General considerations.
Circumstances that should have excluded donation may only become known after stem cells have been taken. For the purposes of these guidelines, these circumstances are categorised below, along with appropriate actions. The action to be taken will be determined by any A-Z entry relevant to the safety of the recipient. If there is no relevant entry, a consideration of recipient safety will underlie the action taken.
Procedures must be maintained by all Services to ensure prompt reporting of late donation information and, if necessary, withdrawal of donated stem cells. Concerns arising from hearsay reports should be addressed by procedures established to ascertain the credibility of any such concerns.
If donations have been used before a withdrawal could be initiated, the Designated Medical Officer must decide upon appropriate action. This will include, if there are likely to be severe consequences from having received the stem cell transplant, contacting the clinician caring for the recipient and discussing notification of the recipient.
1. Late notification of donation test results.
This may occur because:
a) The results of microbiological screening tests are brought into question.
b) Additional information becomes available, e.g. the results of further testing.
c) It is discovered that testing was not performed within the agreed procedures (e.g. as a result of audit or notification of defective reagents by the manufacturer).
d) A report is received from the recipient's medical attendants of a post-transplant infection thought to have been transmitted by the donation.
Action: Inform the Designated Medical Officer.
2. Notification of circumstances that should have triggered deferral at the time of donor selection.
a) Circumstances which place a donor at risk of infection with blood borne organisms (Tissues Safety Entry).
b) Donors in the 'at risk' categories relating to possible transmission of Prion Associated Diseases e.g. CJD and vCJD.
c) Donors with Malignancy (other than those for which there is a discretion in the A-Z)
d) Autoimmune Disease.
e) Allergy.
f) Donors with certain Infectious Diseases at the time of donation or who were in contact with and still within the incubation period of an Infectious Disease at the time of donation.
g) Donors with diseases of unknown aetiology.
Action: Inform the Designated Medical Officer.
This appendix was last updated in TDSG-BM Edition 203, Release 02