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

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.