Blood Regulations (SOR/2013-178)

Marginal note:Reinstatement

• 28 (1) Subject to subsections (2) and (3), the Minister must reinstate an establishment licence if the establishment provides the Minister with sufficient evidence to demonstrate that it is in compliance with these Regulations.

• Marginal note:Exception — compliance history

  (2) The Minister may refuse to reinstate an establishment’s licence if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations.

• Marginal note:Partial reinstatement

  (3) If the Minister does not reinstate any part of a licence that was suspended, the Minister must amend the licence to remove that part.

Marginal note:Cancellation

• 29 (1) The Minister must cancel an establishment licence in any of the following circumstances:

  • (a) the establishment notifies the Minister under paragraph 23(b) that it has ceased all activities under the licence;

  • (b) the establishment fails to provide the Minister with the evidence described in paragraph 27(1)(b) within a reasonable period after the licence was suspended;

  • (c) the establishment’s compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations; or

  • (d) no authorization under which the establishment processes blood remains in effect.

• Marginal note:Notice

  (2) On the cancellation of a licence, the Minister must send the establishment a notice that sets out the reasons for the cancellation and the effective date.

Registration

Marginal note:Requirement to register

• 30 (1) An establishment that processes autologous blood, that transforms blood or that has a pre-assessed donor program must be registered under these Regulations to do so.

• Marginal note:Exceptions

  (2) Subsection (1) does not apply to an establishment that only tests autologous blood or to an establishment whose only transformation activity is to pool cryoprecipitate.

Marginal note:Application for registration

• 31 (1) An establishment must file with the Minister an application for registration in the form established by the Minister that contains all of the following information:

  • (a) the applicant’s name and civic address, and its postal address if different;

  • (b) in the case of an establishment that previously conducted its activities under these Regulations under another name, that other name;

  • (c) the name and telephone number, fax number, email address or other means of communication of a person to contact for further information concerning the application;

  • (d) the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (c);

  • (e) a list of the processing activities that the establishment proposes to conduct in respect of autologous blood and a list of the whole blood and blood components that it proposes to process;

  • (f) a list of the transformation activities that the establishment proposes to conduct and a list of all the whole blood and blood components that it proposes to transform;

  • (g) a statement of whether the establishment has a pre-assessed donor program;

  • (h) the civic address of every building in which it proposes to conduct its activities and a list of the activities that are proposed to be conducted in each building;

  • (i) the name and civic address of any other establishment that it proposes to have conduct any of its activities; and

  • (j) a statement, dated and signed by a senior executive officer, that certifies both of the following:

    • (i) that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations, and

    • (ii) that all of the information in the application is accurate and complete.

• Marginal note:Information on request

  (2) An establishment must provide the Minister, on written request, with any information that the Minister determines is necessary to complete the Minister’s review of the application, by the date specified in the request.

Marginal note:Registration

• 32 (1) On completion of the review of an application for registration, if the Minister determines that the information provided in the application is complete, the Minister must register the establishment and issue a registration number.

• Marginal note:Refusal

  (2) The Minister may refuse to register an establishment if she or he determines that the information provided by the establishment in its application is incomplete or if she or he has reasonable grounds to believe that issuance of the registration could compromise human safety or the safety of blood.

Marginal note:Changes — notice

33 An establishment must notify the Minister in writing of any change to the information provided under section 31, within 30 days after the day on which the change is made, and in the case of a change to the information provided under any of paragraphs 31(1)(e) to (i), include in the notice another statement described in paragraph 31(1)(j).

Marginal note:Amendment by Minister

34 The Minister may amend an establishment’s registration to remove from it any activity or building if she or he has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood.

Marginal note:Annual statement of compliance

35 An establishment must, by April 1 of each year, provide the Minister with a statement dated and signed by a senior executive officer that certifies that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations.

Marginal note:Additional information

36 An establishment must provide the Minister, on written request, with any additional relevant information to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request.

Marginal note:Cancellation

• 37 (1) The Minister may cancel a registration in any of the following circumstances:

  • (a) the Minister receives a notice under section 33 that the establishment has ceased all of its activities that are the subject of the registration;

  • (b) information provided by the establishment under section 31 proves to be false or misleading;

  • (c) the establishment has not complied with a request for additional information made under section 36;

  • (d) the establishment fails to take any corrective action within the required period; or

  • (e) the Minister has reasonable grounds to believe that the establishment is not in compliance with these Regulations or that human safety or the safety of blood could be compromised.

• Marginal note:Notice

  (2) Before cancelling a registration, the Minister must send the establishment a notice that

  • (a) sets out the reasons for the proposed cancellation and the effective date;

  • (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and

  • (c) gives the establishment a reasonable opportunity to be heard concerning the cancellation.

• Marginal note:Urgent circumstances

  (3) Despite subsection (2), the Minister may immediately cancel a registration if she or he has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood.

• Marginal note:Urgent circumstances — notice

  (4) When the Minister cancels a registration under subsection (3), the Minister must send the establishment a notice that

  • (a) sets out the reasons for the cancellation;

  • (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and

  • (c) gives the establishment a reasonable opportunity to be heard concerning the cancellation.

• Marginal note:Action by establishment on cancellation

  (5) On the cancellation of its registration for any reason set out in paragraphs (1)(b) to (e), the establishment must immediately notify any establishment to which it distributed blood that it processed or transformed during the period set out in the notice that its registration has been cancelled and the effective date of the cancellation.

Processing

Donor Suitability Assessment

Marginal note:Non-application — autologous donations

38 Sections 39 to 44 do not apply to an autologous donation.

Marginal note:Licensed establishments

39 A licensed establishment that collects allogeneic blood must, before the collection, assess the donor’s suitability to donate against the establishment’s authorized criteria.

Marginal note:Past unsuitability

40 In conducting a donor suitability assessment, an establishment must verify whether the donor has been previously determined unsuitable, and the reason why and the duration, if applicable.

Marginal note:Donor screening

41 In conducting a donor suitability assessment, an establishment must take both of the following steps:

• (a) obtain information from the donor by use of a questionnaire or other similar means about their identity and medical history, and their social history to the extent that it is relevant in determining the presence of risk factors for diseases transmissible by blood; and

• (b) provide the donor with information about the risks associated with donating blood and the risks to the recipient of contracting a transmissible disease.

Marginal note:Exclusion criteria

42 An establishment must determine that a donor is unsuitable to donate if any of the information obtained under sections 39 to 41 indicates that human safety or the safety of blood could be compromised.

Marginal note:When donor determined unsuitable

43 If a donor is determined unsuitable to donate, the establishment must not collect blood from that donor and must inform the donor of the reasons why they are not suitable to donate and indicate the date, if any, when the donor will again be suitable to donate.

Marginal note:When donor determined suitable

• 44 (1) If a donor is determined suitable to donate, the establishment must take both of the following steps:

  • (a) assign a donor identification code to the donor, if the donor does not already have one; and

  • (b) instruct the donor to inform the establishment in either of the following situations:

    • (i) the donor develops, within the periods set out in the establishment’s operating procedures, an illness or condition that may potentially compromise the safety of donated blood, or

    • (ii) after the donation the donor has any reason to believe that their blood should not be used.

• Marginal note:Reassessment

  (2) On receipt of any post-donation information under paragraph (1)(b), the establishment must evaluate the information to reassess the safety of the current and any other donation made by that donor and the donor’s suitability for future donations.

• Marginal note:Notice

  (3) If the reassessment shows that the safety of the blood may have been compromised and the establishment has already distributed the blood, it must notify every person to which it distributed the blood to that effect, and if the person is an establishment, specify in the notice that the blood must not be distributed or transfused.

Collection

Marginal note:Licensed establishments

45 A licensed establishment that collects allogeneic blood must do so in accordance with its authorization.

Marginal note:Donor identification code

46 An establishment that collects autologous blood must assign a donor identification code to the donor.

Marginal note:Donation code

47 An establishment that collects blood must assign a donation code to every unit of blood that it collects and link the code in its records to the donor identification code.

Marginal note:Labelling of containers

48 Subject to section 59, an establishment that collects blood must ensure that every container is labelled in accordance with section 63 at the time of the collection.

Marginal note:Collection procedures

• 49 (1) An establishment that collects blood must conduct the collection in the following way:

  • (a) use aseptic methods;

  • (b) use collection equipment that is licensed under the Medical Devices Regulations;

  • (c) use containers that are licensed under the Medical Devices Regulations and free from defects or damage; and

  • (d) record the container lot number in the records and link it to the donation code.

• Marginal note:Reuse of containers prohibited

  (2) An establishment must ensure that the containers that it uses are used only once.

Marginal note:Samples

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.

Testing

Marginal note:Authorization

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 12.3.1.2 of the standard.

Marginal note:Autologous donations — ABO and Rh

• 54 (1) An establishment that collects autologous blood must test a sample of the blood at the time of each donation to identify both of the following:

  • (a) the ABO group; and

  • (b) the Rh factor, including weak D testing when appropriate.

• 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.

• Marginal note:Discrepancies

  (3) If the comparison indicates a discrepancy, the establishment must repeat the tests and must not transfuse the blood until the discrepancy is resolved.