All blood samples from living tissue donors must be acquired using positive donor identification by an individual trained to ensure the security of the sample and supporting documentation. Living tissue donors can be tested by either a single sample taken at the time of donation where testing includes a nucleic acid amplification technique (NAT) for, as a minimum, HIV, HBV and HCV, or by two samples including a post 180-day quarantine sample where additional NAT testing is not required. For guidance relating to living stem cell donors, please see Chapter 22.
Where only a single sample is tested the ‘donation sample’ must be obtained at the time of donation or, if not possible, within 7 days post-donation.
Where two samples are tested the post 180-day sample is required after an interval of at least 180 days from the date of donation. In these circumstances of repeat testing, the donation sample can be taken up to 30 days prior to and 7 days after donation. When the donation blood sample is taken prior to the date of tissue donation a system must be in place to ensure that the pre-quarantine sample reflects the risk status at the time of donation. Tissue must not be released from quarantine until the results from both the donation sample and the post 180-day sample have been reviewed and accepted in accordance with defined procedures.
For amnion donation only a maternal sample is required, i.e. a cord blood smaple is not required.