety as either project leader or participation as a partner. These projects were:

Education, Science and Quality Assurance for Radiotherapy (ESQUIRE)2 2003 – leader.

Medical Radiation Protection Education and Training (MEDRAPET)3 2014 – endorsed.

General Guidelines on Risk Management in External Beam Radiotherapy (ACCIRAD group)4 2015 – partner.

ESQUIRE

“The ESQUIRE actions focused on developing the human potential through investment in education and a concerted European approach to the surveillance of the quality of radiotherapy with the aim of pulling clinicians over the confidence threshold for the safe introduction of optimised radiotherapy with better outcome figures without an increased risk to the patient.” One strand of the ESQUIRE project established the EQUAL laboratory and network, which carried out dosimetric checks on over 3000 beams under reference conditions thus ensuring that the dose delivered was consistent with the prescription. A sub-group of another strand developed the Radiation Oncology Safety Information System (ROSIS) a voluntary international reporting and learning system designed to share information between centres thus reducing the potential for incidents and near incidents. The revised ROSEIS system will be provided by ESTRO in 2017 to radiotherapy departments establishing a local reporting and learning system in compliance with EU legislation in the area. A QUASIMODO task group developed a ‘novel approach to the QA of treatment planning systems’ resulting in a publication Quality Assurance of Treatment Planning Systems – Practical examples for non-IMRT photon beams” and the Brachytherapy Physics group developed tools for the external audit of the geometric and dosimetric accuracy of brachytherapy and the publication of the Practical Guide to the Quality Control of Brachytherapy Equipment adding to the publication series in the area of quality and quality management implementation.

MEDRAPET

This project related to all professionals who would use radiation as part of their day-to-day practice. The application of radiation for the individual professions is detailed together with recommendations on the depth and breadth of the radiation protection component of the various education programmes.

ACCIRAD

This project was designed to produce guidelines to help national authorities and radiotherapy services implement reporting and learning systems to meet the requirement detailed in The European Medical Exposure Directive of 1997 (Council Directive 97/43/Euratom) which required that Member States take “all reasonable steps to reduce the probability and the magnitude of accidental or unintended [radiation] doses of patients” in radiotherapy.

ESTRO also collaborates with the International Atomic Energy Agency (IAEA) and the World Health Organisation (WHO) in a wide range of projects relating to quality and safety in radiotherapy.

Education

ESTRO supports improvement in quality and safety through the provision of a range of educational material and publications. ESTRO has two courses, held in alternate years, on comprehensive quality management focussing on quality assessment and improvement and risk management. ESTRO also endorses the short course working towards safer radiotherapy held biannually. Risk management and quality assurance are included as topics in many of the annual scientific meetings and will be the topic of the pre-meeting for ESTRO 36. In addition the DOVE website offers a wide range of podcasts and publications related to the topic.

Radiation Oncology Quality and Safety Committee (ROSQ)

The ROSQ was established in 2016 and held its inaugural meeting on 5th October 2016. Membership reflects the multidisciplinary ethos of ESTRO and emphasises the principle that quality and safety are the responsibility of everyone. Membership also includes a patient representative to reflect the patient perspective and to ensure that their concerns with respect to quality and safety of treatment is acknowledged. The members of the ROSQ are: Mary Coffey (chair, RTT, Ireland), Tommy Knoos (Physicist, Sweden), Dirk Verellen (Physicist, Belgium), Eric Lartigau (Radiation Oncologist, France), Petra Reijnders (RTT, The Netherlands), Anita O’Donovan (RTT, Ireland), Todd Pawlicki (Physicist, AAPM/ASTRO, USA), Bernadino di Bari (Radiation Oncologist, Switzerland, Young Observer), Julian Malicki (Physicist, Poland) and Edward Naessens (patient representative Ireland).

One role of the ROSQ is to support both national societies and individual departments in meeting the requirements of the most recent European Directive 2013/59/EURATOM which makes it a legal requirement to report, analyse and learn from incidents in radiotherapy. ESTRO, through the national societies and institutional membership, will do this by hosting and making available the Radiation Oncology Safety Education and Information System (ROSEIS) to departments who currently have no local reporting system or departments who want to revise their local system and share information with the wider ESTRO membership.

An international collaborative group, comprising expert representatives of national associations and professional societies, has been established within the ROSQ and will meet regularly to consider the wider aspects of safety and the impact on quality at an international level. The group also reflects the multidisciplinarity of radiotherapy and the growing international membership of ESTRO and its members are highly respected in the area of quality and safety. The members of the international liaison group are: Michael Milosevic (Radiation Oncologist, CPQR, Canada), Crystal Angers (Physicist, CPQR, Canada), Brian Liszewski (RTT, CPQR, Canada), John Kildea (Physicist, CPQR, Canada), Geoff Delaney (Radiation Oncologist, RANZCR, Australia), Dion Forstner (Radiation Oncologist, RANZCR, Australia) and Anthony Arnold (RTT, RANZCR, Australia).

Reflecting the growing interest in reporting and learning systems and to increase the learning potential this group will analyse data from a range of international systems and produce information sheets highlighting the most important issues identified. They will also consider risks associated with new technology and how this can be integrated into existing safety information systems. This sharing of knowledge and information is aimed to increase awareness of safety and to reduce the potential of repetition of incidents in different centres. This group will review existing guidelines on incident reporting and learning, together with systems from non-healthcare industries and draw up a consensus document for use both within the ESTRO community and reflecting the international face of ESTRO membership.

The range of projects identified for ROSQ will be further developed over 2017. Current projects include consideration of the role of near misses and, based on preliminary work in this area by the Canadian members of the international group, will expand and explore this issue. A second project on the difficulties associated with excessive ALERTS on treatment units and treatment planning systems will be carried out in conjunction with a group in The Netherlands who have conducted preliminary studies nationally and will expand the participating centres to include other European and international participants. A patient representative is a member of the ROSQ and will explore both the perception of patients about safety and quality in radiotherapy and consider ways to involve patients in its improvement as well as raising awareness of the high level of safety associated with treatment preparation and delivery. Future plans also include the development of educational material as part of an online or blended learning programme.

The establishment of the ROSQ provides a platform for ESTRO to liaise with professional groups, industry and the EU with respect to highlighting the quality and safety issues in radiotherapy and to reflect these issues in future recommendations, publications and directives.