Introduction
A web-based European incident reporting system was developed on the basis of a comparative analysis of national systems. To this end the EQART-ROSIS Network was created which received support from the EQUAL and REACT networks as well as from the EQART Institute. It worked intensively and after 3 meetings taking place in Copenhagen, Leuven and Brussels respectively started a pilot phase. This system will allow safety officers in radiotherapy departments to share their experience and pinpoint problem situations which may lead to errors in the treatment delivery. Small breaks in the quality chain and errors can compromise treatment outcome if allowed to go undetected. A coincidence of several errors can lead to incidents and even to radiation accidents where large groups of patients are exposed to lethal doses or to under-dosage which denies them the chance of cure.
The ROSIS site
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Project Abstract
Radiation Oncology Safety Information System (Rosis) - An ESTRO Project
Mr Ola. Holmberg
1, M. Coffey
2 1Physics Department, St. Luke's Hospital; Rathgar, Dublin,
2School of Therapeutic Radiology, Trinity College, Dublin, Ireland
Tel: +353 1 4065119 Fax: +353 1 4065377 Email:
ola@eircom.netA risk management project was proposed to ESTRO in early 2001 by M. Coffey and O. Holmberg, Dublin. The project aims to establish a common database for the exchange of information on radiotherapy incidents and corrective actions, both in relation to processes and to equipment. The system will emphasize "safety reporting" rather than "error reporting", and risk management strategies from areas outside radiotherapy are for this purpose integrated into the project-approach. It is envisioned that the database will enable knowledge to be shared and continuously updated as an aid to clinical centres, in a confidential way. There are several strands of this project ongoing simultaneously in order to lead up to the introduction of this multinational information pool of adverse events management.
1. The current status of national legislation in relation to incident reporting in radiotherapy within EU/EFTA member states has been investigated through a questionnaire directed to national radiation protection bodies and EFOMP affiliated professional physics organisations. In relation to this, the impact of EU Council Directive 97/43/EURATOM and its interpretation and how it has been transposed into national law has also been queried. The results have been revealing a wide variation in level of regulations for radiotherapy incident reporting within these countries, and also variations of interpretation within single countries.
2. Current clinical practice of incident reporting in radiotherapy is being investigated. In order to do this, radiotherapy clinics with a special interest in risk management, Clinical Partners, were invited from the ESTRO membership. There are currently 45 Clinical Partners from 14 European countries. Some of these project-partners have submitted their incident reporting documentation for analysis and some have submitted a retrospective account of radiotherapy -related incidents for the year 2001. This is in order to carry out a retrospective analysis of incidents for benchmarking of the reporting-systems and for hazard identification.
3. A pilot reporting scheme was undertaken in November 2002. Clinical Partners were invited to report incidents and corrective actions for a limited time-period on a pilot incident report form to a central register. Confidentiality is guaranteed. The pilot scheme has ensured that the reporting form was comprehensive and could be completed easily across a range of centres. Feedback was evaluated.
4. The approach to incident management used by complex non-medical high reliability organisations is translated into a radiotherapy context in parallel with the other strands above.
An outline of these activities within the ROSIS project was reported, together with some general concepts within risk analysis. Examples of hazard identification, frequency analysis and consequence analysis were communicated.