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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

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

Exceptional Distribution (continued)

Marginal note:Labelling

 An establishment that distributes blood under section 81 must label it to indicate that the testing required by these Regulations is incomplete or that all of the test results are not yet available, as the case may be.

Marginal note:Follow-up

  •  (1) An establishment that distributes blood under section 81 either before the testing is complete or before the test results are all available must, after the distribution, conduct any remaining testing and provide the establishment to which it distributed the blood with all of the relevant test results as soon as they become available.

  • Marginal note:Results to be forwarded

    (2) If the establishment to which the blood was distributed did not perform the transfusion, it must send a copy of the test results to the establishment where the transfusion was performed.

Marginal note:When blood not transfused

 If blood that is the subject of an exceptional distribution is not transfused into the intended recipient in the emergency, the establishment that was to perform the transfusion must not store the blood or transfuse it into another recipient.

Pre-assessed Donor Programs

Marginal note:Program characteristics

 An establishment that has a pre-assessed donor program must ensure that the program has both of the following characteristics:

  • (a) it is carried out under the supervision of a medical director; and

  • (b) it is used only when

    • (i) no other alternative source of blood appropriate for the recipient is available, and

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

Marginal note:Donor identification code

 An establishment that has a pre-assessed donor program must assign a donor identification code at the time of the donor’s acceptance into the program.

Marginal note:Regular donor assessment and testing

  •  (1) An establishment that has a pre-assessed donor program must take both of the following steps every three months:

    • (a) assess the suitability of every donor in the program in accordance with sections 40 to 44; and

    • (b) take blood samples from every donor and test them for all of the following:

      • (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard,

      • (ii) the ABO group,

      • (iii) the Rh factor, including weak D testing when appropriate, and

      • (iv) clinically significant antibodies.

  • Marginal note:Comparison of results

    (2) The establishment must compare the results of the tests conducted under subparagraphs (1)(b)(ii) and (iii) with the last available results, if any, for that donor.

  • Marginal note:Discrepancies

    (3) If the comparison indicates a discrepancy, the establishment must repeat the tests and must not collect any blood from that donor until the discrepancy is resolved.

Marginal note:At each collection

 An establishment that collects blood from a pre-assessed donor must take all of the following steps at each collection:

  • (a) assess the suitability of the donor;

  • (b) assign a donation code to the blood collected and link the code in its records to the donor identification code; and

  • (c) take a sample of blood from the donor and test it within 72 hours for all of the following:

    • (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard,

    • (ii) the ABO group,

    • (iii) the Rh factor, including weak D testing when appropriate, and

    • (iv) clinically significant antibodies.

Marginal note:Labelling

 An establishment that collects blood from a pre-assessed donor must ensure that at least the donation code and the ABO group and, when appropriate, the Rh factor appear on the label of the blood.

Marginal note:When blood not transfused

 If blood that is collected from a pre-assessed donor is not transfused into an intended recipient in the emergency, the establishment that was to perform the transfusion must comply with the requirements of section 16.2.5 of the standard.

Importation in Urgent Circumstances

Marginal note:Information — before importation

  •  (1) An establishment may, in urgent circumstances, import allogeneic blood that was not processed in accordance with an authorization if it provides the Minister with all of the following information before the importation:

    • (a) the information required by paragraphs 6(1)(a) and (j) with respect to each foreign establishment that processes blood that it proposes to import;

    • (b) a copy of the circular of information for the blood that is proposed to be imported, or an equivalent document;

    • (c) a copy of the donor screening questionnaire that is used by each foreign establishment that processes blood that it proposes to import, including a document that indicates how that questionnaire differs from the one referred to in section 41;

    • (d) a description of how post-donation information described in paragraph 44(1)(b) is evaluated in the foreign jurisdiction;

    • (e) a description of the conditions of storage and transportation of the blood that is proposed to be imported, both before and after its importation;

    • (f) a description of how the establishment proposes to identify the blood as having been imported in urgent circumstances; and

    • (g) a description of how errors, accidents and adverse reactions are investigated and reported in the foreign jurisdiction.

  • Marginal note:Information — at each importation

    (2) At the time of each importation described in subsection (1), the establishment must provide the Minister with the following information:

    • (a) a written justification that demonstrates the existence of urgent circumstances; and

    • (b) a description of any further processing or labelling that may need to be done to the blood before its transfusion.

  • Meaning of urgent circumstances

    (3) In this section, urgent circumstances means that there is an insufficiency of allogeneic blood in Canada that poses an immediate and substantial risk to public health.

Quality Management

Quality Management System

Marginal note:Organizational structure

  •  (1) A licensed or registered establishment must have an organizational structure that sets out the responsibility of management for all activities that the establishment conducts.

  • Marginal note:Oversight

    (2) The establishment must have an effective quality management system, and must name an individual who has responsibility for it.

  • Marginal note:Periodic review

    (3) The establishment must review its quality management system at regular intervals that are specified in the operating procedures, to ensure its continuing suitability and effectiveness.

Marginal note:Requirements

  •  (1) The quality management system must include all of the following elements:

    • (a) a quality assurance unit;

    • (b) a quality control program;

    • (c) a change control system;

    • (d) a process control program, within the meaning of section 3.1 of the standard;

    • (e) a system for process improvement through complaint monitoring and the implementation of corrective and preventive actions;

    • (f) a system for the identification and investigation of post-donation information, errors, accidents and adverse reactions, including the implementation of corrective action and the conduct of recalls;

    • (g) a program for the training and competency-evaluation of personnel;

    • (h) a proficiency testing program for the evaluation of the accuracy and reliability of test results;

    • (i) a document control and records management system;

    • (j) an internal audit system;

    • (k) emergency contingency plans;

    • (l) a system that uniquely identifies all critical equipment and supplies;

    • (m) written specifications for all critical equipment, supplies and services;

    • (n) a program for the preventive maintenance of critical equipment; and

    • (o) a program for process validation.

  • Marginal note:Separation of functions

    (2) The establishment’s quality assurance unit must be a distinct organizational unit that functions and reports to management independently of any other functional unit.

  • Marginal note:Exception

    (3) Subsection (2) does not apply in the case of a licensed establishment that only tests allogeneic blood or a registered establishment if the establishment ensures that any individual who conducts an internal audit does not have direct responsibility for the activities being audited

 
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