Blood Regulations (SOR/2013-178)

Marginal note:Labelling

83 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

• 84 (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

85 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

86 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

87 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

• 88 (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

89 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

90 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

91 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

• 92 (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

• 93 (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

• 94 (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

Operating Procedures

Marginal note:Operating procedures required

95 An establishment must have operating procedures for all of the activities that it conducts with respect to human safety and the safety of blood.

Marginal note:Requirements

96 The operating procedures must meet all of the following requirements:

• (a) be in a standardized format;

• (b) be approved by a senior executive officer;

• (c) be readily accessible at all locations where the activities to which they relate are conducted; and

• (d) be kept up to date.

Marginal note:Documented evidence

97 An establishment must have documented evidence that demonstrates that the operating procedures that it uses in processing and transforming blood will consistently lead to the expected results.

Personnel, Facilities, Equipment and Supplies

Marginal note:Personnel

• 98 (1) An establishment must have sufficient personnel, who must be qualified by their education, training or experience to perform their respective tasks, to conduct the establishment’s activities.

• Marginal note:Competency

  (2) An establishment must have a program for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency.

Marginal note:Facilities

99 A licensed or registered establishment must have facilities that permit all of the following:

• (a) the conduct of all of its activities;

• (b) the performance by personnel of their respective tasks using proper hygiene;

• (c) the cleaning of the facilities in a way that maintains sanitary conditions;

• (d) environmental controls that are appropriate to all areas where its activities are conducted;

• (e) controlled access to all areas where its activities are conducted; and

• (f) donor screening to be conducted in privacy.

Marginal note:Equipment

• 100 (1) A licensed or registered establishment must ensure that the critical equipment that it uses is cleaned and maintained and, as appropriate, validated for its intended purpose and calibrated.

• Marginal note:Repair or change

  (2) The establishment must, whenever necessary after it repairs or makes any change to critical equipment, revalidate and recalibrate the equipment, as appropriate.

Marginal note:Storage equipment

101 An establishment must use equipment to store blood that enables the establishment to meet the requirements of sections 69 to 72.

Marginal note:Supplies

102 A licensed or registered establishment must ensure that the critical supplies that it uses are validated or qualified, as applicable, for their intended use and must store them under appropriate environmental conditions.

Error and Accident Investigation and Reporting

Errors and Accidents

Marginal note:Error or accident of another establishment

• 103 (1) An establishment that has reasonable grounds to believe that the safety of blood may have been compromised by the occurrence of an error or accident during an activity conducted by another establishment must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) notify all of the following establishments:

    • (i) the establishment that collected the implicated blood,

    • (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and

    • (iii) any establishment to which it distributed implicated blood.

• Marginal note:Contents of notice

  (2) The notice must include all of the following information:

  • (a) the donation codes of the implicated blood;

  • (b) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and

  • (c) the reason for the establishment’s belief that the safety of the blood may have been compromised.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subparagraph (1)(c)(iii) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

  (4) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Establishment’s own error or accident

• 104 (1) An establishment that receives a notice under subparagraph 103(1)(c)(i) or (ii) or suspects that an error or accident that occurred during an activity it conducted may have compromised the safety of blood must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) determine whether there is sufficient evidence to warrant proceeding to an investigation into the suspected error or accident.

• Marginal note:When no investigation — notice

  (2) If the establishment determines that an investigation is not warranted, it must notify the establishment that sent it the notice under subparagraph 103(1)(c)(i) or (ii) that it will not be conducting an investigation and provide its reasons for that decision.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subsection (2) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood.

• Marginal note:Notice of investigation

  (4) If the establishment determines that an investigation is warranted, it must begin the investigation, notify every establishment and other person to which it distributed implicated blood, and include the following information in the notice:

  • (a) the donation codes of all implicated blood; and

  • (b) a description of the suspected error or accident and an explanation of how the safety of the implicated blood may have been compromised.

• Marginal note:Action on receipt of notice

  (5) An establishment that is notified under subsection (4) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

  (6) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.