An archive blood sample should be kept for look-back investigations in the event of an adverse reaction. It is recommended that this should be for a minimum of 10 years from the date of donation.
Tissues can be held for a number of years prior to issue. During this period in storage there may be changes to the mandatory microbiology test requirements and improvements in screening assays for mandatory or other markers. Consideration should be given for an additional blood sample archive for tissues with a long expiry for possible future testing that is not currently available.
When new, or significantly improved, mandatory tests are introduced consideration should be given to the re-testing of archive samples from the donors of tissue still in issuable stock. Where there is no archive sample available to test, a risk assessment must be performed. It should include factors such as the seriousness of the infection, any viral inactivation procedures performed on the tissue, the effect on inventory of discarding such tissues and the severity of impact of possible tissue shortages on recipients.