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We updated our guidance on significant accidental or unintended exposures (SAUE) on 24 August 2020.
Employers must tell us about exposures judged to be ‘significant’ or ‘clinically significant’ accidental or unintended exposures. They should also tell us if radioactive substances are administered without the correct licence in place.
The Ionising Radiation (Medical Exposure) Regulations 2017 and the Ionising Radiation (Medical Exposure) Regulations (Northern Ireland) 2018) are designed to protect people while undergoing examinations and treatment using ionising radiation.
When there is an accidental or unintended exposure to ionising radiation, and the IR(ME)R employer knows or thinks that it is significant, they must investigate the incident and report it (under Regulation 8(4)).
This guidance tells you which incidents you need to report, and is jointly agreed by the English, Welsh, Scottish and Northern Ireland enforcement authorities.
Notifying IR(ME)R licensing breaches
IR(ME)R Regulation 5 requires employers and practitioners to hold a licence for the administration of radioactive substances.
Licences are required by:
- each employer: at each medical radiological installation where radioactive substances are to be administered to humans
- every practitioner: to justify the administration of radioactive substances to humans.
Licences are issued by the Administration of Radioactive Substances Advisory Committee (ARSAC) on behalf of the licensing authority. Each licence sets out the specific purposes for which the person is licensed. It is a breach of Regulation 5 if an administration takes place without the appropriate licence in place.
(Any valid ARSAC certificates after 6 February 2018 are only deemed equivalent to a licence when they meet the requirements set out in the ARSAC notes for guidance.)
You should notify the ARSAC Support Unit of any licensing breaches. We also encourage you to report these incidents to CQC.
Make an IR(ME)R notification
Use our report forms
To bookmark these forms for future use, bookmark this page and not the link for the form itself. This makes sure your report has a unique reference number.
What happens next?
After you submit the form we will send you an automated email with your IR(ME)R notification reference number. Use this reference number whenever you contact us. If you do not see the automated email, check your junk email folder.
If we need more details we may contact you. Otherwise, we will wait until you have submitted your full report before we review it.
When you have completed an investigation report, send it to us within the timeframe stated in the guidance. The report must be anonymised and must not include any patient identifiable information in line with GDPR.
How we process statutory notifications
- conduct initial risk triage
- review the full report
- progress the notification by email correspondence or a site visit
- signal closure of the notification by email
- categorise the incident for internal reporting
- publish headline findings in our annual report
- Last updated:
- 21 August 2020