Clinic incidents
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.
It is recognised that the healthcare setting as with other industries is an environment where accidents, errors and adverse incidents happen. In the most well organised and efficient centres mistakes occur.
We work closely with clinics to identify and report incidents so we can help them minimise the future risks.
In addition to the statutory requirements of the HF&E Act 1990 (as amended) we encourage centres to develop a safety culture.
The reporting of adverse incidents, the monitoring of frequency and investigations using robust policies and procedures will aid learning and reduce the likelihood of re-occurrence.
What is an adverse incident?
The Authority 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 or a licensed centre, including serious adverse events and serious adverse reactions.”
Grading the level of incident
When a centre reports an adverse incident we will grade the incident using our ‘grading matrix’.
HFEA incident grading matrix
The action taken depends on the grade of incident reported. Incidents are graded A, B or C according to the likelihood of a recurrence, and the severity of the potential outcome(s). Near misses are also recorded.
Grade A incidents
Grade A incidents are the most serious covering events such as embryo mix ups, the death of a patient or an incident which affects a number of patients, for example, when a storage unit malfunctions.
We will immediately contact the centre, following it reporting a Grade A incident, to obtain further information and agree what further action needs to be taken.
We will also carry out an incident inspection visit to find out why the incident occurred and what actions need to be taken to prevent a similar incident occurring in the future.
Following this inspection visit and after the centre has completed its own investigation we will produce a root cause analysis report.
This report together with the Person Responsible’s response to the report is presented to the Authority’s Licence Committee which decides what further, if any, regulatory action needs to be taken.
The report and the minutes of the Committee decision are published on this website.
Page last updated: 28 September 2011
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