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

Marginal note:Application

• 6 (1) An application for registration of an establishment must be made in the form established by the Minister, be dated and signed by the medical director or scientific director, and contain all of the following information:

  • (a) the establishment’s name and civic address, and its postal address if different, and the name and telephone number of a person to contact for further information with respect to the application;

  • (b) in the case of an establishment that previously carried out its activities under another name, that other name;

  • (c) a description of the types of cells, tissues and organs that the establishment processes, distributes or imports;

  • (d) a description of the types of processing, distribution or transplantation activities that the establishment carries out or for which it is responsible;

  • (e) the period during which the establishment has been in operation; and

  • (f) a statement dated and signed by the medical director or scientific director that certifies that the establishment is in compliance with these Regulations.

• Marginal note:Information on request

  (2) An establishment must provide the Minister, on written request, with any relevant information necessary to complete the application, by the date specified in the Minister’s request.

Marginal note:Registration number

• 7 (1) On review of an application for registration, if the Minister determines that the information provided in the application is complete, the Minister must register the establishment and issue a registration number.

• Marginal note:Validity

  (2) Subject to section 9, a registration is valid until December 31 in the year after the year in which the registration number is issued.

Marginal note:Refusal

8 The Minister may refuse to register an establishment if he or she has reason to believe that any of the information provided by the establishment in its application is false, misleading, inaccurate or incomplete.

Marginal note:When registration may be cancelled

9 The Minister may cancel a registration in the following circumstances:

• (a) the application for registration contains false or misleading information;

• (b) the Minister receives a notice under section 13 that states that the establishment has ceased an activity;

• (c) the establishment has not complied with a request for additional information made under section 14; or

• (d) the Minister has reason to believe that the establishment is not in compliance with these Regulations or that the safety of cells, tissues or organs has been or could be compromised.

Marginal note:Actions before cancellation

• 10 (1) The Minister must take all of the following actions before cancelling a registration:

  • (a) send a written notice to the establishment that sets out the reasons for the proposed cancellation and specifies the corrective action, if any, that the establishment must take and the time within which it must be taken; and

  • (b) give the establishment an opportunity to be heard in writing with respect to the cancellation.

• Marginal note:Notice of cancellation

  (2) If the establishment does not carry out the corrective action to the Minister’s satisfaction, or does not carry it out within the required time, the Minister must send a notice of cancellation of the registration that includes the reasons for the cancellation and the effective date.

Marginal note:Action by establishment when registration cancelled

11 On the cancellation of its registration, the establishment must immediately take both of the following steps:

• (a) cease carrying out the activities that were authorized by the registration; and

• (b) notify the establishments to whom it has distributed a cell, tissue or organ or made a donor referral, during the period specified in the notice, of the cancellation, the reasons for the cancellation and the effective date.

Marginal note:Cancellation in urgent circumstances

• 12 (1) Despite section 10, the Minister may cancel a registration immediately if he or she considers it necessary to do so in order to prevent injury to the health or safety of the public, by giving the establishment a notice of the cancellation in writing that states the reasons for the cancellation.

• Marginal note:Request to reconsider

  (2) An establishment may, in writing, request the Minister to reconsider the cancellation.

• Marginal note:Opportunity to be heard

  (3) The Minister must, within 45 days after receiving a request for reconsideration, provide the establishment with an opportunity to be heard in writing with respect to the cancellation.

Marginal note:Ongoing requirement to notify Minister

• 13 (1) Subject to subsection (2), an establishment must notify the Minister in writing of any change in the information provided in its application for registration, within 30 days after the change is made.

• Marginal note:Cessation of activity

  (2) If an establishment ceases to process, distribute or import cells, tissues or organs, it must notify the Minister in writing of that fact, within 90 days after it ceases that activity.

• Marginal note:Contents of notice

  (3) The notice must be dated and signed by the medical director or scientific director and include all of the following information:

  • (a) the establishment’s name and civic address, and its postal address if different;

  • (b) the establishment’s registration number;

  • (c) the date on which the change or cessation became effective; and

  • (d) in the case of the cessation of an activity, the disposition of the cells, tissues and organs in the establishment’s possession.

Marginal note:Additional information

14 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

15 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

16 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

17 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

18 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

19 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

20 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

21 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

• 22 (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

• 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