Document ID: chunk:federal_register_of_legislation:F2022C00276:clause:1_10:p1
Version: federal_register_of_legislation:F2022C00276
Segment Type: clause
Provision Reference: sch 1 cl 10 (pt 1/3)
Character Range: 14292–16956

10  Medical and social history of donors

     Living donors
 (1) A medical and social history in relation to a living donor of HCT materials, covering the ineligibility criteria for donor selection specified in Schedule 1 and any other relevant matters, must be obtained by interview.
 (2) The interview must be:
 (a) conducted by an interviewer who is:
 (i) appropriately qualified and trained; and
 (ii) an employee of, or under a contract with, a person engaged in the collection of HCT materials or the manufacture of the HCT product; and
 (b) held face-to-face (to the extent that it is possible in the circumstances) with the donor or the donor's guardian or next of kin; and
 (c) conducted within 30 days before or 30 days after the collection of the HCT materials, and
 (d) documented.

     Deceased donors
 (3) A medical and social history in relation to a deceased donor of HCT materials, covering the ineligibility criteria for donor selection specified in Schedule 1 and any other relevant matters, must be obtained and documented within 7 days before or 7 days after the collection of the HCT materials, by:
 (a) both:
 (i) an interview with a person who is sufficiently informed about the donor's medical and social history; and
 (ii) an examination of relevant documentation in relation to the donor; or
 (b) where the interview mentioned in subparagraph (3)(a)(i) is not possible—an examination of the donor documentation to ensure there is sufficient evidence to determine the acceptability of the donor's medical and social history.
Example: A person who is sufficiently informed about a deceased donor's medical and social history may include the donor's treating physician, next of kin or closest available relative, a member of the donor's household, or a person with a relationship with the donor, such as a carer, friend or partner.

     Donors of HCT materials used exclusively for plasma fractionation
 (4) The periods of ineligibility specified in column 3 of items 2, 4, 13, 16 to 19, and 23 to 26 of the table in Schedule 1 do not apply in relation to a donor of HCT materials that are used exclusively for plasma fractionation in the manufacture of HCT products.
 (5) The periods of ineligibility specified in column 3 of items 1 to 7 and column 3 of items 9 to 26 of the table in Schedule 1 do not apply in relation to a donor of HCT materials that are used exclusively for plasma fractionation in the manufacture of an export only medicine.

     Donors of HCT materials that are human ocular tissue only
 (6) The periods of ineligibility specified in column 3 of items 16 to 19 of the table in Schedule 1 do not apply in relation