Authorizations, Establishment Licences and Registrations (continued)
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.
(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.
(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.
(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
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.
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
(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:
(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.
(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.
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
(a) use aseptic methods;
(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.
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