Experiences of a proactive IR(ME)R inspection in radiotherapy

The Ionizing Radiation (Medical Exposure) Regulations 2000, IR(ME)R, apply to the safety of the patient referred for a medical exposure to ionizing radiation. In Scotland, the Scottish Executive (Department of Health) is responsible for carrying out inspections of compliance with these regulations. IR(ME)R specifically addresses issues concerned with Employer's duties, responsibilities of the Practitioner, Operator and Referrer, justification of individual medical exposures for diagnosis and treatment, optimization of all procedures, clinical audit and adequate training of all duty holders. A proactive IR(ME)R inspection of the Clinical Oncology Department, Raigmore Hospital, Inverness, was carried out in November 2001 by inspectors based at the Department of Health, London, and seconded by the Scottish Executive, Department of Health. The aim of the inspection was to assess the degree of compliance with the regulations. In this case study the experiences of a proactive inspection are described in detail and some of the important elements of implementing IR(ME)R in a department that operates an ISO 9000-2000 Quality Management System addressed. The identification of IR(ME)R Duty Holders' responsibilities is one important aspect which may be inadequately described by the existing Quality Management System documentation. Other key elements of the inspection include the methods of authorizing the justification, the importance of the treatment prescription sheets in the demonstration of compliance with IR(ME)R, patient identification and pregnancy questions and dose recording procedures. The integration of the standard operating procedures as described in Schedule 1 of the regulations is also important. Where the existing Quality Management System documentation is written to include the IR(ME)R require- ments of duty holder's responsibilities and the allocation of all the important tasks, then there is no need to re-badge these documents for IR(ME)R purposes. IR(ME)R encourages departments to focus on the safety of the patient and to document good practice. In order to comply, departments will have to show evidence of optimization of their procedures and must address the clinical governance issues associated with delivery of treatment.