GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Blood Regulations — 25
New or amended terms and conditions 25 (1) The Minister may add terms and conditions to an establishment licence or amend its terms and conditions in either of the following circumstances: (a) the Minister has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood; or (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request. Notice (2) Before adding terms or conditions to a licence or amending its terms or conditions, the Minister must send the establishment a notice at least 15 days before the day on which the proposed terms and conditions are to take effect that sets out the Minister’s reasons and that gives the establishment a reasonable opportunity to be heard concerning them. Urgent circumstances (3) Despite subsection (2), the Minister may immediately add terms and conditions to a licence or amend its terms and conditions 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. Urgent circumstances — notice (4) When the Minister adds or amends terms or conditions under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the new or amended terms and conditions and that gives the establishment a reasonable opportunity to be heard concerning them. Removal of terms and conditions (5) The Minister may, by notice in writing, remove a term or condition from a licence if she or he determines that the term or condition is no longer necessary to prevent a compromise to human safety or the safety of blood.
Blood Regulations — 26
Additional information 26 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.
Blood Regulations — 27
Suspension 27 (1) The Minister may suspend all or part of an establishment licence in any of the following circumstances: (a) information provided by the establishment under section 18 or 22 proves to be inaccurate or incomplete; (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request; or (c) the establishment is not in compliance with these Regulations. Notice (2) Before suspending a licence, the Minister must send the establishment a notice that (a) sets out the reasons for the proposed suspension 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 suspension. Urgent circumstances (3) Despite subsection (2), the Minister may immediately suspend all or part of a licence 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. Urgent circumstances — notice (4) When the Minister suspends a licence under subsection (3), the Minister must send the establishment a notice that (a) sets out the reasons for the suspension; and (b) gives the establishment a reasonable opportunity to be heard concerning the suspension.
Blood Regulations — 28
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. 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. 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.
Blood Regulations — 29
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. 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.
Blood Regulations — 30
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. 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.
Blood Regulations — 31
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. 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.
Blood Regulations — 32
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. 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.
Blood Regulations — 33
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).
Blood Regulations — 34
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.
Blood Regulations — 35
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.
Blood Regulations — 36
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.
Blood Regulations — 37
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. 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. 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. 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. 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.
Blood Regulations — 38
Non-application — autologous donations 38 Sections 39 to 44 do not apply to an autologous donation.
Blood Regulations — 39
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.
Blood Regulations — 40
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.
Blood Regulations — 41
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.
Blood Regulations — 42
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.
Blood Regulations — 43
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.
Blood Regulations — 44
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. 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. 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.
Blood Regulations — 45
Licensed establishments 45 A licensed establishment that collects allogeneic blood must do so in accordance with its authorization.
Blood Regulations — 46
Donor identification code 46 An establishment that collects autologous blood must assign a donor identification code to the donor.
Blood Regulations — 47
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.
Blood Regulations — 48
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.
Blood Regulations — 49
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. Reuse of containers prohibited (2) An establishment must ensure that the containers that it uses are used only once.
Blood Regulations — 50
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.
Blood Regulations — 51
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.
Blood Regulations — 52
Authorization 52 A licensed establishment that tests allogeneic blood — except blood from a pre-assessed donor — must do so in accordance with an authorization.
Blood Regulations — 53
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.
Blood Regulations — 54
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. 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. 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.
Blood Regulations — 55
Medical devices 55 When testing autologous blood or blood that is collected from a pre-assessed donor, an establishment must use medical devices that are licensed under the Medical Devices Regulations for the following purposes: (a) either for diagnosis or for screening donors, in the case of autologous blood; and (b) for screening donors, in the case of blood that is collected from a pre-assessed donor.
Blood Regulations — 56
Test results — allogeneic blood 56 (1) An establishment that collects allogeneic blood must immediately take all of the following actions if a donor’s blood is positive or repeat reactive for a transmissible disease agent or marker listed in its authorization as a contraindication to use: (a) quarantine any blood that was collected from that donor at that donation; (b) identify and quarantine any other implicated blood from the same donor in the establishment’s possession; and (c) notify every person to which it distributed any of the implicated blood from the same donor of the test results and, if the person is an establishment, specify in the notice that the blood must not be distributed or transfused. Test results — autologous blood (2) An establishment that collects autologous blood must inform the donor’s physician of any of the test results described in section 12.3.1.6 of the standard.
Blood Regulations — 57
Licensed establishments 57 A licensed establishment must prepare allogeneic blood components in accordance with its authorization.
Blood Regulations — 58
Registered establishments 58 A registered establishment must prepare autologous blood components in accordance with sections 7.1.3, 7.2, 7.3.1, 7.3.2, 7.5.1.1 (without regard to the reference to Table 3), 7.5.1.2 and 7.5.1.5, paragraphs 7.5.2.1(a) to (c) and section 7.5.2.2 of the standard.
Blood Regulations — 59
Non-application — pre-assessed donors 59 Sections 60 to 68 do not apply to the labelling of blood collected from a pre-assessed donor.
Blood Regulations — 60
Language requirement 60 All of the information that is required by these Regulations to appear on a label or circular of information must be in English or French.
Blood Regulations — 61
General requirements 61 A label must meet all of the following requirements: (a) all information on the label must be accurate and must be presented clearly and legibly; (b) it must be made using only adhesives and inks that will not permeate the container; (c) it must be permanently affixed to the container; and (d) in the case of a tag, it must be firmly attached to the container.
Blood Regulations — 62
Circular of information 62 (1) An establishment that collects allogeneic blood for transfusion must prepare a circular of information in accordance with the authorization and must ensure that it makes the circular available to every establishment to which the blood is distributed and to any other person who requests a copy of it. Exception (2) Subsection (1) does not apply if the blood is transfused in the same establishment where it is collected.
Blood Regulations — 63
Donation code 63 An establishment that collects blood must ensure that every container into which blood is collected has a label on it on which the donation code is permanently marked at the time of the collection.
Blood Regulations — 64
Contents of label — blood for transfusion 64 (1) An establishment that collects blood for transfusion must ensure that all of the following information appears on the label of the blood: (a) the establishment’s name and civic address; (b) the establishment’s licence number, if it has one, or its registration number; (c) the donation code; (d) a statement of whether the donation is whole blood or a blood component, and if it is a component, its name; (e) when appropriate, the ABO group and Rh factor of the blood; (f) except in the case of apheresis, the approximate volume of the whole blood collected; (g) the approximate volume of the contents of the container; (h) the name of any anticoagulant or additive in the container; (i) the recommended storage temperature; (j) the expiry date and, if applicable, the time; (k) in the case of blood for transfusion, a warning that the blood could transmit infectious agents; and (l) in the case of allogeneic blood for transfusion, a direction to refer to any applicable circular of information for indications, contraindications, warnings and a list of possible adverse reactions. Autologous blood (2) In addition to the information required by subsection (1), the establishment must ensure that all of the following information appears on the label of autologous blood: (a) the statement “For Autologous Use Only”; (b) if the test results indicate that the blood is positive for a transmissible disease or disease agent listed in section 12.3.1.2 of the standard, a symbol or words to indicate that the blood is a biohazard; and (c) if the blood has not been tested for the transmissible diseases and disease agents listed in section 12.3.1.2 of the standard, an indication to that effect. Contents of label — blood for use in manufacture of drug for human use (3) An establishment must ensure that all of the following information appears on the label of blood that is for use in the manufacture of a drug for human use: (a) the name, civic address and licence number of the establishment that collected the blood; (b) the donation code; and (c) the statement “Caution: For Manufacturing Use Only”.
Blood Regulations — 65
Aliquots 65 Except for purposes of immunization, an establishment that divides blood into aliquots for transfusion must ensure that all of the following information appears on the label on each aliquot container: (a) the donation code; (b) the name of the blood component; (c) a code that identifies the aliquot; (d) when appropriate, the ABO group and Rh factor of the blood; and (e) the expiry date.
Blood Regulations — 66
Designated donations 66 (1) In addition to the information required by subsection 64 (1), an establishment that collects blood for designated use must ensure that the identity of the intended recipient appears on the label. Change of use (2) The establishment must remove from the label the mention of the identity of the intended recipient when the blood is no longer intended for designated use.
Blood Regulations — 67
Directed donations 67 In addition to the information required by subsection 64 (1), an establishment that collects blood for directed use must ensure that the expression “Directed Use Only” and the identity of the intended recipient appear on the label.
Blood Regulations — 68
Label verification 68 An establishment that labels blood must verify that all of the information that it adds to the label is accurate and complete.