Unintended overexposure of a patient during radiotherapy treatment at the Edinburgh Cancer Centre, in September 2015

2. The format and scope of the investigation and report

This report records the findings of an incident investigation carried out by Dr Arthur Johnston, as the Inspector warranted by the Scottish Ministers, in accordance with the provisions of the IR( ME) Regulations, for the functions described in Sections 19, 20 and 21 of the Health and Safety at Work Act 1974. The investigation was supported by officials from the Scottish Government Health Directorates, and by Mrs Una Findlay of Public Health England, who provided independent expert advice throughout.

The scope of the investigation and of this report extends beyond consideration of compliance with the statutory provisions of the IR( ME) Regulations to more detailed assessment of the circumstances that caused this incident and of the measures that should be enacted to minimize the potential for adverse incidents at the ECC and at other radiotherapy centres in Scotland and elsewhere.

With regard to the provisions of the Data Protection Act 1998, the content of this report has been appropriately anonymized. ECC staff are referred to in terms of job titles. The particular titles used are, 'Radiographer', and 'Physicist'. In addition, to avoid gender identification, the pronouns ' his', ' he' and ' him' and ' himself' are used throughout and are italicised accordingly.

Regarding the possibility of legal action arising from this incident, the regulatory powers of the Inspector appointed by the enforcing authority (the Scottish Ministers) extend to issuing of Improvement Notices and Prohibitions Notices under the provisions of Sections 21 and 22 of the Health and Safety at Work Act 1974. Any consideration of additional legal proceedings in Scotland is a matter for the Crown Office and Procurator Fiscal Service and is not within the scope of this report.

This report makes numerous references to the 'Tumor LOC', 'Aria', and 'RadCalc' commercial software products. It is important to note that the errors described herein were not associated in any way with faults or deficiencies in any of these products.

For reasons of patient confidentiality, no discussion of the condition of the patient following treatment is included in this report. However, the ECC has provided assurance that the patient was properly informed of the incident and of the subsequent investigation, and that appropriate ongoing support and monitoring for potential consequences of the overexposure was provided.