The Care Quality Commission checks whether hospitals, care homes and care services are meeting government standards. Visit our website at www.cqc.org.uk.
What to report
Exposures ‘much greater than intended’ (MGTI), occurring otherwise than as a result of equipment failure, must be reported to us.
Details of what constitutes an MGTI exposure can be found in guidance published on the Department of Health website. This guidance is currently subject to review.
If you are in doubt as to whether the exposure needs to be reported, we are happy to discuss it with you. You should also consult your medical physics expert.
Even where the exposure is below that constituting MGTI, we are prepared to receive a ‘voluntary’ notification if there may be wider learning useful to the community.
When to report an IRMER incident
You should tell us about an Ionising Radiation (Medical Exposure) Regulations (IRMER) incident as soon as practicable after your preliminary investigation has confirmed that the exposure was MGTI or you have decided that a voluntary notification is worthwhile.
We normally expect notifications should be made within two weeks of the exposure taking place. We are happy to receive notifications where you do not yet have every item of information we ask for. We will ask you to provide it during our subsequent investigation.
We often receive a preliminary call or email where the provider believes the incident is a serious one or merits urgent notification.
How to make an IRMER notification
Please make the notification using the online form which asks questions about the organisation, the person submitting the form and the nature of the error.
Since February 2012, a new version of the online form has been in use. The form sends a confirmation email containing a summary of the submitted form rather than a link to the old PDF document.
There are also a number of minor differences with the form. The IRMER numbering system in the new form is different so do not be alarmed if you receive a number significatly different to normal. If you have any queries on the new form, contact details are as below.
IRMER incident report form (opens in new window)
If you wish to save the link to your bookmarks, please use this page and not the link for the form itself as this can affect the IRMER reference number generated by the form.
If you intend to submit a redacted report please also include a brief description of the information in the description box on the final page of the online form.
Once you submit the form you will receive an automatically generated email acknowledgement including an IRMER notification reference number. Please use this number in all subsequent dialogue with us.
Please contact us if you do not receive this confirmation email.
If you have any difficulties, please contact the IRMER desk on 020 7448 9039 or via email at IRMER@cqc.org.uk.
What happens next?
Once you have made the notification we will progress it through to closure. We will normally contact the notifying individual by email within a few days of receiving the form.
If we have not contacted you within a week of making the notification, please get in touch with us to make sure we received it.
After receiving the notification, we will look for a description of what occurred and evidence of:
- internal governance.
- the incident being fed into risk management.
- the patient being informed or the reasons why not.
- senior management being informed.
- an internal investigation taking place.
In dialogue with the provider, we expect to hear how the organisation has learned from what went wrong together with details of remedial action taken with the aim of preventing similar incidents occurring in the future.
Although the lead role in progressing notifications is taken centrally by the IRMER team, our field assessor responsible for the organisation has access to the case and its progress and may become involved as appropriate.
We may also sometimes arrange a more informal visit to a medical exposure provider to discuss notifications in general or seek assurances on a particular matter arising from a notification.
In rare circumstances, we will receive a notification that we believe requires a detailed investigation on-site and the opportunity to discuss the incident face-to-face with relevant staff during a ‘reactive’ inspection.
How is the notification closed?
When this process is complete, we will formally close the notification. This is done by letter to the chief executive of the organisation with a copy sent by email to the individual who submitted the notification.
The letter makes mention that the notification has been closed on the assumption that any recommendations or remedial action have, or are being, followed through.
What if equipment malfunctions cause the exposure?
There may be situations where the patient over-exposure was solely the result of equipment malfunction. In these circumstances, the Health and Safety Executive (HSE) must be notified under the Ionising Radiation Regulations 1999.
You should ask your radiation protection advisor for advice or find out more from the HSE directly.
More information about the HSE’s work can be found on its website and you can make a notification to their ionising radiation team by email.
If there is a safety or performance issue involving the equipment, you should follow the adverse incident reporting process managed by the Medicines and Healthcare products Regulatory Agency (MHRA) in accordance with their guidelines.
Find out more about the MHRA on the Medicines and Healthcare products Regulatory Agency (MHRA) website.