Human Fertilisation and Embryology Authority to publish incident reports
Reports and licence committee minutes relating to serious incidents in fertility clinics are to be published for the first time, the Human Fertilisation and Embryology Authority has announced.
[ClickPress, Tue Nov 10 2009] Speaking yesterday at the Authority’s annual conference, Chair of the HFEA Prof Lisa Jardine said:
“For some years now the HFEA has followed the practice of not publicising incident inspection reports. Nor have we published Licence Committee minutes relating to such reports.
“There was good reason for this approach. We wanted to build trust, to assure centres that our aim was to learn and to promote higher standards, not to punish human error.
“But we now have a solid foundation on which we can continue to build a culture of learning and improvement throughout the sector.
“From today, the inspection reports for all grade A incidents that are reported from now on, will be published on our website. So will the associated Licence Committee reports. This is part of our drive to ensure greater transparency in our work as a regulator. Since December last year, we have introduced a series of measures designed to make more of our work accessible on our website. This is the logical next step.”
Incidents are graded A, B or C according to the likelihood of a recurrence, and the severity of the potential outcome(s) by a multi-disciplinary team which usually includes the inspector for the clinic. Near misses are also recorded.
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.
Incident reports will not be published retrospectively.
Notes to editors
HFEA currently publishes all planned or unplanned inspection reports and licence committee minutes on its website except where they relate to incidents. In addition, it publishes papers and minutes of its Authority meetings and from its Ethics and Law, and Science and Clinical Advances, and Audit committees.
The new policy will apply to those incidents that occur on or after 1st October 2009. The incident reports and corresponding Licence Committee minutes will be published as and when they become available, following the usual investigation process and Licence Committee decisions.
In 2007-08, there were eight incidents graded A, the most serious. Of those, two involved mix ups where the wrong embryo or the wrong gametes had been used.
Out of nearly 52,000 cycles of treatment in 2007-08, there were a total of 182 incidents reported by clinics. Of those two involved mix ups.
The HFEA is the independent regulator for IVF treatment and embryo research. Our role is to protect patients and the public interest, to drive improvement in the treatment and research sectors and to provide information to the public and policymakers about treatment and research.
The HFEA was set up in August 1991 as part of the Human Fertilisation and Embryology Act 1990. The HFEA’s principal tasks are to license and monitor clinics that carry out in vitro fertilisation (IVF), artificial insemination (AI) and human embryo research. The HFEA also regulates the storage of gametes (eggs and sperm) and embryos.