Therapeutic Goods Order No. 88 - Standards for donor selection, testing, and minimising infectious disease transmission via therapeutic goods that are human blood and blood components, human tissues and human cellular therapy products
9. Requirements in relation to the medic9. Requirements in relation to the medical and social history of prospective donors
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9. Requirements in relation to the medical and social history of prospective donors
(1) In the case of a living donor, the blood, blood components, cells or tissues must only be collected from a living donor with whom an interview to obtain the donor’s medical and social history has been conducted and recorded in accordance with the following requirements:
(a) The interview must be conducted with the donor or guardian/next of kin by a trained interviewer and should be a face-to-face interview.
(b) The interview must be conducted no more than 30 days prior to or 30 days after collection of the blood, blood components, cells or tissues, and must occur prior to any release of the relevant product from quarantine, unless otherwise specified in another, current Therapeutic Goods Order made under section 10 of the Act that applies to the relevant product.
(2) In the case of a deceased donor, the medical and social history of the donor must be obtained and recorded no more than 7 days prior to, or following, collection, in the following manner:
(a) by interview with a knowledgeable historian and examination of the donor documentation to obtain and record the medical and social history of the donor; or
(b) if such an interview is not possible, the donor documentation must be examined for sufficient evidence to determine donor acceptability.
(3) Donor medical and social history criteria, as required to be obtained by each of subsection 9(1) and 9(2), must be reviewed and evaluated using the minimum donor medical and social history criteria set out in column 1 of Table 1 below.
(4) A donor of a blood, blood components, cells or tissues for allogeneic use who meets any of the criteria listed in column 1 of Table 1 is subject to the corresponding period of ineligibility prior to donation, as set out in column 2 of Table 1 below.
(5) For a donor of blood, blood components, cells or tissues for autologous use, the manufacturer and sponsor must determine which, if any, of the medical and social history criteria listed in column 1 of Table 1 will apply, based on a risk assessment considering the nature and intended use of the product.
(6) The testing and deferral period requirements of items (a) (iii), (b) (iii), (l), (n), (o), (p) and (q) of Table 1 are not required to be met when the donation is to be used exclusively for plasma for fractionation.
(7) The testing and deferral period requirements of items (n), (o), (p) and (q) of Table 1 are not required to be met when the donation is to be used exclusively for ocular tissue.
(8) When the criteria for donor medical and social history criteria change during the life of any human blood, blood component, tissue or human cellular therapy product that has been taken from the donor and that has been placed in storage, reassessment of the donor against the new medical and social history criteria should be undertaken prior to release of the product. The requirement for reassessment must be determined by the sponsor and manufacturer based on risk, and after consultation with the TGA.