The Human Fertilisation and Embryology Authority is the UK’s independent regulator overseeing the use of gametes and embryos in fertility treatment and research. The HFEA has released its report on adverse incidents that took place in fertility clinics over the 2013 calendar year.
The HFEA report shows that a total of 516 incidents were reported, which is equivalent to less than one percent of the approximately 60,000 cycles of treatment that take place annually. Overall numbers of incidents have remained steady.
There were four ‘A grade’ incidents; 208 ‘B grade’ incidents; 262 ‘C grade’ incidents and 42 cases that were either later classified as near misses or not incidents. This means that ‘C grade’ incidents, the least severe category, represent the majority of all reported cases .
While recognising that the whole IVF sector should continue to report and learn from all incidents so that they can provide better, safer patient care, HFEA Chair, Sally Cheshire, has reiterated her specific call for clinics to reduce the number of ‘C grade’ incidents.
“We remain committed to a reporting system that highlights what can go wrong and, most importantly, how clinics can improve care and safety for patients. After the last report, we told clinics that more must be done in particular to reduce the numbers of avoidable grade C incidents. While it is too early to see the full impact of that message, this 2013 report offers a great opportunity to firmly re-state that clinics must make a concerted effort to eradicate ‘C grade’ incidents.
Sending a letter to the wrong address, for example, may seem a small mistake at first glance, but the effect on the patient can be considerable. Clinics must ensure that their administrative and process errors become increasingly rare occurrences.”
‘A grade’ incidents are classified as the most severe. Four were reported in 2013:
- A storage tank failed, which affected donor sperm samples belonging to 250 patients.
- An equipment failure meant that embryos for seven patients did not progress as expected and therefore were not suitable for embryo transfer.
- An affected embryo was replaced in error during a Pre-Implantation Genetic Diagnosis (PGD) .
- A baby was born with a condition following the transfer of a frozen PGD embryo.
- ‘B grade’ incidents are the middle category. Most clinical ‘B grade’ incidents relate to incidences of severe or critical OHSS, while non-clinical ‘B grade’ incidents include issues around consent and breach of confidentiality.
Director of Compliance and Information, Nick Jones, urged people to see this as an opportunity to share lessons learned, rather than for naming and shaming:
“While the report honours our commitment to transparency, and making the best use of our world-leading data, it is not intended to be used for the naming and shaming of particular clinics. UK clinic staff are highly professional, and are often almost as devastated as the patient when a mistake occurs.
The best means of reducing mistakes is to create a culture of shared best practice and improvement. Clinics must do better, and this report can help them do so.”
The HFEA expects clinics to use this report in conjunction with the earlier 2010-2012 report, and to reflect upon their own practices. The HFEA will be sending a copy of this report to each licensed clinic.