Blood Regulations — 1
Definitions 1 The following definitions apply in these Regulations. accident means an unexpected event that is not attributable to a deviation from the operating procedures or applicable laws and that could compromise human safety or the safety of blood. ( accident ) Act means the Food and Drugs Act . ( Loi ) adverse reaction means an undesirable response that is associated with (a) in the case of a donor, the collection of blood; and (b) in the case of a recipient, the safety of the transfused blood. ( effet indésirable ) allogeneic , in respect of blood or a blood donation, means that the blood is collected from an individual either for transfusion into another individual or for use in the manufacture of a drug for human use. ( allogénique ) authorization , in respect of any blood or process, means an authorization that is issued under section 7 . ( homologation ) autologous , in respect of blood or a blood donation, means that the blood is collected from an individual for transfusion into the same individual at a later time. ( autologue ) blood means human blood that is collected either for transfusion or for use in the manufacture of a drug for human use, and for greater certainty, it includes whole blood and blood components. ( sang ) circular of information means a document that describes all of the following in relation to blood: (a) the composition and properties of the blood; (b) directions for storage and for use; and (c) indications for use, contraindications, warnings and a list of possible adverse reactions. ( document d’information ) critical , in respect of equipment, supplies and services, means that the equipment, supply or service could, if it does not meet its specifications, compromise human safety or the safety of blood. ( essentiel ) designated donation means a blood donation that is made by a donor who is selected for medical reasons to make the donation for a specific recipient. ( don désigné ) directed donation means a blood donation that is made by a donor who is known by the recipient and selected for medical reasons by the recipient’s physician. ( don dirigé ) distribute does not include to transfuse. ( distribution ) donation code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a unit of blood at the time of collection. ( code d’identification du don ) donor identification code means the unique group of numbers, letters or symbols, or combination of any of them, that an establishment assigns to a donor. ( code d’identification du donneur ) donor suitability assessment means an evaluation of a donor that is based on all of the following criteria: (a) the donor’s medical history; (b) the results of any donor tests and physical examination; and (c) the donor’s social history, to the extent that it is relevant in determining the presence of risk factors for diseases transmissible by blood. ( évaluation de l’admissibilité du donneur ) error means a deviation from the operating procedures or applicable laws that could compromise human safety or the safety of blood. ( manquement ) establishment means a person that conducts any of the following activities in respect of blood: (a) importation; (b) processing; (c) distribution; (d) transformation; or (e) transfusion. ( établissement ) human safety means the safety of donors and recipients of blood, in so far as it relates to the safety of the blood. ( sécurité humaine ) medical director , in respect of an establishment, means a physician who is entitled under the laws of a province to practise the profession of medicine and who is responsible for all medical procedures carried out by the establishment and for the application of the operating procedures that relate to them. ( directeur médical ) operating procedures , in respect of an establishment, means the component of the establishment’s quality management system that is composed of instructions that set out the processes to follow in