ARCHIVED — Vol. 147, No. 22 — October 23, 2013

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SOR/2013-178 October 9, 2013

FOOD AND DRUGS ACT

Blood Regulations

P.C. 2013-1065 October 9, 2013

His Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 30 (see footnote a) of the Food and Drugs Act (see footnote b), makes the annexed Blood Regulations.

BLOOD REGULATIONS

INTERPRETATION

Definitions

1. The following definitions apply in these Regulations.

“accident”
« 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.

“Act”
« Loi »

“Act” means the Food and Drugs Act.

“adverse reaction”
« effet indésirable »

“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.

“allogeneic”
« allogénique »

“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.

“authorization”
« homologation »

“authorization”, in respect of any blood or process, means an authorization that is issued under section 7.

“autologous”
« autologue »

“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.

“blood”
« sang »

“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.

“circular of information”
« document d’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.

“critical”
« essentiel »

“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.

“designated donation”
« don désigné »

“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.

“directed donation”
« don dirigé »

“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.

“distribute”
« distribution »

“distribute” does not include to transfuse.

“donation code”
« code d’identification du don »

“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.

“donor identification code”
« code d’identification du donneur »

“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.

“donor suitability assessment”
« évaluation de l’admissibilité du donneur »

“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.

“error”
« manquement »

“error” means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood.

“establishment”
« établissement »

“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.

“human safety”
« sécurité humaine »

“human safety” means the safety of donors and recipients of blood, in so far as it relates to the safety of the blood.

“medical director”
« directeur médical »

“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.

“operating procedures”
« procédures opérationnelles »

“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.

“pre-assessed donor”
« donneur pré-évalué »

“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.

“processing”
« traitement »

“processing” means any of the following activities:

  • (a) donor suitability assessment;
  • (b) collection;
  • (c) testing; or
  • (d) blood component preparation.

“safety”
« sécurité »

“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.

“serious adverse reaction”
« effet indésirable grave »

“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.

“standard”
« norme »

“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.

“transformation”
« transformation »

“transformation”, in respect of blood components, means washing, pooling and irradiation that are performed after blood has been determined safe for transfusion.

“unexpected adverse reaction”
« effet indésirable imprévu »

“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.

APPLICATION

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.

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.

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.

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

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).

Exception — pre-assessed donor programs

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

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.

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.

Transformations

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

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).

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

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.

Exception — pre-assessed donor programs

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

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.

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.

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.

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.

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.

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.

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.

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).

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.

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.

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.

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.

Amendment by Minister

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

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.

Application to amend authorization

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

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.

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.

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.

Urgent circumstances — notice

(4) When the Minister adds or amends terms or conditions under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the new or amended terms and conditions and that gives the establishment a reasonable opportunity to be heard concerning them.

Removal of terms and conditions

(5) The Minister may, by notice in writing, remove a term or condition from an authorization if she or he determines that the term or condition is no longer necessary to prevent a compromise to human safety or the safety of blood.

Suspension

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.

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.

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.

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.

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.

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.

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.

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

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.

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.

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).

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.

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.

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.

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.

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.

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.

Applications

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

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.

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).

New or amended terms and conditions

25. (1) The Minister may add terms and conditions to an establishment licence or amend its terms and conditions in either of the following circumstances:

  • (a) the Minister has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood; or
  • (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request.

Notice

(2) Before adding terms or conditions to a licence or amending its terms or conditions, the Minister must send the establishment a notice at least 15 days before the day on which the proposed terms and conditions are to take effect that sets out the Minister’s reasons and that gives the establishment a reasonable opportunity to be heard concerning them.

Urgent circumstances

(3) Despite subsection (2), the Minister may immediately add terms and conditions to a licence or amend its terms and conditions if she or he has reasonable grounds to believe that it is necessary to do so to prevent a compromise to human safety or the safety of blood.

Urgent circumstances — notice

(4) When the Minister adds or amends terms or conditions under subsection (3), the Minister must send the establishment a notice that sets out the reasons for the new or amended terms and conditions and that gives the establishment a reasonable opportunity to be heard concerning them.

Removal of terms and conditions

(5) The Minister may, by notice in writing, remove a term or condition from a licence if she or he determines that the term or condition is no longer necessary to prevent a compromise to human safety or the safety of blood.

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.

Suspension

27. (1) The Minister may suspend all or part of an establishment licence in any of the following circumstances:

  • (a) information provided by the establishment under section 18 or 22 proves to be inaccurate or incomplete;
  • (b) the establishment fails to provide the Minister, on written request, with sufficient evidence to demonstrate that the activities it conducts are in compliance with these Regulations, by the date specified in the request; or
  • (c) the establishment is not in compliance with these Regulations.

Notice

(2) Before suspending a licence, the Minister must send the establishment a notice that

  • (a) sets out the reasons for the proposed suspension and the effective date;
  • (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and
  • (c) gives the establishment a reasonable opportunity to be heard concerning the suspension.

Urgent circumstances

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

Urgent circumstances — notice

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

  • (a) sets out the reasons for the suspension; and
  • (b) gives the establishment a reasonable opportunity to be heard concerning the suspension.

Reinstatement

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

Exception — compliance history

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

Partial reinstatement

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

Cancellation

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

  • (a) the establishment notifies the Minister under paragraph 23(b) that it has ceased all activities under the licence;
  • (b) the establishment fails to provide the Minister with the evidence described in paragraph 27(1)(b) within a reasonable period after the licence was suspended;
  • (c) the establishment’s compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations; or
  • (d) no authorization under which the establishment processes blood remains in effect.

Notice

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

REGISTRATION

Requirement to register

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

Exceptions

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

Application for registration

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

  • (a) the applicant’s name and civic address, and its postal address if different;
  • (b) in the case of an establishment that previously conducted its activities under these Regulations under another name, that other name;
  • (c) the name and telephone number, fax number, email address or other means of communication of a person to contact for further information concerning the application;
  • (d) the name and telephone number of a person to contact in an emergency, if different from the person mentioned in paragraph (c);
  • (e) a list of the processing activities that the establishment proposes to conduct in respect of autologous blood and a list of the whole blood and blood components that it proposes to process;
  • (f) a list of the transformation activities that the establishment proposes to conduct and a list of all the whole blood and blood components that it proposes to transform;
  • (g) a statement of whether the establishment has a pre-assessed donor program;
  • (h) the civic address of every building in which it proposes to conduct its activities and a list of the activities that are proposed to be conducted in each building;
  • (i) the name and civic address of any other establishment that it proposes to have conduct any of its activities; and
  • (j) a statement, dated and signed by a senior executive officer, that certifies both of the following:
    • (i) that the establishment has sufficient evidence to demonstrate that it is in compliance with these Regulations, and
    • (ii) that all of the information in the application is accurate and complete.

Information on request

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

Registration

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

Refusal

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

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).

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.

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.

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.

Cancellation

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

  • (a) the Minister receives a notice under section 33 that the establishment has ceased all of its activities that are the subject of the registration;
  • (b) information provided by the establishment under section 31 proves to be false or misleading;
  • (c) the establishment has not complied with a request for additional information made under section 36;
  • (d) the establishment fails to take any corrective action within the required period; or
  • (e) the Minister has reasonable grounds to believe that the establishment is not in compliance with these Regulations or that human safety or the safety of blood could be compromised.

Notice

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

  • (a) sets out the reasons for the proposed cancellation and the effective date;
  • (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and
  • (c) gives the establishment a reasonable opportunity to be heard concerning the cancellation.

Urgent circumstances

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

Urgent circumstances  — notice

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

  • (a) sets out the reasons for the cancellation;
  • (b) if applicable, indicates that the establishment must take corrective action and specifies the date by which it must be taken; and
  • (c) gives the establishment a reasonable opportunity to be heard concerning the cancellation.

Action by establishment on cancellation

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

PROCESSING

DONOR SUITABILITY ASSESSMENT

Non-application — autologous donations

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

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.

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.

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.

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.

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.

When donor determined suitable

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

  • (a) assign a donor identification code to the donor, if the donor does not already have one; and
  • (b) instruct the donor to inform the establishment in either of the following situations:
    • (i) the donor develops, within the periods set out in the establishment’s operating procedures, an illness or condition that may potentially compromise the safety of donated blood, or
    • (ii) after the donation the donor has any reason to believe that their blood should not be used.

Reassessment

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

Notice

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

COLLECTION

Licensed establishments

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

Donor identification code

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

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.

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.

Collection procedures

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

  • (a) use aseptic methods;
  • (b) use collection equipment that is licensed under the Medical Devices Regulations;
  • (c) use containers that are licensed under the Medical Devices Regulations and free from defects or damage; and
  • (d) record the container lot number in the records and link it to the donation code.

Reuse of containers prohibited

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

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.

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

Authorization

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

Autologous donations — transmissible disease testing

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.

Autologous donations — ABO and Rh

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

  • (a) the ABO group; and
  • (b) the Rh factor, including weak D testing when appropriate.

Comparison of results

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

Discrepancies

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

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.

Test results — allogeneic blood

56. (1) An establishment that collects allogeneic blood must immediately take all of the following actions if a donor’s blood is positive or repeat reactive for a transmissible disease agent or marker listed in its authorization as a contraindication to use:

  • (a) quarantine any blood that was collected from that donor at that donation;
  • (b) identify and quarantine any other implicated blood from the same donor in the establishment’s possession; and
  • (c) notify every person to which it distributed any of the implicated blood from the same donor of the test results and, if the person is an establishment, specify in the notice that the blood must not be distributed or transfused.

Test results — autologous blood

(2) An establishment that collects autologous blood must inform the donor’s physician of any of the test results described in section 12.3.1.6 of the standard.

BLOOD COMPONENT PREPARATION

Licensed establishments

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

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

Non-application — pre-assessed donors

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

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.

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.

Circular of information

62. (1) An establishment that collects allogeneic blood for transfusion must prepare a circular of information in accordance with the authorization and must ensure that it makes the circular available to every establishment to which the blood is distributed and to any other person who requests a copy of it.

Exception

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

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.

Contents of label — blood for transfusion

64. (1) An establishment that collects blood for transfusion must ensure that all of the following information appears on the label of the blood:

  • (a) the establishment’s name and civic address;
  • (b) the establishment’s licence number, if it has one, or its registration number;
  • (c) the donation code;
  • (d) a statement of whether the donation is whole blood or a blood component, and if it is a component, its name;
  • (e) when appropriate, the ABO group and Rh factor of the blood;
  • (f) except in the case of apheresis, the approximate volume of the whole blood collected;
  • (g) the approximate volume of the contents of the container;
  • (h) the name of any anticoagulant or additive in the container;
  • (i) the recommended storage temperature;
  • (j) the expiry date and, if applicable, the time;
  • (k) in the case of blood for transfusion, a warning that the blood could transmit infectious agents; and
  • (l) in the case of allogeneic blood for transfusion, a direction to refer to any applicable circular of information for indications, contraindications, warnings and a list of possible adverse reactions.

Autologous blood

(2) In addition to the information required by subsection (1), the establishment must ensure that all of the following information appears on the label of autologous blood:

  • (a) the statement “For Autologous Use Only”;
  • (b) if the test results indicate that the blood is positive for a transmissible disease or disease agent listed in section 12.3.1.2 of the standard, a symbol or words to indicate that the blood is a biohazard; and
  • (c) if the blood has not been tested for the transmissible diseases and disease agents listed in section 12.3.1.2 of the standard, an indication to that effect.

Contents of label — blood for use in manufacture of drug for human use

(3) An establishment must ensure that all of the following information appears on the label of blood that is for use in the manufacture of a drug for human use:

  • (a) the name, civic address and licence number of the establishment that collected the blood;
  • (b) the donation code; and
  • (c) the statement “Caution: For Manufacturing Use Only”.

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.

Designated donations

66. (1) In addition to the information required by subsection 64(1), an establishment that collects blood for designated use must ensure that the identity of the intended recipient appears on the label.

Change of use

(2) The establishment must remove from the label the mention of the identity of the intended recipient when the blood is no longer intended for designated use.

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.

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

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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

Transformation methods

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

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.

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.

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.

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.

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

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.

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.

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.

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.

Notice in recipient’s file

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

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

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.

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

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.

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

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.

Oversight

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

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.

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.

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.

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

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.

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.

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

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.

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.

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.

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.

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.

Storage equipment

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

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

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.

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.

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.

Written notice

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

Establishment’s own error or accident

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.

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.

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.

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.

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.

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

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.

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.

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.

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.

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.

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.

Written notice

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

Final report to Minister

(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.

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.

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.

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

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.

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.

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

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.

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.

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.

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.

Written notice

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

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

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.

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.

Written notice

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

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.

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.

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.

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

Record quality

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

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.

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.

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.

TABLE TO SECTION 119

RECORDS AND RETENTION PERIODS

Item

Column 1

Records

Column 2

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

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.

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.

TABLE TO SECTION 120

RECORDS AND RETENTION PERIODS

Item

Column 1

Records

Column 2

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

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.

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.

TABLE TO SECTION 121

RECORDS AND RETENTION PERIODS

Item

Column 1

Records

Column 2

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

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.

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.

TABLE TO SECTION 122

RECORDS AND RETENTION PERIODS

Item

Column 1

Records

Column 2

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

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

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. Section 18 of the Regulations Amending the Food and Drug Regulations (1475 — Good Manufacturing Practices) (see footnote 1) is replaced by the following:

18. The Food and Drug Regulations, as they read immediately before the coming into force of these Regulations, continue to apply in respect of whole blood and blood components until the day before the day on which subsection 3(2) of the Blood Regulations comes into force.

TRANSITIONAL PROVISIONS

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.

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.

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.

Duration

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

COMING INTO FORCE

One year after publication

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.

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.

Section 125

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

REGULATORY IMPACT ANALYSIS STATEMENT

(This statement is not part of the regulations.)

Executive summary

Issue: Blood and blood components are currently regulated as drugs using a combination of provisions that are not specific to blood, found in several Divisions of Part C of the Food and Drug Regulations (FDR). Justice Krever’s report to the Commission of Inquiry on the Blood System in Canada found that while blood and blood components used in Canada are safe, safety could be further strengthened. To achieve this, the Commission recommended that Health Canada should outline regulatory requirements that are clear, intelligible, comprehensive and specific to blood. Equally important, current regulatory requirements for blood and blood components are being applied only to the blood operators, despite the fact that some hospital blood banks perform some of the same activities. This creates a gap in our regulatory oversight of these activities, which was also recognized by Justice Krever’s recommendations. These recommendations are the main drivers for the new Blood Regulations (the Regulations).

Description: The purpose of this initiative is to introduce under the Food and Drugs Act (FDA) specific regulations for human blood and its components intended for transfusion or for further manufacturing into human drugs. The regulatory framework will address human safety and the safety of blood and its components with requirements related to the donor suitability assessment, collection, testing, labelling, storage, distribution and importation, for all establishments performing these activities. The regulatory initiative will consolidate the existing requirements in new regulations specific for blood and its components, apply to all establishments that perform any of the regulated activities, and apply the level of oversight that is commensurate with the level of risk of the activities performed by each establishment. This will result in a more consistent and comprehensive safety profile of blood and its components from the donor to recipient. These Regulations will come into force one year after the day on which they are published in Part II of the Canada Gazette and include provisions that will allow establishments to continue to perform their activities while they update their processes in order to comply with the regulatory requirements.

Cost-benefit statement: The Regulations serve to consolidate and clarify current regulatory requirements, and, for those standards from the CAN/CSA-Z902 Blood and blood components (CSA Blood Standards) that are referenced in the Regulations, the Regulations codify the safety requirements described therein. The CSA Blood Standards were first published by the Canadian Standards Association (CSA) in 2004 and updated in 2010. Since additional regulatory requirements will not be imposed on establishments currently regulated under existing provisions of the FDR and key stakeholders committed to adopting the safety requirements in the CSA Blood Standards, regulated establishments will not experience any further costs as a result of the publication of the Regulations. However, clearer regulatory requirements consolidated within the Regulations will provide the necessary clarity, transparency and flexibility to meet the challenges of the future, which will benefit the regulated establishments, the regulator and ultimately Canadians.

“One-for-One” Rule and small business lens: The “One-for-One” Rule applies to the Blood Regulations with respect to provisions relating to one Establishment Licence (EL) specific to the collection and processing of plasma. The Blood Regulations are considered neither an “IN” nor an “OUT” as the overall change in administrative burden of the one for-profit blood establishment is negligible. The small business lens does not apply to the Blood Regulations because the one for-profit blood establishment impacted by the Regulations does not meet the definition of a small business.

Domestic and international coordination and cooperation: Since blood and its components are not sold within Canada, there are no domestic trade issues with the Regulations. The Regulations have a mechanism to allow blood to be imported in urgent circumstances when there may be insufficient allogeneic blood available in Canada. Since Canada’s main trading partner for blood components is the United States, and the Regulations align well with those of the United States, there is no anticipated impact on the supply of blood components imported from the United States for transfusion. As for plasma that has been manufactured into blood products, these products would continue to be regulated under Division 8 of the FDR, and will not be affected by the Regulations.

Issue

Blood and blood components are currently regulated as drugs using a combination of provisions that are not specific to blood, found in the Food and Drugs Act (FDA) and several Divisions of Part C of the Food and Drug Regulations (FDR). Justice Krever’s report to the Commission of Inquiry on the Blood System in Canada found that while blood and blood components used in Canada are safe, safety could be further strengthened. To achieve this, the Commission recommended that Health Canada should outline regulatory requirements that are clear and intelligible, comprehensive and specific to blood, harmonized across Canada, and that allow for timely updating as new technologies or risks emerge.

Equally important, current regulatory requirements for blood and its components are being applied only to the currently licensed blood operators (i.e. Canadian Blood Services and Héma-Québec) and Cangene (a private manufacturer collecting blood for the purpose of manufacturing drugs), despite the fact that some hospital blood banks perform some of the same activities. This creates a gap in Health Canada’s regulatory oversight of these activities, which was also recognized by Justice Krever’s recommendations. These recommendations are the main drivers for the new Regulations.

Objectives

The purpose of this initiative is to introduce under the FDA specific regulations for blood and its components intended for transfusion or further manufacturing into human drugs. The Regulations will apply to all establishments that handle blood, and allocate the level of oversight that corresponds to the level of risk of the activity being performed by each establishment. Having separate requirements that take into consideration the unique characteristics of blood will accommodate future innovation in transfusion sciences and clarify the requirements for both stakeholders and the regulator. The Regulations will provide Health Canada’s final response to the Krever Commission recommendations, and at the same time meet the broader departmental commitment to modernize regulations that have become outdated.

Interim approach — National blood standards

In response to Justice Krever’s recommendation that the safety requirements for blood and its components be standardized, Health Canada contracted with the Canadian Standards Association (CSA) to develop the National Standard of Canada CAN/CSA-Z902 entitled Blood and blood components (CSA Blood Standards) which were first published in 2004 and updated in March 2010. The CSA Blood Standards were developed through extensive consultation and the participation of the blood operators, experts in the field of haematology, provincial and territorial representatives, interested stakeholders and Health Canada. Prior to their initial publication, the provincial and territorial governments committed to use the CSA Blood Standards as the basis for their accreditation of hospital blood banks, thus harmonizing safety standards for the handling of blood and its components at the hospital blood banks under their jurisdiction. To ensure an easy transition for the newly regulated hospital blood banks performing the regulated activities, sections of the CSA Blood Standards related to transformation activities (i.e. irradiation, washing or pooling), processing of autologous blood, pre-assessed donor programs and storage conditions for blood will be referenced in the Regulations, thus making those requirements in the voluntary standards into law.

Amendments to the existing Food and Drugs Act and Food and Drug Regulations

The regulatory amendments consolidate the applicable requirements under Division 1A and Division 2, and the regulatory requirements for plasma collected by plasmapheresis found in sections C.04.400 to C.04.423 of the FDR into regulations specific to blood and its components. The plasmapheresis sections in Division 4, as well as the labelling requirement in subparagraph C.04.019(b)(ii) [that applies only to blood] will also be repealed since all requirements for blood and its components, including plasma, will be found in the new Regulations. Schedule D to the FDA will be amended to combine all drugs that are blood or are made from blood into a single item in the schedule.

Description

The purpose of this regulatory initiative is to consolidate the existing requirements into new Regulations specific for blood and its components, apply the requirements to all establishments that perform any of the regulated activities, and apply the level of oversight that is commensurate with the level of risk of the activities performed by each establishment.

The Regulations will regulate the processing, labelling, storage, distribution and importation of blood and its components intended for transfusion or for further manufacturing into human drugs. Blood or blood components that are covered under other regulations, such as peripheral blood stem cells (covered under the Safety of Cells, Tissues and Organs for Transplantation Regulations),blood used in clinical trials (covered in Division 5 of the FDR) or blood imported for the purpose of manufacturing drugs (covered in Division 8 of the FDR), will not be applicable to these Regulations.

Establishments that process or import allogeneic blood or its components (i.e. blood to be transfused into a person other than the donor), including those who process plasma, will require an Authorization and an Establishment Licence (EL) to conduct these activities from the federal Minister of Health (the Minister), as well as a fully functional quality management system (QMS). This category includes establishments that are licensed to collect allogeneic blood for transfusion or for further manufacture into a blood product. Currently, these establishments include two blood operators and a private manufacturer of drugs from blood. This regulatory approach is consistent with the current level of oversight being applied to the regulation of these establishments under the existing provisions of the FDR, and will continue to allow for future innovations in transfusion medicine and manage emerging hazards to the blood system.

Establishments that collect and process blood for autologous transfusion (i.e. blood that is to be transfused back into the donor at a later time), have pre-assessed donor programs or perform transformation activities will require a Registration issued by the Minister to conduct these activities, as well as a full QMS. Establishments in this category include the blood operators and some hospitals. The Regulations will reference specific sections of the CSA Blood Standards that apply to activities that are not regulated as part of an Authorization, thus standardizing best practices across establishments while allowing for future innovations with respect to these activities.

Establishments that only transfuse the blood received from the collecting establishment or store and transport blood will only need to comply with the specific requirements associated with those activities, as specified in the Regulations. Establishments in this category will include a majority of the hospital blood banks. These hospital blood banks will not need an Authorization, EL or Registration, nor will they need a full QMS.

In addition to the requirements described above, all establishments performing any of the regulated activities will need to comply with the requirements in the Regulations related to operating procedures, record keeping, personnel, storage and the monitoring, investigation and reporting of serious adverse reactions and errors and accidents (E/A). Compliance and enforcement measures for all establishments performing any of the regulated activities could include inspections, compliance verification for cause and other enforcement options under the authority of the Act.

A brief summary of the key elements contained in the Regulations follows.

Authorization

Establishments that process allogeneic blood and blood components for transfusion will be required to have an Authorization from Health Canada. Also, establishments that process plasma for further manufacturing into drugs for human use will have to have an Authorization to perform these activities. To obtain an Authorization, establishments will submit an application to the Minister containing a detailed description of the proposed processes and evidence to demonstrate that the blood or blood components meet the safety requirements of the Regulations. If the Minister is satisfied that the application is complete and that the issuance of the Authorization is not likely to compromise human safety or the safety of blood or blood components, the Minister will issue the Authorization. Once issued, an Authorization will not need to be renewed but will be amended by Health Canada following review and approval of any proposed changes to the originally authorized processes.

Establishments that import blood for transfusion will have to obtain an Authorization unless the blood is already the subject of another establishment’s Authorization, and will also require an EL. Establishments that only test allogeneic blood require an EL, but if they are under contract to an establishment that holds an Authorization, they will be exempted from holding an Authorization if they do not perform any other processing activities with respect to allogeneic blood. The Regulations require, in the case of a foreign establishment that only tests allogeneic blood, that an EL be held by the Canadian importing establishment and that the foreign testing be done pursuant to an Authorization.

Establishment licensing

In addition to an Authorization, establishments that process allogeneic blood or blood components for transfusion, or process plasma for further manufacturing into drugs for human use, will require an EL issued under these Regulations in order to perform these activities. To obtain an EL, the establishment will have to provide evidence to demonstrate that the establishment’s buildings, equipment and proposed practices and procedures meet the applicable requirements of the Regulations, to maximize the safety of the blood and blood components. In addition, prior to receiving an EL, the establishment may undergo an inspection to assess their compliance with the requirements for a quality management system (referred to as good manufacturing practices under the FDR) and other applicable requirements of the Regulations. Once an establishment has its EL, it will remain valid unless it is suspended or cancelled. However, licensed establishments will have to undergo routine inspections to assess their continued compliance with the requirements of these Regulations in order to retain their EL.

Establishments that administer a pre-assessed donor program for allogeneic blood will be exempt from the EL or the Authorization requirements if they do not process any other allogeneic blood or blood components. Rather, pre-assessed donor programs will require a Registration.

Registration

Establishments that collect blood or blood components for autologous use or that administer a pre-assessed donor program will have to obtain a Registration. In addition, establishments that perform transformation activities (i.e. irradiation, washing, or pooling, except for an establishment that only pools cryoprecipitate) with respect to blood or blood components that have been determined safe for distribution or transfusion will also have to obtain a Registration.

To obtain a Registration, an establishment will file an application that describes the activities it performs and the blood or blood components that it processes or transforms, along with a signed statement that certifies that the establishment has sufficient evidence to demonstrate that it is in compliance with the Regulations. If the establishment only performs activities that require a Registration, an inspection will not be essential to initially obtain the Registration, nor will they need an Authorization. However, registered establishments may be subject to an inspection of their facilities and activities. Furthermore, establishments will be required to annually re-certify their continued compliance with the Regulations in order to retain the Registration.

Processing

Processing includes donor suitability assessment, collection, testing, and blood component preparation. The Regulations will require establishments that process allogeneic blood and blood components to perform their activities in accordance with the processes approved by Health Canada in the Authorization. It is important to note that establishments that perform testing of allogeneic blood under contract for another establishment will be required to hold an EL and will have to perform the tests in accordance with the processes approved in the Authorization of the contracting establishment. The Regulations require, in the case of a foreign establishment that only tests allogeneic blood, that an EL be held by the Canadian importing establishment and that the foreign testing be done pursuant to an Authorization.

Labelling

As an essential component of the safety and accurate identification of blood and blood components, labelling requirements for allogeneic, directed, designated and autologous donations, as well as labelling requirements for blood for further manufacture are set out in the Regulations. The Regulations will require licensed establishments that collect and distribute allogeneic blood for distribution to another establishment for transfusion to prepare a circular of information that describes the composition and properties of the blood; the directions for storage and for use; and the indications, contraindications and list of possible adverse reactions; and to ensure that the circular is available to anyone who requests it. To facilitate rapid and accurate identification of blood and its components intended for transfusion, information on the label will have to be clear and legible for blood and its components, including plasma for transfusion.

Storage and storage during transportation

To maximize the safety and quality of blood and its components, and thereby the safety of recipients, it is imperative that the appropriate storage temperature be maintained throughout all handling/storage and transportation. The Regulations will include provisions outlining the acceptable storage conditions.

Distribution

The Regulations will require that establishments that collect blood or its components be satisfied that the blood has been processed in accordance with the Regulations and that it is safe prior to distributing it. In addition, the Regulations will describe the steps required to ensure that the blood that is distributed has not undergone any deterioration while the blood was in storage, and that all information required on the label is legible or retrievable from the establishments’ records.

Transformation

Transformation refers to the washing, pooling (including the pooling of cryoprecipitate), and irradiation of blood components after they have been determined safe for distribution or transfusion. It does not include component preparation or pathogen reduction technologies that are considered part of component preparation. The Regulations will require that establishments use transformation methods that are safe and effective, and that components that undergo transformation be labelled to reflect the additional modifications. Specific sections of the CSA Blood Standards that describe transformation requirements will also be referenced in the Regulations.

Exceptional distribution

In emergency situations where an allogeneic blood or blood component that has been fully tested in accordance with an Authorization is not immediately available, establishments will be allowed to distribute blood or blood components for transfusion if specific conditions are met. The Regulations will require that an establishment first confirm that the intended recipient’s physician requests the use of the blood in the emergency treatment of their patient. Both the collecting establishment’s medical director and the recipient’s physician will also have to approve the emergency distribution in writing.

Under the exceptional distribution process, establishments that distribute blood or blood components for transfusion before the donor testing is complete will have to carry out any follow-up testing and notify the relevant establishment of the results as soon as possible after the distribution. Any blood or blood components distributed prior to completion of testing will be required to be clearly labelled to indicate that they have not been fully tested, and any such components that are not transfused into the intended recipient in the emergency will be prohibited from being stored or transfused into another recipient.

Pre-assessed donor programs

Establishments that administer a pre-assessed donor program for allogeneic blood will be exempt from the EL or the Authorization requirements if they do not perform any other processing activity, but will require a Registration. The use of pre-assessed donor programs will only be allowed in emergency situations when no alternate source of appropriate blood is available, and will require the oversight of a medical director and the confirmation that the intended recipient’s physician requests the use of the blood in the emergency treatment of their patient. The Regulations will specify requirements related to donor suitability assessment, testing, and labelling, and any relevant time frames for these activities. Specific sections of the CSA Blood Standards that describe the testing requirements and relevant time frames for pre-assessed donor programs, as well as the final disposition of the blood collected from such programs that is not transfused in the emergency for which it was collected, will also be referenced in the Regulations. Establishments that test blood from pre-assessed donor programs will be required to obtain an EL.

Importation in urgent circumstances

In urgent circumstances, such as instances when there may be an insufficiency of allogeneic blood available in Canada that poses an immediate and substantial risk to public health, an establishment may import allogeneic blood for transfusion that has not been processed in accordance with an Authorization if it provides the Minister with the required information before the importation, and at the time of each importation. The establishment will also be required to be licensed to import blood.

Quality management system

To maximize the safety of blood or blood components, all licensed and registered establishments that process, transform or import blood or blood components will be required to have a quality management system (QMS) that is an integrated system of quality assurance. The Regulations list the required elements of a QMS, including management requirements and the need for periodic reviews of the QMS to ensure its continuing suitability and effectiveness.

All establishments, including hospitals that only store blood or blood components for transfusion, will be required to meet the provisions related to operating procedures for all regulated activities they perform, including provisions related to personnel, facilities, equipment, and supplies. In addition, they will be required to maintain the records referred to in the Regulations, use validated storage equipment that can maintain appropriate storage conditions, and meet the investigation and reporting requirements related to E/A, adverse donor reactions, and adverse recipient reactions.

Errors and accidents (E/A)

An establishment that has reasonable grounds to believe that an error or accident has occurred which could adversely affect human safety or the safety of blood or blood components will be required to do the following: determine the nature and scope of the error or accident; identify and quarantine all the implicated blood or blood components in its possession; and notify the establishment from which it received the implicated blood or its components, the collecting establishment, and any establishment to which it may have distributed implicated blood or blood components.

On receipt of a notice of an error or accident which could adversely affect human safety or the safety of blood or blood components, the establishment will be required to initiate an investigation into the suspected error or accident if it determines that it occurred during an activity that it conducted. Within 24 hours after the start of such an investigation into an error or accident that is identified after the blood has been distributed or transfused, the investigating establishment will be required to notify the Minister in writing of the suspected cause of the error or accident if there is reasonable probability that the error or accident could lead to a serious adverse transfusion reaction. A written report will be required within 15 days after the start of the investigation and upon request by the Minister at any time after the preliminary report.

Adverse donor reactions

An establishment that has reasonable grounds to believe that a donor has experienced an unexpected adverse reaction or a serious adverse reaction, during or within 72 hours after the blood collection, will be required to investigate and notify the Minister. The Regulations will require that the notice be made within 24 hours of the reaction in the case of a fatality, and within 15 days of the reaction in any other case. In the case of a verbal notice, the establishment will have to follow up as soon as possible with a written report including a description of the reaction, the corrective actions taken to address the reaction and the final outcome.

Adverse recipient reactions

The Regulations will require an establishment that has reasonable grounds to believe that when a recipient experiences an unexpected adverse reaction or a serious adverse reaction to determine the nature and scope of the adverse reaction; identify and quarantine all of the implicated blood or blood components in its possession; determine if the root cause of the adverse reaction is attributable to an activity that it carried out, and if so, conduct an investigation into the adverse reaction and notify any establishment to which it may have distributed implicated blood or blood components. If the preliminary inquiry indicates that the root cause of the adverse reaction is attributable to an activity carried out by another establishment, the establishment must notify the establishment that collected the implicated blood, the establishment from which it received the blood and any establishment to which it distributed the implicated blood.

An establishment that is conducting an investigation will be required to report to the Minister within 24 hours after the establishment becomes aware of the reaction in the case of a fatality and within 15 days after the establishment becomes aware of any other unexpected adverse reaction or serious adverse reaction. In either case, if the report was made verbally, a written report must be provided as soon as possible after the verbal notice. The Regulations further specify the information to be included in the final and annual summary reports to the Minister. In addition, the establishment that is conducting the investigation will be required to notify all establishments to which it distributed the implicated blood of the results of the investigation.

Records

Establishments will be required to maintain records that are accurate, complete, legible, indelible and readily retrievable, and stored in a location that has appropriate environmental conditions and is secure against unauthorized entry. The Regulations further require that the record-keeping system be structured so that with the donor identification code or with the blood’s donation code, the establishment can identify the donor and link it to the applicable blood unit, samples and other records.

The Regulations specify the retention period for records as they relate to blood safety by dividing them into four separate tables representing records based on the blood establishment activities. Records that link the donor to the recipient of the blood will be required to be retained for 50 years.

Transitional provisions and coming into force

Since these Regulations will come into force one year after the day on which they are published in Part II of the Canada Gazette, provisions are included that will allow establishments to continue to perform their activities while they update their processes in order to comply with the regulatory requirements. During the one-year period, oversight of currently licensed blood operators will continue under the existing FDR.

Establishments that have previously filed sufficient safety and effectiveness information acceptable to the Minister under sections C.01A.005 to C.01A.007 and C.01A.014 of the FDR will be deemed to have an Authorization under section 7 of these Regulations. Similarly, establishments that already hold an EL issued under section C.01A.008 of the FDR will be able to continue to operate until a new EL is issued under these regulations provided that the establishment applies for an EL within three months after these regulations come into force. These establishments will not be required to re-submit information described in paragraphs 18(1)(j) and (k) of these Regulations when applying for their EL under these Regulations. In the meantime, any licence issued under the FDR will continue to be valid until an EL is issued or refused under section 20 or 21, respectively, of the Regulations.

In addition, establishments that are already performing any of the activities that require a Registration, such as processing autologous blood or transformation activities, or that have pre-assessed donor programs, could continue these activities provided that they submit an application for a Registration under section 31 of the Regulations within three months after the Regulations come into force. The prohibitions for activities that require a Registration as it applies to registration numbers and the requirement to have the establishment’s registration number on the label, respectively subsections 4(4) to (6) and paragraph 64(1)(b) of these Regulations, will come into force six months after the day on which these Regulations come into force.

International perspective

The Regulations align well with the blood regulatory requirements, guidelines and policies of the United States, the European Union, the United Kingdom and Australia, including the overall approach of protecting the health of blood donors and recipients through oversight of the donor suitability assessment, collection, testing, storage, and distribution of blood and its components. Similarity with these international regulatory frameworks provides confidence that blood or its components from these countries meets the same high safety standards set by the Canadian Blood Regulations.

These Blood Regulations compare with international regulatory frameworks in the following ways:

  • The United Kingdom regulatory system of authorization for the collection and testing of blood;
  • Compliance and enforcement requirements, including licensure and inspections, in the United States, the European Union and Australia;
  • Referencing sections of the CAN/CSA-Z902, Blood and blood components is similar to Australia’s standards-based regulatory framework;
  • The United States’ adverse reaction reporting requirements;
  • Good manufacturing practices (GMP) requirements in the United States and the European Union align with the quality management system requirements included in these Regulations.

Establishments that import blood for transfusion will require an EL under these Regulations and will have to obtain an Authorization unless the blood is already the subject of another establishment’s Authorization. The Regulations describe requirements for the importation of blood and its components for transfusion when there is an insufficiency of allogeneic blood in Canada that poses an immediate and substantial risk to public health. In addition, the Canadian importer will have to apply for and obtain an EL for importation by demonstrating that the blood is manufactured to meet the same high safety standards as any blood collected in Canada.

These Canadian Blood Regulations will not apply to the importation of blood components into Canada for further manufacture — rather, the requirements of Division 1A of the FDR will continue to apply to those products.

Regulatory and non-regulatory options considered

The options outlined below provide an overview of the alternatives that were considered.

Option 1: Leaving the existing regulations in place (maintain the status quo)

The status quo is not considered to be a viable option. The existing regulatory requirements are located in multiple divisions of the FDR, namely, Division 1A, Division 2 and Division 4.

Since the current regulatory requirements were intended to apply to pharmaceuticals and biologic drugs, it is not immediately clear how they apply to blood since they are not specific to blood. The current regulatory requirements are being applied only to the blood operators that handle blood, despite the fact that some hospital blood banks perform some of the same activities. For these reasons, this option would not address the Krever report’s recommendations to consolidate all requirements related to blood, and provide regulatory oversight over all establishments that handle blood.

Option 2: Amend the existing regulations to include requirements specific to blood and blood components

Amending the existing regulations is not considered to be a viable option. The scope of the existing regulations applies to all drugs, including pharmaceuticals and biologic drugs. By amending the existing regulations, stakeholders would still be required to consult multiple divisions in the FDR to determine what requirements apply to them. In addition, adding specific requirements to the existing divisions would greatly complicate the regulations so as to make them difficult to understand for the regulated establishments. In addition, this option would not address the Krever report’s recommendation to provide regulatory oversight over all establishments that handle blood.

Option 3: Develop new regulations specific to blood and blood components

The development of new regulations specific to blood or blood components was considered the best option. The objectives of the new regulatory framework include outlining clear and intelligible requirements; allowing for timely updating of the requirements as new technologies/products/issues emerge; and achieving greater harmonization in Canada related to the collection, handling and post-market surveillance of blood and blood components. To achieve this harmonization and avoid duplication, the existing regulatory requirements for plasma collected by plasmapheresis (found in sections C.04.400 to C.04.423 of the FDR) will be merged into the new Regulations so that all the requirements for whole blood and other blood components collected for transfusion or further manufacturing will be consolidated.

The new regulatory framework for blood and its components will apply to all establishments performing any of the regulated activities, and consolidate and clarify the requirements specific to blood and its components for the regulated establishments.

One of the elements of this regulatory framework was the development of safety standards for blood and blood components. The CSA Blood Standards were developed following extensive collaboration with experts in the field of haematology, the blood establishments and federal and provincial government stakeholders. The CSA Blood Standards are aimed at maintaining and enhancing the quality and safety of blood collection, testing, labelling, storage and transfusion. Establishments collecting/handling blood or blood components can obtain a copy of the CSA Blood Standards, which have been published and are available for purchase from the CSA.

With the specific regulations, Health Canada will be better able to fulfil its mandate of protecting the health and safety of Canadians who donate or receive blood or blood components.

Benefits and costs

Costs and benefits for the national blood standards

A cost-benefit analysis was completed in 2003 to assess the impact of the implementation of the CSA Blood Standards on establishments, governments and consumers. Establishments were asked to quantify the gaps between their current practices and what the CSA Blood Standards prescribe in the following categories: buildings, facilities, and equipment; pre-transfusion testing, selection of components, and emergency transfusions; autologous blood collection; dedicated donations; computer systems; storing, transporting, and releasing tested blood; transfusion services; records management; removing unsafe components and donors from the blood supply; and adverse medical event monitoring and reporting. The costs were broken into initial and ongoing costs to recognize that some costs would be recurring and some would not. The analysis estimated that the level of benefits for meeting the requirements of the CSA Blood Standards over the next 20 years would range between $3.3 and $4.4 billion (at an 8% discount rate). This greatly exceeds the total costs estimated at $438.55 million over the same period (discounted at 8%).

However, the scope of the CSA Blood Standards is significantly broader than that of the sections of the standards being referenced in these Regulations — specifically sections related to activities that are within federal jurisdiction such as processing of autologous blood, transformation activities, and pre-assessed donor programs. During the development of the CSA Blood Standards, key stakeholders, such as the blood operators and representatives of the provincial/territorial governments, committed to adopting the CSA Blood Standards. It is therefore expected that these establishments will have already undertaken the efforts required to comply with the CSA Blood Standards, and that these establishments will only experience relatively minor costs associated with maintaining their already updated processes.

Costs and benefits for the Blood Regulations
Estimated costs

The Regulations serve to consolidate and clarify current regulatory requirements, and, for those from the CSA Blood Standards that are referenced in the Regulations, the Blood Regulations serve to codify the safety requirements described therein. The CSA Blood Standards were first published by the CSA in 2004 and updated in 2010. Since additional regulatory requirements will not be imposed on establishments currently regulated under existing provisions of the FDR and key stakeholders committed to adopting the safety requirements in the CSA Blood Standards, regulated establishments will not experience any further costs as a result of the publication of the Regulations. It is therefore expected that establishments will today only experience the costs associated with maintaining their already updated processes.

The Regulations will introduce a novel registration scheme for establishments that perform autologous blood collection or transformation activities or have pre-assessed donor programs, which includes both the blood operators and some hospital blood banks. To obtain a Registration, establishments will be required to complete and submit an application form within three months of the Regulations’ coming into force. The labelling provisions with respect to registration numbers come into force six months after the day on which these Regulations come into force. There will be no fee associated with the registration process, so the only negligible cost will result from the short time taken to complete and submit the form.

Estimated benefits

The objective of introducing the Regulations is to consolidate and clarify current regulatory requirements and to codify the improvements in blood safety resulting from establishments adopting the CSA Blood Standards. Benefits from implementing the Regulations will accrue from greater clarity and consistency in safety procedures performed by all establishments across the country, thus strengthening Health Canada’s legislative authority to continue to monitor the safety of processes carried out in all establishments that handle blood and blood components. Clearer regulatory requirements consolidated within the Regulations will provide the necessary flexibility for the blood system to meet the challenges of the future, which will benefit the regulated establishments, the regulator and the Canadian public.

Based on the analysis above, Health Canada has concluded that implementing the Regulations will have a positive net benefit. A comparison of the costs and benefits for each stakeholder group follows.

1. Blood operators
Costs
  • There will be no fee attached to the application process for an Authorization, an EL or a Registration under these Regulations.
  • Blood operators that process allogeneic blood will require time to prepare and submit the paperwork associated with an application for an Authorization amendment and an EL as required by the Regulations. There will be no additional costs or administrative burden since the Authorization and licensing scheme in the Regulations is similar to that in the current regulations.
  • Blood operators that process autologous blood, have pre-assessed donor programs or perform blood transformation activities will need to maintain their QMS, submit an application for a Registration, update their information as it changes, and annually re-certify their continued compliance with the Regulations.
Benefits
  • There will be a transition period during which establishments may continue to perform their activities while they apply for an EL or a Registration.
  • These Regulations will clarify and consolidate the current requirements for the blood operators, while at the same time not placing additional burdens on these establishments.
  • Elimination of the current requirement for annual renewal of an EL should reduce the paperwork burden on blood operators without adversely affecting the safety or quality of blood or blood components. Human safety and the safety of blood and blood components will not be compromised in meeting the needs of blood operators.
2. Hospital blood banks
Costs
  • There will be no fee attached to the application process for a Registration under these Regulations.
  • Hospital blood banks that process autologous blood, perform blood transformation activities, or have pre-assessed donor programs will need to have a QMS, submit an application for a Registration, update their information as it changes, and annually re-certify their continued compliance with the Regulations. It is anticipated that hospitals that require a QMS will need only minor changes, if any, to achieve compliance, given that the provincial and territorial governments committed to using the CSA Blood Standards as the basis of accreditation of their hospital blood banks. In addition, there is a one-year delay in the coming into force of the Regulations which enables establishments to implement any required changes and there is the possibility for resource sharing with larger facilities.
  • The Regulations will formalize the current practice of investigating adverse reactions and E/A, and report those that are “serious” to Health Canada.
Benefits
  • There will be a transition period during which hospital blood banks may continue to perform their activities while they apply for a Registration, if required.
  • Implementation of a QMS at hospital blood banks that process autologous blood, perform blood transformation activities, or have pre-assessed donor programs can be expected to result in continuously improving processes in these establishments.
  • Referencing the CSA Blood Standards in the Regulations for activities performed at hospital blood banks related to processing of autologous blood, blood transformation activities, or those related to pre-assessed donor programs will make those requirements in the voluntary standard into law, thus resulting in consistent safety practices across the country.
  • Standardized storage and handling requirements for blood and blood components will maximize the safety of the blood throughout the distribution chain.
3. Canadian public (donors and recipients)
Costs
  • The public will not pay a direct cost for the investments that some establishments may be required to make in order to comply with the Regulations.
Benefits
  • Standardization of blood safety requirements across the country may further improve the already high level of public confidence in the safety of the blood system, potentially resulting in greater numbers of Canadians willing to become blood donors.
  • The benefit to blood and blood component donors is the confirmation in regulation of current requirements that must be met by establishments to protect donors’ health and safety as it relates to the safety of blood. The health and safety of donors is a major concern for Health Canada, since there cannot be a national blood system without healthy, dedicated donors.
  • The benefit to the patient receiving blood and blood components from a donor pool is that the patient will be further protected by clear regulatory requirements and there is a greater likelihood of a safer product when the donor pool is stable and consistent.
  • Blood safety requirements will be clear and consistent across Canada, and across the supply chain, from the collecting establishment to the end user.
  • The Regulations will clarify Health Canada’s legal authority to take compliance and enforcement action in the best interests of the Canadian public, should the need arise.
4. Health Canada
Costs

Existing ELs held by the blood operators (Canadian Blood Services, Héma-Québec, and Cangene) will be grandfathered as the establishment’s Authorization under the new Regulations and their EL will be updated as required by the transitional provisions in sections 126 and 127 of the Regulations. In the event that a new establishment were to apply for an Authorization and an EL, Health Canada will require additional time to review the new establishment’s applications for an Authorization and an EL, and to inspect the establishment. Once establishments submit their applications for a Registration, Health Canada will require additional time to process the establishments’ applications and issue a Registration. However, it is expected that Health Canada will be able to administer these programs with existing resources.

Benefits
  • Clear and consistent requirements will simplify Health Canada’s oversight of all establishments under the Regulations.
  • The transition period provided during which establishments may continue to perform their activities while they apply for an EL or a Registration will allow Health Canada the time necessary to process the applications and issue the ELs and Registrations.
  • The Regulations provide the federal government’s final response to Krever’s recommendations.
  • The Regulations will clarify Health Canada’s legal authority to take compliance and enforcement action, should the need arise.

An analysis of the costs and benefits associated with the implementation of the CSA Blood Standards is available upon request.

Rationale

The cost-benefit analysis conducted in 2003 estimated that the benefits of implementing the CSA Blood Standards would greatly outweigh the associated costs. With the publication of the CSA Blood Standards in 2004, key stakeholders committed to adopting the CSA Blood Standards and have since aligned their processes with those described in the standards. Thus, the baseline for this regulatory initiative is a blood system that has been improved and is safe. For establishments that process or import allogeneic blood, the stand-alone Regulations specific to blood serve to consolidate and clarify current regulatory requirements described in provisions of the FDR. For establishments that process autologous blood, have pre-assessed donor programs, perform transformation activities or store and transport blood and blood components for transfusion, the Regulations codify current best practices described in the CSA Blood Standards and clarify regulatory requirements. This regulatory scheme allows the blood system to be flexible enough to cope with future technological developments and challenges, and to continue to be one of the safest systems in the world.

Canada’s stand-alone Regulations compare well with international regulatory authorities who have separate regulations for blood and blood components, and have included hospital blood banks in their regulatory frameworks. Furthermore, the Regulations specific to blood and blood components address Justice Krever’s recommendations, which were the main drivers for the development of these Regulations. Despite some concerns of possible overlap of some provincial requirements for hospitals, stakeholders are supportive of having separate regulations that take into consideration blood and blood components’ unique characteristics, since it will clarify the requirements for both stakeholders and the regulator.

“One-for-One” Rule

The “One-for-One” Rule applies to the Blood Regulations with respect to provisions relating to one Establishment Licence (EL) specific to the collection and processing of plasma. The Blood Regulations are considered neither an “IN” nor an “OUT” as the overall change in administrative burden of a for-profit blood establishment is negligible.

It should be noted that the reduction in the administrative burden of all other blood establishments is not considered under the “One-for-One” Rule, accounted for since not-for-profit entities are excluded from the “One-for-One” Rule.

Small business lens

The small business lens does not apply to the Blood Regulations because the one for-profit blood establishment impacted by the Regulations does not meet the definition of a small business.

Consultation

Over the past decade, stakeholders have been given the opportunity to provide input on these Regulations through a series of public consultations and communication activities across Canada.

Consultation prior to the publication of these Regulations in the Canada Gazette, Part I, on March 10, 2012

Information regarding all consultation activities prior to publication in the Canada Gazette,Part I, is contained in the Regulatory Impact Analysis Statement (RIAS) which was published with the proposed Regulations. In order to refer to that information please consult the RIAS, Vol. 146, No. 10, page 459, published on March 10, 2012.

Consultation following publication of the Regulations in the Canada Gazette, Part I

The proposed Blood Regulations were published in the Canada Gazette, Part I, on March 10, 2012. At that time, provincial/territorial governments, blood operators, hospital blood banks and other blood stakeholders were notified of the publication and informed of the 75-day comment period that followed the publication.

In response to the 75-day comment period, Health Canada received over 500 comments. Over 100 of these comments related to questions and requests for explanation to various sections of the Regulations. Some comments were related to policies that do not appear in the Regulations. The Guidance Document Interpreting the Blood Regulations (Guidance Document) will explain all of the requirements of the Regulations. A draft Guidance Document was published for consultation on May 28, 2012. The final Guidance Document is expected to be published on or before the coming into force of the Regulations.

During the comment period following publication of the Blood Regulations in the Canada Gazette, Part I, a wide range of stakeholders requested more communication regarding how the Regulations will impact their establishments, who the Minister is, and why there is no delegation of authority provision in the Regulations. Stakeholders from provincial/territorial governments and hospital transfusion medicine laboratories/blood banks (hospitals) asked questions about how the Regulations would apply to their situation. The document Questions & Answers — proposed Blood Regulations and applicability to hospitals, sent to all stakeholders on November 19, 2012, explains various requirements of the Regulations and reaffirms Health Canada’s commitment to communicate and clarify issues raised by stakeholders concerning the Regulations. This document also highlights five different scenarios that explain the various hospital situations and how the Regulations apply to those situations.

Health Canada has continued to communicate both in writing and in meetings with blood operators, provincial/territorial governments, hospitals and professional associations to discuss the impact of the Regulations on their establishments and operations. Two face-to-face meetings and one teleconference were held with the currently licensed blood operators (Canadian Blood Services, Héma-Québec and Cangene) in the fall of 2012 and winter of 2013 to address stakeholder comments and to solicit their input. Several teleconferences were also held during and after the publication of the proposed Regulations with representatives from provincial/territorial governments, hospitals and professional associations to discuss and clarify their comments. The consultation mechanisms employed in the development of the Regulations have permitted extensive opportunity for stakeholder engagement and feedback.

In addition to the requests for clarification, Health Canada received sets of comments and recommendations from 30 organizations: blood operators (3), provincial/territorial governments (9), professional associations (5), hospital transfusion medicine laboratories/blood banks [hospitals] (7), laboratory services (2), industry (1), patient and consumer groups (2) and foreign governments (1).

Comments resulting in changes to the Regulations, as well as comments not incorporated into the regulatory framework, and the responses to these comments are outlined below.

Comments (C) and responses (R)
General

C: The blood operators and one provincial/territorial government commented that within the Regulations there are instances where requirements are prescriptive at the level of operational details and should not be found in regulations, for example codifying specific technologies.

R: Given the prescriptive nature of some requirements in the Regulations, these requirements were amended to be technology neutral or removed to allow blood establishments to amend their authorization so they could implement new technologies and advancements as they become available.

C: Throughout the Regulations, a wide range of stakeholders commented that English or French language or terminology that is not commonly used in the community was found in the Regulations.

R: Health Canada recognizes that some of the terminology and language used in the Regulations may not be commonly used. There are constraints on the use of language in the context of legal text, such as regulations, that must be taken into account. For this reason, language familiar to the community was not always suitable for use in the Regulations; however, commonly understood language is employed whenever possible.

C: Two blood operators commented that “in writing” is a restrictive requirement that precludes other communication means.

R: The Regulations were amended to say the establishment is given “reasonable opportunity to be heard,” without the specification of “in writing.”

C: One blood operator commented, with respect to red blood cells for immunization, that a circular of information (CoI) is not currently provided for these red blood cells; donors are frequent donors with phenotyping on record and therefore are not tested for ABO/Rh/clinically significant antibodies at every donation, and red blood cells for immunization may be collected and transfused within the same establishment.

Another blood operator commented that minimum requirements for ABO and Rh testing should be required as per current requirements under the FDR for the safety of the recipient.

R: The intent of the Regulations was to reflect current requirements under the FDR. Therefore, the Regulations have been amended to indicate that a CoI must be prepared for allogeneic blood for distribution to another establishment for transfusion. In the case of red blood cells for immunization, information found in the CoI can be communicated to a recipient as part of the consent process. The Regulations will also require the testing of allogeneic blood for ABO and Rh to be conducted according to an Authorization, an approved process that is appropriate and acceptable for that situation.

Interpretation

C: It was unclear to a wide range of stakeholders whether autologous blood collection and processing included perioperative blood collection, collection for diagnosis, collection in the operating room, or collection for use with a cell saver or for serum eye drops.

R: Autologous blood is defined as blood that is collected, processed and stored for use at a later time and would therefore exclude perioperative collection, considered to be a practice of medicine, and would not be subject to the Regulations. The application of serum eye drops is not considered to be a form of transfusion. Therefore, the Regulations do not apply.

The Regulations are not intended to include autologous blood used for diagnostic purposes. Therefore, the Regulations have been amended to remove the definition of “transfusion” clarifying that “transfusion” does not include the collection of autologous blood used for diagnostic purposes. This amendment leaves no doubt that autologous blood used for diagnostic purposes that is collected, radio labelled and injected is excluded from the Regulations and not stored in a hospital blood bank for use at a later time.

C: One blood operator commented that the word “efficacy” found throughout the Regulations in the phrase “. . . the safety of the donor or recipient or the safety, quality or efficacy of blood” does not apply to source plasma collected for further manufacture. The stakeholder suggested that the word “efficacy” be removed from the Regulations.

R: The Regulations have been amended to include a definition of “safety” whereby “efficacy” does not apply to blood for further manufacture.

C: Two blood operators and one provincial/territorial government commented that the provisions of the Regulations could be interpreted to go beyond federal authority, specifically regarding donor safety. They questioned the meaning of donor safety in the context of regulating blood as a drug. The proposed Regulations reference blood that is “safe for distribution” without listing any objective criteria and do not clearly define “safe for distribution.” These stakeholders expressed concern that in order to determine that blood is safe, it must be without any risk.

R: Health Canada recognizes the inherent risk of biologic drugs such as blood. The Regulations now define human safety to mean the safety of donors and recipients of blood, insofar as it relates to the safety of the blood itself. Wording has been added to clarify that blood can be determined safe for distribution or autologous transfusion if the establishment is satisfied that it has been processed in accordance with the Regulations.

C: A wide range of stakeholders have serious concerns regarding the inclusion of pooling of cryoprecipitate within the definition of transformation. Stakeholders pointed out that the pooling of cryoprecipitate is conducted at the majority of hospitals and should be considered a lower risk activity.

These stakeholders asked why other activities such as plasma extraction, supernatant reduction, super concentrating of platelets, aliquoting or the addition of saline were not considered by Health Canada to be transformation.

R: Based on the comments received and further analysis, Health Canada considers the pooling of cryoprecipitate to be a lower risk activity. Therefore, the Regulations were amended to not require a Registration of establishments performing only this transformation activity. The pooling of cryoprecipitate will remain a transformation activity and establishments must adhere to the requirements for pooling in these Regulations.

The washing, pooling and irradiation of blood components are defined as transformation activities in these Regulations. Transformation activities, with the exception of the pooling of cryoprecipitate, are considered to be medium risk activities. Plasma extraction, supernatant reduction and super concentrating of platelets are not included in the definition of transformation. Aliquoting of blood is also not included within the scope of transformation. An establishment that aliquots blood is not required to register with Health Canada. However, establishments must meet the relabeling requirements, specific to aliquots, found in section 65 of the Regulations. The addition of saline would be considered a transformation activity only if performed as a part of washing. The definition of transformation was not expanded to include any of the above-mentioned activities.

Prohibition

C: One blood operator commented as follows: Transfusion is a medical practice and outside the scope of the Regulations.

R: Health Canada acknowledges that the act of transfusing blood falls outside the scope of federal authority. The Regulations do not regulate the activity of transfusion, but rather prohibit an establishment, for example a hospital, from transfusing blood that has not been processed in accordance with an Authorization. Consequently, no change to the Regulations was needed.

Application

C: Two blood operators, two provincial/territorial governments and a laboratory services group commented that there are few requirements pertaining to blood establishments which collect and process allogeneic blood that reference the CSA Blood Standards. Stakeholders expressed their disappointment that the CSA Standards were not referenced more than they were, as they felt this would allow for the flexibility needed to administer the blood system.

R: The regulatory framework for blood and blood components recognizes that if the clinical/technical requirements found in the Regulations were based solely on the referencing of the CSA Blood Standards, the needed flexibility for the higher risk activities would not be provided. Although the amendment process for the CSA Standards would be more efficient than amending provisions written within regulations, Health Canada is of the view that the Authorization amendment process is even more flexible and will better address future innovations in transfusion medicine and manage emerging hazards to the blood system. Therefore, an Authorization process that regulates what is considered to be higher risk activities, including the processing and importation of allogeneic blood, was set out in the regulatory framework and is reflected in the Regulations.

The CSA Blood Standards have been used as the tool to regulate what is considered to be the medium and lower risk activities, including the collection of blood for autologous use, pre-assessed donor program, transformation, and storage. For these activities, applicable sections of the CSA Blood Standards have been referenced and these provisions are considered to be standards-based. No changes to the Regulations were needed.

Authorization / Establishment Licence (EL) / Registration

C: One blood operator commented that all three regulatory licensing tools (Authorization, Establishment Licence [EL] or Registration) may apply to some establishments and they would prefer only one tool be required for each blood establishment. The stakeholder also commented that the proposed requirements will result in a duplication of information being submitted to Health Canada. This stakeholder requests that the applications for these licensing tools be linked internally at Health Canada.

R: The requirement for an Authorization, EL or Registration is determined by the activity, not the type of establishment. The level of oversight is commensurate with the level of risk associated with those activities. Therefore, an establishment that performs both medium and higher risk activities must hold an Authorization, an EL and a Registration.

An Authorization is a pre-approval process reserved for higher risk activities. The establishment must provide a detailed description of the proposed processes and supporting evidence. An Authorization is granted if the Minster is satisfied that the establishment’s processes will result in safe blood. In order for an establishment to receive an EL, it must be able to demonstrate that it has the capacity to perform, and is adhering to, its authorized processes. The combination of the Authorization and EL is consistent with the current level of oversight being applied to the regulation of these activities under the existing provisions of the FDR. The Registration process is for medium risk activities and does not include a pre-approval process.

C: Two blood operators and one hospital commented as follows: The Regulations do not allow for one-time variances.

R: Blood establishments have existing approved processes in place for deviations from their standard operating procedures. These approved processes will be “grandfathered” via the transitional provisions for an Authorization. No changes to the Regulations were made.

C: Two blood operators and one provincial/territorial government commented that the Regulations should be clear and explicit, and the risk of the activities should be proportional to the regulated performance review times. Also, an inspection strategy should be outlined. One stakeholder asked where the licensing and inspection policy information would be found as it is not in the Regulations.

R: Health Canada notes that performance timelines for review of regulated activities will be outlined in Guidance and are not found in the Regulations. It is anticipated that prior to the coming into force of the Regulations, Guidance will be published describing the regulatory requirements in more detail.

The authority to inspect is found under section 23 of the FDA, and therefore would not be described in the Regulations. However, Health Canada will consult with stakeholders regarding any revisions to the blood regulatory inspection strategy. No changes to the Regulations were made.

C: Two blood operators and one provincial/territorial government commented that the “Request for Information” provisions are too broad and vague. This right should be limited to only relevant information to determine the application of an Authorization, EL or a Registration.

Health Canada heard from these stakeholders that the Minister should not be able to request samples without a search warrant or subpoena issued by a court of competent authority. Under section 23 of the FDA, an inspector only has the right to request information that the inspector believes on reasonable grounds contains any information relevant to the enforcement of this Act with respect to any article to which this Act or the Regulations apply.

R: The “request for information” requirements allow for an evaluation of necessary information as part of the processes for an Authorization, EL or a Registration, or for the administering of terms and conditions. This is not part of the search power provided for in section 23 of the FDA, which applies only to compliance and enforcement activities. No changes were made to the requirements for information as part of these processes.

As the inspector powers relative to taking samples already appear under section 23 of the FDA, it is not required to repeat this information in the Regulations. Health Canada recognizes that there is no need to include “blood and blood samples” as part of the current application process. Any reference to the taking of “blood and blood samples” has been removed.

Registration

C: One provincial/territorial government and one hospital transfusion medicine laboratory asked, “Does a health authority with multiple sites register for all of its sites or is it necessary for each individual site to register?”

R: The intent of the Regulations is to allow the application and amendment processes for a Registration or an EL to accommodate a health authority or a blood establishment with multiple sites by listing multiple sites (buildings) under a single Registration or EL. To make this clearer, the sections of the Regulations regarding the application for a Registration were amended to reflect this scenario. However, the other applicable sections of the Regulations already accommodated multiple buildings or sites; therefore, it was determined that no further changes to the Regulations were needed.

Processing

C: It was unclear to one blood operator whether a foreign establishment who performs Chagas testing for a Canadian establishment must hold an EL. This requirement would prevent a Canadian blood establishment from outsourcing the testing of blood samples to a foreign establishment and, therefore, necessitate performing the test itself at a higher cost.

R: The Regulations have been amended to make it clear that, in the case of a foreign establishment that only tests, the EL can be held by the Canadian contracting establishment which also holds the Authorization. According to the requirements of the Authorization, the Canadian contracting establishment would be required to provide information related to the foreign establishment, including evidence that the foreign establishment is compliant with these Regulations.

Labelling

C: The three blood operators commented that the labelling section was prescriptive and contained duplications of other requirements. One stakeholder commented the Regulations only specify requirements for the verification of labelling and not for the verification of other critical centre activities.

R: The labelling of blood and blood components is an activity that all establishments carry out. Prescriptive requirements must be in the Regulations for establishments that will not hold an Authorization or EL, and where there is no applicable section in the CSA Blood Standards to reference. In these cases, there were no changes made to the Regulations.

Health Canada agrees that referring to specific technologies in detail in the labelling requirements could limit future technological developments. Therefore, the requirement for machine-readable code was removed.

Health Canada understands that specific labelling requirements for blood collected for further manufacturing would be determined by the drug manufacturer and contained in an agreement between the two parties. Therefore, the Regulations were changed to include only a very general requirement for the labelling of blood for further manufacture.

Transformation

C: One blood operator commented that the CSA Blood Standards clause 7.11.4 only applies to platelets pooled using a closed system, such as the buffy coat process used by Canadian Blood Services, during the processing of blood prior to the blood being determined safe for distribution, and not to platelets pooled using an open system (transformation) once they have been determined safe for distribution.

R: Health Canada agreed with the comment and the reference to clause 7.11.4 of the CSA Blood Standards was removed from the Regulations.

Exceptional distribution

C: One blood operator commented that a blood establishment that collects blood under exceptional distribution has traceability information to the establishment where the blood was shipped but not to where the transfusion occurred. In addition, transfusion may not necessarily have taken place.

The blood operator indicated that requirements for exceptional distribution should be amended so that blood can be distributed before test results for ABO and Rh are available in cases where there are historical records available for those donors.

R: Health Canada acknowledges that the blood establishment that collects blood and distributes it under exceptional distribution may not know where or if the transfusion took place. The Regulations were amended accordingly.

The intent of the Regulations was to reflect current requirements under the FDR. Therefore, the Regulations have been amended to indicate that in addition to transmissible disease testing results, exceptional distribution may also take place if the ABO and Rh test results are not yet available.

C: One professional association commented as follows: Under the requirements for exceptional distribution there is an obligation for the treating physician to “accept” or “agree” to the use of the blood when the test results for transmissible diseases are not yet available thereby shifting the responsibility for the safety of blood in these circumstances to the treating physician. The association believes that there is no legal basis upon which treating physicians should assume such responsibility. It has stated that while it is reasonable for the physician to be notified when the blood provided for transfusion has not yet been fully tested, responsibility for the safety of the blood remains with the establishment supplying it, such as the collecting blood establishment or the hospital performing the transfusion.

R: The requirements were written with the intent to describe the current process for what is referred to as “exceptional distribution” under the Regulations. To address this issue, the Regulations have been amended to indicate that the recipient’s physician “requests” the use of blood for which the test results are not immediately available in the emergency treatment of their patient.

Importation in urgent circumstances

C: Two blood operators commented that the requirements for importation in urgent circumstances go beyond what had previously been communicated by Health Canada to the blood operators. They concluded that these requirements would prevent blood operators from putting into place appropriate business continuity arrangements with foreign blood establishments.

Another blood operator would like to see a requirement allowing for the importation of allogeneic blood components when there is an insufficient supply in an instance other than a catastrophic event, for example a shortage of red blood cells used to immunize source plasma donors.

R: These provisions only apply in urgent circumstances when there is “an insufficiency of allogeneic blood in Canada that poses an immediate and substantial risk to public health.” Under the Regulations, a shortage of red blood cells used to immunize source plasma donors would not be considered an urgent circumstance. The intent is to match the current policy requirements for importation in urgent circumstances. The Regulations were amended accordingly.

Quality management system

C: One blood operator and three provincial/territorial governments commented that the quality management system requirements should not dictate how an establishment chooses to conduct its operations, particularly with respect to organizational structure.

R: It was not the intent of the Regulations to dictate how an establishment is organized. Rather, the Regulations were intended to reflect current quality management practices at all establishments. Therefore, the Regulations were amended to remove reference to specific titles and replace them with the more generic term “senior executive officer.” In addition, in the case of establishments that are only required to register, the quality management system requirements with regard to the organizational structure and reporting function of the quality assurance unit were amended to align with expectations of a smaller operation, for example a hospital transfusion medicine laboratory or blood bank.

Errors or accidents (E/A) and adverse reactions

C: A wide range of stakeholders commented that the reporting requirements for E/A and adverse reactions would be too onerous as proposed. It was unclear to hospitals why there were requirements for reporting in addition to those for the Transfusion Transmission Injuries Surveillance System (TTISS) and Transfusion Error Surveillance System (TESS). There was a request for clarification regarding who is required to report what and to whom.

R: The timelines in the Regulations for reporting of both E/A and adverse reactions are aligned with other regulations under the FDA and with the current requirements in the Annex to the establishment’s licence. These requirements exist in addition to the voluntary TTISS and TESS.

The Regulations’ adverse recipient reaction reporting was amended to clarify that, as in the scheme for the reporting of E/A, the establishment that conducts the activity that is the root cause of the adverse reaction is the establishment that conducts the investigation and reports to the Minister. This emphasizes that the investigation and reporting for both E/A and adverse reactions should be linked to reasonable grounds to believe that the serious or unexpected adverse reaction is associated with the blood, and the establishment that conducted the activity investigates and reports.

The content and timing of reports to the Minister for the investigations into suspected E/A — identified after the blood is distributed or transfused — was amended to remove the requirement for interim reports every 15 days and now requires reports to be filed 15 days after the start of the investigation and on request by the Minister.

Records

C: A wide range of stakeholders commented that the requirements for record keeping and storage need to be carefully considered from a cost-benefit perspective. Record-keeping periods are different than those required by other regulatory frameworks, and those found in the CSA Blood Standards. The requirements for record keeping should be chosen as they relate to blood safety.

R: As recommended, Health Canada has amended the existing table in the Regulations to better align it with the anticipated revision to the CSA Blood Standards Record Retention Table 4 by basing the record keeping times as they relate to blood safety, dividing the table into four separate tables representing records based on the blood establishment activity, and aligning the retention periods with the CSA Blood Standards where possible. Stakeholders should note that the record retention period for records that link the donor to the recipient remain unchanged at 50 years.

Transitional provisions

C: One blood operator requested that establishments that already have an EL only be required to submit administrative information when renewing their licence once the Regulations come into force.

R: Health Canada recognizes that establishments who already hold an EL have already submitted all the evidence to establish that they conduct their processes such that blood can be determined safe for distribution and that their activities do not compromise the safety of blood. The Regulations have been amended to ensure that establishments will not have to resubmit evidence already submitted under the FDR.

Health Canada continued to communicate both in writing and in meetings with stakeholders after the close of the 75-day comment period. The comments and recommendations received both during and after the close of the comment period were crucial in the further development of these Regulations. As a direct result of stakeholder input, changes that clarify, refine and correct have been made to the Regulations. While the safety of blood remains the primary focus, these changes resulted in regulatory requirements that better reflect current processes, are more flexible and will better address emerging technologies and diseases. Stakeholders have indicated that they both welcome and support the clarity and flexibility that the Blood Regulations will provide.

Implementation, enforcement and service standards

Since these Regulations will come into force one year after the day on which they are published in Part II of the Canada Gazette, transitional provisions are included that will allow establishments to continue to perform their activities while they update their processes in order to comply with the regulatory requirements.

These Regulations do not alter existing compliance provisions under the FDA. Compliance and enforcement measures for all establishments performing any of the regulated activities include inspections, compliance verification for cause, and other existing enforcement options under the authority of the Act. This practice will continue under the Regulations.

For establishments that collect allogeneic blood and blood components, test or import allogeneic blood, an inspection may be required prior to the issuance of an EL and on an ongoing basis. The inspection verifies compliance with all of the requirements in the Regulations.

Compliance and enforcement requirements also include Health Canada inspections for establishments that only process autologous blood have pre-assessed donor programs or perform transformation activities. In addition to these establishments being registered, they may be inspected on a priority basis according to specific criteria such as the risk level of the activities that they perform as well as their compliance history.

Hospitals performing the lowest risk activities — storage and transportation of blood and blood components for transfusion — will not need to register. Rather, these establishments may be inspected for cause or on a priority system based on the risk associated with the activities that they perform.

Performance measurement and evaluation

Because this initiative is largely a consolidation of existing regulatory requirements that apply to blood and is expected to have little impact on the blood system, the evaluation will focus on whether all establishments in Canada that handle blood for transfusion or for future manufacturing are being regulated and whether mandatory reporting of E/A and adverse reactions is effective in identifying serious cases of interest to the regulator. Ongoing attention will be paid to the identification of situations within the blood system that could be unintended consequences related to the Regulations.

Evaluating whether the initiative has been successful in regulating all establishments that handle blood intended for transfusion or further manufacturing has two components. The first relates to determining whether all establishments that perform activities that require an Authorization, an EL or a Registration under the Regulations have been identified and issued the appropriate paperwork. The second relates to determining whether regulatory requirements are adequately understood by all of the regulated establishments, including hospitals that will not require a Registration but must still comply with the requirements for storage, record keeping, and the investigation of E/A and adverse reactions, and reporting those that are considered serious.

To evaluate whether all establishments that process or transform blood or that have pre-assessed donor programs are being regulated, the ratios for actual and anticipated Authorization, Licensing and Registration will be measured immediately following the end of the implementation period to determine whether these establishments have been captured in the Authorization, Licensing and Registration system. This data will be readily available from the Health Products and Food Branch Inspectorate, and Health Canada expects that all establishments that should be captured by the Regulations will be identified and aware of their responsibilities to meet the regulatory requirements following implementation efforts.

To evaluate whether the Regulations are adequately understood, inquiry, inspection and/or compliance data will be assessed following the implementation period to determine whether there are any trends associated with non-compliance that might suggest that sections of the Regulations are not understood by all or particular groups of regulated parties. The evaluators do not expect to find any trends or unclear sections, but are committed to addressing any that are identified.

To evaluate the effectiveness of mandatory reporting of E/A and adverse reactions, the number of these reports received following publication of the Regulations will be compared to the baseline of those received prior to the coming into force of the Regulations. Analysis of this data will take place annually, beginning one year after the final Regulations come into force. The expectation is an initial increase in reporting, followed by a decline as reporting requirements are fully understood and then a levelling off.

Environmental scanning will be ongoing to identify any issues or situations within the blood system that could be unintended consequences of this initiative.

Contact

Liz Anne Gillham-Eisen
Blood, Cells, Tissues and Organs and Xenografts Unit
Office of Policy and International Collaboration
Biologics and Genetic Therapies Directorate
Health Products and Food Branch
Address Locator: 0702B
Health Protection Building, 2nd Floor
Tunney’s Pasture
Ottawa, Ontario
K1A 0K9
Telephone: 613-946-7212
Fax: 613-952-5364
Email: BGTD.OPIC@hc-sc.gc.ca