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Blood Regulations (SOR/2013-178)

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Regulations are current to 2020-01-27 and last amended on 2015-04-23. Previous Versions

Quality Management (continued)

Records (continued)

Marginal note:Retention periods — transformation

  •  (1) An establishment that transforms 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 10 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 121

    Records and Retention Periods

    ItemColumn 1Column 2
    RecordsRetention period
    1Donation code10 years
    2Records of washing, pooling and irradiation of blood10 years
    3Lot number and name of manufacturer of critical supplies for each transformation1 year
    4Complaints and their investigation5 years
    5Internal audit reports5 years
    6Quality control testing5 years
    7Maintenance, validation, qualification and calibration of critical equipment3 years
    8Critical supplies, including their qualification3 years
    9Every version of the operating procedures that was implemented10 years
    10Personnel qualifications, training and competency evaluation10 years
    11Investigations and reports of errors and accidents10 years
    12Investigations and reports of adverse reactions10 years

Marginal note:Retention periods — transfusion

  •  (1) An establishment that transfuses 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 11 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 122

    Records and Retention Periods

    ItemColumn 1Column 2
    RecordsRetention period
    1Donation code — allogeneic blood50 years
    2Donation code — autologous blood10 years
    3Shipping documents1 year
    4Blood storage temperature monitoring5 years
    5Distribution50 years
    6Exceptional distribution50 years
    7Record of transfusion or disposition of allogeneic blood, including identification of recipient50 years
    8Record of transfusion or disposition of autologous blood10 years
    9Complaints and their investigation5 years
    10Every version of the operating procedures that was implemented10 years
    11Personnel qualifications, training and competency evaluation10 years
    12Investigations and reports of errors and accidents10 years
    13Investigations and reports of adverse reactions10 years

Marginal note:Storage of records

 An establishment must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.

Powers of Inspectors

Marginal note:Making visual recordings

 An inspector may, in the administration of these Regulations, take photographs and make recordings of any of the following:

  • (a) any article that is referred to in subsection 23(2) of the Act;

  • (b) any place where the inspector believes on reasonable grounds any article referred to in paragraph (a) is processed, transformed or stored; and

  • (c) anything that the inspector believes on reasonable grounds is used or is capable of being used in the conduct of an establishment’s activities.

Consequential Amendment

 [Amendment]

Transitional Provisions

Marginal note:Deemed authorization

 The information that is required by section 6 to be included in an application for an authorization and that was filed with and accepted by the Minister under sections C.01A.005 to C.01A.007 and C.01A.014 of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued by the Minister under section 7 of these Regulations.

Marginal note:Licence continued

 If an establishment files an application for a licence under section 18 — without regard to paragraphs (1)(j) and (k) — within three months after the day on which these Regulations come into force, any licence that was issued to the establishment under section C.01A.008 of the Food and Drug Regulations before that day is continued until a licence is either issued under section 20 or refused under section 21 of these Regulations.

Marginal note:Delayed registration

  •  (1) An establishment that, before the day on which these Regulations come into force, conducts any of the activities mentioned in section 30 may continue to do so without a registration if it files an application for registration under section 31 within three months after that day.

  • Marginal note:Duration

    (2) Subsection (1) applies until the determination of the application under section 32.

Coming into Force

Marginal note:One year after publication

  • Footnote * (1) These Regulations — except subsections 4(4) to (6), paragraph 64(1)(b) as it applies to registration numbers, and section 125 — come into force one year after the day on which they are published in the Canada Gazette, Part II.

  • Marginal note:Subsections 4(4) to (6) and paragraph 64(1)(b)

    (2) Subsections 4(4) to (6) and paragraph 64(1)(b), as it applies to registration numbers, come into force six months after the day on which these Regulations come into force.

  • Marginal note:Section 125

    (3) Section 125 comes into force on the day on which these Regulations are registered.

  • Return to footnote *[Note: Regulations, except subsections 4(4) to (6), paragraph 64(1)(b) and section 125, in force October 23, 2014; subsections 4(4) to (6) and paragraph 64(1)(b) in force April 23, 2015.]

 
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