Adverse incidents at UK fertility clinics increase slightly

The latest data from the Human Fertilisation and Embryology Authority (HFEA) has shown that the number of adverse incidents in UK fertility clinics has increased slightly.

There were 517 adverse incidents reported to the HFEA in 2015, an increase from 465 in 2014 (see BioNews 820). Of these, 200 were classed as 'grade B', which include events such as the loss of embryos, breaches of confidentiality or equipment failure that has affected the quality of a patient's embryos.

There were no 'grade A' incidents reported in 2015, compared with two the year before. Grade A errors include events such as the death of a patient, being implanted with the wrong embryo, or something that affects a large number of patients such as a storage unit malfunction.

Sally Cheshire, chair of the HFEA, said that clinics should continue to do more to prevent errors from taking place: 'It's not only "grade A" incidents that can have an adverse effect on patients. All incidents, whether it's a letter sent to the wrong address, or a case of ovarian hyperstimulation, can have serious consequences for patients, and more has got to be done to make sure that fewer people are affected in the future.'

Of the reported incidents in 2015, administration errors accounted for 141 cases. Of these, the HFEA notes in its report that there has been a significant change in the number of times patient confidentiality has been breached, increasing from 59 out of 102 administrative errors in 2014 to 124 in 2015.

It says that mistakes such as emailing invoices to the wrong recipient were common and it has reminded clinics to avoid sending sensitive information by email, among other things.

The report also highlights how a number of failures by clinics to ensure the correct consent protocols are followed have caused 'significant distress' to patients. In 2009 the HFEA asked clinics to conduct an audit of their records, the results of which 'illustrated worryingly widespread instances of poor practice in this area,' the report states.

Eighteen consent errors were reported to the HFEA in 2015 (compared with 15 in 2014), and the High Court has been involved in over 23 cases so far involving anomalies in consent to legal parenthood (see BioNews 870).

The report highlights that it remains the clinics' responsibility 'to ensure patients understand legal parenthood and that consent is properly taken and recorded'. The most common mistakes revealed by the audit involved absent or incorrectly completed HFEA consent forms – which have also been the subject of some criticism at the High Court (see BioNews 865 and 819).

Since the cases came to light, the HFEA has said it has highlighted best practice for clinics and conducted a series of consent workshops. It says that there have been no new consent incidents since September 2015, indicating that clinics have improved their consent process.

However, while the HFEA also notes that incidents are more openly discussed and reported, it concludes that the fertility sector 'still has some way to go'. 'The purpose of open reporting is that lessons are learned by the clinic experiencing the incident and by other clinics which may suffer the same misfortune. We are not convinced this is always taking place,' the report concludes.

The HFEA points out that the figures must be read in light of an overall increase in the number of cycles performed annually, which now stands at over 70,000, and that the adverse incident rate remains less than one percent. There was also a slight increase in the number of severe ovarian hyperstimulation syndrome (OHSS) cases reported, and the overall number of incidents reported over the past five years remains broadly the same.