Glossary

Some of the definitions contained in this glossary are taken from the Plasmapheresis Regulations, and may not appear the same in the final Blood Regulations.

accident
An unexpected event that is not attributable to a deviation from the blood establishment's operating procedures or applicable laws and that could adversely affect the safety of a donor or recipient or the safety, efficacy or quality of blood or blood components. Sincerely

allogeneic
Cells or tissues from individuals belonging to the same species but genetically dissimilar (and hence immunologically incompatible), e.g. blood.

autologous donation
Blood that is collected from an individual for the purpose of transfusion back into the same individual at a later time. It does not include perioperative donations.

blood component
Blood is a fluid composed of cells and plasma that flow in the arteries and veins of the body. The cellular components of blood are red blood cells, white blood cells and platelets. Plasma is the fluid component of blood that carries red and white blood cells to the body's organs as well as the nutrients and by-products of metabolism.

blood product
A therapeutic product manufactured or processed from whole blood, blood components or blood plasma.

blood safety
Refers to the safety of whole blood and blood components.

Blood Standards (Canadian Standards Association)
The CSA Standards are consensus standards developed by Canadian experts in their respective fields. The CSA Blood Standards (Blood Standards) are identified as CAN/CSA-Z902-04, Blood and Blood Components.

The Blood Standards, developed by the CSA Technical Committee on Blood and Blood Components, outline specific requirements aimed at ensuring the safety and quality of whole blood and blood components and include requirements for the collection, processing, preservation, packaging, labelling, storage, quarantining, record keeping, distribution, adverse event reporting, and recall of whole blood and blood components. They include activities that fall under both federal and provincial/territorial jurisdiction.

compliance
The state of conformity of a regulated party (including a corporation, institution, individual or other legal entity) or a product with a legislative or regulatory requirement.

compliance monitoring
Actions planned to maintain regular surveillance in order to evaluate compliance with applicable requirements of the Food and Drugs Act and its associated regulations. This includes a wide variety of fact gathering and assessment activities such as inspections, market surveys and a product sampling program.

compliance verification
Actions taken to verify compliance in response to information regarding known or suspected non-compliance with the applicable requirements of the Food and Drugs Act and its associated regulations. This includes actions such as information gathering either off-site or by on-site visits.

deviation management system
A system that includes policies, processes and procedures to ensure the identification, assessment, investigation and monitoring of deviations from meeting, or failing to meet, specified requirements. It should also include methods and procedures to input product or quality problems into a corrective and preventive action system.

distributed products
Whole blood or blood components that have left the control of the establishment (including hospital blood banks).

enforcement
Actions that may be taken to induce, encourage or compel compliance with the Food and Drugs Act and its associated regulations.

error
A deviation from a blood establishment's operating procedures or applicable laws that could adversely affect the safety of a donor or recipient or the safety, efficacy or quality of blood or blood component.

establishment
A person, a partnership or an unincorporated entity, or a part of any of them, that carries out any of the following activities with respect to blood or blood components:

1. collection;
2. testing;
3. processing;
4. distribution;
5. transformation;
6. importation;
7. storage; or
8. transfusion

establishment license
A licence granted by Health Canada to undertake activities that are regulated by the department. EL must be applied for in the manner described in the regulations. In the case of blood safety, EL will be required for the following activities: allogeneic whole blood and blood component collection, testing, processing, initial distribution into the general blood supply and importation.

establishment license/registration
A licence/registration granted by Health Canada to undertake activities that are regulated by the department. ELR application involves informing the federal department, in the manner described in the regulations, of the activities being carried out.

incident
An accident or error that could lead to an adverse outcome affecting (a) the safety, or quality of whole blood or blood components; or (b) the safety of recipients.

inspection
An on-site monitoring and assessment against the applicable requirements of the Food and Drugs Act and its associated regulations. Inspections are routinely conducted on a predetermined cycle or as required to assess compliance.

investigation
An action taken to gather evidence to support a case referral for potential judicial determination regarding specific violations of the Food and Drugs Act and its associated regulations. This includes taking statements and activities carried out under the Criminal Code, i.e., executing search warrants.

jurisdiction
The geographical area over which a court or government body has the power and right to exercise authority.

lookback
A procedure in which previous donations (and related blood components) from a donor who is subsequently found to have a transfusion-transmissible infection are identified, and follow-up activities are undertaken to notify any involved organizations and affected individuals.

National Standards
National Standards must be developed through a consensus process by a balanced stakeholder committee. National Standards are consistent with existing international standards. The public has an opportunity to comment on standards. Although compliance with National Standards is voluntary, accreditation by an accrediting body is often associated with standards compliance.

The Standards Council of Canada (SCC) has responsibility for co-ordination of the Standards System in Canada and has accredited the Canadian Standards Association (CSA) as a standard development organization to develop National Standards of Canada.

non-serious error/accident (E/A)
Any E/A that does not have a direct impact on the safety of blood and blood components, and for which the associated risk may be minimal.

prescriptive regulations
Regulations specifically describe the means to achieve the objective. Establishments must all meet the regulatory requirement in the same way. The government verifies information from regulated establishments and conducts compliance inspections.

performance-based regulations
Describes ends in terms of performance that will assure meeting the objective. Establishments must meet the objective, however, the manner in which they do so can vary. This allows for advances in technological innovations and, consequently, fewer regulatory amendments.

quality system
The following are mandatory requirements for a complete quality system:

1. change control system
2. document control and record retention system
3. emergency contingency plan
4. proficiency testing program, if applicable
5. quality control program
6. internal audit system
7. a system for the identification of critical elements
8. written specifications for all critical supplies, equipment and services
9. a system for the reconciliation of donation numbers and collection sets
10. preventive maintenance of equipment
11. validation of computer systems
12. deviation management system, including recall
13. process control
14. process improvement through complaint monitoring, and corrective and preventive action
15. training program

regulation
Regulations are a form of law with the same binding legal effect as Acts. Regulations are made under the authority of an enabling Act.

regulatory authority
Health Canada derives its authority to regulate the safety, quality and efficacy of health products under the Food and Drugs Act (F&DA). The objective of the F&DA is to protect the health and safety of Canadians and to prevent fraud and deception in the manufacture and sale of food, drugs, devices, and cosmetics. Blood is defined in the F&DA as a Schedule D drug.

In Canada, the law states that any distribution of whole blood and blood components is prohibited unless the manufacturing premises and the processes and conditions of manufacture have been found suitable to ensure that the blood and blood components are safe and of high quality for use in Canada.

regulatory framework
Laws and regulations that outline the legal requirements to be met. They may also be complemented by policies, standards, directives and guidelines. Key elements of a regulatory framework for drugs may include: clinical trials, pre-approval requirements, licensing schemes, product safety standards, compliance and enforcement policies and post-approval surveillance requirements.

serious adverse transfusion reaction
An unexpected and undesirable response in a recipient associated with the transfusion of blood or blood components that results in any of the following consequences for the recipient:

1. hospitalization or its prolongation;
2. persistent or significant disability or incapacity;
3. a medical or surgical intervention to preclude a persistent or significant
4. disability or incapacity;
5. a life threatening condition; or death

serious adverse donor reaction
An unexpected and undesirable response in a donor associated with the collection of blood or blood components that results in any of the following consequences for the donor:

1. hospitalization;
2. persistent or significant disability or incapacity;
3. a medical or surgical intervention to preclude a persistent or significant disability or incapacity;
4. a life threatening condition; or
5. death

traceback
A traceback is the process of investigating a report of a suspected transfusion-associated infection in order to identify a potential implicated donor.

transform
Transform means to wash, pool or irradiate blood.