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

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.

Marginal note:Action on receipt of notice

49. An establishment that is not a source establishment and that receives a notice under section 48 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:Requirement to cooperate

50. An establishment must provide the source establishment that is conducting an investigation with any relevant information in its possession with respect to cells, tissues or organs that it distributed or transplanted.

Marginal note:Reports to Minister

• 51. (1) A source establishment that is conducting an investigation into either of the following subject-matters must provide the Minister with the reports described in subsection (2):

  • (a) a suspected error or accident that is identified after distribution of cells, tissues or organs that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent; and

  • (b) an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent.

• Marginal note:Contents and timing

  (2) The reports must include the following information and be provided at the following times:

  • (a) within 24 hours after the start of the investigation, a preliminary report that includes all relevant information that is available at that time; and

  • (b) within 15 days after the start of the investigation and every 15 days after that until the final report is made, an update on any new information about the suspected error or accident or serious adverse reaction, on the progress made in the investigation during those 15 days and on the steps taken to mitigate further risks.