Document ID: chunk:federal_register_of_legislation:F2021C01065:clause:1_14:p2
Version: federal_register_of_legislation:F2021C01065
Segment Type: clause
Provision Reference: sch 1 cl 14 (pt 2/3)
Character Range: 20092–23121

function tests (LFTs); and
 (b) serology testing for antibodies to HIV-1 / HIV-2, HBV, HCV, HTLV-1 / HTLV-2, Strongyloides stercoralis, and syphilis (Treponema pallidum); and
 (c) HAV testing (unless RNA testing is conducted on the stool samples).

Stool sample testing
 (6) Subject to subsections (7) and (8), stool samples must be tested for each of the following microorganisms:
 (a) Campylobacter spp.;
 (b) Cryptosporidium spp.;
 (c) Entamoeba histolytica;
 (d) Giardia;
 (e) Helicobacter pylori, where stool is proposed to be collected for use in the manufacture of FMT products delivered by the upper gastrointestinal route;
 (f) multidrug-resistant organisms (MDROs) including:
 (i) extended spectrum beta-lactamase (ESBL)-producing Enterobacterales;
 (ii) vancomycin-resistant enterococci (VRE);
 (iii) carbapenemase-producing Enterobacterales (CPE);
 (iv) methicillin-resistant Staphylococcus aureus;
 (g) norovirus;
 (h) rotavirus;
 (i) Salmonella spp.;
 (j) Shigella spp.;
 (k) toxigenic Clostridioides difficile;
 (l) any other microorganism of clinical significance that may affect the quality or safety of the stool collected for use in the manufacture of FMT products, determined on the basis of a risk assessment.
 (7) Stool samples taken in accordance with paragraph 13(2)(c) must be tested for the microorganisms mentioned in subsection (6) determined on the basis of a risk assessment, such that every microorganism is tested at least once every 90 days.

Other sample testing
 (8) The microorganisms mentioned in subsection (6) may be tested using a sample taken in accordance with subsection 13(5), where the test method is scientifically justified in the circumstances.

Additional testing requirements
 (9) Where stool is to be collected outside Australia, a risk assessment must be conducted and documented in relation to whether additional blood, stool or other samples may be needed to be tested to ensure the quality, safety and efficacy of the FMT products.
 (10) Where FMT products are intended to be administered to, or applied in the treatment of, patients with increased susceptibility to infection, further testing of blood, stool and other samples must be considered in order to ensure patient safety.

Assessment of results
 (11) Where FMT products are intended for autologous use, and the testing of blood, stool or other samples in accordance with this section has resulted in repeatedly reactive results:
 (a) the FMT products and stool collected for use in the manufacture of those products must be segregated and quarantined from any other stool or FMT products; and
 (b) the justification for the autologous use must be documented and maintained.
 (12) Where the FMT products are intended for allogeneic use, and the testing of blood, stool or 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