17Microbial control procedures

17 Microbial control procedures

General requirements (1) Microbial control procedures that are validated must be implemented in the manufacture of FMT products and must: (a) include a strategy to minimise the proliferation of intrinsic microbial contamination and to prevent extrinsic microbial contamination of stool during the manufacture of FMT products; and (b) specify storage, handling and transportation requirements (including in relation to temperature and duration) for stool used in the manufacture of FMT products. Immediate processing of stool following collection (2) Stool used in the manufacture of FMT products, other than fresh FMT products, must: (a) be processed as soon as possible, and not later than 6 hours after defaecation; and (b) during any interval to the processing mentioned in paragraph (a) including transportation of the stool—be cooled to 4C or kept as otherwise validated by the manufacturer; and (c) following the processing mentioned in paragraph (a)—be stored in accordance with subsection (5). Processing and storage of stool used in the manufacture of fresh FMT products (3) Stool collected from an accepted donor for use in the manufacture of fresh FMT products must be processed not later than 6 hours after defaecation: (a) at ambient temperature (maximum 37°C); or (b) under specifications set and validated by the manufacturer. (4) Fresh FMT products must be administered to, or applied in the treatment of, a person: (a) on the same day the stool is collected; or (b) not later than 5 days after the stool is collected where the fresh FMT products are stored under conditions that will not impact the quality, safety or efficacy of those products. Storage and transportation of stool and FMT products (5) FMT products, other than fresh FMT products, and stool to be used in the manufacture of FMT products must be stored: (a) at or below minus 70°C in a suitable cryopreservation agent for not longer than 12 months; or (b) in accordance with justified time and temperature specifications. (6) FMT products must be appropriately sealed within a sterile container that: (a) prevents leakage of the FMT products from the container; and (b) ensures that any breach of integrity of the container is evident. (7) FMT products, other than fresh FMT products, must be transported in accordance with justified time and temperature specifications.

Schedule 1—Ineligibility criteria for donor selection

Note: See section 12.

<table cellspacing="0" cellpadding="0" style="width:418.2pt; margin-right:auto; margin-left:auto; border-collapse:collapse"><thead><tr><td colspan="3" style="width:407.5pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Ineligibility criteria for donor selection</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Column 3</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Medical and social history criteria</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="TableHeading"><span>Period of ineligibility</span></p></td></tr></thead><tbody><tr><td style="width:53.1pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:194.85pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>a person who is infected with:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HIV-1;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>HIV-2;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-1;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(d)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-2; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(e)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>syphilis</span></p></td><td style="width:138.15pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>a person who is infected with:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HAV;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>HBV; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HCV</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible until an uninfected state is established</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been a recipient of viable, non-human animal cells or tissues</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>4</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who is at risk of prion disease because the person has been, or potentially been, exposed to the putative causative agent of one of the family of pathogenic transmissible spongiform encephalopathies, including:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>genetic (familial) exposure;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>environmental exposure, including living in or visiting England, Scotland, Wales, Northern Ireland or the Isle of Man for a cumulative period of 6 months or more, at any time between 1 January 1980 and 31</span><span> </span><span>December 1996; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>iatrogenic exposure, including receiving a transfusion or injection of blood or blood components while in England, Scotland, Wales, Northern Ireland or the Isle of Man </span><span></span><span>at any time on or after 1 January 1980</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>5</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has received an injection of any substance in connection with a use that is not a therapeutic use or cosmetic use</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 5 years from the last injection</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>6</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has engaged in sexual activity that puts the person at an increased risk of acquiring infectious diseases that could be transmitted through stool</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 12 months from the last sexual contact</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>7</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been exposed to any of the following risks of acquiring a blood borne infection transmissible by stool:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>mucosal splash with blood or other bodily fluids;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>needle stick injury;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>tattoo;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(d)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>body piercing (including earring); or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(e)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>acupuncture or dry-needling, unless performed using sterile, single-use needles</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>where the person tests negative for HCV using nucleic acid amplification testing—ineligible for at least 4 months from exposure; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for at least 6 months from exposure</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>8</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been a recipient of human pituitary-derived hormone</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>9</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has an active infection, fever or infectious illness</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 2 weeks from the date of full recovery</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>10</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a history of functional gastrointestinal disorders</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>11</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a history of gastrointestinal malignancy</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>12</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a known genetic polyp condition</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>13</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a history of major gastrointestinal surgery</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>14</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person using antibiotics or immunosuppressive agents</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 90 days from ceasing use</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>15</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has symptoms of a gastrointestinal illness including abdominal pain, diarrhoea, fever, nausea, vomiting, and haematochezia</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 30 days since last showing symptoms</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>16</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has had contact with a household member who has symptoms of a gastrointestinal illness including abdominal pain, diarrhoea, fever, nausea, vomiting, haematochezia</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 30 days since contact</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>17</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a history of any autoimmune disease</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>18</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a metabolic syndrome or diabetes</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>permanently ineligible</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>19</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has a body mass index of, or greater than, 30</span><span> </span><span>kg per m</span><span style="font-size:6.67pt; vertical-align:super">2</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible until that person has a body mass index less than 30 kg per m</span><span style="font-size:6.67pt; vertical-align:super">2</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>20</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>has travelled to a country or place in Australia with a high endemic risk of travellers’ diarrhoea or multidrug-resistant organisms; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>has had exposure to similar epidemiological situations as described in paragraph (a)</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>ineligible for a period of time based on a risk assessment using the most up-to-date epidemiological data; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>where epidemiological data is not available—ineligible for at least 90 days from exposure</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>21</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who is at risk of being a carrier of multidrug-resistant organisms, including a person who:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>is or has been a healthcare worker with exposure to patients in hospitals or long-term care facilities;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>has recently been hospitalised or discharged from long-term care facilities;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>has regularly attended or regularly attends outpatient medical or surgical clinics;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(d)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>has recently engaged in medical tourism</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible until it has been demonstrated that the person is not a carrier of a multidrug-resistant organism</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>22</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been vaccinated with a live vaccine, where there is a risk of transmission of the vaccine strain</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for a period of time that is consistent with defined criteria for the vaccine</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>23</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>a person who has potentially been exposed to:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HCV;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>HIV-1;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(c)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HIV-2;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(d)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-1;</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(e)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-2; or</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(f)</span><span style="width:8.51pt; text-indent:0pt; display:inline-block"> </span><span>syphilis</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible until it has been demonstrated that the person is not infected</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>24</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has potentially been exposed to HBV</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible until it has been demonstrated that the person is:</span></p><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>immune from HBV infection; or</span></p><p style="margin-top:6pt; margin-left:18.5pt; text-indent:-18.5pt; line-height:normal; font-size:10pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>not infected with HBV, as confirmed by a nucleic acid amplification test</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>25</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been a recipient of allogeneic blood, blood components, human derived clotting factors, organs, cells or tissues that did not conform with TGO</span><span> </span><span>108</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext" style="margin-left:18.5pt; text-indent:-18.5pt"><span>(a)</span><span style="width:7.4pt; text-indent:0pt; display:inline-block"> </span><span>where the person tests negative for HCV using nucleic acid amplification testing—ineligible for at least 4 months from receiving the allogeneic blood, blood components, human derived clotting factors, organs, cells or tissues;</span></p><p style="margin-top:6pt; margin-left:18.5pt; text-indent:-18.5pt; line-height:normal; font-size:10pt"><span>(b)</span><span style="width:6.84pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for at least 6 months from receiving the allogeneic blood, blood components, human derived clotting factors, organs, cells or tissues</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>26</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has been imprisoned for a consecutive period of 72 hours or longer</span></p><p class="Tabletext"><span></span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for 12 months from the date of release from prison</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>27</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who works or has worked with animals, in an environment where transmission of zoonotic infections is likely</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 90 days following exposure to the work environment</span></p></td></tr><tr><td style="width:53.1pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>28</span></p></td><td style="width:194.85pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has had chronic therapy with proton pump inhibitors</span></p></td><td style="width:138.15pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for at least 6 months from ceasing therapy</span></p></td></tr></tbody></table>