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Blood Regulations (SOR/2013-178)

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Regulations are current to 2020-01-08 and last amended on 2015-04-23. Previous Versions

Quality Management (continued)

Adverse Reaction Investigation and Reporting (continued)

Investigation and Reporting of Adverse Recipient Reactions (continued)

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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