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| TGO108 | Sunsetting TGO 88 | Regulatory Requirement | Summary of change from current standard |
|---|---|---|---|
| Preliminary | |||
| General requirements | |||
| Medical and Social history | |||
| Blood sampling and testing | |||
| Physical assessment | |||
| Ineligibility criteria for donor selection - Schedule 1 in TGO108 | |||
| 4 | 5 | No change | Definitions - Redrafted to clarify intent |
| 5 | 6 | No change | No change |
| 6 (a) | Not in standard | No change | New - Clarification for standard does not apply to FMT products |
| 6 (b) | 7(2) | No change | No change |
| 6 (c) | Not in standard | Decrease | New - Autologous exemption |
| 9(1) | 8(1)(a) | No change | No change |
| 9(2) | Not in standard | No change | New - Clarification of intent of TGO |
| 9(3) | 8(1)(c) | No change | No change |
| 9(4) (a,b) | 10(3, 4) | No change | No change |
| 9(4) (c) | Not in standard | No change | Clarification of intent in TGO88 10(6) |
| 9(5) | 10(6) | No change | Redrafted to clarify intent |
| 9(6) | 10(7) | No change | Redrafted to clarify intent |
| 9(7-8) | 10(5) | No change | No change |
| 9(9) | 10(11) | No change | No change |
| 9(10) | 8(1)(b) | No change | No change |
| 10(1,2) | 9(1) | No change | No change |
| 10(3) | 9(2) | No change | No change |
| 10(4) | 9(6) & 9(11) | No change | No change |
| 10(5) | Not in standard | Decrease | New - Plasma fractionation in the manufacture of an export only medicine exemption |
| 10(6) | 9(7) | No change | No change |
| 10(7) | 9(8) | No change | No change |
| 10(8) | 9(3) | No change | Redrafted to clarify intent |
| 10(9) | 9(4) | No change | No change |
| 10(10-13) | 9(9) | No change | Redrafted to clarify intent |
| 10(14) | 9(b) | Increase | Exemptions for directed allogeneic HCT products |
| 11(1,2) | 10(1) | No change | No change |
| 11(3) | 10(2) & 11(3) & 11(4)(a) & 11(4)(b) | No change | No change |
| 11(4) | 10(2), 10(9)(a) & 11(3) & 11(4)(c) | No change | No change |
| 11(5) | 10(2) & 11(3) & 11(4) | No change | No change |
| 11(6) | 10(3) & 11(3) & 11(4) | Increase | Proposal not to exempt cornea only donors from NAT |
| 11(7) | 11(3) & 11(4) | Increase | Proposal not to exempt cornea only donors from NAT |
| 11(8) | 11(3) & 11(4) | No change | No change |
| 11(9) | Not in standard | Decrease | New - Alternative option for HTLV testing |
| 11(10) | 11(3) & 11(4)(c) | No change | No change |
| 11(11) | 11(3) | Increase | Mandate NAT HBV testing for plasma for fractionation donors |
| 11(12) | 11(4)(d) | No change | No change |
| 11(13) | 11(3)(b) | No change | No changea |
| 11(14) | 11(4)(d) | No change | No change |
| 11(15) | 10(8) | No change | No change |
| 11(16) | 11(3)(a)(i) | No change | No change |
| 11(17) | 7(b) | Increase | Exemptions for directed allogeneic HCT products |
| 11(18) | 10(9)(b) & 10(9)(c) | Decrease | Allowance for alternative archival timeframes subject to appropriate validation |
| 11(19) | 10(10) | No change | No change |
| 12(1)(a) | 11(2)(a) | Decrease | Plasma fractionation in the manufacture of an export only medicine exemption |
| 12(1)(b) | TGO83 7(3) | Decrease | Musculoskeletal - Allowance for conducting on the day or 30 days after collection for living donor |
| 12(1)(c) | 11(2)(b) | No change | No change |
| 12(2) | 11(2) | No change | No change |
| Item 1 | Table 1 (a) | No change | No change |
| Item 2 | Table 1 (a)(iii) | No change | No change |
| Item 3 | Table 1 (b) | No change | No change |
| Item 3 | Table 1 (b)(iii) | No change | No change |
| Item 5 | Table 1 (c) | No change | Redrafted to clarify intent |
| Item 6 | Table 1 (d) | Increase | Ineligibility criteria extended to persons injecting a substance for cosmetic use |
| Item 7 | Table 1 (e) | No change | No change |
| Item 8 | Table 1 (f) | No change | No change |
| Item 9 | Table 1 (g) | No change | No change |
| Item 10 | Table 1 (h) | Increase | Ineligibility criteria clarified to include 'other bodily fluids', 'earrings' and 'dry needling' |
| Item 11 | Table 1 (j) | No change | No change |
| Item 12 | Table 1 (k) | Decrease | Decrease in period of ineligibility for high risk sexual behaviour donors (conditions for 3month deferral period may be specified based on consultation) |
| Item 13 | Table 1 (l) | No change | No change |
| Item 14 | Table 1 (m) | Increase | Ineligibility criteria clarified to include 'active infections'. |
| Item 15 | Table 1 (s) | No change | No change |
| Item 16 | Table 1 (n) | Decrease | Malaria - Requirements re-articulated to clarify intent in TGO88. Alternatives to immunological test specified |
| Item 17 | Table 1 (ep) | Decrease | |
| Item 18 | Table 1 (o) | Decrease | |
| Item 19 | Table 1 (q) | No change | |
| Item 20 | Table 1 (r) | No change | No change |
| Item 21 | Table 1 (i) | No change | No change |
| Item 22 | Section 11(2)(c) | No change | Included in table for social and medical history ineligibility criteria from physical assessment. Term 'autopsy' replaced with 'post-mortem' |
| Item 23-26 | Table 2 | No change | No change |