12Medical and social history

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 of stool from that donor for use in the manufacture of FMT products intended for autologous use. Diseases or conditions not mentioned in Schedule 1 (8) Where a proposed donor or accepted donor has a disease or condition that may compromise the quality, safety or efficacy of FMT products manufactured using stool collected from the donor, and the disease or condition is not mentioned in the table in Schedule 1, then stool collected from that donor must not be used in the manufacture of FMT products, unless: (a) criteria for donor selection and periods of ineligibility are applied that support and justify the quality, safety and efficacy of the FMT products for the intended use of the products, and the application of the criteria is documented; or (b) a registered medical practitioner has agreed to, and documented the rationale for, the use of the stool in the manufacture of FMT products. Stool collected outside Australia (9) Where stool is proposed to be collected outside Australia, a risk assessment must be conducted as to whether any additional matters, including additional medical and social history criteria and periods of ineligibility, need to be considered and documented in addition to the ineligibility criteria specified in Schedule 1. Upper and lower age limits (10) Upper and lower age limits must be applied in relation to a proposed donor, having regard to the intended use of the FMT products and the extent to which the age of the proposed donor may compromise the quality, safety, or efficacy of FMT products that are manufactured using stool collected from that donor.