Blood Regulations (SOR/2013-178)

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.

Marginal note:Results of investigation

• 114 (1) The 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:Final report to Minister

115 On completion of the 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

116 At the end of each year, an establishment must prepare an annual report that summarizes all of the final reports that it filed in the year, including a concise critical analysis of the investigations that were the subjects of those reports, and must file it with the Minister on request.

Records

Marginal note:Record quality

117 Records kept by an establishment must be accurate, complete, legible, indelible and readily retrievable.

Marginal note:Donation code part of all records

118 An establishment must ensure that the donation code is a component of all of its records that relate to the processing, distribution, transformation and transfusion of blood.

Marginal note:Retention periods — allogeneic blood

• 119 (1) An establishment that collects allogeneic blood must keep the records set out in column 1 of the table to this section for the period set out in column 2.

• Marginal note:Calculation of record retention period

  (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 28 of the table, in which case the period begins on the last day on which the employee was last employed by the establishment.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	50 years
  2	Donation code	50 years
  3	Reconciliation of donation codes	10 years
  4	Donor suitability assessment	5 years
  5	Determinations of donor unsuitability — indefinite	50 years
  6	Determinations of donor unsuitability — temporary	10 years
  7	Collection — date of donation	50 years
  8	Collection — donor apheresis	5 years
  9	Collection — record of donation	5 years
  10	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  11	Test results for transmissible disease testing, ABO group and Rh factor, and clinically significant antibody testing	50 years
  12	Blood component preparation	10 years
  13	Blood storage temperature monitoring	5 years
  14	Destruction or other disposition of blood	50 years
  15	Distribution	50 years
  16	Shipping documents	1 year
  17	Exceptional distribution	50 years
  18	Importation in urgent circumstances	50 years
  19	Post-donation information	10 years
  20	Complaints and their investigation	5 years
  21	Internal audit reports	5 years
  22	Quality control testing	5 years
  23	Maintenance, validation, qualification and calibration of critical equipment	3 years
  24	Critical supplies, including their qualification	3 years
  25	Proficiency testing	5 years
  26	Every version of the operating procedures that was implemented, other than those related to donor suitability assessments	10 years
  27	Every version of the operating procedures related to donor suitability assessments	50 years
  28	Personnel qualifications, training and competency evaluation	10 years
  29	Investigations and reports of errors and accidents	10 years
  30	Investigations and reports of adverse reactions	10 years

Marginal note:Retention periods — autologous blood

• 120 (1) An establishment that collects autologous blood must keep the records set out in column 1 of the table to this section for the period set out in column 2.

• Marginal note:Calculation of record retention period

  (2) The record retention period begins on the day on which the record is created, except for the personnel records set out in item 18 of the table, in which case the period begins on the last day on which the employee was employed by the establishment.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	10 years
  2	Donation code	10 years
  3	Collection — donor record	5 years
  4	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  5	Test results for transmissible disease testing, ABO group and Rh factor	10 years
  6	Blood component preparation	10 years
  7	Blood storage temperature monitoring	5 years
  8	Destruction or other disposition of blood	10 years
  9	Distribution	10 years
  10	Shipping documents	1 year
  11	Complaints and their investigation	5 years
  12	Internal audit reports	5 years
  13	Quality control testing	5 years
  14	Maintenance, validation, qualification and calibration of critical equipment	3 years
  15	Critical supplies, including their qualification	3 years
  16	Proficiency testing	5 years
  17	Every version of the operating procedures that was implemented	10 years
  18	Personnel qualifications, training and competency evaluation	10 years
  19	Investigations and reports of errors and accidents	10 years
  20	Investigations and reports of adverse reactions	10 years