Blood Regulations

Blood Regulations His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30a of the Food and Drugs Actb, makes the annexed Blood Regulations. S.C. 2012, c. 19, ss. 414(2) and 415 R.S., c. F-27 Definitions The following definitions apply in these Regulations. accident means an unexpected event that is not attributable to a deviation from the operating procedures or applicable laws and that could compromise human safety or the safety of blood. (accident) Act means the Food and Drugs Act. (Loi) adverse reaction means an undesirable response that is associated with in the case of a donor, the collection of blood; and in the case of a recipient, the safety of the transfused blood. (effet indésirable) allogeneic, in respect of blood or a blood donation, means that the blood is collected from an individual either for transfusion into another individual or for use in the manufacture of a drug for human use. (allogénique) authorization, in respect of any blood or process, means an authorization that is issued under section 7. (homologation) autologous, in respect of blood or a blood donation, means that the blood is collected from an individual for transfusion into the same individual at a later time. (autologue) blood means human blood that is collected either for transfusion or for use in the manufacture of a drug for human use, and for greater certainty, it includes whole blood and blood components. (sang) circular of information means a document that describes all of the following in relation to blood: the composition and properties of the blood; directions for storage and for use; and indications for use, contraindications, warnings and a list of possible adverse reactions. (document d’information) critical, in respect of equipment, supplies and services, means that the equipment, supply or service could, if it does not meet its specifications, compromise human safety or the safety of blood. (essentiel) designated donation means a blood donation that is made by a donor who is selected for medical reasons to make the donation for a specific recipient. (don désigné) directed donation means a blood donation that is made by a donor who is known by the recipient and selected for medical reasons by the recipient’s physician. (don dirigé) distribute does not include to transfuse. (distribution) donation code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a unit of blood at the time of collection. (code d’identification du don) donor identification code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a donor. (code d’identification du donneur) donor suitability assessment means an evaluation of a donor that is based on all of the following criteria: the donor’s medical history; the results of any donor tests and physical examination; and the donor’s social history, to the extent that it is relevant in determining the presence of risk factors for diseases transmissible by blood. (évaluation de l’admissibilité du donneur) error means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood. (manquement) establishment means a person that conducts any of the following activities in respect of blood: importation; processing; distribution; transformation; or transfusion. (établissement) human safety means the safety of donors and recipients of blood, in so far as it relates to the safety of the blood. (sécurité humaine) medical director, in respect of an establishment, means a physician who is entitled under the laws of a province to practise the profession of medicine and who is responsible for all medical procedures carried out by the establishment and for the application of the operating procedures that relate to them. (directeur médical) operating procedures, in respect of an establishment, means the component of the establishment’s quality management system that is composed of instructions that set out the processes to follow in conducting its activities. (procédures opérationnelles) pre-assessed donor means a donor who has been accepted into a pre-assessed donor program described in sections 86 to 91 from whom blood is taken in an emergency to be transfused before completion of the testing. (donneur pré-évalué) processing means any of the following activities: donor suitability assessment; collection; testing; or blood component preparation. (traitement) safety, in respect of blood, means that the blood has been determined safe for distribution or for autologous transfusion, as the case may be, in accordance with section 73, and includes in the case of blood for transfusion, its quality and efficacy; and in the case of blood for use in the manufacture of a drug for human use, its quality. (sécurité) serious adverse reaction means an adverse reaction that results in any of the following consequences for the donor or recipient: their in-patient hospitalization or its prolongation; persistent or significant disability or incapacity; medical or surgical intervention to preclude a persistent or significant disability or incapacity; a life-threatening condition; or death. (effet indésirable grave) standard means National Standard of Canada CAN/CSA-Z902 published by the Canadian Standards Association and entitled Blood and blood components, as amended from time to time. (norme) transformation, in respect of blood components, means washing, pooling and irradiation that are performed after blood has been determined safe for transfusion. (transformation) unexpected adverse reaction means an adverse reaction that is not identified among the possible adverse reactions either in the circular of information or in any other information provided to the recipient. (effet indésirable imprévu) Scope of Regulations These Regulations apply to blood that is collected for transfusion or for use in the manufacture of a drug for human use. Non-application — various therapeutic products These Regulations do not apply to any of the following therapeutic products: cord blood and peripheral blood that are for use in lymphohematopoietic cell transplantation and that are regulated under the Safety of Human Cells, Tissues and Organs for Transplantation Regulations; blood that is the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations; or blood that is imported for use in the manufacture of a drug for human use. Non-application — regulations Except for section A.01.045 of the Food and Drug Regulations, no other regulation made under the Act applies to blood that is the subject of these Regulations. Non-application — imported rare phenotypes Sections 4 to 124 do not apply to blood that is of a rare phenotype if it is imported pursuant to a prescription. Allogeneic blood Subject to subsections (2) and (3), an establishment must not import, distribute or transfuse allogeneic blood unless it is processed by an establishment in accordance with an authorization and determined safe for distribution under subsection 73(1). Exception — pre-assessed donor programs Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program. Exception — urgent circumstances An establishment may, in urgent circumstances, import, in accordance with section 92, allogeneic blood that has not been processed in accordance with an authorization; and distribute or transfuse such blood if the importer imported it in accordance with section 92. Pre-assessed donors An establishment must not transfuse allogeneic blood that is collected from a pre-assessed donor unless the establishment has complied with the requirements of sections 86 to 91. Transformations An establishment must not distribute or transfuse blood that has been transformed unless the transformation is conducted by a registered establishment. Autologous blood An establishment must not distribute or transfuse autologous blood unless it has been processed by a registered establishment and determined safe for autologous transfusion under subsection 73(2). Investigations An establishment must not distribute or transfuse blood in either of the following circumstances: while the blood is in quarantine; or when the results of an investigation into a suspected error or accident or an unexpected adverse reaction or serious adverse reaction are inconclusive or indicate that there has been a compromise to the safety of the blood. Authorization — processing Except for an establishment that only tests blood, an establishment that processes allogeneic blood must have an authorization to do so. Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program. Authorization — importation Subject to section 92, an establishment that imports blood must have an authorization to do so, unless the blood is already the subject of another establishment’s authorization. Application for authorization An establishment must file with the Minister an application for an authorization in the form established by the Minister. The application must be dated and signed by a senior executive officer and contain all of the following information: the applicant’s name and civic address, and its postal address if different, and the civic address of each building in which it proposes to conduct its activities; 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; the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (b); a statement of whether the establishment proposes to import whole blood or blood components; a list of the whole blood and blood components that the establishment proposes to process or import; a list of the processing activities that are proposed to be conducted in each building; a description of the establishment’s facilities, including its buildings and all critical equipment, supplies and services that it proposes to use in the conduct of its activities; a description of the processes that the establishment proposes to use or to have used on its behalf in respect of blood and each blood component in the conduct of its activities; a draft of each proposed label and circular of information; evidence that any foreign establishment that it proposes to have conduct any of its processing activities is licensed in the foreign jurisdiction; and sufficient evidence to demonstrate that the proposed processes will not compromise human safety and will result in blood that can be determined safe for distribution. Site inspection During the review of an application, the Minister may inspect the establishment’s facilities to evaluate on site the information provided in the application. Information on request 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. Issuance On completion of the review of an application, the Minister must issue an authorization, with or without terms or conditions, if she or he determines that the establishment has provided sufficient evidence to demonstrate that issuance of the authorization will not compromise human safety or the safety of blood. Refusal The Minister may refuse to issue an authorization if she or he determines that the information provided by the establishment in its application is inaccurate or incomplete. Significant changes Before making a significant change, an establishment must file with the Minister an application to amend its authorization and include with it all relevant information to enable the Minister to determine whether the change or the way in which it is implemented could compromise human safety or the safety of blood. Applications to amend Sections 6 to 8 apply to an application to amend an authorization, with any necessary modifications. Meaning of significant change In this section and sections 10 and 12, significant change means any of the following changes: the addition of blood or a blood component to the list required by paragraph 6(1)(e); the deletion of or a change to any authorized process; the addition of a process described in paragraph 6(1)(h); or a change to the description of the establishment’s facilities referred to in paragraph 6(1)(g). Emergency changes In an emergency, if it becomes necessary for an establishment to implement a significant change before filing an application to amend its authorization, the establishment may do so if the change is necessary to prevent a compromise to human safety or the safety of blood. Notice and application The establishment must notify the Minister in writing of any significant change that it implements under subsection (1) no later than the day after implementing it and file an application to amend its authorization within 15 days after the day on which that notice is given. Administrative changes — notice An establishment must notify the Minister in writing of any change to the information provided under paragraphs 6(1)(a) to (c) as soon as possible after the change is made, and the Minister must amend the authorization accordingly. Other changes — annual report An establishment must file with the Minister an annual report that describes any changes made in the year that are not described in section 9 or 11 and that could compromise human safety or the safety of blood. Amendment by Minister On receipt of the report, the Minister must amend the establishment’s authorization accordingly. When changes determined significant If the Minister determines that a change that was included in a report under subsection (1) is a significant change, the Minister must notify the establishment in writing to that effect and may require the establishment to cease or reverse the implementation of the change. Application to amend authorization On receipt of the notice, the establishment must file an application to amend its authorization New or amended terms and conditions The Minister may add terms and conditions to an establishment’s authorization or amend its terms and conditions in either of the following circumstances: 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 the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that its processes will not compromise human safety and will result in blood that can be determined safe for distribution, by the date specified in the request. Notice Before adding terms or conditions to an authorization or amending its terms or conditions, the Minister must send the establishment a notice at least 15 days before 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 Despite subsection (2), the Minister may immediately add terms and conditions to an authorization 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 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 The Minister may, by notice in writing, remove a term or condition from an authorization 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. Suspension The Minister may suspend all or part of an authorization in either of the following circumstances: information provided by the establishment under section 6 or 9 proves to be inaccurate or incomplete; or Before suspending an authorization, the Minister must send the establishment a notice that sets out the reasons for the proposed suspension and the effective date; if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and gives the establishment a reasonable opportunity to be heard concerning the suspension. Despite subsection (2), the Minister may immediately suspend all or part of an authorization 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. When the Minister suspends an authorization under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the suspension; and Reinstatement Subject to subsection (2), the Minister must reinstate an authorization if the establishment provides the Minister with sufficient evidence to demonstrate that its processes will not compromise human safety and will result in blood that can be determined safe for distribution. Partial reinstatement If the Minister does not reinstate any part of an authorization that was suspended, the Minister must amend the authorization to remove that part. Cancellation The Minister must cancel an authorization in either of the following circumstances: the establishment fails to provide the Minister with the evidence described in paragraph 14(1)(b) within a reasonable period after the authorization was suspended; or the establishment’s licence is cancelled under section 29. When the Minister cancels an authorization, she or he must send the establishment a notice that sets out the reasons for the cancellation and the effective date. Establishment licence required An establishment that processes allogeneic blood — except, subject to subsection (2), blood from a pre-assessed donor — or that imports blood must have an establishment licence to do so. Test labs An establishment that tests blood from a pre-assessed donor for transmissible diseases or disease agents must have an establishment licence to do so. Application for establishment licence An establishment must file with the Minister an application for an establishment licence in the form established by the Minister. The application must be dated and signed by a senior executive officer and contain all of the following information: the applicant’s name and civic address, and its postal address if different; the civic address of each building in which records will be stored; in the case of an establishment that previously conducted its activities under another name, that other name; the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (d); a list of the establishment’s activities; a list of the whole blood and blood components in respect of which the activities are proposed to be conducted; 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; the name, civic address and licence number, if any, of any other establishment that it proposes to have conduct any of its activities; sufficient evidence to demonstrate that the establishment can conduct its activities in accordance with its quality management system and the requirements of these Regulations and that its activities will not compromise human safety or the safety of blood; in the case of an importer or an establishment that proposes to have any of its testing conducted by a foreign establishment, the information described in paragraphs (a) and (f) to (j) with respect to every foreign establishment that processes or distributes the blood that they propose to process or import; and in the case of an establishment that proposes to import blood in urgent circumstances, all of the information required by subsection 92(1). Inspection During the review of an application for an establishment licence, the Minister may inspect the establishment’s facilities and equipment to assess whether the applicant’s activities are conducted in accordance with its proposed authorization and with these Regulations. An establishment must provide the Minister, on written request, with any information that she or he determines is necessary to complete the inspection, by the date specified in the request. On completion of the review of an application, the Minister must issue an establishment licence, with or without terms or conditions, if both of the following requirements are met: an authorization has been issued with respect to the blood — except blood from a pre-assessed donor — that is proposed to be processed or imported under the licence; and the Minister determines that the application provides sufficient evidence to demonstrate that issuance of the licence will not compromise human safety or the safety of blood. The Minister may refuse to issue a licence if she or he determines that any of the information provided by the establishment in its application is inaccurate or incomplete. Changes requiring application to amend licence Before making any change that affects the information provided under any of paragraphs 18(1)(f) to (i), (k) and (l), the establishment must, subject to paragraph 23(b), file with the Minister an application to amend the licence. Applications Sections 18 to 21 apply to an application to amend a licence, with any necessary modifications. An establishment must notify the Minister in writing of the following changes: as soon as possible after any change is made to the information provided under any of paragraphs 18(1)(a) to (e); and within 30 days after the cessation of any licensed activity. Changes requiring amendment of licence by Minister The Minister must amend an establishment licence in any of the following circumstances: an authorization is amended in a way that affects the information provided by the establishment under any of paragraphs 18(1)(f) to (k); the Minister receives a notice from the establishment under paragraph 23(a) concerning a change to the information provided under paragraph 18(1)(a); the Minister receives a notice from the establishment under paragraph 23(b) that it has ceased one or more but not all of its licensed activities; or an authorization is cancelled, and the cancellation affects the information provided by the establishment under any of paragraphs 18(1)(f) to (k). The Minister may add terms and conditions to an establishment licence or amend its terms and conditions in either of the following circumstances: 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. 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. 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. 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. Additional information 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. The Minister may suspend all or part of an establishment licence in any of the following circumstances: information provided by the establishment under section 18 or 22 proves to be inaccurate or incomplete; 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 the establishment is not in compliance with these Regulations. Before suspending a licence, the Minister must send the establishment a notice that 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. When the Minister suspends a licence under subsection (3), the Minister must send the establishment a notice that 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 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. If the Minister does not reinstate any part of a licence that was suspended, the Minister must amend the licence to remove that part. The Minister must cancel an establishment licence in any of the following circumstances: the establishment notifies the Minister under paragraph 23(b) that it has ceased all activities under the licence; 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; the establishment’s compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations; or no authorization under which the establishment processes blood remains in effect. 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. Requirement to register 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 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. Application for registration 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: in the case of an establishment that previously conducted its activities under these Regulations under another name, that other name; the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (c); 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; 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; a statement of whether the establishment has a pre-assessed donor program; the name and civic address of any other establishment that it proposes to have conduct any of its activities; and a statement, dated and signed by a senior executive officer, that certifies both of the following: that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations, and that all of the information in the application is accurate and complete. Registration 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. 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. Changes — notice 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). 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. Annual statement of compliance 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. The Minister may cancel a registration in any of the following circumstances: the Minister receives a notice under section 33 that the establishment has ceased all of its activities that are the subject of the registration; information provided by the establishment under section 31 proves to be false or misleading; the establishment has not complied with a request for additional information made under section 36; the establishment fails to take any corrective action within the required period; or 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. Before cancelling a registration, the Minister must send the establishment a notice that sets out the reasons for the proposed cancellation and the effective date; gives the establishment a reasonable opportunity to be heard concerning the cancellation. 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. When the Minister cancels a registration under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the cancellation; Action by establishment on cancellation 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. Non-application — autologous donations Sections 39 to 44 do not apply to an autologous donation. Licensed establishments A licensed establishment that collects allogeneic blood must, before the collection, assess the donor’s suitability to donate against the establishment’s authorized criteria. Past unsuitability 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. Donor screening In conducting a donor suitability assessment, an establishment must take both of the following steps: 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 provide the donor with information about the risks associated with donating blood and the risks to the recipient of contracting a transmissible disease. Exclusion criteria 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. When donor determined unsuitable 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. When donor determined suitable If a donor is determined suitable to donate, the establishment must take both of the following steps: assign a donor identification code to the donor, if the donor does not already have one; and instruct the donor to inform the establishment in either of the following situations: 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 after the donation the donor has any reason to believe that their blood should not be used. Reassessment 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. 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. A licensed establishment that collects allogeneic blood must do so in accordance with its authorization. Donor identification code An establishment that collects autologous blood must assign a donor identification code to the donor. Donation code 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. Labelling of containers 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. Collection procedures An establishment that collects blood must conduct the collection in the following way: use aseptic methods; use collection equipment that is licensed under the Medical Devices Regulations; use containers that are licensed under the Medical Devices Regulations and free from defects or damage; and record the container lot number in the records and link it to the donation code. Reuse of containers prohibited An establishment must ensure that the containers that it uses are used only once. Samples 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. Autologous donations An establishment that collects autologous blood must comply with the criteria set out in section 12.2.1 of the standard; and when appropriate, adjust the volume of the blood collected and the volume of anticoagulant based on the donor’s weight. Authorization A licensed establishment that tests allogeneic blood — except blood from a pre-assessed donor — must do so in accordance with an authorization. Autologous donations — transmissible disease testing 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. Autologous donations — ABO and Rh 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: the ABO group; and the Rh factor, including weak D testing when appropriate. Comparison of results 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 If the comparison indicates a discrepancy, the establishment must repeat the tests and must not transfuse the blood until the discrepancy is resolved. Medical devices 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: either for diagnosis or for screening donors, in the case of autologous blood; and for screening donors, in the case of blood that is collected from a pre-assessed donor. Test results — allogeneic blood 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: quarantine any blood that was collected from that donor at that donation; identify and quarantine any other implicated blood from the same donor in the establishment’s possession; and 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 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. A licensed establishment must prepare allogeneic blood components in accordance with its authorization. Registered establishments 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. Non-application — pre-assessed donors Sections 60 to 68 do not apply to the labelling of blood collected from a pre-assessed donor. Language requirement 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. General requirements A label must meet all of the following requirements: all information on the label must be accurate and must be presented clearly and legibly; it must be made using only adhesives and inks that will not permeate the container; it must be permanently affixed to the container; and in the case of a tag, it must be firmly attached to the container. Circular of information 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 Subsection (1) does not apply if the blood is transfused in the same establishment where it is collected. 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. Contents of label — blood for transfusion An establishment that collects blood for transfusion must ensure that all of the following information appears on the label of the blood: the establishment’s name and civic address; the establishment’s licence number, if it has one, or its registration number; the donation code; a statement of whether the donation is whole blood or a blood component, and if it is a component, its name; when appropriate, the ABO group and Rh factor of the blood; except in the case of apheresis, the approximate volume of the whole blood collected; the approximate volume of the contents of the container; the name of any anticoagulant or additive in the container; the recommended storage temperature; the expiry date and, if applicable, the time; in the case of blood for transfusion, a warning that the blood could transmit infectious agents; and 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. 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: the statement “For Autologous Use Only”; 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 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 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: the name, civic address and licence number of the establishment that collected the blood; the donation code; and the statement “Caution: For Manufacturing Use Only”. Aliquots 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: the name of the blood component; a code that identifies the aliquot; when appropriate, the ABO group and Rh factor of the blood; and the expiry date. Designated donations 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 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. Directed donations 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. Label verification An establishment that labels blood must verify that all of the information that it adds to the label is accurate and complete. Criteria — collecting establishment An establishment that collects blood must store the blood in accordance with the following: in the case of a licensed establishment, its authorization; and in the case of a registered establishment, the storage and expiration criteria specified in Table 2 of the standard. Criteria — receiving establishment An establishment that receives blood from another establishment must store it in accordance with the directions on its label and with any other directions that are specified in writing by the establishment that collected it. Storage location An establishment that stores blood must do so in a location that has appropriate environmental conditions that maintain the safety of the blood and that is secure against the entry of unauthorized persons. Segregation — autologous, designated and directed donations An establishment that stores blood must ensure that blood that is intended for autologous, designated or directed use is segregated from blood that is intended for other allogeneic use. Segregation — untested or positive or reactive test results An establishment that stores blood must segregate all of the following blood from blood that has been determined safe for distribution or autologous transfusion under section 73: blood that is untested; blood for which the testing is incomplete or for which all of the test results are not yet available; and blood for which the test results on blood samples are positive or repeat reactive for transmissible disease agents or markers. Determination of safety — allogeneic blood An establishment that collects allogeneic blood must, before distributing it for transfusion or for use in the manufacture of a drug for human use, determine that it is safe for distribution once the establishment is satisfied that the blood has been processed in accordance with these Regulations. Determination of safety — autologous blood An establishment that collects autologous blood must, before distributing it for transfusion, determine that it is safe for autologous transfusion once the establishment is satisfied that the blood has been processed in accordance with these Regulations. Verification Before distributing blood for transfusion or for use in the manufacture of a drug for human use, an establishment must examine the container to verify all of the following: the information on the label is legible; the integrity of the container is intact; there are no signs of deterioration or contamination of the blood; and any frozen blood components show no signs of thawing. Prohibition — distribution An establishment must not distribute blood for transfusion or for use in the manufacture of a drug for human use if the verification carried out under subsection (1) indicates any of the following: the donation code is missing or illegible; any information — other than the donation code — that is required by these Regulations to appear on the label of blood is missing or is illegible, unless the missing or illegible information can be retrieved from the establishment’s records; the container is defective or damaged to the extent that it does not protect the blood against external conditions; or there are signs of deterioration or contamination of the blood. Shipping containers An establishment that ships blood must examine the blood containers before shipping to verify the integrity of the container and the legibility of the labels; and use shipping containers that are capable of resisting damage and maintaining the safety of the blood. Storage during transportation An establishment that ships blood for transfusion must ensure that the blood is stored during transportation in accordance with the criteria specified in Table 2 of the standard. Transformation methods An establishment that transforms blood must do so using safe and effective methods. Washing An establishment that washes blood must do so in accordance with sections 7.5.2.3 and 7.5.3 of the standard. Labels An establishment that washes blood must amend the label to add to it a mention of the washing and any new expiry date and time. Pooling An establishment that pools blood components must do so in accordance with sections 7.11.1 and 7.11.3 of the standard. An establishment that pools blood components must ensure that all of the information specified in sections 10.8.2 and 10.8.3 of the standard appears on the label of the pooled components. Irradiation An establishment that irradiates blood must do so in accordance with sections 7.12.2 to 7.12.6 of the standard. Conditions An establishment may distribute or transfuse allogeneic blood for transfusion for which the test results for ABO group, Rh factor and transmissible diseases or disease agents are not yet available if both of the following conditions are met: blood that has been determined safe for distribution is not immediately available; and the recipient’s physician requests the blood for use in the emergency treatment of their patient. Notice of exceptional distribution An establishment that distributes blood under section 81 must complete a notice of exceptional distribution that contains all of the following information:

the name of the establishment and the signature of the medical director; a statement of whether the blood was whole blood or a blood component, and if it was a component, its name; a list of the test results that were not available at the time of the distribution; the name and signature of the recipient’s physician; the justification for the distribution; the name of the establishment to which it distributed the blood; and the date and time of the distribution. Notice in establishments’ records The establishment must keep the notice in its records and send a copy of it to the establishment to which it distributed the blood. Notice to be forwarded If the establishment to which the blood is distributed does not perform the transfusion, it must send a copy of the notice to the establishment where the transfusion is performed. Notice in recipient’s file The establishment where the transfusion is performed must keep the notice in the recipient’s file. Labelling 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. Follow-up 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. Results to be forwarded 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. When blood not transfused 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. Program characteristics An establishment that has a pre-assessed donor program must ensure that the program has both of the following characteristics: it is carried out under the supervision of a medical director; and it is used only when no other alternative source of blood appropriate for the recipient is available, and 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. Regular donor assessment and testing An establishment that has a pre-assessed donor program must take both of the following steps every three months: assess the suitability of every donor in the program in accordance with sections 40 to 44; and take blood samples from every donor and test them for all of the following: the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard, the ABO group, the Rh factor, including weak D testing when appropriate, and clinically significant antibodies. 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. 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. At each collection An establishment that collects blood from a pre-assessed donor must take all of the following steps at each collection: assess the suitability of the donor; assign a donation code to the blood collected and link the code in its records to the donor identification code; and take a sample of blood from the donor and test it within 72 hours for all of the following: 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. 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. Information — before importation 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: the information required by paragraphs 6(1)(a) and (j) with respect to each foreign establishment that processes blood that it proposes to import; a copy of the circular of information for the blood that is proposed to be imported, or an equivalent document; 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; a description of how post-donation information described in paragraph 44(1)(b) is evaluated in the foreign jurisdiction; a description of the conditions of storage and transportation of the blood that is proposed to be imported, both before and after its importation; a description of how the establishment proposes to identify the blood as having been imported in urgent circumstances; and a description of how errors, accidents and adverse reactions are investigated and reported in the foreign jurisdiction. Information — at each importation At the time of each importation described in subsection (1), the establishment must provide the Minister with the following information: a written justification that demonstrates the existence of urgent circumstances; and a description of any further processing or labelling that may need to be done to the blood before its transfusion. Meaning of urgent circumstances 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. Organizational structure A licensed or registered establishment must have an organizational structure that sets out the responsibility of management for all activities that the establishment conducts. Oversight The establishment must have an effective quality management system, and must name an individual who has responsibility for it. Periodic review 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. Requirements The quality management system must include all of the following elements: a quality assurance unit; a quality control program; a change control system; a process control program, within the meaning of section 3.1 of the standard; a system for process improvement through complaint monitoring and the implementation of corrective and preventive actions; 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; a program for the training and competency-evaluation of personnel; a proficiency testing program for the evaluation of the accuracy and reliability of test results; a document control and records management system; an internal audit system; emergency contingency plans; a system that uniquely identifies all critical equipment and supplies; written specifications for all critical equipment, supplies and services; a program for the preventive maintenance of critical equipment; and a program for process validation. Separation of functions The establishment’s quality assurance unit must be a distinct organizational unit that functions and reports to management independently of any other functional unit. 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 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. The operating procedures must meet all of the following requirements: be in a standardized format; be approved by a senior executive officer; be readily accessible at all locations where the activities to which they relate are conducted; and be kept up to date. 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 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. Competency An establishment must have a program for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency. Facilities A licensed or registered establishment must have facilities that permit all of the following: the conduct of all of its activities; the performance by personnel of their respective tasks using proper hygiene; the cleaning of the facilities in a way that maintains sanitary conditions; environmental controls that are appropriate to all areas where its activities are conducted; controlled access to all areas where its activities are conducted; and donor screening to be conducted in privacy. Equipment 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. Repair or change The establishment must, whenever necessary after it repairs or makes any change to critical equipment, revalidate and recalibrate the equipment, as appropriate. Storage equipment An establishment must use equipment to store blood that enables the establishment to meet the requirements of sections 69 to 72. 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 or accident of another establishment 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: determine the donation codes of the implicated blood; identify and quarantine any implicated blood in its possession; and notify all of the following establishments: the establishment that collected the implicated blood, the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and any establishment to which it distributed implicated blood. Contents of notice The notice must include all of the following information: the donation codes of the implicated blood; a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and the reason for the establishment’s belief that the safety of the blood may have been compromised. Action on receipt of notice 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. Written notice If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards. Establishment’s own error or accident 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: determine whether there is sufficient evidence to warrant proceeding to an investigation into the suspected error or accident. When no investigation — notice 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. 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. Notice of investigation 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: the donation codes of all implicated blood; and a description of the suspected error or accident and an explanation of how the safety of the implicated blood may have been compromised. 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. Requirement to cooperate 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. Communication 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. Investigation results 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. 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. Reports to Minister An establishment that is conducting an investigation into a suspected error or accident that is thought to have occurred during an activity that it conducted and that is identified after the blood is distributed or transfused must file the reports described in subsection (2) with the Minister if there is a reasonable probability that the error or accident could lead to a serious adverse reaction. Contents and timing The reports must include the following information and be filed at the following times: a preliminary report that includes all relevant information that is available, within 24 hours after the start of the investigation; and a written update on any new information about the suspected error or accident, on the progress made in the investigation since the last report and on the steps taken to mitigate further risks, within 15 days after the start of the investigation, and on request of the Minister at any time after the preliminary report. If the report under paragraph (2)(a) is given verbally, a written report must be filed as soon as possible afterwards. Final report to Minister On completion of an investigation, the establishment must file a final report with the Minister that contains all of the following information: the results of the investigation; the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and any corrective actions taken and any other changes that are recommended to be made to relevant processes. Annual report An establishment must prepare an annual report that summarizes all of the error and accident investigations that it conducted in the previous 12 months, including a concise critical analysis of those investigations, and must file it with the Minister on request. When to notify Minister If the analysis reveals a previously unidentified risk to the safety of blood, the establishment must notify the Minister immediately. Additional reports An establishment must, on the Minister’s request, file additional reports described in subsection (1) in respect of the period specified in the request. Notice to Minister An establishment that has reasonable grounds to believe that a donor has experienced a serious adverse reaction during a donation or within 72 hours after a donation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of the donor or within 15 days after it learns of the adverse reaction in any other case. The notice must contain all of the following information: a description of the adverse reaction; any actions that were taken to address it; and the outcome. Required action Subject to section 111, an establishment that has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction must immediately take all of the following actions: determine the donation codes of all implicated blood; identify and quarantine any implicated blood in its possession; if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction and notify any establishment to which it distributed implicated blood; and if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity carried out by another establishment, notify all of the following establishments: the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and The notice required by paragraphs (1)(c) and (d) must contain all of the following information: an explanation of how the safety of the implicated blood may have been compromised, if known; the donation codes of all implicated blood; the name of any suspected transmissible disease or disease agent, if known. Quarantine An establishment that is notified under subsection (1) or under this subsection must immediately notify to the same effect every establishment and other person to which it distributed implicated blood and quarantine any implicated blood in its possession. Investigation An establishment that is notified under subparagraph (1)(d)(i) or (ii) must, if a preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity that it carried out, conduct an investigation into the adverse reaction. An establishment that both collects and transfuses the same autologous blood must, if it has reasonable grounds to believe that a recipient has experienced an unexpected adverse reaction or a serious adverse reaction, immediately quarantine any other blood from that donor in its possession and conduct an investigation into the adverse reaction and the implicated blood. An establishment must, on request, provide every establishment that is conducting an investigation with any relevant information in its possession in respect of blood that it distributed or transfused. An establishment that is conducting an investigation must notify the Minister of the adverse reaction within 24 hours after it learns of the death of a recipient or within 15 days after it learns of any other unexpected adverse reaction or serious adverse reaction. Results of investigation The 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. On completion of the investigation, the establishment must file a final report with the Minister that contains all of the following information: At the end of each year, an establishment must prepare an annual report that summarizes all of the final reports that it filed in the year, including a concise critical analysis of the investigations that were the subjects of those reports, and must file it with the Minister on request. Record quality Records kept by an establishment must be accurate, complete, legible, indelible and readily retrievable. Donation code part of all records An establishment must ensure that the donation code is a component of all of its records that relate to the processing, distribution, transformation and transfusion of blood. Retention periods — allogeneic blood An establishment that collects allogeneic blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. Calculation of record retention period The record retention period begins on the day on which the record is created, except for the personnel records set out in item 28 of the table, in which case the period begins on the last day on which the employee was last employed by the establishment. Retention periods — autologous blood An establishment that collects autologous blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. The record retention period begins on the day on which the record is created, except for the personnel records set out in item 18 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. Retention periods — transformation An establishment that transforms blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. The record retention period begins on the day on which the record is created, except for the personnel records set out in item 10 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. Retention periods — transfusion An establishment that transfuses blood must keep the records set out in column 1 of the table to this section for the period set out in column 2. The record retention period begins on the day on which the record is created, except for the personnel records set out in item 11 of the table, in which case the period begins on the last day on which the employee was employed by the establishment. Storage of records An establishment must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons. Making visual recordings An inspector may, in the administration of these Regulations, take photographs and make recordings of any of the following: any article that is referred to in subsection 23(2) of the Act; any place where the inspector believes on reasonable grounds any article referred to in paragraph (a) is processed, transformed or stored; and anything that the inspector believes on reasonable grounds is used or is capable of being used in the conduct of an establishment’s activities. [Amendment] Deemed authorization The information that is required by section 6 to be included in an application for an authorization and that was filed with and accepted by the Minister under sections C.01A.005 to C.01A.007 and C.01A.014 of the Food and Drug Regulations before the day on which these Regulations come into force is deemed to be an authorization issued by the Minister under section 7 of these Regulations. Licence continued If an establishment files an application for a licence under section 18 — without regard to paragraphs (1)(j) and (k) — within three months after the day on which these Regulations come into force, any licence that was issued to the establishment under section C.01A.008 of the Food and Drug Regulations before that day is continued until a licence is either issued under section 20 or refused under section 21 of these Regulations. Delayed registration An establishment that, before the day on which these Regulations come into force, conducts any of the activities mentioned in section 30 may continue to do so without a registration if it files an application for registration under section 31 within three months after that day. Duration Subsection (1) applies until the determination of the application under section 32. One year after publication These Regulations — except subsections 4(4) to (6), paragraph 64(1)(b) as it applies to registration numbers, and section 125 — come into force one year after the day on which they are published in the Canada Gazette, Part II. Subsections 4(4) to (6) and paragraph 64(1)(b) Subsections 4(4) to (6) and paragraph 64(1)(b), as it applies to registration numbers, come into force six months after the day on which these Regulations come into force. Section 125 Section 125 comes into force on the day on which these Regulations are registered. [Note: Regulations, except subsections 4(4) to (6), paragraph 64(1)(b) and section 125, in force October 23, 2014; subsections 4(4) to (6) and paragraph 64(1)(b) in force April 23, 2015.]