More than 60,000 cycles of IVF treatment are carried out each year in the UK. The vast majority of those cycles are carried out without any problems occurring. However, as in any clinical setting, mistakes can happen and when they do, the person responsible or another member of staff are required to report it to us within certain timeframes.
From April 2018, when a clinic reports a case of severe or critical OHSS the clinical governance team at the HFEA will provide them with an OHSS proforma to complete.
Process for reporting a clinic incident
Clinic staff are required to complete an incident report form and email it to us within 12 working hours for a serious incident and 24 hours for all others (including near misses).
Download the Incident report form (DOCX 79KB)
What is an adverse incident?
We define an adverse incident as:
“An ‘adverse incident’ is 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 or a licensed centre. This includes serious adverse events, serious adverse reactions, breaches of confidentiality, anomalies or deficiencies in the obtaining or recording of consent, and ovarian hyperstimulation syndrome (OHSS) which has a severity grading of severe or critical.”
When a clinic reports an incident to us, we grade it as A (the most serious), B, C or as a ‘near miss’ using our incident grading matrix, which assesses the severity of incidents and the likelihood of their recurrence.
Please sign in to the portal to view more information about incident within the Performance and compliance part of the Portal under the Clinical Governance tab.
HFEA risk matrix
The HFEA risk matrix is used to access the severity of incidents and near misses and the likelihood of a recurrence.