Blood Regulations (SOR/2013-178)

Interpretation

Marginal note:Definitions

1 The following definitions apply in these Regulations.

accident

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

Act means the Food and Drugs Act. (Loi)

adverse reaction

adverse reaction means an undesirable response that is associated with

• (a) in the case of a donor, the collection of blood; and

• (b) in the case of a recipient, the safety of the transfused blood. (effet indésirable)

allogeneic

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

authorization, in respect of any blood or process, means an authorization that is issued under section 7. (homologation)

autologous

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

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

circular of information means a document that describes all of the following in relation to blood:

• (a) the composition and properties of the blood;

• (b) directions for storage and for use; and

• (c) indications for use, contraindications, warnings and a list of possible adverse reactions. (document d’information)

critical

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

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

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

distribute does not include to transfuse. (distribution)

donation code

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

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

donor suitability assessment means an evaluation of a donor that is based on all of the following criteria:

• (a) the donor’s medical history;

• (b) the results of any donor tests and physical examination; and

• (c) 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

error means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood. (manquement)

establishment

establishment means a person that conducts any of the following activities in respect of blood:

• (a) importation;

• (b) processing;

• (c) distribution;

• (d) transformation; or

• (e) transfusion. (établissement)

human safety

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

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

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

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

processing means any of the following activities:

• (a) donor suitability assessment;

• (b) collection;

• (c) testing; or

• (d) blood component preparation. (traitement)

safety

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

• (a) in the case of blood for transfusion, its quality and efficacy; and

• (b) in the case of blood for use in the manufacture of a drug for human use, its quality. (sécurité)

serious adverse reaction

serious adverse reaction means an adverse reaction that results in any of the following consequences for the donor or recipient:

• (a) their in-patient hospitalization or its prolongation;

• (b) persistent or significant disability or incapacity;

• (c) medical or surgical intervention to preclude a persistent or significant disability or incapacity;

• (d) a life-threatening condition; or

• (e) death. (effet indésirable grave)

standard

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

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

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)

Application

Marginal note:Scope of Regulations

2 These Regulations apply to blood that is collected for transfusion or for use in the manufacture of a drug for human use.

Marginal note:Non-application — various therapeutic products

• 3 (1) These Regulations do not apply to any of the following therapeutic products:

  • (a) 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;

  • (b) blood that is the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations; or

  • (c) blood that is imported for use in the manufacture of a drug for human use.

• Marginal note:Non-application — regulations

  (2) 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.

• Marginal note:Non-application — imported rare phenotypes

  (3) Sections 4 to 124 do not apply to blood that is of a rare phenotype if it is imported pursuant to a prescription.

Prohibitions

Marginal note:Allogeneic blood

• 4 (1) 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).

• Marginal note:Exception — pre-assessed donor programs

  (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program.

• Marginal note:Exception — urgent circumstances

  (3) An establishment may, in urgent circumstances,

  • (a) import, in accordance with section 92, allogeneic blood that has not been processed in accordance with an authorization; and

  • (b) distribute or transfuse such blood if the importer imported it in accordance with section 92.

• Marginal note:Pre-assessed donors

  (4) 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.

• Marginal note:Transformations

  (5) An establishment must not distribute or transfuse blood that has been transformed unless the transformation is conducted by a registered establishment.

• Marginal note:Autologous blood

  (6) 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).

• Marginal note:Investigations

  (7) An establishment must not distribute or transfuse blood in either of the following circumstances:

  • (a) while the blood is in quarantine; or

  • (b) 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.

Authorizations, Establishment Licences and Registrations

Authorizations

Marginal note:Authorization — processing

• 5 (1) Except for an establishment that only tests blood, an establishment that processes allogeneic blood must have an authorization to do so.

• Marginal note:Exception — pre-assessed donor programs

  (2) Subsection (1) does not apply if the processing is conducted as part of a pre-assessed donor program.

• Marginal note:Authorization — importation

  (3) 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.

Marginal note:Application for authorization

• 6 (1) 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:

  • (a) 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;

  • (b) 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;

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

  • (d) a statement of whether the establishment proposes to import whole blood or blood components;

  • (e) a list of the whole blood and blood components that the establishment proposes to process or import;

  • (f) a list of the processing activities that are proposed to be conducted in each building;

  • (g) 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;

  • (h) 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;

  • (i) a draft of each proposed label and circular of information;

  • (j) evidence that any foreign establishment that it proposes to have conduct any of its processing activities is licensed in the foreign jurisdiction; and

  • (k) 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.

• Marginal note:Site inspection

  (2) During the review of an application, the Minister may inspect the establishment’s facilities to evaluate on site the information provided in the application.

• Marginal note:Information on request

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

Marginal note:Issuance

7 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.

Marginal note:Refusal

8 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.

Marginal note:Significant changes

• 9 (1) 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.

• Marginal note:Applications to amend

  (2) Sections 6 to 8 apply to an application to amend an authorization, with any necessary modifications.

• Meaning of significant change

  (3) In this section and sections 10 and 12, significant change means any of the following changes:

  • (a) the addition of blood or a blood component to the list required by paragraph 6(1)(e);

  • (b) the deletion of or a change to any authorized process;

  • (c) the addition of a process described in paragraph 6(1)(h); or

  • (d) a change to the description of the establishment’s facilities referred to in paragraph 6(1)(g).

Marginal note:Emergency changes

• 10 (1) 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.

• Marginal note:Notice and application

  (2) 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.

Marginal note:Administrative changes — notice

11 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.

Marginal note:Other changes — annual report

• 12 (1) 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.

• Marginal note:Amendment by Minister

  (2) On receipt of the report, the Minister must amend the establishment’s authorization accordingly.

• Marginal note:When changes determined significant

  (3) 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.

• Marginal note:Application to amend authorization

  (4) On receipt of the notice, the establishment must file an application to amend its authorization

Marginal note:New or amended terms and conditions

• 13 (1) The Minister may add terms and conditions to an establishment’s authorization 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 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.

• Marginal note:Notice

  (2) 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.

• Marginal note:Urgent circumstances

  (3) 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.

• Marginal note: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.

• Marginal note:Removal of terms and conditions

  (5) 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.

Marginal note:Suspension

• 14 (1) The Minister may suspend all or part of an authorization in either of the following circumstances:

  • (a) information provided by the establishment under section 6 or 9 proves to be inaccurate or incomplete; or

  • (b) 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.

• Marginal note:Notice

  (2) Before suspending an authorization, 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.

• Marginal note:Urgent circumstances

  (3) 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.

• Marginal note:Urgent circumstances — notice

  (4) When the Minister suspends an authorization 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.

Marginal note:Reinstatement

• 15 (1) 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.

• Marginal note:Partial reinstatement

  (2) If the Minister does not reinstate any part of an authorization that was suspended, the Minister must amend the authorization to remove that part.

Marginal note:Cancellation

• 16 (1) The Minister must cancel an authorization in either of the following circumstances:

  • (a) 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

  • (b) the establishment’s licence is cancelled under section 29.

• Marginal note:Notice

  (2) 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 Licences

Marginal note:Establishment licence required

• 17 (1) 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.

• Marginal note:Test labs

  (2) An establishment that tests blood from a pre-assessed donor for transmissible diseases or disease agents must have an establishment licence to do so.

Marginal note:Application for establishment licence

• 18 (1) 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:

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

  • (b) the civic address of each building in which records will be stored;

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

  • (d) 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;

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

  • (f) a list of the establishment’s activities;

  • (g) a list of the whole blood and blood components in respect of which the activities are proposed to be conducted;

  • (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, civic address and licence number, if any, of any other establishment that it proposes to have conduct any of its activities;

  • (j) 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;

  • (k) 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

  • (l) in the case of an establishment that proposes to import blood in urgent circumstances, all of the information required by subsection 92(1).

• Marginal note:Information on request

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

Marginal note:Inspection

• 19 (1) 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.

• Marginal note:Information on request

  (2) 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.

Marginal note:Issuance

20 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:

• (a) 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

• (b) 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.

Marginal note:Refusal

21 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.

Marginal note:Changes requiring application to amend licence

• 22 (1) 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.

• Marginal note:Applications

  (2) Sections 18 to 21 apply to an application to amend a licence, with any necessary modifications.

Marginal note:Administrative changes — notice

23 An establishment must notify the Minister in writing of the following changes:

• (a) as soon as possible after any change is made to the information provided under any of paragraphs 18(1)(a) to (e); and

• (b) within 30 days after the cessation of any licensed activity.

Marginal note:Changes requiring amendment of licence by Minister

24 The Minister must amend an establishment licence in any of the following circumstances:

• (a) an authorization is amended in a way that affects the information provided by the establishment under any of paragraphs 18(1)(f) to (k);

• (b) the Minister receives a notice from the establishment under paragraph 23(a) concerning a change to the information provided under paragraph 18(1)(a);

• (c) 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

• (d) an authorization is cancelled, and the cancellation affects the information provided by the establishment under any of paragraphs 18(1)(f) to (k).

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note:Reinstatement

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

• Marginal note:Exception — compliance history

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

• Marginal note:Partial reinstatement

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

Marginal note:Cancellation

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

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

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

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

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

• Marginal note:Notice

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

Registration

Marginal note:Requirement to register

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

• Marginal note:Exceptions

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

Marginal note:Application for registration

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

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

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

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

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

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

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

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

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

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

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

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

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

• Marginal note:Information on request

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

Marginal note:Registration

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

• Marginal note:Refusal

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

Marginal note:Changes — notice

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

Marginal note:Amendment by Minister

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

Marginal note:Annual statement of compliance

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

Marginal note:Additional information

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

Marginal note:Cancellation

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

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

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

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

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

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

• Marginal note:Notice

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

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

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

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

• Marginal note:Urgent circumstances

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

• Marginal note:Urgent circumstances — notice

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

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

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

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

• Marginal note:Action by establishment on cancellation

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

Processing

Donor Suitability Assessment

Marginal note:Non-application — autologous donations

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

Marginal note:Licensed establishments

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

Marginal note:Past unsuitability

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

Marginal note:Donor screening

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

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

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

Marginal note:Exclusion criteria

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

Marginal note:When donor determined unsuitable

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

Marginal note:When donor determined suitable

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

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

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

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

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

• Marginal note:Reassessment

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

• Marginal note:Notice

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

Collection

Marginal note:Licensed establishments

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

Marginal note:Donor identification code

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

Marginal note:Donation code

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

Marginal note:Labelling of containers

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

Marginal note:Collection procedures

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

  • (a) use aseptic methods;

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

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

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

• Marginal note:Reuse of containers prohibited

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

Marginal note:Samples

50 An establishment that collects blood must obtain samples of blood for testing at the same time as the collection in a way that avoids contamination of the donated blood and the samples.

Marginal note:Autologous donations

51 An establishment that collects autologous blood must

• (a) comply with the criteria set out in section 12.2.1 of the standard; and

• (b) when appropriate, adjust the volume of the blood collected and the volume of anticoagulant based on the donor’s weight.

Testing

Marginal note:Authorization

52 A licensed establishment that tests allogeneic blood — except blood from a pre-assessed donor — must do so in accordance with an authorization.

Marginal note:Autologous donations — transmissible disease testing

53 An establishment that collects autologous blood must test a sample of the blood using appropriate and effective tests for transmissible diseases and disease agents in accordance with section 12.3.1.2 of the standard.

Marginal note:Autologous donations — ABO and Rh

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

  • (a) the ABO group; and

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

• Marginal note:Comparison of results

  (2) The establishment must compare the results of the tests conducted under paragraphs (1)(a) and (b) with the last available results, if any, for that donor.

• Marginal note:Discrepancies

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

Marginal note: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.

Marginal note: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.

• Marginal note: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 Component Preparation

Marginal note:Licensed establishments

57 A licensed establishment must prepare allogeneic blood components in accordance with its authorization.

Marginal note: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.

Labelling

Marginal note:Non-application — pre-assessed donors

59 Sections 60 to 68 do not apply to the labelling of blood collected from a pre-assessed donor.

Marginal note: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.

Marginal note: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.

Marginal note: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.

• Marginal note:Exception

  (2) Subsection (1) does not apply if the blood is transfused in the same establishment where it is collected.

Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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”.

Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note: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.

Storage

Marginal note:Criteria — collecting establishment

• 69 (1) An establishment that collects blood must store the blood in accordance with the following:

  • (a) in the case of a licensed establishment, its authorization; and

  • (b) in the case of a registered establishment, the storage and expiration criteria specified in Table 2 of the standard.

• Marginal note:Criteria — receiving establishment

  (2) 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.

Marginal note:Storage location

70 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.

Marginal note:Segregation — autologous, designated and directed donations

71 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.

Marginal note:Segregation — untested or positive or reactive test results

72 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:

• (a) blood that is untested;

• (b) blood for which the testing is incomplete or for which all of the test results are not yet available; and

• (c) blood for which the test results on blood samples are positive or repeat reactive for transmissible disease agents or markers.

Distribution

Marginal note:Determination of safety — allogeneic blood

• 73 (1) 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.

• Marginal note:Determination of safety — autologous blood

  (2) 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.

Marginal note:Verification

• 74 (1) 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:

  • (a) the information on the label is legible;

  • (b) the integrity of the container is intact;

  • (c) there are no signs of deterioration or contamination of the blood; and

  • (d) any frozen blood components show no signs of thawing.

• Marginal note:Prohibition — distribution

  (2) 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:

  • (a) the donation code is missing or illegible;

  • (b) 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;

  • (c) the container is defective or damaged to the extent that it does not protect the blood against external conditions; or

  • (d) there are signs of deterioration or contamination of the blood.

Marginal note:Shipping containers

75 An establishment that ships blood must

• (a) examine the blood containers before shipping to verify the integrity of the container and the legibility of the labels; and

• (b) use shipping containers that are capable of resisting damage and maintaining the safety of the blood.

Marginal note:Storage during transportation

76 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

Marginal note:Transformation methods

77 An establishment that transforms blood must do so using safe and effective methods.

Marginal note:Washing

• 78 (1) An establishment that washes blood must do so in accordance with sections 7.5.2.3 and 7.5.3 of the standard.

• Marginal note:Labels

  (2) 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.

Marginal note:Pooling

• 79 (1) An establishment that pools blood components must do so in accordance with sections 7.11.1 and 7.11.3 of the standard.

• Marginal note:Labels

  (2) 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.

Marginal note:Irradiation

80 An establishment that irradiates blood must do so in accordance with sections 7.12.2 to 7.12.6 of the standard.

Exceptional Distribution, Pre-Assessed Donor Programs and Importation in Urgent Circumstances

Exceptional Distribution

Marginal note:Conditions

81 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:

• (a) blood that has been determined safe for distribution is not immediately available; and

• (b) the recipient’s physician requests the blood for use in the emergency treatment of their patient.

Marginal note:Notice of exceptional distribution

• 82 (1) An establishment that distributes blood under section 81 must complete a notice of exceptional distribution that contains all of the following information:

  • (a) the name of the establishment and the signature of the medical director;

  • (b) the donation code;

  • (c) a statement of whether the blood was whole blood or a blood component, and if it was a component, its name;

  • (d) a list of the test results that were not available at the time of the distribution;

  • (e) the name and signature of the recipient’s physician;

  • (f) the justification for the distribution;

  • (g) the name of the establishment to which it distributed the blood; and

  • (h) the date and time of the distribution.

• Marginal note:Notice in establishments’ records

  (2) The establishment must keep the notice in its records and send a copy of it to the establishment to which it distributed the blood.

• Marginal note:Notice to be forwarded

  (3) 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.

• Marginal note:Notice in recipient’s file

  (4) The establishment where the transfusion is performed must keep the notice in the recipient’s file.

Marginal note:Labelling

83 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.

Marginal note:Follow-up

• 84 (1) 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.

• Marginal note:Results to be forwarded

  (2) 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.

Marginal note:When blood not transfused

85 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.

Pre-assessed Donor Programs

Marginal note:Program characteristics

86 An establishment that has a pre-assessed donor program must ensure that the program has both of the following characteristics:

• (a) it is carried out under the supervision of a medical director; and

• (b) it is used only when

  • (i) no other alternative source of blood appropriate for the recipient is available, and

  • (ii) the recipient’s physician requests the blood for use in the emergency treatment of their patient.

Marginal note:Donor identification code

87 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.

Marginal note:Regular donor assessment and testing

• 88 (1) An establishment that has a pre-assessed donor program must take both of the following steps every three months:

  • (a) assess the suitability of every donor in the program in accordance with sections 40 to 44; and

  • (b) take blood samples from every donor and test them for all of the following:

    • (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard,

    • (ii) the ABO group,

    • (iii) the Rh factor, including weak D testing when appropriate, and

    • (iv) clinically significant antibodies.

• Marginal note:Comparison of results

  (2) 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.

• Marginal note:Discrepancies

  (3) 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.

Marginal note:At each collection

89 An establishment that collects blood from a pre-assessed donor must take all of the following steps at each collection:

• (a) assess the suitability of the donor;

• (b) assign a donation code to the blood collected and link the code in its records to the donor identification code; and

• (c) take a sample of blood from the donor and test it within 72 hours for all of the following:

  • (i) the transmissible diseases and disease agents listed in sections 8.4.1 and 8.4.2 of the standard,

  • (ii) the ABO group,

  • (iii) the Rh factor, including weak D testing when appropriate, and

  • (iv) clinically significant antibodies.

Marginal note:Labelling

90 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.

Marginal note:When blood not transfused

91 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.

Importation in Urgent Circumstances

Marginal note:Information — before importation

• 92 (1) 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:

  • (a) the information required by paragraphs 6(1)(a) and (j) with respect to each foreign establishment that processes blood that it proposes to import;

  • (b) a copy of the circular of information for the blood that is proposed to be imported, or an equivalent document;

  • (c) 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;

  • (d) a description of how post-donation information described in paragraph 44(1)(b) is evaluated in the foreign jurisdiction;

  • (e) a description of the conditions of storage and transportation of the blood that is proposed to be imported, both before and after its importation;

  • (f) a description of how the establishment proposes to identify the blood as having been imported in urgent circumstances; and

  • (g) a description of how errors, accidents and adverse reactions are investigated and reported in the foreign jurisdiction.

• Marginal note:Information — at each importation

  (2) At the time of each importation described in subsection (1), the establishment must provide the Minister with the following information:

  • (a) a written justification that demonstrates the existence of urgent circumstances; and

  • (b) a description of any further processing or labelling that may need to be done to the blood before its transfusion.

• Meaning of urgent circumstances

  (3) 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.

Quality Management

Quality Management System

Marginal note:Organizational structure

• 93 (1) A licensed or registered establishment must have an organizational structure that sets out the responsibility of management for all activities that the establishment conducts.

• Marginal note:Oversight

  (2) The establishment must have an effective quality management system, and must name an individual who has responsibility for it.

• Marginal note:Periodic review

  (3) 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.

Marginal note:Requirements

• 94 (1) The quality management system must include all of the following elements:

  • (a) a quality assurance unit;

  • (b) a quality control program;

  • (c) a change control system;

  • (d) a process control program, within the meaning of section 3.1 of the standard;

  • (e) a system for process improvement through complaint monitoring and the implementation of corrective and preventive actions;

  • (f) 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;

  • (g) a program for the training and competency-evaluation of personnel;

  • (h) a proficiency testing program for the evaluation of the accuracy and reliability of test results;

  • (i) a document control and records management system;

  • (j) an internal audit system;

  • (k) emergency contingency plans;

  • (l) a system that uniquely identifies all critical equipment and supplies;

  • (m) written specifications for all critical equipment, supplies and services;

  • (n) a program for the preventive maintenance of critical equipment; and

  • (o) a program for process validation.

• Marginal note:Separation of functions

  (2) The establishment’s quality assurance unit must be a distinct organizational unit that functions and reports to management independently of any other functional unit.

• Marginal note:Exception

  (3) 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

Marginal note:Operating procedures required

95 An establishment must have operating procedures for all of the activities that it conducts with respect to human safety and the safety of blood.

Marginal note:Requirements

96 The operating procedures must meet all of the following requirements:

• (a) be in a standardized format;

• (b) be approved by a senior executive officer;

• (c) be readily accessible at all locations where the activities to which they relate are conducted; and

• (d) be kept up to date.

Marginal note:Documented evidence

97 An establishment must have documented evidence that demonstrates that the operating procedures that it uses in processing and transforming blood will consistently lead to the expected results.

Personnel, Facilities, Equipment and Supplies

Marginal note:Personnel

• 98 (1) An establishment must have sufficient personnel, who must be qualified by their education, training or experience to perform their respective tasks, to conduct the establishment’s activities.

• Marginal note:Competency

  (2) An establishment must have a program for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency.

Marginal note:Facilities

99 A licensed or registered establishment must have facilities that permit all of the following:

• (a) the conduct of all of its activities;

• (b) the performance by personnel of their respective tasks using proper hygiene;

• (c) the cleaning of the facilities in a way that maintains sanitary conditions;

• (d) environmental controls that are appropriate to all areas where its activities are conducted;

• (e) controlled access to all areas where its activities are conducted; and

• (f) donor screening to be conducted in privacy.

Marginal note:Equipment

• 100 (1) A licensed or registered establishment must ensure that the critical equipment that it uses is cleaned and maintained and, as appropriate, validated for its intended purpose and calibrated.

• Marginal note:Repair or change

  (2) The establishment must, whenever necessary after it repairs or makes any change to critical equipment, revalidate and recalibrate the equipment, as appropriate.

Marginal note:Storage equipment

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

Marginal note:Supplies

102 A licensed or registered establishment must ensure that the critical supplies that it uses are validated or qualified, as applicable, for their intended use and must store them under appropriate environmental conditions.

Error and Accident Investigation and Reporting

Errors and Accidents

Marginal note:Error or accident of another establishment

• 103 (1) An establishment that has reasonable grounds to believe that the safety of blood may have been compromised by the occurrence of an error or accident during an activity conducted by another establishment must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) notify all of the following establishments:

    • (i) the establishment that collected the implicated blood,

    • (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and

    • (iii) any establishment to which it distributed implicated blood.

• Marginal note:Contents of notice

  (2) The notice must include all of the following information:

  • (a) the donation codes of the implicated blood;

  • (b) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and

  • (c) the reason for the establishment’s belief that the safety of the blood may have been compromised.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subparagraph (1)(c)(iii) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

  (4) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Establishment’s own error or accident

• 104 (1) An establishment that receives a notice under subparagraph 103(1)(c)(i) or (ii) or suspects that an error or accident that occurred during an activity it conducted may have compromised the safety of blood must immediately take all of the following actions:

  • (a) determine the donation codes of the implicated blood;

  • (b) identify and quarantine any implicated blood in its possession; and

  • (c) determine whether there is sufficient evidence to warrant proceeding to an investigation into the suspected error or accident.

• Marginal note:When no investigation — notice

  (2) If the establishment determines that an investigation is not warranted, it must notify the establishment that sent it the notice under subparagraph 103(1)(c)(i) or (ii) that it will not be conducting an investigation and provide its reasons for that decision.

• Marginal note:Action on receipt of notice

  (3) An establishment that is notified under subsection (2) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood.

• Marginal note:Notice of investigation

  (4) If the establishment determines that an investigation is warranted, it must begin the investigation, notify every establishment and other person to which it distributed implicated blood, and include the following information in the notice:

  • (a) the donation codes of all implicated blood; and

  • (b) a description of the suspected error or accident and an explanation of how the safety of the implicated blood may have been compromised.

• Marginal note:Action on receipt of notice

  (5) An establishment that is notified under subsection (4) or under this subsection must immediately notify to the same effect every establishment to which it distributed implicated blood and quarantine all implicated blood in its possession.

• Marginal note:Written notice

  (6) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Investigation and Reporting

Marginal note:Requirement to cooperate

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

• Marginal note:Communication

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

Marginal note:Investigation results

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

• Marginal note:Notice to be forwarded

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

Marginal note:Reports to Minister

• 107 (1) 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.

• Marginal note:Contents and timing

  (2) The reports must include the following information and be filed at the following times:

  • (a) a preliminary report that includes all relevant information that is available, within 24 hours after the start of the investigation; and

  • (b) 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,

    • (i) within 15 days after the start of the investigation, and

    • (ii) on request of the Minister at any time after the preliminary report.

• Marginal note:Written notice

  (3) If the report under paragraph (2)(a) is given verbally, a written report must be filed as soon as possible afterwards.

• Marginal note:Final report to Minister

  (4) On completion of an investigation, the establishment must file a final report with the Minister that contains all of the following information:

  • (a) the results of the investigation;

  • (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and

  • (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.

Marginal note:Annual report

• 108 (1) 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.

• Marginal note:When to notify Minister

  (2) If the analysis reveals a previously unidentified risk to the safety of blood, the establishment must notify the Minister immediately.

• Marginal note:Additional reports

  (3) An establishment must, on the Minister’s request, file additional reports described in subsection (1) in respect of the period specified in the request.

Adverse Reaction Investigation and Reporting

Adverse Donor Reactions

Marginal note:Notice to Minister

• 109 (1) 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.

• Marginal note:Contents of notice

  (2) The notice must contain all of the following information:

  • (a) a description of the adverse reaction;

  • (b) any actions that were taken to address it; and

  • (c) the outcome.

• Marginal note:Written notice

  (3) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Adverse Recipient Reactions

Marginal note:Required action

• 110 (1) 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:

  • (a) determine the donation codes of all implicated blood;

  • (b) identify and quarantine any implicated blood in its possession;

  • (c) 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

  • (d) 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:

    • (i) the establishment that collected the implicated blood,

    • (ii) the establishment from which it received the implicated blood, if different from the establishment mentioned in subparagraph (i), and

    • (iii) any establishment to which it distributed implicated blood.

• Marginal note:Contents of notice

  (2) The notice required by paragraphs (1)(c) and (d) must contain all of the following information:

  • (a) a description of the adverse reaction;

  • (b) an explanation of how the safety of the implicated blood may have been compromised, if known;

  • (c) the donation codes of all implicated blood;

  • (d) a statement of whether the implicated blood is whole blood or blood components, and the names of the implicated blood components; and

  • (e) the name of any suspected transmissible disease or disease agent, if known.

• Marginal note:Quarantine

  (3) 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.

• Marginal note:Investigation

  (4) 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.

• Marginal note:Written notice

  (5) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Autologous donations

111 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.

Investigation and Reporting of Adverse Recipient Reactions

Marginal note:Requirement to cooperate

112 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.

Marginal note:Notice to Minister

• 113 (1) 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.

• Marginal note:Written notice

  (2) If a notice under this section is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note:Results of investigation

• 114 (1) 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.

• Marginal note:Notice to be forwarded

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

Marginal note:Final report to Minister

115 On completion of the investigation, the establishment must file a final report with the Minister that contains all of the following information:

• (a) the results of the investigation;

• (b) the final disposition of the blood that was the subject of the investigation and the reasons for that disposition; and

• (c) any corrective actions taken and any other changes that are recommended to be made to relevant processes.

Marginal note:Annual report

116 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.

Records

Marginal note:Record quality

117 Records kept by an establishment must be accurate, complete, legible, indelible and readily retrievable.

Marginal note:Donation code part of all records

118 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.

Marginal note:Retention periods — allogeneic blood

• 119 (1) 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.

• Marginal note:Calculation of record retention period

  (2) 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.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	50 years
  2	Donation code	50 years
  3	Reconciliation of donation codes	10 years
  4	Donor suitability assessment	5 years
  5	Determinations of donor unsuitability — indefinite	50 years
  6	Determinations of donor unsuitability — temporary	10 years
  7	Collection — date of donation	50 years
  8	Collection — donor apheresis	5 years
  9	Collection — record of donation	5 years
  10	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  11	Test results for transmissible disease testing, ABO group and Rh factor, and clinically significant antibody testing	50 years
  12	Blood component preparation	10 years
  13	Blood storage temperature monitoring	5 years
  14	Destruction or other disposition of blood	50 years
  15	Distribution	50 years
  16	Shipping documents	1 year
  17	Exceptional distribution	50 years
  18	Importation in urgent circumstances	50 years
  19	Post-donation information	10 years
  20	Complaints and their investigation	5 years
  21	Internal audit reports	5 years
  22	Quality control testing	5 years
  23	Maintenance, validation, qualification and calibration of critical equipment	3 years
  24	Critical supplies, including their qualification	3 years
  25	Proficiency testing	5 years
  26	Every version of the operating procedures that was implemented, other than those related to donor suitability assessments	10 years
  27	Every version of the operating procedures related to donor suitability assessments	50 years
  28	Personnel qualifications, training and competency evaluation	10 years
  29	Investigations and reports of errors and accidents	10 years
  30	Investigations and reports of adverse reactions	10 years

Marginal note:Retention periods — autologous blood

• 120 (1) 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.

• Marginal note:Calculation of record retention period

  (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.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donor identification code	10 years
  2	Donation code	10 years
  3	Collection — donor record	5 years
  4	Lot number and name of manufacturer of container and other critical supplies for each donation	1 year
  5	Test results for transmissible disease testing, ABO group and Rh factor	10 years
  6	Blood component preparation	10 years
  7	Blood storage temperature monitoring	5 years
  8	Destruction or other disposition of blood	10 years
  9	Distribution	10 years
  10	Shipping documents	1 year
  11	Complaints and their investigation	5 years
  12	Internal audit reports	5 years
  13	Quality control testing	5 years
  14	Maintenance, validation, qualification and calibration of critical equipment	3 years
  15	Critical supplies, including their qualification	3 years
  16	Proficiency testing	5 years
  17	Every version of the operating procedures that was implemented	10 years
  18	Personnel qualifications, training and competency evaluation	10 years
  19	Investigations and reports of errors and accidents	10 years
  20	Investigations and reports of adverse reactions	10 years

Marginal note:Retention periods — transformation

• 121 (1) 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.

• Marginal note:Calculation of record retention period

  (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.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donation code	10 years
  2	Records of washing, pooling and irradiation of blood	10 years
  3	Lot number and name of manufacturer of critical supplies for each transformation	1 year
  4	Complaints and their investigation	5 years
  5	Internal audit reports	5 years
  6	Quality control testing	5 years
  7	Maintenance, validation, qualification and calibration of critical equipment	3 years
  8	Critical supplies, including their qualification	3 years
  9	Every version of the operating procedures that was implemented	10 years
  10	Personnel qualifications, training and competency evaluation	10 years
  11	Investigations and reports of errors and accidents	10 years
  12	Investigations and reports of adverse reactions	10 years

Marginal note:Retention periods — transfusion

• 122 (1) 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.

• Marginal note:Calculation of record retention period

  (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.

  Item	Column 1	Column 2
  	Records	Retention period
  1	Donation code — allogeneic blood	50 years
  2	Donation code — autologous blood	10 years
  3	Shipping documents	1 year
  4	Blood storage temperature monitoring	5 years
  5	Distribution	50 years
  6	Exceptional distribution	50 years
  7	Record of transfusion or disposition of allogeneic blood, including identification of recipient	50 years
  8	Record of transfusion or disposition of autologous blood	10 years
  9	Complaints and their investigation	5 years
  10	Every version of the operating procedures that was implemented	10 years
  11	Personnel qualifications, training and competency evaluation	10 years
  12	Investigations and reports of errors and accidents	10 years
  13	Investigations and reports of adverse reactions	10 years

Marginal note:Storage of records

123 An establishment must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.

Powers of Inspectors

Marginal note:Making visual recordings

124 An inspector may, in the administration of these Regulations, take photographs and make recordings of any of the following:

• (a) any article that is referred to in subsection 23(2) of the Act;

• (b) any place where the inspector believes on reasonable grounds any article referred to in paragraph (a) is processed, transformed or stored; and

• (c) anything that the inspector believes on reasonable grounds is used or is capable of being used in the conduct of an establishment’s activities.

Consequential Amendment

125 [Amendment]

Transitional Provisions

Marginal note:Deemed authorization

126 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.

Marginal note:Licence continued

127 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.

Marginal note:Delayed registration

• 128 (1) 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.

• Marginal note:Duration

  (2) Subsection (1) applies until the determination of the application under section 32.

Coming into Force

Marginal note:One year after publication

• Footnote ^*129 (1) 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.

• Marginal note:Subsections 4(4) to (6) and paragraph 64(1)(b)

  (2) 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.

• Marginal note:Section 125

  (3) Section 125 comes into force on the day on which these Regulations are registered.

• Return to footnote ^*[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.]