Safety of Human Cells, Tissues and Organs for Transplantation Regulations
Version of section 32 from 2007-12-08 to 2015-02-10:
Marginal note:Organs
32 An establishment that distributes organs must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this section is provided on the interior label, in the package insert and on the exterior label.
TABLE TO SECTION 32
LABELLING REQUIREMENTS FOR ORGANS
| Column 1 | Column 2 | Column 3 | |||||
|---|---|---|---|---|---|---|---|
| DECEASED DONOR: From retrieval establishment to transplant establishment | LIVING DONOR: From retrieval establishment to transplant establishment | ||||||
| Item | Required information | Interior label | Package insert | Exterior label | Interior label | Package insert | Exterior label |
| Information about donor and organ | |||||||
| 1 | Name of organ, and whether left or right side, if applicable | X | X | X | X | X | |
| 2 | Description of organ | X | X | ||||
| 3 | Donor identification code, clearly labelled as such | X | X | X | X | ||
| 4 | All information in the donor assessment record that is not capable of identifying the donor | X | |||||
| 5 | ABO group and Rh factor of donor | X | X | X | X | ||
| 6 | The hazard symbol entitled “Biohazardous Infectious Material” set out in Schedule II to the Controlled Products Regulations, if applicable | X | X | X | X | ||
| Retrieval information | |||||||
| 7 | Date, time and time zone of asystole or aortic clamping, if applicable | X | |||||
| 8 | Date, time and time zone of retrieval | X | X | ||||
| 9 | Information specific to retrieval procedure | X | X | ||||
| 10 | Name of perfusion solution | X | X | ||||
| Processing information | |||||||
| 11 | Name of storage solution | X | X | ||||
| Information for transplant establishment | |||||||
| 12 | Statement that the organ has been declared safe for transplantation | X | |||||
| 13 | Statement “For Exceptional Distribution”, if applicable | X | X | X | X | ||
| 14 | If applicable, the reasons for exceptional distribution and a statement of how the organ does not meet the requirements of these Regulations | X | X | ||||
| 15 | Instructions on how to report errors, accidents and adverse reactions | X | X | ||||
| Establishment information | |||||||
| 16 | Name of retrieval establishment, its civic address and contact information | X | X | X | X | ||
| 17 | Name of source establishment, its civic address and contact information | X | X | X | X | ||
| 18 | Registration number of source establishment, clearly labelled as such | X | X | X | X | ||
| 19 | Name of transplant establishment, its civic address and contact information | X | X | ||||
| Storage information | |||||||
| 20 | Statement “Human organ for transplant” | X | X | ||||
| 21 | Handling instructions for storage and for storage during transportation | X | X | ||||
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