Safety of Human Cells, Tissues and Organs for Transplantation Regulations (SOR/2007-118)

Interpretation

Marginal note:Definitions

1 The following definitions apply in these Regulations.

accident

accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws and that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs. (accident)

Act

Act means the Food and Drugs Act. (Loi)

adverse reaction

adverse reaction means an undesirable response in the recipient to transplanted cells, tissues or organs, including the transmission of a disease or disease agent. (effet indésirable)

banked

banked, with respect to cells and tissues, means processed cells and tissues that have been determined safe for transplantation and that are stored by the source establishment in its inventory and available for distribution or transplantation. (mise en banque)

cell

cell means the fundamental biological unit of a human organism that is for use in transplantation. (cellule)

distribute

distribute does not include to transplant. (distribution)

donor

donor means a living or deceased person from whom cells, tissues or organs are retrieved. (donneur)

donor assessment record

donor assessment record includes the donor screening, any available donor testing results, information obtained from the donor’s medical records and a copy of the donor consent. (dossier de l’évaluation du donneur)

donor identification code

donor identification code means the unique numeric or alphanumeric designation that is assigned by the source establishment to a donor under section 56 and that associates each cell, tissue and organ, or part of one, to that donor. (code d’identification du donneur)

donor screening

donor screening means an evaluation based on the donor’s medical and social history and physical examination, the results of any diagnostic procedures performed, and, if applicable, the autopsy. (évaluation préliminaire du donneur)

donor suitability assessment

donor suitability assessment means an evaluation based on the donor screening and

• (a) in the case of lymphohematopoietic cells, tissues and organs retrieved from live donors and of tissues retrieved from deceased donors, all donor testing results; and

• (b) in the case of fresh skin, islet cells and organs retrieved from deceased donors, the donor testing results that are necessary at the time of transplantation. (évaluation de l’admissibilité du donneur)

donor testing

donor testing means the laboratory tests and measurements done on a donor or donor specimen to determine all of the following:

• (a) whether the donor has or ever had a transmissible disease or is or ever was infected with a transmissible disease agent;

• (b) donor compatibility; and

• (c) the degree of functionality of the cell, tissue or organ that is to be retrieved. (examen du donneur)

error

error means a deviation from the standard operating procedures or applicable laws that could adversely affect the safety of a transplant recipient or the safety, efficacy or quality of cells, tissues or organs. (manquement)

establishment

establishment means a person, a partnership or an unincorporated entity, or a part of any of them, that carries out any of the following activities in respect of cells, tissues or organs:

• (a) importation;

• (b) processing;

• (c) distribution; and

• (d) transplantation. (établissement)

exceptional distribution

exceptional distribution means the distribution under sections 40 to 42 of cells, tissues or organs that have not been processed under these Regulations. (distribution exceptionnelle)

exterior label

exterior label means the label that is affixed to the exterior package. (étiquette extérieure)

exterior package

exterior package means the outermost package in which a cell, tissue or organ is delivered, transported or shipped. (emballage extérieur)

general standard

general standard means National Standard of Canada CAN/CSA-Z900.1 entitled Cells, Tissues, and Organs for Transplantation and Assisted Reproduction: General Requirements, as amended from time to time. (norme générale)

homologous

homologous, in respect of a cell, tissue or organ, means that the cell, tissue or organ performs the same basic function after transplantation. (homologue)

interior label

interior label means the label that is affixed to the interior package. (étiquette intérieure)

interior package

interior package means the innermost package of a cell, tissue or organ that has a non-sterile exterior. (emballage intérieur)

lymphohematopoietic standard

lymphohematopoietic standard means National Standard of Canada CAN/CSA-Z900.2.5 entitled Lymphohematopoietic Cells for Transplantation, as amended from time to time. (norme sur les cellules lymphohématopoïétiques)

medical director

medical director, in respect of an establishment, means a physician or dentist who is licensed under the laws of the jurisdiction in which the establishment is situated to provide health care or dental care and who is responsible for the application of the standard operating procedures and for all medical or dental procedures carried out there, as the case may be. (directeur médical)

minimally manipulated

minimally manipulated means

• (a) in respect of a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; and

• (b) in respect of cells and nonstructural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility. (manipulation minimale)

ocular standard

ocular standard means National Standard of Canada CAN/CSA-Z900.2.4 entitled Ocular Tissues for Transplantation, as amended from time to time. (norme sur les tissus oculaires)

organ

organ means a perfusable human organ for use in transplantation, whether whole or in parts, and whose specific function is intended to return after revascularization and reperfusion. It includes any adjunct vessels that are retrieved with the organ for use in organ transplantation. (organe)

organ standard

organ standard means National Standard of Canada CAN/CSA-Z900.2.3 entitled Perfusable Organs for Transplantation, as amended from time to time. (norme sur les organes)

package insert

package insert means the document that is prepared by the source establishment to accompany a cell, tissue or organ. (encart informatif)

processing

processing, in respect of cells, tissues and organs, means any of the following activities:

• (a) donor screening;

• (b) donor testing;

• (c) donor suitability assessment;

• (d) retrieval, except for organs and islet cells;

• (e) testing and measurements performed on the cells, tissues or organs after they are retrieved;

• (f) preparation for use in transplantation, except for organs;

• (g) preservation;

• (h) quarantine;

• (i) banking; and

• (j) packaging and labelling. (traitement)

quality assurance system

quality assurance system means the co-ordinated activities of an establishment that relate to the safety of cells, tissues and organs. It includes

• (a) the standard operating procedures;

• (b) records to demonstrate that the standard operating procedures have been implemented; and

• (c) audit processes to verify that the standard operating procedures are being implemented. (système d’assurance de la qualité)

scientific director

scientific director, in respect of an establishment, means an individual who is responsible for the application of the standard operating procedures and for all technical procedures carried out there. (directeur scientifique)

serious adverse reaction

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

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

• (b) persistent or significant disability or incapacity;

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

• (d) a life-threatening condition; and

• (e) death. (effet indésirable grave)

source establishment

source establishment means

• (a) subject to paragraph (b), in the case of an organ from a deceased donor, the relevant organ donation organization;

• (b) in the case of adjunct vessels that are retrieved with an organ and not used immediately in the organ transplantation, the relevant tissue bank;

• (c) in the case of an organ from a living donor or lymphohematopoietic cells that are not banked, the relevant transplant establishment;

• (d) in the case of tissues or banked lymphohematopoietic cells, the relevant cell or tissue bank; and

• (e) in the case of islet cells, the establishment that prepares the cells for use in transplantation. (établissement central)

standard operating procedures

standard operating procedures means the component of the quality assurance system that comprises instructions that set out the processes and procedures to follow in carrying out the activities of an establishment. (procédures d’opération normalisées)

tissue

tissue means a functional group of human cells for use in transplantation. It includes the cells and tissues listed in the definition tissue in section 3.1 of the general standard, except for paragraphs (g) and (l). (tissu)

tissue standard

tissue standard means National Standard of Canada CAN/CSA-Z900.2.2 entitled Tissues for Transplantation, as amended from time to time. (norme sur les tissus)

transplant

transplant means to implant cells, tissues or organs into a recipient. (transplantation)

Application

Marginal note:Scope of Regulations

2 These Regulations apply only to organs and minimally manipulated cells and tissues.