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

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.

Quarantine

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.

Storage

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 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.

Marginal note:Segregation — tissues

38 An establishment that stores tissues must ensure that those that are intended for autologous use are segregated from those intended for allogeneic use.

Marginal note:Segregation — transmissible disease agents and markers

39 An establishment that stores cells, tissues or organs must ensure that any of them that are untested or for which the results of tests on donor blood samples are positive or reactive for transmissible disease agents or markers or are unavailable are segregated from all other cells, tissues and organs.

Exceptional Distribution

Marginal note:Conditions

40 A source establishment may distribute cells, tissues or organs that have not been determined safe for transplantation if all of the following conditions are met:

• (a) a cell, tissue or organ that has been determined safe for transplantation is not immediately available;

• (b) the transplant physician or dentist, based on their clinical judgement, authorizes the exceptional distribution; and

• (c) the transplant establishment obtains the informed consent of the recipient.

Marginal note:Notice in source establishment’s records

• 41 (1) A source establishment that distributes cells, tissues or organs under section 40 must keep a copy of the notice of exceptional distribution in its records.

• Marginal note:Notice in transplant establishment’s records

  (2) The transplant establishment must keep a copy of the notice of exceptional distribution in its records.

• Marginal note:Contents of notice

  (3) A notice of exceptional distribution must contain all of the following information:

  • (a) the name of the transplanted cell, tissue or organ;

  • (b) the provisions of these Regulations with which the cell, tissue or organ is not in compliance at the time of its distribution;

  • (c) the justification for the distribution that formed the basis for the transplant physician’s or dentist’s decision to authorize it;

  • (d) the name of the source establishment that distributed the cell, tissue or organ;

  • (e) the name of the transplant establishment and of the transplant physician or dentist who authorized the distribution; and

  • (f) the time and date of the written authorization of the distribution and a copy of the authorization signed by the transplant physician or dentist.

Marginal note:Follow-up

42 A source establishment that distributes a cell, tissue or organ under section 40 before the donor suitability assessment is complete must, after the distribution, complete the assessment, carry out any other appropriate follow-up testing and notify the relevant transplant establishment of the results.

Error, Accident and Adverse Reaction Investigation and Reporting

Errors and Accidents

Marginal note:Required action

• 43 (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that the safety of a cell, tissue or organ that is or was in its possession has been compromised by the occurrence of an error or accident during processing must immediately take all of the following steps:

  • (a) determine the donor identification codes of all implicated cells, tissues and organs;

  • (b) identify and quarantine any other implicated cells, tissues and organs in its possession; and

  • (c) notify the following establishments:

    • (i) the relevant source establishment, and

    • (ii) if the cells, tissues or organs were imported, the establishment that imported them.

• Marginal note:Exception — importers

  (2) If the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment.

• Marginal note:Contents of notice

  (3) The notice must include all of the following information:

  • (a) the reasons for the establishment’s belief that the safety of cells, tissues or organs has been compromised;

  • (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

  • (c) the donor identification codes of all implicated cells, tissues and organs; and

  • (d) the name of any suspected transmissible disease or disease agent, if known.

• Marginal note:Written notice

  (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Action by source establishment

• 44 (1) A source establishment that has reasonable grounds to believe that the safety of cells, tissues or organs for whose processing it is responsible has been compromised by the occurrence of an error or accident during processing must immediately take all of the following actions:

  • (a) quarantine any implicated cells, tissues and organs in its possession;

  • (b) send a notice described in subsection (2) to all of the following establishments:

    • (i) if the cells, tissues or organs were imported, the establishment that imported them,

    • (ii) any source establishment from which it received the donor referral, if applicable,

    • (iii) any source establishment to which it made a donor referral, if applicable, and

    • (iv) any establishment to which it distributed implicated cells, tissues or organs; and

  • (c) initiate an investigation into the suspected error or accident.

• Marginal note:Contents of notice

  (2) The notice must include all of the following information:

  • (a) the reasons for its belief that the safety of the cells, tissues or organs has been compromised;

  • (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

  • (c) the donor identification codes of all implicated cells, tissues and organs;

  • (d) the name of any suspected transmissible disease or disease agent, if known; and

  • (e) a statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.

Marginal note:When no investigation necessary

45 If, on receipt of a notice under subsection 43(1), the source establishment does not have reasonable grounds to believe that an investigation is necessary, it must notify the establishment to that effect in writing and provide its reasons for the decision not to conduct an investigation.

Marginal note:Action on receipt of notice

46 An establishment that is not a source establishment and that receives a notice under section 44 or a copy of such a notice under this section must immediately take both of the following actions:

• (a) quarantine all implicated cells, tissues and organs in its possession; and

• (b) forward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.

Adverse Reactions

Marginal note:Required action

• 47 (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that an unexpected adverse reaction has occurred must immediately take all of the following steps:

  • (a) determine the donor identification codes of the transplanted cells, tissues or organs;

  • (b) identify and quarantine any other cells, tissues and organs in its possession that could potentially cause an adverse reaction in the same way as the transplanted cells, tissues or organs; and

  • (c) notify the following establishments:

    • (i) the relevant source establishment, and

    • (ii) if the cells, tissues or organs were imported, the establishment that imported them.

• Marginal note:Exception — importers

  (2) If the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment.

• Marginal note:Contents of notice

  (3) The notice must include all of the following information:

  • (a) a description of the adverse reaction;

  • (b) the donor identification codes of all implicated cells, tissues and organs; and

  • (c) the name of any suspected transmissible disease or disease agent, if known.

• Marginal note:Written notice

  (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Action by source establishment

• 48 (1) A source establishment that has reasonable grounds to believe that an unexpected adverse reaction has occurred that involves cells, tissues or organs for whose processing it is responsible must immediately take all of the following actions:

  • (a) quarantine any implicated cells, tissues and organs in its possession;

  • (b) send a notice described in subsection (2) to all of the following establishments:

    • (i) if the implicated cells, tissues or organs were imported, the establishment that imported them,

    • (ii) any source establishment from which it received the donor referral, if applicable,

    • (iii) any source establishment to which it made a donor referral, and

    • (iv) any establishment to which it distributed implicated cells, tissues or organs; and

  • (c) initiate an investigation into the adverse reaction.

• Marginal note:Contents of notice

  (2) The notice must include all of the following information:

  • (a) a description of the nature of the adverse reaction;

  • (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

  • (c) the donor identification codes of all implicated cells, tissues and organs;

  • (d) the name of any suspected transmissible disease or disease agent, if known; and

  • (e) a statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.