Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_14:p3
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 14 (pt 3/3)
Character Range: 22878–25157

other samples in accordance with this section, other than testing of blood samples in accordance with paragraphs (4)(a) and (5)(a), has resulted in a reactive result, then the stool collected for use in the manufacture of FMT products must not be used in such manufacture or, if FMT products are manufactured from the stool, the products must not be released for supply, unless:
 (a) confirmatory testing of an initial reactive result in relation to such samples confirms that the result was a biological false reactive; or
 (b) further testing of samples indicates that the presence of the specified microorganism has cleared.
 (13) Where abnormal results are obtained from testing conducted in accordance with paragraphs (4)(a) or (5)(a), a medical practitioner must assess the potential impact on the quality, safety or efficacy of stool collected, or to be collected, for use in the manufacture of FMT products intended for allogeneic use.

Notification and record-keeping
 (14) Procedures must be implemented for notifying the proposed donor, the accepted donor, health practitioners, hospitals and other health facilities, about a test result that is indicative of a disease or carrier state at the time of the collection of the sample.
 (15) Records must be maintained in relation to the following:
 (a) the IVD medical device or in-house IVD medical device used for infectious disease testing;
 (b) any test modifications;
 (c) the results of analytical and clinical performance testing;
 (d) any evaluation of, and anomalies in, the test results.

Storage of blood and stool samples
 (16) Blood and stool samples collected from an accepted donor (including any serum or plasma) must be placed in long-term storage in accordance with the following conditions:
 (a) blood samples must be stored at or below minus 20°C; and
 (b) stool samples must be stored at or below minus 70°C; and
 (c) retained for a minimum of two years after the expiry date of the products.
 (17) Despite paragraphs 14(16)(a) and (b), other storage specifications may be used in relation to the samples, if those specifications are validated (including in relation to temperature) or recommended by the manufacturer of the IVD medical device or in-house IVD medical device used to test the samples.