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

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.

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.