12Physical assessment

12 Physical assessment

(1) A physical assessment must be conducted in relation to a donor of HCT materials (other than a donor of HCT materials used exclusively for plasma fractionation in the manufacture of an export only medicine) as follows: (a) in the case of a living donor (other than a living donor of human musculoskeletal tissue only)—at the time of the collection of the HCT materials; or (b) in the case of a living donor of human musculoskeletal tissue only—within 30 days before or 30 days after the collection of the tissue; or (c) in the case of a deceased donor—before the collection of the HCT materials. (2) A physical assessment must: (a) include a clinical inspection of any physical features or characteristics of a donor (such as an abrasion, laceration, bruise, haematoma, fracture, tattoo, piercing, scar, skin lesion, or surgical incision) that may indicate that the donor poses a risk of infectious disease transmission; and (b) be conducted by a person who is: (i) appropriately qualified and trained; and (ii) an employee of, or under a contract with, a person engaged in the collection of HCT materials or the manufacture of HCT products; and (c) demonstrate that the donor does not pose a risk of infectious disease transmission.

Schedule 1—Ineligibility criteria for donor selection

Note 1: See section 10.

Note 2: The testing mentioned in column 3 of each item of this table (if any) must comply with the general requirements specified in subsections 9(4) to (10).

<table cellspacing="0" cellpadding="0" style="width:418.5pt; 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><td style="vertical-align:top"></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:194.9pt; 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:138.1pt; 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 3</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:138.1pt; 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>Period of ineligibility</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HCV;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>HIV-1; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HIV-2</span></p></td><td style="width:138.1pt; 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" style="margin-left:18.5pt; text-indent:-18.5pt"><span>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-1; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-2</span></p></td><td style="width:138.1pt; 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" style="margin-left:18.5pt; text-indent:-18.5pt"><span>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HCV;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>HIV-1; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HIV-2</span></p></td><td style="width:138.1pt; 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>ineligible until such time as the person is demonstrated not to be infected</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-1; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>HTLV-2</span></p></td><td style="width:138.1pt; 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>ineligible until such time as the person is demonstrated not to be infected</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 infected with, or has potentially been exposed to, HBV</span></p></td><td style="width:138.1pt; 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>ineligible until such time as the person is demonstrated to be:</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>immune from HBV infection; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>not infected with HBV, as confirmed by NAT</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>therapeutic use; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>cosmetic use where the injection is delivered as part of a procedure that is conducted under the professional supervision or direction of a medical or dental practitioner</span></p></td><td style="width:138.1pt; 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>ineligible for a period of at least 5 years from the last injection received by the person</span></p></td><td style="vertical-align:top"></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:194.9pt; 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, in connection with treatment for a disease, ailment, defect or injury, has been a recipient of viable animal cells or tissues</span></p><p class="Tabletext" style="margin-left:22.7pt; text-indent:-22.7pt"><span style="font-size:9pt">Note:</span><span style="width:2.7pt; text-indent:0pt; display:inline-block"> </span><span style="font-size:9pt">Viable animal cells or tissues are animal cells or tissues that are live and capable of functioning as intended to provide or support a therapeutic use.</span></p></td><td style="width:138.1pt; 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>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 has 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:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>genetic (familial) exposure;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; 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:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; 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 at any time on or after 1 January 1980</span></p></td><td style="width:138.1pt; 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>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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:138.1pt; 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>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 experienced any of the following events, which may give rise to a risk of acquiring a blood borne transmissible infection:</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>mucosal splash with blood;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>needle stick injury;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>tattooing;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(d)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>body piercing; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(e)</span><span style="width:5.7pt; 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:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where the person tests negative for HCV using NAT—ineligible for a period of at least 4 months from the event; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>where the blood samples of the person has undergone serology testing in accordance with subsection 11(4), and the donated tissue was placed in quarantine in accordance with subsection 11(15)—no ineligibility period applies; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for a period of at least 6 months from the event</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 this instrument</span></p></td><td style="width:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where the person tests negative for HCV using NAT—ineligible for a period of at least 4 months from the date the person received the allogeneic blood, blood components, human derived clotting factors, organs, cells or tissues;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for a period of at least 6 months from the date the person received the allogeneic blood, blood components, human derived clotting factors, organs, cells or tissues</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:53.1pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk96522271"></a><a id="_Hlk96523550"><span>12</span></a></p></td><td style="width:194.9pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who has engaged in any activity of a sexual nature that puts the person at an increased risk of acquiring infectious diseases </span><a id="_Hlk97279072"><span>that could be transmitted through blood, cells or tissues</span></a></p></td><td colspan="2" style="width:138.4pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for a period of at least 3 months from the date the person last engaged in the activity</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:194.9pt; 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></td><td style="width:138.1pt; 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>ineligible for a period of 12 months from the date of release of the person from prison</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 symptomatic infection, fever or infectious illness</span></p></td><td style="width:138.1pt; 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>ineligible for a period of at least 2 weeks from the date of full recovery of the person</span></p></td><td style="vertical-align:top"></td></tr><tr><td style="width:53.1pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><a id="_Hlk96523592"><span>15</span></a></p></td><td style="width:194.9pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>a person who resides in, or has travelled to:</span></p><p class="Tabletext" style="margin-left:16.05pt; text-indent:-16.05pt"><span>(a)</span><span style="width:4.95pt; text-indent:0pt; display:inline-block"> </span><span>a region within Australia; or</span></p><p class="Tabletext" style="margin-left:16.05pt; text-indent:-16.05pt"><span>(b)</span><span style="width:4.39pt; text-indent:0pt; display:inline-block"> </span><span>another country;</span></p><p class="Tabletext"><span>in which a particular epidemiological situation, such as an outbreak of a disease, existed at the time the person resided in, or travelled to, the region or country</span></p></td><td colspan="2" style="width:138.4pt; padding-right:5.35pt; padding-left:5.35pt; vertical-align:top"><p class="Tabletext"><span>ineligible for a period of time based on a risk assessment using the most up-to-date epidemiological data in relation to the particular epidemiological situation in that region or country</span></p><p class="Tabletext" style="margin-left:22.7pt; text-indent:-22.7pt"><span style="font-size:9pt">Note:</span><span style="width:2.7pt; text-indent:0pt; display:inline-block"> </span><span style="font-size:9pt">A risk assessment using the most up-to-date epidemiological data means an assessment of possible hazards associated with an </span><a id="_Hlk97279644"><span style="font-size:9pt">epidemiological situation </span></a><span style="font-size:9pt">such as a disease outbreak, using the most current information available about that situation.</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:194.9pt; 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 lived in a malaria endemic region for a continuous period of 6 months or more at any time</span></p></td><td style="width:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where HCT materials donated by the person are subject to:</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>terminal sterilisation that is validated to ensure a maximal sterility assurance level of 10</span><span style="font-size:6.67pt; vertical-align:super">-6</span><span>; or</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>≥ 25 kGy of gamma irradiation;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span style="width:16.8pt; text-indent:0pt; display:inline-block"></span><span>no ineligibility period applies; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test is performed at least 4</span><span> </span><span>months after the return of the person from the malaria endemic region (an </span><span style="font-weight:bold; font-style:italic">immunological test</span><span>)—ineligible until such time as the immunological test demonstrates a negative result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances, including where the immunological test demonstrates a positive result—permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 (other than a person mentioned in item</span><span> </span><span>16) who has visited a malaria endemic region</span></p></td><td style="width:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where HCT materials donated by the person are subject to:</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>terminal sterilisation that is validated to ensure a maximal sterility assurance level of 10</span><span style="font-size:6.67pt; vertical-align:super">-6</span><span>; or</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>≥ 25 kGy of gamma irradiation;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span style="width:16.8pt; text-indent:0pt; display:inline-block"></span><span>no ineligibility period applies; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test is performed at least 4 months after the return of the person from the malaria endemic region (an </span><span style="font-weight:bold; font-style:italic">immunological test</span><span>)—ineligible until such time as the immunological test demonstrates a negative result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test demonstrates a positive result—ineligible for a period of 3 years from the date of the test result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(d)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for a period of 12</span><span> </span><span>months commencing from the return of the person from the malaria endemic region</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 or has had malaria</span></p></td><td style="width:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where HCT materials donated by the person are subject to:</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>terminal sterilisation that is validated to ensure a maximal sterility assurance level of 10</span><span style="font-size:6.67pt; vertical-align:super">-6</span><span>; or</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>≥ 25 kGy of gamma irradiation;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span style="width:16.8pt; text-indent:0pt; display:inline-block"></span><span>no ineligibility period applies; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test is performed at least 4 months after the later of the cessation of treatment or the person’s last symptoms (an </span><span style="font-weight:bold; font-style:italic">immunological</span><span> </span><span style="font-weight:bold; font-style:italic">test</span><span>)—ineligible until such time as the immunological test demonstrates a negative result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test demonstrates a positive result—ineligible for a period of 3 years from the date of the test result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(d)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 or has had an undiagnosed febrile illness, with symptoms consistent with malaria during, or within 6 months of return from, a visit to a malaria endemic region</span></p></td><td style="width:138.1pt; 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" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(a)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where HCT materials donated by the person are subject to:</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(i)</span><span style="width:4.76pt; text-indent:0pt; display:inline-block"> </span><span>terminal sterilisation that is validated to ensure a maximal sterility assurance level of 10</span><span style="font-size:6.67pt; vertical-align:super">-6</span><span>; or</span></p><p class="Tabletext" style="margin-left:29.9pt; text-indent:-14.2pt"><span>(ii)</span><span style="width:1.98pt; text-indent:0pt; display:inline-block"> </span><span>≥ 25 kGy of gamma irradiation;</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span style="width:16.8pt; text-indent:0pt; display:inline-block"></span><span>no ineligibility period applies; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(b)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test is performed at least 4 months after the later of the cessation of treatment or the person’s last symptoms (an </span><span style="font-weight:bold; font-style:italic">immunological</span><span> </span><span style="font-weight:bold; font-style:italic">test</span><span>)—ineligible until such time as the immunological test demonstrates a negative result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(c)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>where an immunological test demonstrates a positive result—ineligible for a period of 3 years from the date of the test result; or</span></p><p class="Tabletext" style="margin-left:16.8pt; text-indent:-16.8pt"><span>(d)</span><span style="width:5.14pt; text-indent:0pt; display:inline-block"> </span><span>in all other circumstances—ineligible for a period of 3 years from the later of the cessation of treatment or the person’s last symptoms</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 with an active infection that would render HCT materials collected from that person unsuitable for use in the manufacture of HCT products</span></p></td><td style="width:138.1pt; 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>ineligible until such time as the person is demonstrated no longer to be infected</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 deceased person who, within 12 months prior to asystole, has been a recipient of allogeneic HCT materials or an allogeneic organ that did not conform with this instrument</span></p></td><td style="width:138.1pt; 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>permanently ineligible</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 deceased person whose cause of death is unknown</span></p></td><td style="width:138.1pt; 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>ineligible until such time as a post-mortem examination of the person provides sufficient information to conclude that the death of the person was not caused by a transmissible disease</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 that contains attenuated bacteria or viruses, other than a vaccine mentioned in item</span><span> </span><span>24</span></p></td><td style="width:138.1pt; 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>ineligible for 4 weeks</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 against smallpox</span></p></td><td style="width:138.1pt; 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>ineligible for 8 weeks</span></p></td><td style="vertical-align:top"></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:194.9pt; 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 that contains sera of animal origin</span></p></td><td style="width:138.1pt; 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>ineligible for 12 weeks</span></p></td><td style="vertical-align:top"></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>26</span></p></td><td style="width:194.9pt; 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 been vaccinated with an unknown vaccine</span></p></td><td style="width:138.1pt; 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>ineligible for 12 months</span></p></td><td style="vertical-align:top"></td></tr></tbody><tbody><tr style="height:0pt"><td style="width:63.8pt"></td><td style="width:205.6pt"></td><td style="width:148.8pt"></td><td style="width:0.3pt"></td></tr></tbody></table>