13Blood, stool and other samples—taking

13 Blood, stool and other samples—taking

Fresh FMT products (1) Where stool is to be collected from a person for use in the manufacture of fresh FMT products, blood samples must be taken: (a) from the person (as a proposed donor) not more than 30 days before the first collection of stool; and (b) from the person (as an accepted donor) at the time of the first collection of stool; and (c) from the person (as an accepted donor) on an ongoing basis, such that each blood sample is taken within 90 days of the last blood sample. (2) Where stool is to be collected from a person for use in the manufacture of fresh FMT products, stool samples must be taken: (a) from the person (as a proposed donor) not more than 30 days before the first collection of stool; and (b) from the person (as an accepted donor) at the time of the first collection of stool; and (c) from the person (as an accepted donor) at regular intervals determined on the basis of a risk assessment. FMT products other than fresh FMT products (3) Where stool is to be collected from a person for use in the manufacture of FMT products, other than fresh FMT products, blood samples must be taken in accordance with either of the following paragraphs: (a) blood samples must be taken: (i) from the person (as a proposed donor) not more than 30 days before the first collection of stool; and (ii) from the person (as an accepted donor) on the day that, or not more than 30 days after, the collection period ends; and (iii) from the person (as an accepted donor) on an ongoing basis, such that each blood sample is taken within 90 days of the last blood sample; or (b) blood samples must be taken: (i) from the person (as a proposed donor) not more than 30 days before the first collection of stool; and (ii) from the person (as an accepted donor) not less than 90 days after the blood samples were collected in accordance with subparagraph (i); and (iii) from the person (as an accepted donor) on an ongoing basis, such that each blood sample is taken within 90 days of the last blood sample. (4) Where stool is to be collected from a person for use in the manufacture of FMT products, other than fresh FMT products, stool samples must be taken: (a) from the person (as a proposed donor) not more than 30 days before the first collection of stool; and (b) from the person (as an accepted donor) on the day that, or not more than 30 days after, the collection period ends; and (c) from the person (as an accepted donor) on an ongoing basis, such that each stool sample is taken within 90 days of the last stool sample. Other samples (5) In addition to the samples required to be taken in accordance with this section, samples other than blood or stool samples may be taken from a proposed donor or an accepted donor where scientifically justified in the circumstances. Stool samples for storage (6) A stool sample must be taken from each stool that is collected for use in the manufacture of FMT products, and stored in accordance with subsections 14(16) and 14(17).