Past and present members of the Human Fertilisation and Embryology Authority (HFEA) have challenged the UK Government's plans to abolish it. They say it's led to improvements in access to information and choice for patients, and to better treatment and research through careful regulation and inspection. Recently, the HFEA's record of preventing errors has been given as another reason to retain its special role regulating fertility clinics. But what is the evidence that the HFEA has reduced errors in our fertility clinics?
To answer this question properly, we would need data on the numbers of errors made in fertility clinics over a given period. Ideally, we would look at the error rate before and after the HFEA's introduction. But this data is not available and, even if it were, it would not be comparable because what counts as an 'error' has changed in the intervening period.
Another question it isn't possible to answer is whether there's been a reduction in errors after the introduction of certain monitoring and reporting tools. For example, the incident alert system where clinics report errors from near misses up to serious incidents to the HFEA. Again, the way the HFEA classifies errors has changed in this period, and, in any case, the data is not publically available. A recent Freedom of Information request to HFEA for data on errors was refused on the grounds of excessive costs to produce it.
We could use the HFEA's role in establishing the incident alert scheme as evidence of how they prevent error in assisted conception. The scheme was introduced after a serious incident at Leeds which involved a 'mix up' of embryos and the subsequent birth of a mixed-race child to a white couple. The vast majority of assisted conception clinics have welcomed this scheme.
Another example of the HFEA's role preventing errors is the sharing of good practice and the development of lab protocols by clinic inspection and licensing. The HFEA have also been associated with the introduction of electronic tagging of embryos to prevent them being given to the wrong couple. They also improve professional practice by supporting conferences and events where safety matters are discussed.
On the other hand, the HFEA have been heavily criticised for not doing more to prevent error. For example, their role in the introduction of incident reporting and alerts is not as pioneering as it might first appear. In fact, it was prompted by a report into Leeds 'mix up' and other, more minor, incidents, which criticised the HFEA's inspection procedures and approaches to risk management.
The report author, Professor Brian Toft subsequently criticised the HFEA as 'not fit for purpose' following another series of incidents at a London hospital. This suggests that lack of communication between Hospital Trusts and the HFEA, as well as the failure to act on staff concerns, is a continuing problem.
Inspection procedures and incident reporting are also far from perfect. Staff have criticised inspections as largely paper exercises. They have also questioned the workings of the incident reporting structures and the heavy-handed approach to investigating some errors. More seriously, their experiences suggest the proliferation of protocols and other initiatives like double witnessing can be a double-edged sword - creating work and anxiety, which can undermine people's ability to do their job well and avoid errors.
Developments such as electronic witnessing are largely welcome, but it is not clear that the HFEA have been instrumental in these changes. And it remains difficult to get information from the HFEA about incidents and steps taken to prevent them. This type of analysis ought to be routine and transparent to ensure the error-reporting system is working well.
All this shows the jury is out on whether the HFEA have prevented errors and ought to be retained as a distinct entity to carry on this good work. Breaking up the HFEA's functions could make it more difficult to collect information and analyse data and to co-ordinate error prevention. However, a more joined-up approach to monitoring and preventing error could also be beneficial - fostering innovation and sharing of best practice.
Either way, systems of monitoring and reporting should not take practitioners' attention away from good patient care. Professionals need some form of oversight to improve their practice, but they also need to develop and apply their own 'error wisdom' in clinics and labs. This involves good team work, clear processes and communication and - above all - the dedication and agility of mind of individuals working in high-pressure environments. Whatever the shape of the regulator to come, it must take this as the starting point for error prevention.