Packaging and Labelling (continued)
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.
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 pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations, if applicable||X||X||X||X|
|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|
|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|
|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|
|20||Statement “Human organ for transplant”||X||X|
|21||Handling instructions for storage and for storage during transportation||X||X|
- SOR/2015-17, s. 18
Marginal note:Additional information required
33 A registered establishment that imports and distributes, or that only distributes, a cell or tissue must ensure that the following information is added to that required by sections 30 and 31:
(a) on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; and
(b) on the exterior label and in the package insert, the establishment’s registration number.
Marginal note:Quarantine — cells and tissues
34 (1) A source establishment must ensure that cells, except islet cells, and tissues are quarantined until all of the following processing activities are completed:
(a) the donor is found to be suitable after completion of the donor suitability assessment;
(b) except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; and
(c) all processing records are reviewed for completeness and compliance with the standard operating procedures.
Marginal note:Additional requirement — live donors of tissue
(2) In addition to the requirements set out in subsection (1), the source establishment must quarantine tissues that are retrieved from live donors in accordance with section 17.2 of the tissue standard.
Marginal note:Storage limits
35 An establishment that distributes cells, tissues or organs and that stores cells, tissues and adjunct vessels that were not used at the time of transplantation of the organ with which they were retrieved must observe scientifically based maximum storage periods.
Marginal note:Storage location
36 An establishment that distributes cells, tissues or organs must store them in a location that has appropriate environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons.
Marginal note:Storage during transportation
37 An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions and adequate packaging materials.
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