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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

Quality Management (continued)

Operating Procedures

Marginal note:Operating procedures required

 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

 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

 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

  •  (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

 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

  •  (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

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

Marginal note:Supplies

 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

  •  (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

  •  (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.

Investigation and Reporting

Marginal note:Requirement to cooperate

  •  (1) An establishment must, on request, provide any establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused.

  • Marginal note:Communication

    (2) When more than one establishment is affected by an error or accident or the investigation of one, each establishment must ensure that every other establishment that is so affected is kept informed of all relevant information and of all developments and issues that arise during the investigation.

Marginal note:Investigation results

  •  (1) An establishment that is conducting an investigation must notify in writing every establishment and other person to which it distributed implicated blood of the results of the investigation and of any action that is required to be taken.

  • Marginal note:Notice to be forwarded

    (2) An establishment that is notified under subsection (1) or under this subsection must send a copy of the notice to every establishment to which it distributed implicated blood.

 
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