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

11 Consideration of the need for enforcement action

11.1 Blame attributable to the employer

This investigation has identified a number of areas for improvement in the means of implementation of the employer's duties under the Regulations, and these are the subject of the Recommendations in Section 9 of this report. Of particular concern among these is the quality and consistency of current arrangements for provision and recording of training and the linkage between training and entitlement of duty holders.

However, notwithstanding these concerns, no areas have been identified where the employer failed clearly to comply with the requirements of the Regulations. The general finding is, therefore, that the provisions that were in place for compliance with the employer's duties under the IR( ME) Regulations were robust and were being properly implemented and overseen.

11.2 Blame attributable to duty holders

In considering the degree of fault or blame attributable to any of the operators involved with this incident, it is important to draw a distinction between wrongdoing, negligence, and making a mistake.

In this regard, this investigation has identified a number of mistakes made by the operators concerned in both the manual and electronic calculations involved. Given the combined level of experience of these operators, it could reasonably be expected that the errors involved should have been identified prior to treatment, particularly in light of the alerts and indications that arose during the independent monitor unit calculation in RadCalc.

However, no instances have been identified where it could be said clearly that these mistakes were as a result of wrongdoing by those involved, such as failing to follow documented procedures, or knowingly carrying out tasks for which they were neither trained nor entitled by the employer. Equally, nothing has emerged to suggest that any of these operators were negligent in their approach to their duties.

The general finding is, therefore, that the operators concerned acted in accordance with the Regulations in carrying out duties for which they believed themselves to be appropriately trained and experienced, albeit that the findings of this investigation indicate that this was not the case.

11.3 Consideration of the need for an Improvement Notice

A previous investigation of the overexposure of Miss Lisa Norris at the Beatson Oncology Centre in Glasgow, reported in 2006, [3] identified a number of areas where the employer had failed to comply with the provisions of the IR( ME) Regulations. This resulted in the issue of an improvement notice to the employer under the provisions of Sections 21 and 22 of the Health and Safety at Work Act 1974.

For the incident under consideration here, no areas have been identified where the employer failed clearly to comply with the requirements of the Regulations. Nevertheless, serious consideration has again been given to the need for an Improvement Notice with regard to the provision and recording of operator training. However, given undertakings by the ECC that these deficiencies are already under review, such enforcement action has been deferred pending consideration of the outcome of this internal review and the response of the ECC to the recommendations of this report.

The need for an Improvement Notice regarding training or any other aspect of the Recommendations of this report will be reviewed by the Inspector three months after the date of publication of this report.