Any medical condition, or possible contraindication to donation, elicited at any point during donation, processing or storage, must be managed according to the A-Z section of these guidelines. Any donated stem cells, which, as a result, are unsuitable for clinical use, must be clearly labelled as unfit for use.
Any new health risks identified by this process should be notified to the Standing Advisory Committee on Tissues and Cellular Therapy Products, so they can be considered for incorporation into future revisions of these guidelines.
If late information is provided by the donor, or through any other source, that the donation is medically unfit, this must be recorded and reported to the Designated Medical Officer.
Donations must not be accepted from donors who exhibit health risks that are not listed in this guidance, without referral to, and acceptance by, the Designated Medical Officer.
This section was last updated in TDSG-BM Edition 203, Release 02.