Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_15
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 15
Character Range: 25159–26263

15  Physical assessment
 (1) A physical assessment must be conducted in relation to a proposed donor not more than 30 days before the first collection of stool for use in the manufacture of FMT products.
 (2) Subsequent physical assessments must be conducted in relation to an accepted donor on an ongoing basis, such that each physical assessment is conducted within 90 days of the last physical assessment.
 (3) A physical assessment must:
 (a) include a clinical assessment of any physical features or characteristics that may indicate that a proposed donor or accepted donor is at risk of a communicable disease potentially transmissible by faecal microbiota transplant; and
 (b) be conducted by an appropriate health practitioner.
 (4) Where a physical assessment identifies an unacceptable risk of communicable disease transmission in relation to a proposed donor or accepted donor, the donor is ineligible to donate stool for use in the manufacture of FMT products until a subsequent physical assessment is conducted that does not identify the risk.

Division 3Requirements following collection