3. Incident reporting by the ECC
Regulation 4(5) of the IR( ME) Regulations requires that: ' Where the employer knows or has reason to believe that an incident has or may have occurred in which a person, while undergoing a medical exposure was, otherwise than as a result of a malfunction or defect in equipment, exposed to ionising radiation to an extent much greater than intended, he shall make an immediate preliminary investigation of the incident and, unless that investigation shows beyond a reasonable doubt that no such overexposure has occurred, he shall forthwith notify the appropriate authority and make or arrange for a detailed investigation of the circumstances of the exposure and an assessment of the dose received.'
The treatment error was identified initially on 29 th September 2015. The first, informal, notification to the 'appropriate authority' was an e-mail from the ECC's Head of Therapeutic Radiography to the Warranted Inspector dated 30 th September 2015, indicating that an error had been identified and was under investigation. This was followed by a second e-mail, again from the ECC's Head of Therapeutic Radiography, dated 1 st October 2015, to which was attached a formal notification from the ECC's Associate Medical Director dated 29 th September 2015, indicating that the error had first been identified that same day, and that 'A report providing details of the incident, and any actions taken by the department to prevent a recurrence, will be forwarded to the Inspector as soon as practicable.'
An e-mail response to a question from the Inspector on the clinical significance of the incident was received on 22 nd October 2015, (details not included here on the grounds of patient confidentiality), and a detailed incident report from the 'Radiotherapy Incident Group' ( RIG) dated 5 th November 2015 was received as an attachment to an e-mail from the ECC's Head of Therapeutic Radiography, also dated 5 th November 2015.
The 'Radiotherapy Incident Group' comprised the Head of Oncology Physics, the Head of Therapeutic Radiography and a Consultant Clinical Oncologist.
Initial investigations by the ECC confirmed that no other patients had been similarly affected.
In all senses, it is the view of the inspector that notification was both timely and comprehensive, and fully in accordance with the requirements of Regulation 4(5).