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Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Regulations are current to 2020-03-05 and last amended on 2020-02-04. Previous Versions

Registration (continued)

Marginal note:Additional information

 An establishment must provide the Minister, on written request, with any additional relevant information to demonstrate that the activities it carries out are in compliance with these Regulations, by the date specified in the Minister’s request.

Source Establishment

Marginal note:Responsibility

 A source establishment is responsible for the processing of cells, tissues and organs, whether the processing is carried out by the source establishment itself or by another establishment, and for determining whether the cells, tissues and organs are safe for transplantation.

Processing

General

Marginal note:Documented evidence

 An establishment must have documented evidence that demonstrates that the activities, processes and technical procedures that it uses in processing cells, tissues and organs will consistently lead to the expected results.

Marginal note:When pooling permitted

 An establishment may only pool cells, tissues or organs from different donors during processing to create a therapeutic dose for a single recipient.

Donor Suitability Assessment

Marginal note:Requirements — cell, tissue and organ donors

 In assessing the suitability of a donor of cells, tissues or organs, except a donor of lymphohematopoietic cells, an establishment must perform all of the following steps:

  • (a) obtain the donor information and history in accordance with sections 12.2 and 12.3 of the general standard;

  • (b) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the general standard and in Annex E to that standard;

  • (c) perform a physical examination of the donor in accordance with section 13.2 of the general standard; and

  • (d) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the general standard.

Marginal note:Plasma dilution algorithm

 In assessing the suitability of a donor, an establishment must apply a plasma dilution algorithm if a donor pre-transfusion or pre-infusion blood sample is unavailable.

Marginal note:Additional exclusion criteria — tissue donors

 In assessing the suitability of a tissue donor, except an ocular tissue donor, an establishment must perform both of the following steps:

  • (a) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.2 of the tissue standard; and

  • (b) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the tissue standard.

Marginal note:Additional exclusion criteria — ocular tissue donors

 In assessing the suitability of an ocular tissue donor, an establishment must determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in sections 13.1.3 to 13.1.6 of the ocular standard.

Marginal note:Additional requirements — organ and islet cell donors

  •  (1) In assessing the suitability of an organ or islet cell donor, an establishment must perform all of the following steps:

    • (a) obtain the donor information and history in accordance with sections 12.2.2.3, 12.2.2.4, 12.2.3.4 and 12.2.3.7 of the organ standard;

    • (b) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.2.2 of the organ standard;

    • (c) perform the tests specified in sections 14.1.2 and 14.3.2 of the organ standard; and

    • (d) perform appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard.

  • Marginal note:Exception — imported organs

    (2) Despite subsection (1), in the case of an imported organ, the transplant establishment need only have the following:

    • (a) documentation of the donor suitability assessment according to the requirements of the jurisdiction where the assessment was performed;

    • (b) documentation that the tests specified in sections 14.1.2 and 14.3.2 of the organ standard have been performed;

    • (c) documentation that appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard have been performed; and

    • (d) in the case of those of the tests for the diseases or disease agents specified in section 14.2.6.3 of the organ standard that must be performed before transplantation and the blood group test for ABO, a copy of the test results.

Marginal note:Requirements — lymphohematopoietic cells

  •  (1) In assessing the suitability of a donor of lymphohematopoietic cells, an establishment must perform all of the following steps:

    • (a) obtain the donor information and history in accordance with sections 12.2.2.2 and 12.2.2.3 of the lymphohematopoietic standard;

    • (b) perform a physical examination of the donor in accordance with section 13.2 of the lymphohematopoietic standard;

    • (c) determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the lymphohematopoietic standard;

    • (d) perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard; and

    • (e) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard.

  • Marginal note:Exception — imported lymphohematopoietic cells

    (2) Despite subsection (1), in the case of imported lymphohematopoietic cells, the source establishment must

    • (a) have documentation of the donor suitability assessment;

    • (b) perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard;

    • (c) perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard; and

    • (d) determine that the donor is not unsuitable to donate on the basis of the exclusion criteria set out in section 13.1.3.4 of the lymphohematopoietic standard.

Retrieval

Marginal note:Retrieval interval — tissues

 An establishment that retrieves tissue from a deceased donor must carry out the retrieval within the scientifically based maximum interval between the cardiac asystole of the donor and the retrieval of the tissue.

Testing

Marginal note:Licensed diagnostic devices

  •  (1) Subject to subsection (2), in vitro diagnostic devices that are used by an establishment in the testing of donor blood for transmissible disease agents or markers under these Regulations must be licensed either

    • (a) in Canada, if the testing is performed in Canada; or

    • (b) in Canada or the United States, if the testing is performed outside Canada.

  • Marginal note:Exception — lymphohematopoietic cells

    (2) In the case of lymphohematopoietic cells that are imported into Canada for transplantation into a specific recipient, the in vitro diagnostic devices may be licensed in Canada or any other jurisdiction.

Marginal note:In vitro diagnostic devices — cells and tissues

  •  (1) In the case of cells and tissues, in vitro diagnostic devices that are used by an establishment in the testing of donor blood for transmissible disease agents or markers under these Regulations must be licensed for screening donors.

  • Marginal note:Exception — syphilis

    (2) Despite subsection (1), in vitro diagnostic devices that are used in the testing of donor blood for syphilis may be licensed either for diagnosis or screening donors.

Marginal note:Bacteriological testing — tissues

 An establishment that retrieves tissue, except ocular tissue, must perform bacteriological testing in accordance with section 14.3 of the tissue standard, except for section 14.3.2.8.

Packaging and Labelling

Packaging

Marginal note:Packaging materials

 An establishment that packages cells, tissues or organs must ensure that it uses appropriate packaging materials that are free from damage and capable of maintaining the integrity of the cells, tissues and organs.

Labelling

Marginal note:Language requirement

 All of the information that is required by these Regulations to appear on a label or package insert must be in either English or French.

 
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