Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_12:p1
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 12 (pt 1/2)
Character Range: 9950–12673

12  Medical and social history

     Medical and social history of proposed donors
 (1) A complete medical and social history, covering the ineligibility criteria for donor selection specified in Schedule 1 and any other relevant matters, must be obtained from a proposed donor by interview, and reviewed for the purposes of screening.
 (2) The interview must be:
 (a) conducted by an interviewer who is appropriately qualified; and
 (b) undertaken not more than 30 days prior to the first collection of stool for use in the manufacture of FMT products; and
 (c) held face to face between the proposed donor and the interviewer, to the extent that it is possible in the circumstances; and
 (d) documented.

Medical and social history of accepted donors
 (3) The complete medical and social history must be repeated in relation to an accepted donor on an ongoing basis, such that each complete medical and social history is obtained within 90 days of the last complete medical and social history.
 (4) An abridged medical and social history must be obtained, reviewed and documented, each time stool is collected for use in the manufacture of FMT products from an accepted donor, covering any relevant matters determined on the basis of a risk assessment, including one or more of the ineligibility criteria for donor selection specified in Schedule 1.

Review of an accepted donor
 (5) Where the circumstances of an accepted donor change in relation to either the ineligibility criteria for donor selection specified in Schedule 1 or a disease or condition referred to in subsection (8), the relevant aspects of the medical and social history of the donor must be reviewed with respect to those changes before:
 (a) stool collected from the accepted donor is used in the manufacture of FMT products; and
 (b) FMT products that are manufactured using stool collected from the accepted donor are released for supply.

Screening requirements for allogeneic use
 (6) Where a proposed donor or accepted donor meets any of the ineligibility criteria for donor selection specified in column 2 of an item in the table in Schedule 1, the donor is subject to the period of ineligibility specified in column 3 of that item in relation to the collection of stool from that donor for use in the manufacture of FMT products intended for allogeneic use.

Screening requirements for autologous use
 (7) Where a proposed donor or accepted donor meets any of the ineligibility criteria for donor selection specified in column 2 of an item in the table in Schedule 1, a risk assessment must be conducted as to whether the donor should be subject to the period of ineligibility specified in column 3 of that item, in relation to the collection