Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_11:p2
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 11 (pt 2/3)
Character Range: 22469–25144

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.
Note: An infant donor of HPC(CB) only is not required to be tested in accordance with this section.

     Testing in relation to donors who have consumed breast milk
 (14) If a donor has consumed breast milk from a person (the relevant person) within the previous six months, then the relevant person must be subjected to the same testing requirements that are applicable to the donor, as set out in subsection (1) to (11).

     Assessment of testing results
 (15) An HCT product must be placed in quarantine, and must not be released for supply, until the results of the testing mentioned in subsections (1) to (14) are assessed.
 (16) If the testing of a blood sample demonstrates a reactive result, then the relevant HCT product must not be released for supply.
 (17) Subsection (16) does not apply to an HCT product that is manufactured for directed allogeneic use where the medical or dental practitioner who is responsible for the administration to, or application in the treatment of, the designated patient is notified about the testing results.

     Serum or plasma of blood samples
 (18) The serum or plasma of a blood sample taken from a donor of HCT materials in accordance with subsection (3), (4) or (6) must be:
 (a) archived at or below minus 25°C, or in accordance with conditions that are validated or