Clinic incidents

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 problem occurring. However, as in any clinical setting, mistakes can happen. When a mistake does happen, clinic staff must report adverse incidents to the HFEA within 12 hours for a serious incident and 24 hours for all others. This includes near misses.

Reporting adverse incidents is a statutory requirement but it is also 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.

Many incidents are caused by diligent, hardworking people trying to provide a high quality service for their patients. We do not focus upon who is at fault. Instead, we have worked hard to promote an open learning culture in which clinics are encouraged to report incidents. Our approach seeks to identify error-prone situations and settings and to implement systems that help to prevent staff from making errors, to catch errors before they cause harm, or to mitigate harm from errors before they impact on patients.

Adverse incidents in fertility clinics: lessons to learn

As part of our work to promote transparency and maximise opportunities for learning from incidents, we now publish an annual report.

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.”

How are incidents dealt with?

When a clinic reports an incident to us, we grade it as A (the most serious), B, C or as a ‘near miss’, taking into account the severity of the outcome, or potential outcome, and the likelihood of a reoccurrence. We use an incident grading matrix to guide this process.. The action taken depends on the grade of incident reported.

HFEA incident grading matrix

The HFEA incident grading matrix is used to assess the severity of incidents and the likelihood of their recurrence.

What is a grade A incident?

A grade incidents are the most serious. They happen infrequently and examples may include a patient being implanted with an embryo that is intended for someone else, the death of a patient or an incident which affects a number of patients, for example, when a storage unit malfunctions.

How are they dealt with?

When an A grade incident is reported, we immediately contact the centre 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 the action needed to minimise the risk of a similar incident reoccurring in the future. 

Following this inspection visit and after the centre has completed its own investigation, we produce a root cause analysis report.

This report together with the Person Responsible’s response to the report is presented to the HFEA’s Licence Committee which decides if any further regulatory action needs to be taken.

The report and the minutes of the Committee decision are published on this website on the relevant clinic’s page in the Choose a Fertility Clinic section. The exception to this practice is where the information is considered potentially patient identifying.

What is a B grade incident?

B grade incidents are serious adverse events or reactions such as the loss of embryos for one patient, breaches of confidentially where sensitive personal data or data relating to more than one patient is sent to the wrong recipient, or when a piece of equipment malfunctions affecting the quality of a patient’s embryos.

How are they dealt with?

We require clinics to investigate these incidents and provide us with their report within 10 working days. We may carry out an incident inspection visit to review events and actions proposed to prevent a similar incident occurring. We discuss the findings in the report with the clinic and then monitor how well their actions have been implemented. We may also follow up at our next inspection.

What is a C grade incident?

These are adverse events or reactions such as one of many eggs rendered unusable during processing (for example the moving of an egg between dishes). How are they dealt with?

The incident report is logged onto the incident database for the purpose of trend analysis. While the HFEA does not require clinics to submit their investigation reports, we do expect one to have been carried out. As with B grade incidents, C grade incident information is reviewed and informs the focus of inspections.

What is a near miss?

 A near miss is considered an unplanned event that did not result in injury, illness, or damage – but had the potential to do so. Only a fortunate break in the chain of events prevented an injury, fatality or damage; in other words, a miss that was nonetheless very near. The incorrect donor sperm being prepared for a patient and this error picked up prior to the insemination taking place could be considered as a ‘near miss’.

How are they dealt with?

The near miss report is logged onto the incident database for the purpose of trend analysis. While the HFEA does not require clinics to submit their investigation reports, we do expect one to have been carried out. 
 

Reported grade A incidents

The following reports on grade A incidents published by the HFEA have been grouped together on this page so that clinics can learn from each other and reflect on their own practice to avoid such incidents in the future.

*CARE Nottingham reported two incidents involving preimplantation genetic diagnosis within a short time frame so the Licence Committee minutes examine both incidents.

Page last updated: 21 September 2015

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