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

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.