10Medical and social history of donors

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.

Note: 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 to a donor of HCT materials that are human ocular tissue only. Change in circumstances of donor (7) Where the circumstances of a donor of HCT materials used in the manufacture of an HCT product change in relation to the ineligibility criteria for donor selection specified in Schedule 1, the relevant aspects of the medical and social history of the donor must be reviewed by the manufacturer of the HCT product with respect to those changes, before the HCT product is released for supply. Screening requirements (8) An HCT product must not be released for supply, unless the medical and social history of a donor is reviewed and evaluated in accordance with this section. (9) Where a donor meets any of the medical and social history criteria specified in column 2 of an item of the table in Schedule 1, the donor must be subjected to the period of ineligibility specified in column 3 of that item, in relation to the collection of HCT materials from that donor for use in the manufacture of HCT products. Screening in relation to donors less than 18 months old (10) If the donor is less than 18 months old, a medical and social history in relation to the donor’s birth mother, covering the ineligibility criteria for donor selection specified in column 2 of items 1 to 7, 11 to 13, 17 and 20 of the table in Schedule 1 must be obtained. (11) Where the donor’s birth mother meets the medical and social history criteria specified in column 2 of item 1 to 7, 11 to 13, 17 or 20 of the table in Schedule 1, then the donor must be subjected to the period of ineligibility specified in column 3 of that item, in relation to the collection of HCT materials from the donor. Screening in relation to donors who have consumed breast milk (12) If the donor has consumed breast milk from a person (the relevant person) within the previous six months, a medical and social history in relation to the relevant person, covering the ineligibility criteria for donor selection specified in column 2 of the items 1 to 7, 11 to 13, 17 and 20 of the table in Schedule 1 must be obtained. (13) Where the relevant person meets the medical and social history criteria specified in column 2 of item 1 to 7, 11 to 13, 17 or 20 of the table in Schedule 1, then the donor must be subjected to the period of ineligibility specified in column 3 of that item, in relation to the collection of HCT materials from the donor. HCT products that are manufactured for directed allogeneic use (14) Subsections (9), (11) and (13) do not apply in relation to HCT products that are 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 provided the complete medical and social history of the donor of the HCT materials, including (where applicable) the medical and social history of the donor’s birth mother or the relevant person.