Reducing the risk to patients, gametes and embryos
Errors occur across all industries. Within the healthcare sector it is essential that when an error occurs, or is prevented from happening (a ‘near miss’), that the incident is reported and lessons are learned.
Staff at HFEA licensed fertility clinics are required to report adverse incidents and near misses that happen at their clinic.
Reporting adverse incidents is recognised as one of the best ways of ensuring that errors and their causes are identified and the opportunity for them to happen again is reduced.
We work closely with clinics to identify and report incidents so we can help them minimise the future risks.
What is an adverse incident?
The HFE Act defines an adverse incident as “any event, circumstance, activity or action which has caused, or has been identified as potentially causing harm, loss or damage to patients, their embryos and/or gametes, or to staff at a licensed centre, including serious adverse events and serious adverse reactions.”
Should patients be concerned about adverse incidents?
IVF involves delicate procedures, handling microscopic materials, so it is impossible to eliminate all human error.
However, the number of serious incidents reported each year is extremely low. 182 incidents were reported to the HFEA out of 40,000 cycles of treatment in 2007/08.
We ask clinics to report less serious incidents so problems can be identified early on and changes can be made to reduce the risk of future, possibly more serious, errors.
How we prevent future errors
We work with centres to make sure the lessons are learned. In the vast majority of cases, centres are committed to taking remedial action themselves and our inspectors help them to do so. If necessary, a Licence Committee could be asked to consider licensing action with regards to a clinic.
Clinics must report serious incidents to the HFEA within 24 hours by telephone or Incident report. There is then a requirement for a thorough investigation by the centre and usually by the HFEA’s own inspection staff.
When a serious adverse incident, or a series of incidents occur that highlight a trend, or expose a lesson for the whole sector, the HFEA will issue an Alert to all centres.
The purpose of the HFEA's Alerts is to share with clinics:
- information on all adverse incidents or near misses
- what led to its occurrence
- the causes identified from investigation
- the actions that can be taken to minimise the chance of reoccurrence
All Alerts are anonymised to protect patient and clinic confidentiality.
It is the duty of the Person Responsible in each clinic to review every Alert as soon as it is issued and make sure their team is aware of its content.
Clinics are expected to discuss Alerts in team meetings to ensure good practice in all areas of patient and embryo care, this is monitored at inspections to ensure widespread awareness of the contents of the Alert.
Not all incidents will result in an Alert being issued. Similarly, not all Alerts will relate to adverse incidents, for example an Alert could be about a manufacturer’s fault in a piece of equipment commonly used in fertility clinics.
Read about how we inspect clinics:
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Page last updated: 05 January 2010