Government of Canada / Gouvernement du Canada
Symbol of the Government of Canada

Search

Blood Regulations (SOR/2013-178)

Full Document:  

Regulations are current to 2020-03-05 and last amended on 2015-04-23. Previous Versions

Labelling (continued)

Marginal note:Aliquots

 Except for purposes of immunization, an establishment that divides blood into aliquots for transfusion must ensure that all of the following information appears on the label on each aliquot container:

  • (a) the donation code;

  • (b) the name of the blood component;

  • (c) a code that identifies the aliquot;

  • (d) when appropriate, the ABO group and Rh factor of the blood; and

  • (e) the expiry date.

Marginal note:Designated donations

  •  (1) In addition to the information required by subsection 64(1), an establishment that collects blood for designated use must ensure that the identity of the intended recipient appears on the label.

  • Marginal note:Change of use

    (2) The establishment must remove from the label the mention of the identity of the intended recipient when the blood is no longer intended for designated use.

Marginal note:Directed donations

 In addition to the information required by subsection 64(1), an establishment that collects blood for directed use must ensure that the expression “Directed Use Only” and the identity of the intended recipient appear on the label.

Marginal note:Label verification

 An establishment that labels blood must verify that all of the information that it adds to the label is accurate and complete.

Storage

Marginal note:Criteria — collecting establishment

  •  (1) An establishment that collects blood must store the blood in accordance with the following:

    • (a) in the case of a licensed establishment, its authorization; and

    • (b) in the case of a registered establishment, the storage and expiration criteria specified in Table 2 of the standard.

  • Marginal note:Criteria — receiving establishment

    (2) An establishment that receives blood from another establishment must store it in accordance with the directions on its label and with any other directions that are specified in writing by the establishment that collected it.

Marginal note:Storage location

 An establishment that stores blood must do so in a location that has appropriate environmental conditions that maintain the safety of the blood and that is secure against the entry of unauthorized persons.

Marginal note:Segregation — autologous, designated and directed donations

 An establishment that stores blood must ensure that blood that is intended for autologous, designated or directed use is segregated from blood that is intended for other allogeneic use.

Marginal note:Segregation — untested or positive or reactive test results

 An establishment that stores blood must segregate all of the following blood from blood that has been determined safe for distribution or autologous transfusion under section 73:

  • (a) blood that is untested;

  • (b) blood for which the testing is incomplete or for which all of the test results are not yet available; and

  • (c) blood for which the test results on blood samples are positive or repeat reactive for transmissible disease agents or markers.

Distribution

Marginal note:Determination of safety — allogeneic blood

  •  (1) An establishment that collects allogeneic blood must, before distributing it for transfusion or for use in the manufacture of a drug for human use, determine that it is safe for distribution once the establishment is satisfied that the blood has been processed in accordance with these Regulations.

  • Marginal note:Determination of safety — autologous blood

    (2) An establishment that collects autologous blood must, before distributing it for transfusion, determine that it is safe for autologous transfusion once the establishment is satisfied that the blood has been processed in accordance with these Regulations.

Marginal note:Verification

  •  (1) Before distributing blood for transfusion or for use in the manufacture of a drug for human use, an establishment must examine the container to verify all of the following:

    • (a) the information on the label is legible;

    • (b) the integrity of the container is intact;

    • (c) there are no signs of deterioration or contamination of the blood; and

    • (d) any frozen blood components show no signs of thawing.

  • Marginal note:Prohibition — distribution

    (2) An establishment must not distribute blood for transfusion or for use in the manufacture of a drug for human use if the verification carried out under subsection (1) indicates any of the following:

    • (a) the donation code is missing or illegible;

    • (b) any information — other than the donation code — that is required by these Regulations to appear on the label of blood is missing or is illegible, unless the missing or illegible information can be retrieved from the establishment’s records;

    • (c) the container is defective or damaged to the extent that it does not protect the blood against external conditions; or

    • (d) there are signs of deterioration or contamination of the blood.

Marginal note:Shipping containers

 An establishment that ships blood must

  • (a) examine the blood containers before shipping to verify the integrity of the container and the legibility of the labels; and

  • (b) use shipping containers that are capable of resisting damage and maintaining the safety of the blood.

Marginal note:Storage during transportation

 An establishment that ships blood for transfusion must ensure that the blood is stored during transportation in accordance with the criteria specified in Table 2 of the standard.

Transformation

Marginal note:Transformation methods

 An establishment that transforms blood must do so using safe and effective methods.

Marginal note:Washing

  •  (1) An establishment that washes blood must do so in accordance with sections 7.5.2.3 and 7.5.3 of the standard.

  • Marginal note:Labels

    (2) An establishment that washes blood must amend the label to add to it a mention of the washing and any new expiry date and time.

Marginal note:Pooling

  •  (1) An establishment that pools blood components must do so in accordance with sections 7.11.1 and 7.11.3 of the standard.

  • Marginal note:Labels

    (2) An establishment that pools blood components must ensure that all of the information specified in sections 10.8.2 and 10.8.3 of the standard appears on the label of the pooled components.

Marginal note:Irradiation

 An establishment that irradiates blood must do so in accordance with sections 7.12.2 to 7.12.6 of the standard.

Exceptional Distribution, Pre-Assessed Donor Programs and Importation in Urgent Circumstances

Exceptional Distribution

Marginal note:Conditions

 An establishment may distribute or transfuse allogeneic blood for transfusion for which the test results for ABO group, Rh factor and transmissible diseases or disease agents are not yet available if both of the following conditions are met:

  • (a) blood that has been determined safe for distribution is not immediately available; and

  • (b) the recipient’s physician requests the blood for use in the emergency treatment of their patient.

Marginal note:Notice of exceptional distribution

  •  (1) An establishment that distributes blood under section 81 must complete a notice of exceptional distribution that contains all of the following information:

    • (a) the name of the establishment and the signature of the medical director;

    • (b) the donation code;

    • (c) a statement of whether the blood was whole blood or a blood component, and if it was a component, its name;

    • (d) a list of the test results that were not available at the time of the distribution;

    • (e) the name and signature of the recipient’s physician;

    • (f) the justification for the distribution;

    • (g) the name of the establishment to which it distributed the blood; and

    • (h) the date and time of the distribution.

  • Marginal note:Notice in establishments’ records

    (2) The establishment must keep the notice in its records and send a copy of it to the establishment to which it distributed the blood.

  • Marginal note:Notice to be forwarded

    (3) If the establishment to which the blood is distributed does not perform the transfusion, it must send a copy of the notice to the establishment where the transfusion is performed.

  • Marginal note:Notice in recipient’s file

    (4) The establishment where the transfusion is performed must keep the notice in the recipient’s file.

 
Date modified: