50 An establishment that collects blood must obtain samples of blood for testing at the same time as the collection in a way that avoids contamination of the donated blood and the samples.
Marginal note:Autologous donations
51 An establishment that collects autologous blood must
(a) comply with the criteria set out in section 12.2.1 of the standard; and
(b) when appropriate, adjust the volume of the blood collected and the volume of anticoagulant based on the donor’s weight.
52 A licensed establishment that tests allogeneic blood — except blood from a pre-assessed donor — must do so in accordance with an authorization.
Marginal note:Autologous donations — transmissible disease testing
53 An establishment that collects autologous blood must test a sample of the blood using appropriate and effective tests for transmissible diseases and disease agents in accordance with section 126.96.36.199 of the standard.
Marginal note:Autologous donations — ABO and Rh
Marginal note:Comparison of results
(2) The establishment must compare the results of the tests conducted under paragraphs (1)(a) and (b) with the last available results, if any, for that donor.
(3) If the comparison indicates a discrepancy, the establishment must repeat the tests and must not transfuse the blood until the discrepancy is resolved.
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 188.8.131.52 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, 184.108.40.206 (without regard to the reference to Table 3), 220.127.116.11 and 18.104.22.168, paragraphs 22.214.171.124(a) to (c) and section 126.96.36.199 of the standard.
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.
(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
(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 188.8.131.52 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 184.108.40.206 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:
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