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

Marginal note:Requirements — lymphohematopoietic cells

• 23 (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

24 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

• 25 (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

• 26 (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

27 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

28 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

29 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.

Marginal note:Cells, except islet cells

• 30 (1) An establishment that distributes cells, except islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.

  	Column 1	Column 2			Column 3			Column 4
  		From retrieval establishment to transplant establishment			From retrieval establishment to cell bank			From cell bank to any other establishment
  Item	Required information	Interior label	Package insert	Exterior label	Interior label	Package insert	Exterior label	Interior label	Package insert	Exterior label
  Information about donor and cell
  1	Name of cell	X	X		X	X		X	X
  2	Description of cell		X			X			X
  3	Donor identification code, clearly labelled as such	X	X					X	X
  4	Information capable of identifying the donor				X	X
  5	Donor assessment record					X
  6	ABO group and Rh factor of donor, if applicable	X	X		X	X		X	X
  7	The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations, if applicable	X		X	X		X	X		X
  Retrieval information
  8	Date, time and time zone of retrieval		X			X
  9	Information specific to retrieval procedure		X			X
  Processing information
  10	Name of anticoagulant and other additive, if applicable		X			X			X
  11	Statement “For Autologous Use Only”, if applicable	X	X		X	X		X	X
  Information for transplant establishment
  12	Statement that the cell has been declared safe for transplantation								X
  13	Statement “For Exceptional Distribution”, if applicable		X						X
  14	If applicable, the reasons for exceptional distribution and a statement of how the cell does not meet the requirements of these Regulations		X						X
  15	Instructions on how to report errors, accidents and adverse reactions								X
  16	Expiry date and time, if applicable							X	X
  Establishment information
  17	Name of retrieval establishment, its civic address and contact information		X	X		X	X
  18	Name of source establishment, its civic address and contact information		X	X		X	X		X	X
  19	Registration number of source establishment, clearly labelled as such		X	X					X	X
  20	Name of transplant establishment, if known, its civic address and contact information			X						X
  Storage information
  21	Statement “Human cells for transplant”			X			X			X
  22	Handling instructions for storage and for storage during transportation			X			X			X

• Marginal note:Pancreas and islet cells

  (2) An establishment that distributes a pancreas for islet cell transplantation, or islet cells, must ensure that all of the applicable information, as indicated by an “X”, set out in the table to this subsection is provided on the interior label, in the package insert and on the exterior label.

  	Column 1	Column 2			Column 3
  		PANCREAS: From retrieval establishment to source establishment			ISLET CELLS: From source establishment to any other establishment
  Item	Required information	Interior label	Package insert	Exterior label	Interior label	Package insert	Exterior label
  Information about donor and organ or islet cells
  1	Name of organ or cells, as applicable	X	X		X	X
  2	Description of organ or cells, as applicable		X			X
  3	Donor identification code, clearly labelled as such				X	X
  4	Information capable of identifying the donor	X	X
  5	Donor assessment record		X
  6	ABO group and Rh factor of donor, if applicable	X	X		X	X
  7	The pictogram entitled “Biohazardous infectious materials” set out in Schedule 3 to the Hazardous Products Regulations, if applicable	X		X	X		X
  Retrieval information
  8	Date, time and time zone of asystole or aortic clamping, if applicable		X
  9	Date, time and time zone of retrieval		X
  10	Information specific to retrieval procedure		X
  11	Name of perfusion solution		X
  Processing information
  12	Name of storage solution		X
  13	Name of additives, if applicable					X
  Information for establishments
  14	Statement that the cells have been declared safe for transplantation					X
  15	Statement “For Exceptional Distribution”, if applicable		X		X	X
  16	If applicable, the reasons for exceptional distribution and a statement of how the organ or cells do not meet the requirements of these Regulations		X			X
  17	Instructions on how to report errors, accidents and adverse reactions		X			X
  18	Expiry date and time, if applicable				X	X
  Establishment information
  19	Name of retrieval establishment, its civic address and contact information		X	X		X	X
  20	Name of source establishment, its civic address and contact information		X	X		X	X
  21	Registration number of source establishment, clearly labelled as such		X	X		X	X
  22	Name of other establishment, its civic address and contact information						X
  Storage information
  23	Statement “Human organ for transplant” or “Human cells for transplant”, as applicable			X			X
  24	Handling instructions for storage and for storage during transportation			X			X