11Blood samples—taking and testing

11 Blood samples—taking and testing

(1) Blood samples must be: (a) taken from a donor of HCT materials; and (b) tested for the purpose of donor screening. (2) Blood samples must be taken using aseptic procedures. Blood samples—living donors of HCT materials other than materials used exclusively for plasma fractionation (3) Subject to subsections (4) and (5) blood samples of a living donor of HCT materials must: (a) be taken within 7 days before, or 7 days after, the collection of the HCT materials from the donor; and (b) undergo both NAT and serology testing in accordance subsection (7). (4) Where an HCT product is able to be stored for more than 180 days without compromising the quality, safety or efficacy of the product, blood samples of a living donor of the HCT materials used in the manufacture of the product may instead: (a) be taken: (i) within 7 days before, or 7 days after, the collection of the HCT materials from the donor; and (ii) at least 180 days after the collection of the HCT materials from the donor; and (b) undergo serology testing in accordance with subsections (8) and (10). Blood samples—living donors of HCT materials used exclusively for plasma fractionation (5) Blood samples of a living donor of HCT materials that are used exclusively for plasma fractionation must: (a) be taken within 7 days before, or 7 days after, the collection of the HCT materials from the donor; and (b) undergo both NAT and serology testing in accordance subsection (11). Blood samples—deceased donors of HCT materials (6) Blood samples of a deceased donor of HCT materials must: (a) be taken: (i) in accordance with subsection 9(4); or (ii) within 7 days before the collection of the HCT materials; and (b) undergo NAT and serology testing in accordance with subsection (7). Testing—living and deceased donors of HCT materials (7) Subject to subsection (9), the following testing must be conducted in relation to blood samples taken in accordance with paragraphs (3)(a) or (6)(a): (a) serology testing for HIV-1, HIV-2, HCV, HBsAg, HTLV-1, HTLV-2, and syphilis (Treponema pallidum); and (b) NAT for HIV-1, HIV-2, HBV, and HCV. (8) Subject to subsection (9), the following testing must be conducted in relation to blood samples taken in accordance with subparagraph (4)(a)(i): (a) serology testing for HIV-1, HIV-2, HCV, HBsAg, HTLV-1, HTLV-2, and syphilis (Treponema pallidum). (9) Serology testing for HTLV-1 and HTLV-2 is not required if a risk assessment, in relation to the type of the HCT materials and the geographical history of the donor, is undertaken, which demonstrates that: (a) the risk of transmission of HTLV-1 and HTLV-2 from the donor is mitigated in the absence of donor testing; and (b) the donor, the parents of the donor, and the sexual partners of the donor, originate from a low risk area; and (c) the HCT materials is not a viable leukocyte-rich cell or tissue. (10) The following testing must be conducted in relation to blood samples taken in accordance with subparagraph (4)(a)(ii): (a) serology testing for HIV-1, HIV-2, HCV, and HBsAg. Testing—living donors of HCT materials used exclusively for plasma fractionation (11) The following testing must be conducted in relation to blood samples taken in accordance with paragraph (5)(a): (a) serology testing for HIV-1, HIV-2, HCV, and HBsAg; and (b) NAT for HIV-1, HIV-2, HBV and HCV. Testing in relation to donors less than 18 months old (12) If a donor of HCT materials is less than 18 months old, then the donor’s birth mother must be subjected to the same testing requirements that are applicable to the donor, as set out in subsections (1) to (11). (13) In the case of a donor of the HCT materials that are HPC(CB) only, the applicable testing requirements in this section apply only in relation to the donor’s birth mother.