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SAUE: Criteria for making a notification

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  • Organisations we regulate

The table shows the criteria for a significant accidental or unintended exposure (SAUE) that must be notified to the appropriate enforcing authority.

We use the ‘effective dose’ as the principal dose parameter, including for radiotherapy planning and verification imaging. However, where it is difficult to assess the effective dose or where alternative dose units are more relevant, the notification form allows you to add this information in the relevant section.

Interventional radiology and cardiology

Determining the extent of any ‘unintended’ dose across a range of examinations and treatments in interventional radiology and cardiology is complex.

Where there is a local diagnostic reference level (DRL), enforcing authorities have determined that a dose greater than or equal to 10 times the local DRL will help you to determine what incidents are notifiable. This applies even when there has been no procedural failure.

Where local DRLs are not available, you should compare the dose with the estimated intended exposure if it is quantifiable.

You may also consider submitting a notification if it will lead to wider learning. This is at the discretion of the employer.

We also include deterministic effects (excluding transient erythema) in the criteria for making notifications of interventional radiology and cardiology exposures. We will keep these criteria under review.

In England only, there are now age-related dose thresholds for notifications of accidental exposures.

Under-exposures

Regulation 8(4)(b) requires employers to make notifications of radiotherapeutic exposures that are significantly lower than intended. This includes molecular radiotherapy, brachytherapy and intraoperative therapy.

You do not need to make a notification of exposures lower than intended for non-radiotherapeutic modalities.

Complementary notification codes

As well as notification codes 1-8, the table includes complementary codes that help to identify specific types of incident:

Voluntary: incidents that do not necessarily meet the criteria for statutory notification but, because of other significant or unusual circumstances, may be submitted for wider learning.

Clinically significant: incidents involving ‘clinically significant’ exposure(s). The criteria for these are developed and published by professional bodies.

Multiple individuals (more than one): incidents where a theme has been identified over a number of incidents or where a single incident has involved multiple individuals.

Equipment: refers to incidents where equipment failures are the direct cause.

Where a notification specifies a complementary notification code as the basis for an incident, it must also be accompanied by a notification code 1-8, to indicate the most relevant exposure category for the incident.

Incidents that do not meet the notification criteria

You do not need to make a statutory notification for:

  • Repeat exposures involving no procedural, human, systematic or equipment errors. These are not included in the definition of SAUE. For example, where original images are undiagnostic and need a technical repeat or are not diagnostic due to contrast extravasation or movement.
  • Foetal exposures where there has been no procedural failure.

Incidents involving medical and non-medical ionising radiation that do not meet the dose threshold and notification criteria for SAUE still need to be investigated and analysed locally under Regulation 8(3). Employers must record the analyses of these events, which should consider any thematic reviews and trend analyses.

You should also consider coding all incidents to understand total numbers of similar incidents irrespective of whether they are notified or below the relevant notification threshold.

This is particularly important for incidents that were previously reported as MGTI under IR(ME)R 2000. Examples included referral errors, the wrong individual or wrong anatomy, timing errors, use of wrong radiopharmaceutical, and radiotherapy partial geographical misses.

The appropriate enforcing authority will review these analyses through regulatory monitoring activity and will collect data from employers periodically. This type of evidence, together with SAUE notifications and knowledge of local governance processes for managing radiation incidents, may be used to assess compliance with Regulation 8 more generally.

This guidance will be reviewed periodically and revised as necessary, based on analyses of notifications received by enforcing authorities. This is to ensure consistent notification practice among employers and to share wider learning of SAUE incidents.

Last updated:
03 June 2019

 


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