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Blood Regulations (SOR/2013-178)

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Regulations are current to 2022-07-13 and last amended on 2015-04-23. Previous Versions

Quality Management (continued)

Error and Accident Investigation and Reporting (continued)

Investigation and Reporting

Marginal note:Requirement to cooperate

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

  •  (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

 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

 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

  •  (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

  •  (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

 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

 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

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

Marginal note:Donation code part of all records

 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

  •  (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.

    TABLE TO SECTION 119

    Records and Retention Periods

    ItemColumn 1Column 2
    RecordsRetention period
    1Donor identification code50 years
    2Donation code50 years
    3Reconciliation of donation codes10 years
    4Donor suitability assessment5 years
    5Determinations of donor unsuitability — indefinite50 years
    6Determinations of donor unsuitability — temporary10 years
    7Collection — date of donation50 years
    8Collection — donor apheresis5 years
    9Collection — record of donation5 years
    10Lot number and name of manufacturer of container and other critical supplies for each donation1 year
    11Test results for transmissible disease testing, ABO group and Rh factor, and clinically significant antibody testing50 years
    12Blood component preparation10 years
    13Blood storage temperature monitoring5 years
    14Destruction or other disposition of blood50 years
    15Distribution50 years
    16Shipping documents1 year
    17Exceptional distribution50 years
    18Importation in urgent circumstances50 years
    19Post-donation information10 years
    20Complaints and their investigation5 years
    21Internal audit reports5 years
    22Quality control testing5 years
    23Maintenance, validation, qualification and calibration of critical equipment3 years
    24Critical supplies, including their qualification3 years
    25Proficiency testing5 years
    26Every version of the operating procedures that was implemented, other than those related to donor suitability assessments10 years
    27Every version of the operating procedures related to donor suitability assessments50 years
    28Personnel qualifications, training and competency evaluation10 years
    29Investigations and reports of errors and accidents10 years
    30Investigations and reports of adverse reactions10 years

Marginal note:Retention periods — autologous blood

  •  (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.

    TABLE TO SECTION 120

    Records and Retention Periods

    ItemColumn 1Column 2
    RecordsRetention period
    1Donor identification code10 years
    2Donation code10 years
    3Collection — donor record5 years
    4Lot number and name of manufacturer of container and other critical supplies for each donation1 year
    5Test results for transmissible disease testing, ABO group and Rh factor10 years
    6Blood component preparation10 years
    7Blood storage temperature monitoring5 years
    8Destruction or other disposition of blood10 years
    9Distribution10 years
    10Shipping documents1 year
    11Complaints and their investigation5 years
    12Internal audit reports5 years
    13Quality control testing5 years
    14Maintenance, validation, qualification and calibration of critical equipment3 years
    15Critical supplies, including their qualification3 years
    16Proficiency testing5 years
    17Every version of the operating procedures that was implemented10 years
    18Personnel qualifications, training and competency evaluation10 years
    19Investigations and reports of errors and accidents10 years
    20Investigations and reports of adverse reactions10 years
 
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