HFEA statement on the systems currently in place to prevent use of the 'wrong' infertility treatment
11 September 2002
The HFEA is prevented, for legal reasons, from commenting on the alleged "IVF mix up" that has been widely reported. However, the HFEA can confirm that it is aware of the background and has investigated the matter. Patients and prospective patients can be assured that all clinics are required to have procedures in place that minimise the risk of such errors occurring.
All clinics that provide treatment involving the use of stored or donated eggs and sperm or embryos created outside the body are licensed by the Human Fertilisation & Embryology Authority. The Authority regularly inspects clinics to ensure they comply with its Code of Practice and the Human Fertilisation and Embryology Act.
Clinical and scientific inspectors check that clinics have procedures in place to double-check the identification of:
- the individuals undergoing treatment,
- the sperm and eggs at the time of insemination;
- the embryos and the patient at the time of embryo transfer.
This ´cross-identification´ should minimise the risk of the ´wrong´ sperm, eggs or embryos being used.
The HFEA Code of Practice provides guidance to clinics on how services should be provided. It contains a section on ´The Storage and Handling of Gametes and Embryos which includes directions that:
- Centres should ensure that the highest possible standards are maintained in the storage and handling of gametes and embryos. (10.1)
- The Person Responsible should allow access only to named individuals in the centre, for whom such access is essential to their work. No other person should have access to gametes and embryos. (10.3)
- The location of gametes and embryos in storage should be recorded in detail, in order to minimise the amount of handling required in retrieving them. Each occasion on which gametes or embryos are handled should be recorded. (10.4)
- There should be an effective monitoring system to ensure high standards of security wherever gametes and embryos are handled or stored. (10.5)
- The source of gametes and embryos should be accurately recorded and labelled in a manner that is not susceptible to unauthorised or undetectable alteration. (10.6)
- Records should enable authorised staff to trace what happens to an individual embryo, egg or sperm sample from the date of collection. (10.7)
The HFEA also refers centres to guidance from the Association of Clinical Embryologists (ACE) which includes:
- There should be written procedures relating to the secure labelling of material from individual patients which ensure the unique identification of a patient´s material and records at all stages of treatment. (3.5.3)
The HFEA has developed new Standard Operating Procedures for witnessing clinical and laboratory activities which are presently out to consultation with ACE.
Notes for editors
For further information please contact the HFEA press office.
Page last updated: 13 March 2009