11. Requirements in relation to donor physical assessment and testing
(1) All potential donors of human blood or blood components, human tissues or human cellular therapy products must be evaluated in accordance with this section before any such products are collected from that donor. Each potential donor of human blood or blood components, human tissues or human cellular therapy products must be assessed and tested for evidence of infectious diseases in accordance with the relevant and applicable donor groups.
(2) A physical assessment of the potential donor must be conducted by a trained assessor, and must take place:
(a) in the case of a living donor, at the time of collection, unless otherwise specified in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product;
(b) in the case of a deceased donor, prior to cell or tissue collection;
(c) in the case of a deceased donor whose cause of death is unknown, the cells and tissues must be deemed unacceptable, and the person must no longer be considered a potential donor, unless autopsy provides sufficient information to conclude that death has not been caused by a transmissible disease or any other condition that would be a contraindication to transplantation of the human tissues or human cellular therapy product from that donor.
(3) Blood samples from all potential donors of human blood, blood components, cells and tissues must be tested in accordance with the requirements set out in Table 3.
(a) in Table 3, a “” sign indicates that the test must be performed.
- For all donors except autologous donors, a test indicated in Table 3 with a “” sign must demonstrate that the samples tested are non-reactive.
- For autologous donors, a test indicated with a “” sign in Table 3must be performed and if the test demonstrates that the samples tested are reactive then subsection 11(6) applies.
(b) The HPC-C testing requirements set out in Table 3 apply only to the birth mother and do not apply to the respective donor infant.
(c) The requirements in the “deceased donors” column of Table 3 includes testing to be performed on blood samples of deceased donors for the donation of any tissue, other than cornea only donors.
(4) In addition to the requirements set out in subsection 10(3), blood samples from all potential donors must be tested in accordance with and must comply with the following requirements:
(a) all donor samples collected in accordance with subsection 10(2) or 10(3) must be tested by serology, and
(b) NAT testing for HIV, HCV and HBV must be performed on samples collected in accordance with subsection 10(2) or 10(3); or
(c) where products can be stored for more than 180 days without impairing the fitness of the product for use in a recipient, the donor must be repeat sampled after 180 days post collection and tested by serology for HIV, HCV and HBV, unless NAT testing was performed at the time of collection.
(d) To address the possible vertical transmission of infectious agents in infant donors of less than 18 months old, or up to 6 months beyond breast feeding, whichever is the greater time, the birth mother must also be screened and tested in accordance with Section 10 and paragraphs (a) to (c) above.
(5) The requirements to test for HBV by NAT in paragraph 11(4)(b) and (4)(c) do not apply when the donation is used exclusively for the purpose of plasma for fractionation.
(6) In cases where human blood or blood components, human tissue or human cellular therapy products are manufactured for autologous use from a donor with repeatedly reactive mandatory screening tests as set out in Table 3:
(a) segregation and quarantine must be applied to that human blood or blood component, human tissue or human cellular therapy product, and cross-contamination is to be avoided; and
(b) if requested, records must be made available to the Head of the Office of Scientific Evaluation of the TGA to demonstrate the rationale for the use of the product.