14Blood, stool and other samples—testing

14 Blood, stool and other samples—testing

General testing requirements (1) Samples taken in accordance with section 13, other than stool samples taken in accordance with subsection 13(6), must be tested as soon as practicable after collection in accordance with this section, and within the claimed sample stability timeframe specified by the manufacturer of the IVD medical device or in-house IVD medical device to be used for the testing. (2) Samples that are tested for infectious diseases must be tested using IVD medical devices or in-house IVD medical devices that: (a) use the most appropriate methodology available for testing the samples in relation to the target organisms; and (b) where testing is conducted in Australia—are either included in the Register or exempt from the requirement to be included in the Register, or the subject of an approval or authority under the Act; and (c) where testing is conducted outside Australia: (i) are approved by a relevant regulatory authority in the country in which the testing is conducted; and (ii) are used in a facility that has been approved for such testing by a relevant regulatory authority in the country in which the testing is conducted; and (iii) are considered acceptable by the Therapeutic Goods Administration. (3) Where testing is conducted by a laboratory that is not under the direct control of the manufacturer of the FMT products: (a) the testing must be conducted under a contract between the manufacturer and the laboratory; and (b) the contract mentioned in paragraph (a) must clearly set out the responsibilities of the manufacturer and the laboratory, and include arrangements to ensure information relating to matters in this section and any other relevant details relating to the IVD medical devices or in-house IVD medical devices used for such testing can be obtained from the laboratory. Blood sample testing (4) The following tests must be conducted in relation to blood samples taken in accordance with subsection 13(1) or paragraph 13(3)(a): (a) C-reactive protein (CRP), full blood count (FBC) and liver 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); and (d) nucleic acid amplification testing for HIV-1, HBV and HCV. (5) The following tests must be conducted in relation to the blood samples taken in accordance with subsection 13(3)(b): (a) C-reactive protein (CRP), full blood count (FBC) and liver 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 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.