Safety of Sperm and Ova Regulations — 1
Definitions 1 (1) The following definitions apply in these Regulations. accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws, including these Regulations and that could compromise human health and safety or the safety of sperm or ova. ( accident ) activity , in respect of sperm or ova, means any of the following activities: (a) processing, which means (i) performing the donor suitability assessment, (ii) obtaining the sperm or ova from a donor, (iii) preparing, (iv) identifying, (v) testing, (vi) preserving, (vii) assessing quality, (viii) labelling, (ix) quarantining, or (x) storing; (b) distributing; and (c) importing. ( activité ) adverse reaction means the unexpected presence of an infectious disease agent or the unexpected occurrence of an infectious disease in a recipient of sperm or ova or a child created from that sperm or those ova. ( effet indésirable ) Directive means the document entitled Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors , published by the Department of Health, as amended from time to time. ( directive ) donation code means the unique group of numbers, letters, symbols or a combination of any of them that identifies the sperm or ova donation. ( code d’identification du don ) donor identification code means the unique group of numbers, letters, symbols or a combination of any of them that is assigned to a donor. ( code d’identification du donneur ) donor suitability assessment means an assessment of a donor that is based on the following: (a) donor screening; (b) physical examination of the donor; and (c) donor testing. ( évaluation de l’admissibilité du donneur ) error means a deviation from the standard operating procedures or applicable laws, including these Regulations, that could compromise human health and safety or the safety of sperm or ova. ( manquement ) establishment means a person, partnership, unincorporated entity or a part of any of them that conducts an activity but only includes a health professional if the health professional conducts an activity that is not referred to in the definition health professional . ( établissement ) health professional means a person who is authorized under the laws of a province to make use of sperm or ova in that province and who (a) makes use of sperm or ova or distributes sperm to a recipient for their personal use; (b) prepares, quarantines, labels or stores sperm or ova for the purpose of their use by that person; or (c) prepares, quarantines, labels or stores sperm for the purpose of its distribution by that person to a recipient for their personal use. ( professionnel de la santé ) human health and safety means the health and safety of a recipient of sperm or ova or a child created from that sperm or those ova to the extent that their health and safety relate to the safety of the sperm or ova. ( santé et sécurité humaines ) medical director , in respect of a primary establishment, means a person who is authorized under the laws of the jurisdiction in which the primary establishment is situated to practise the profession of medicine and who is responsible for all medical and technical procedures carried out during the processing of sperm or ova. ( directeur médical ) primary establishment means an establishment that conducts all processing activities in respect of sperm or ova, whether it conducts them itself or another establishment conducts any of the activities on its behalf. ( établissement principal ) quarantine , with respect to sperm and ova, means the quarantine described in subsection 28 (2) conducted by an establishment or a health professional. ( mise en quarantaine ) standard operating procedures means the component of a quality management system that comprises instructions that set out the processes applicable to the components of the system and to the activities carried out by an establishment. ( procédures opération