Blood Regulations (SOR/2013-178)

Marginal note:Medical devices

55 When testing autologous blood or blood that is collected from a pre-assessed donor, an establishment must use medical devices that are licensed under the Medical Devices Regulations for the following purposes:

• (a) either for diagnosis or for screening donors, in the case of autologous blood; and

• (b) for screening donors, in the case of blood that is collected from a pre-assessed donor.

Marginal note:Test results — allogeneic blood

• 56 (1) An establishment that collects allogeneic blood must immediately take all of the following actions if a donor’s blood is positive or repeat reactive for a transmissible disease agent or marker listed in its authorization as a contraindication to use:

  • (a) quarantine any blood that was collected from that donor at that donation;

  • (b) identify and quarantine any other implicated blood from the same donor in the establishment’s possession; and

  • (c) notify every person to which it distributed any of the implicated blood from the same donor of the test results and, if the person is an establishment, specify in the notice that the blood must not be distributed or transfused.

• Marginal note:Test results — autologous blood

  (2) An establishment that collects autologous blood must inform the donor’s physician of any of the test results described in section 12.3.1.6 of the standard.

Blood Component Preparation

Marginal note:Licensed establishments

57 A licensed establishment must prepare allogeneic blood components in accordance with its authorization.

Marginal note:Registered establishments

58 A registered establishment must prepare autologous blood components in accordance with sections 7.1.3, 7.2, 7.3.1, 7.3.2, 7.5.1.1 (without regard to the reference to Table 3), 7.5.1.2 and 7.5.1.5, paragraphs 7.5.2.1(a) to (c) and section 7.5.2.2 of the standard.

Labelling

Marginal note:Non-application — pre-assessed donors

59 Sections 60 to 68 do not apply to the labelling of blood collected from a pre-assessed donor.

Marginal note:Language requirement

60 All of the information that is required by these Regulations to appear on a label or circular of information must be in English or French.

Marginal note:General requirements

61 A label must meet all of the following requirements:

• (a) all information on the label must be accurate and must be presented clearly and legibly;

• (b) it must be made using only adhesives and inks that will not permeate the container;

• (c) it must be permanently affixed to the container; and

• (d) in the case of a tag, it must be firmly attached to the container.

Marginal note:Circular of information

• 62 (1) An establishment that collects allogeneic blood for transfusion must prepare a circular of information in accordance with the authorization and must ensure that it makes the circular available to every establishment to which the blood is distributed and to any other person who requests a copy of it.

• Marginal note:Exception

  (2) Subsection (1) does not apply if the blood is transfused in the same establishment where it is collected.

Marginal note:Donation code

63 An establishment that collects blood must ensure that every container into which blood is collected has a label on it on which the donation code is permanently marked at the time of the collection.

Marginal note:Contents of label — blood for transfusion

• 64 (1) An establishment that collects blood for transfusion must ensure that all of the following information appears on the label of the blood:

  • (a) the establishment’s name and civic address;

  • (b) the establishment’s licence number, if it has one, or its registration number;

  • (c) the donation code;

  • (d) a statement of whether the donation is whole blood or a blood component, and if it is a component, its name;

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

  • (f) except in the case of apheresis, the approximate volume of the whole blood collected;

  • (g) the approximate volume of the contents of the container;

  • (h) the name of any anticoagulant or additive in the container;

  • (i) the recommended storage temperature;

  • (j) the expiry date and, if applicable, the time;

  • (k) in the case of blood for transfusion, a warning that the blood could transmit infectious agents; and

  • (l) in the case of allogeneic blood for transfusion, a direction to refer to any applicable circular of information for indications, contraindications, warnings and a list of possible adverse reactions.

• Marginal note:Autologous blood

  (2) In addition to the information required by subsection (1), the establishment must ensure that all of the following information appears on the label of autologous blood:

  • (a) the statement “For Autologous Use Only”;

  • (b) if the test results indicate that the blood is positive for a transmissible disease or disease agent listed in section 12.3.1.2 of the standard, a symbol or words to indicate that the blood is a biohazard; and

  • (c) if the blood has not been tested for the transmissible diseases and disease agents listed in section 12.3.1.2 of the standard, an indication to that effect.

• Marginal note:Contents of label — blood for use in manufacture of drug for human use

  (3) An establishment must ensure that all of the following information appears on the label of blood that is for use in the manufacture of a drug for human use:

  • (a) the name, civic address and licence number of the establishment that collected the blood;

  • (b) the donation code; and

  • (c) the statement “Caution: For Manufacturing Use Only”.

Marginal note:Aliquots

65 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

• 66 (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

67 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

68 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

• 69 (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

70 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

71 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

72 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

• 73 (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

• 74 (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

75 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

76 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

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

Marginal note:Washing

• 78 (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

• 79 (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

80 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

81 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

• 82 (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.