Eighth Edition - R.3 - Human Fertilisation & Embryology Authority

Mandatory requirements (cont)
T53
The centre must ensure that the laboratory tests required by licence condition T52 meet the following
requirements, namely:
a. the test must be carried out by a qualified laboratory, which has suitable accreditation (for
example by CPA (UK) Ltd or another body accrediting to an equivalent standard), using
CE marked testing kits where appropriate. The type of test used must be validated for the
purpose in accordance with current scientific knowledge,
b. blood samples must be obtained at the time of donation, and
c. donor sperm must be quarantined for a minimum of 180 days, after which repeat testing is
required. If the blood donation sample is additionally tested by the nucleic acid amplication
technique (NAT) for HIV, HBV and HCV, testing of a repeat blood sample is not required.
Retesting is also not required if the processing includes an inactivation step that has been
validated for the viruses concerned.
T55
Potential donors that are known to have a gene, chromosome or mitochondrion abnormality involving a
significant risk that a person with the abnormality will have or develop:
a. a serious physical or mental disability,
Directions
b. a serious illness, or
c. any other serious medical condition,
must not be preferred to those that are not known to have such an abnormality.
0001 – Gametes and embryos
0005 – Collecting and recording information for the HFEA
Regulations
For a copy of the relevant Directions visit www.hfea.gov.uk
Human Fertilisation and Embryology Authority (Disclosure of Donor Information) Regulations 2004
HFEA Mandatory guidance requirements
Advertising
11.1 Advertising and publicity materials should be designed and written with regard to the sensitive issues
involved in recruiting donors.
See also guidance note:
13 – Payments for donors
Age of prospective donors
11.2 Unless there are exceptional reasons, sperm for the treatment of others should not be taken from donors
aged 46 or over. If there are exceptional reasons, the centre should record them in the patient records.
Human Fertilisation and Embryology Authority
Guidance note | 11. Donor recruitment, assessment and screening
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