The UK's Human Fertilisation and Embryology Authority (HFEA) has established a new procedure for fertility clinics to report mistakes. The principal tasks of the authority are to license and monitor clinics that carry out IVF, donor insemination (DI) and human embryo research. It also regulates the storage of gametes and embryos. The new Incident Alert System - operating as a pilot scheme until September - requires clinics to report any adverse incidents that may harm patients 'without delay' to the HFEA. According to the authority, an adverse incident 'means anything relating to services which is potentially harmful or actually causes harm to any person, embryos, gametes or staff'.
The alert system has been introduced in the wake of incidents within fertility clinics across the UK in recent years involving either equipment failure (such as freezer malfunction, as happened at the Western General Hospital in Edinburgh in 2001, leading to the destruction of some sperm samples) or human error (such as the misreading of name labels on sperm samples which happened at Leeds General Infirmary in the twins mix-up case last year). The HFEA recognises that it would be impossible to eliminate all human error, but hopes the 'alert system will reduce the risk by enabling clinics to change the way they work' in the future. Each clinic will have a designated 'Person Responsible' to check equipment or procedures and take avoiding action to avoid repeating mistakes.
According to the HFEA, there is an average of about five incidents reported per month. Most of these relate to equipment failure or breaches of protocol which cause serious concern but no actual harm. If an incident occurs during the pilot scheme, an alert will be sent to all 110 licensed fertility centres in the UK, HFEA inspectors and some professional bodies, such as the British Fertility Society (BFS) and the Association of Clinical Embryologists (ACE). It is hoped that following feedback on the pilot alert scheme, a permanent system will be introduced.
Commenting on the scheme, Suzi Leather, chair of the HFEA, said the role of the authority is 'to protect patients' and that it is 'dedicated to sharing information with clinics, so that we can all learn and clinics can improve their work practices'.