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06 June 2001

Dear Colleague,

Screening of Patients

In 1998 a working group made up of HFEA members and representatives of relevant professional organisations, including ACE, BAS and the BFS, met to discuss the issues surrounding the safe cryopreservation of human gametes and embryos.

In June of that year the HFEA published a consultation on this subject to elicit a wider range of views. Responses to this document were received from a number of bodies including, licensed centres, patient groups and professional bodies, including those with an interest in fertility.

Following this consultation the working group on safe cryopreservation was reconvened for further discussions, which resulted in a series of recommendations to the HFEA on all aspects of cryopreservation. Many of these recommendations have been incorporated into the fifth edition of the Code of Practice.

One of the working group's recommendations, endorsed by the Authority but not yet enshrined in the Code, stated that all patients placing gametes or embryos in storage should be screened. A further recommendation suggested that screened samples should be kept in a separate cryostore from unscreened samples.

Full screening and separate storage reduces the risk of cross contamination between stored samples. A comprehensive screening protocol may also reduce the need for hazardous sanitisation or secondary containment of samples since the risk of introducing a contaminated sample would be greatly reduced.

The HFEA therefore requests that all centres submit to their Inspector Co-ordinator, by the 30th August 2001, a timetable for the implementation of a policy for the routine screening of all patients for Hepatitis B, Hepatitis C and HIV, as outlined in the ACE Guidelines at section 9.4. It is suggested that presently such screening might simply involve immediate, first round screening and not a quarantine period. Such a screening policy will reduce the risk of cross contamination between samples.

Centres should also detail their plans for the separate cryostorage of screened and unscreened samples. This might involve, for example, a separate holding vessel to hold samples for the short period of time necessary to carry out screening; a storage vessels for clear samples; one for HIV positive samples; one for Hepatitis B infected samples; and one for Hepatitis C infected samples.

This screening policy should be in place as soon as possible and will be a requirement for all centres by 31st December 2004 unless exceptional circumstances for an extension of this period can be demonstrated. These circumstances should be detailed in a letter accompanying that centre's implementation timetable.

I look forward to receiving your centre's action plan, if you have any queries please get in touch with your HFEA inspector co-ordinator.

Yours sincerely, 

Ruth Deech
Chairman

Page last updated: 14 April 2009

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