Blood Regulations (SOR/2013-178)

Marginal note:Supplies

102 A licensed or registered establishment must ensure that the critical supplies that it uses are validated or qualified, as applicable, for their intended use and must store them under appropriate environmental conditions.

Error and Accident Investigation and Reporting

Errors and Accidents

Marginal note:Error or accident of another establishment

• 103 (1) An establishment that has reasonable grounds to believe that the safety of blood may have been compromised by the occurrence of an error or accident during an activity conducted by another establishment must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) notify all of the following establishments:

    • (i) the establishment that collected the implicated blood,

    • (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and

    • (iii) any establishment to which it distributed implicated blood.

• Marginal note:Contents of notice

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

  • (a) the donation codes of the implicated blood;

  • (b) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and

  • (c) the reason for the establishment’s belief that the safety of the blood may have been compromised.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subparagraph (1)(c)(iii) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

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

Marginal note:Establishment’s own error or accident

• 104 (1) An establishment that receives a notice under subparagraph 103(1)(c)(i) or (ii) or suspects that an error or accident that occurred during an activity it conducted may have compromised the safety of blood must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) determine whether there is sufficient evidence to warrant proceeding to an investigation into the suspected error or accident.

• Marginal note:When no investigation — notice

  (2) If the establishment determines that an investigation is not warranted, it must notify the establishment that sent it the notice under subparagraph 103(1)(c)(i) or (ii) that it will not be conducting an investigation and provide its reasons for that decision.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subsection (2) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood.

• Marginal note:Notice of investigation

  (4) If the establishment determines that an investigation is warranted, it must begin the investigation, notify every establishment and other person to which it distributed implicated blood, and include the following information in the notice:

  • (a) the donation codes of all implicated blood; and

  • (b) a description of the suspected error or accident and an explanation of how the safety of the implicated blood may have been compromised.

• Marginal note:Action on receipt of notice

  (5) An establishment that is notified under subsection (4) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

  (6) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Investigation and Reporting

Marginal note:Requirement to cooperate

• 105 (1) An establishment must, on request, provide any establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused.

• Marginal note:Communication

  (2) When more than one establishment is affected by an error or accident or the investigation of one, each establishment must ensure that every other establishment that is so affected is kept informed of all relevant information and of all developments and issues that arise during the investigation.

Marginal note:Investigation results

• 106 (1) An establishment that is conducting an investigation must notify in writing every establishment and other person to which it distributed implicated blood of the results of the investigation and of any action that is required to be taken.

• Marginal note:Notice to be forwarded

  (2) An establishment that is notified under subsection (1) or under this subsection must send a copy of the notice to every establishment to which it distributed implicated blood.

Marginal note:Reports to Minister

• 107 (1) An establishment that is conducting an investigation into a suspected error or accident that is thought to have occurred during an activity that it conducted and that is identified after the blood is distributed or transfused must file the reports described in subsection (2) with the Minister if there is a reasonable probability that the error or accident could lead to a serious adverse reaction.

• Marginal note:Contents and timing

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

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

  • (b) a written update on any new information about the suspected error or accident, on the progress made in the investigation since the last report and on the steps taken to mitigate further risks,

    • (i) within 15 days after the start of the investigation, and

    • (ii) on request of the Minister at any time after the preliminary report.

• Marginal note:Written notice

  (3) If the report under paragraph (2)(a) is given verbally, a written report must be filed as soon as possible afterwards.

• Marginal note:Final report to Minister

  (4) On completion of an investigation, the establishment must file a final report with the Minister that contains all of the following information:

  • (a) the results of the investigation;

  • (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and

  • (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.

Marginal note:Annual report

• 108 (1) An establishment must prepare an annual report that summarizes all of the error and accident investigations that it conducted in the previous 12 months, including a concise critical analysis of those investigations, and must file it with the Minister on request.

• Marginal note:When to notify Minister

  (2) If the analysis reveals a previously unidentified risk to the safety of blood, the establishment must notify the Minister immediately.

• Marginal note:Additional reports

  (3) An establishment must, on the Minister’s request, file additional reports described in subsection (1) in respect of the period specified in the request.

Adverse Reaction Investigation and Reporting

Adverse Donor Reactions

Marginal note:Notice to Minister

• 109 (1) An establishment that has reasonable grounds to believe that a donor has experienced a serious adverse reaction during a donation or within 72 hours after a donation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of the donor or within 15 days after it learns of the adverse reaction in any other case.

• Marginal note:Contents of notice

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

  • (a) a description of the adverse reaction;

  • (b) any actions that were taken to address it; and

  • (c) the outcome.

• Marginal note:Written notice

  (3) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Adverse Recipient Reactions

Marginal note:Required action

• 110 (1) Subject to section 111, an establishment that has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction must immediately take all of the following actions:

  • (a) determine the donation codes of all implicated blood;

  • (b) identify and quarantine any implicated blood in its possession;

  • (c) if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction and notify any establishment to which it distributed implicated blood; and

  • (d) if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity carried out by another establishment, notify all of the following establishments:

    • (i) the establishment that collected the implicated blood,

    • (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and

    • (iii) any establishment to which it distributed implicated blood.

• Marginal note:Contents of notice

  (2) The notice required by paragraphs (1)(c) and (d) must contain all of the following information:

  • (a) a description of the adverse reaction;

  • (b) an explanation of how the safety of the implicated blood may have been compromised, if known;

  • (c) the donation codes of all implicated blood;

  • (d) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and

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

• Marginal note:Quarantine

  (3) An establishment that is notified under subsection (1) or under this subsection must immediately notify to the same effect every establishment and other person to which it distributed implicated blood and quarantine any implicated blood in its possession.

• Marginal note:Investigation

  (4) An establishment that is notified under subparagraph (1)(d)(i) or (ii) must, if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction.

• Marginal note:Written notice

  (5) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Autologous donations

111 An establishment that both collects and transfuses the same autologous blood must, if it has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction, immediately quarantine any other blood from that donor in its possession and conduct an investigation into the adverse reaction and the implicated blood.

Investigation and Reporting of Adverse Recipient Reactions

Marginal note:Requirement to cooperate

112 An establishment must, on request, provide every establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused.

Marginal note:Notice to Minister

• 113 (1) An establishment that is conducting an investigation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of a recipient or within 15 days after it learns of any other unexpected adverse reaction or serious adverse reaction.

• Marginal note:Written notice

  (2) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.