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Safety of Sperm and Ova Regulations (SOR/2019-192)

Regulations are current to 2023-09-19 and last amended on 2022-09-27. Previous Versions

Donor Suitability (continued)

Directed Donation Process (continued)

Donor Suitability Assessment and Confirmation (continued)

Marginal note:Donor suitability assessment

 A primary establishment, in the context of a directed donation, must ensure that a donor suitability assessment is conducted.

Marginal note:Donor screening

 An establishment that performs donor screening, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading “Donor Screening”.

Marginal note:Physical examination of donor

 An establishment that performs physical examinations on donors, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading “Physical Examination”.

Marginal note:Donor testing

 An establishment that performs donor testing, in the context of a directed donation, must do so in accordance with the requirements set out in the Directive under the heading “Donor Testing”.

Marginal note:Donor reassessment

 A primary establishment, in the context of a directed donation, must ensure that a repeat donor is reassessed in accordance with the requirements set out in the Directive under the heading “Donor Reassessment”.

Marginal note:Review by primary establishment

  •  (1) A primary establishment, in the context of a directed donation, must ensure that its medical director reviews the information obtained from the donor suitability assessment and, if applicable, the donor reassessment.

  • Marginal note:Summary document

    (2) A primary establishment must ensure that its medical director creates and signs a summary document that confirms the review and that contains

    • (a) the age of the donor;

    • (b) a statement that the donor suitability assessment and, if applicable, donor reassessment have been conducted in accordance with these Regulations;

    • (c) the dates and results of the donor testing and the assessment of the risk of genetic disease transmission; and

    • (d) a list of any criteria set out in the Directive under the heading “Donor Exclusion” that have been met.

Marginal note:Donor suitability assessment cannot be conducted

  •  (1) Despite sections 31, 35 and 36, a primary establishment, in the context of a directed donation, must ensure that its medical director meets the requirements set out in subsection (2) if

    • (a) a donation of sperm or ova has previously been obtained from the donor;

    • (b) the donor suitability assessment in respect of the donation was not conducted in accordance with these Regulations; and

    • (c) it is not medically possible to obtain another donation of sperm or ova from the donor or obtaining another donation of sperm or ova would pose a serious risk to the donor.

  • Marginal note:Requirements — medical director

    (2) The medical director must meet the following requirements:

    • (a) review any available medical information about the donor;

    • (b) review any available results of any donor screening, physical examination or donor testing that was previously conducted;

    • (c) unless it is not medically possible to do so, take appropriate measures to complete the donor suitability assessment; and

    • (d) create and sign a summary document that confirms the medical director’s review and that contains

      • (i) the age of the donor,

      • (ii) the medical reasons for which another donation cannot be obtained or an explanation of the risk,

      • (iii) the dates and results of any donor screening, physical examination or donor testing,

      • (iv) a list of any criteria set out in the Directive under the heading “Donor Exclusion” that have been met, and

      • (v) a list of any parts of the donor suitability assessment that have not been conducted and, for each one, an explanation of the reasons it was not conducted.

Quarantine

Marginal note:Requirement

 An establishment that processes sperm or ova in the context of directed donation must quarantine that sperm or ova until the medical director of the primary establishment that is responsible for the quarantine of that sperm and those ova has

  • (a) confirmed the review of the donor suitability assessment and, if applicable, the donor reassessment; and

  • (b) determined and documented that the sperm and ova can be released from quarantine.

Marginal note:Storage

 An establishment and a health professional must ensure that sperm or ova that are in their possession or control and are intended for directed donation are segregated from sperm and ova that are not intended for directed donation.

Communication of Risk

Marginal note:Before distributing or making use

 A health professional must meet the following requirements, in the context of directed donation, before making use of sperm or ova or distributing sperm to a recipient for their personal use:

  • (a) create a document that states that, based on the summary document and any risk mitigating measures with respect to that sperm or those ova, in their medical opinion, the use of the sperm or those ova would not pose a serious risk to human health and safety; and

  • (b) create a document that states that the health professional has informed the recipient of the risks that the use of the sperm or ova could pose to human health and safety and that the health professional has obtained written consent from the recipient.

Quality Management

Marginal note:Risk reduction

 An establishment that conducts an activity must do so in such a way as to reduce the risks to human health and safety and the safety of sperm or ova by having appropriate quality management measures, including the taking of measures

  • (a) to prevent contamination or cross-contamination;

  • (b) to prevent the transmission of an infectious disease; and

  • (c) to maintain the quality of the sperm or ova.

Quality Management System

Marginal note:Organizational structure

 An establishment must have an organizational structure that sets out the responsibility of management for all activities that it conducts and all measures that it takes in order to meet the requirements related to quality management.

Marginal note:Components of system

 An establishment must, with respect to the activities that it conducts and the measures that it takes in order to meet the requirements related to quality management, establish and maintain a quality management system that includes the following components and must name an individual to be responsible for that system:

  • (a) standard operating procedures;

  • (b) a process control program that includes a system for verifying and validating any change to a process;

  • (c) a system that allows for process improvement and that includes complaint monitoring and the implementation of corrective and preventative actions including recalls; and

  • (d) a document control and records management system.

Marginal note:Standard operating procedures

  •  (1) The standard operating procedures must meet the following requirements:

    • (a) they are in a standardized format;

    • (b) they are approved by the individual responsible for the quality management system;

    • (c) they are easily accessible at each location where the relevant activities are conducted;

    • (d) all changes to them are approved by the individual responsible for the quality management system before they are implemented; and

    • (e) they are kept up-to-date.

  • Marginal note:Review of procedures

    (2) An establishment must review its standard operating procedures every two years or after either of the following events and every two years after that event:

    • (a) following any amendment to these Regulations; and

    • (b) when a deficiency in the standard operating procedures is revealed as a result of an investigation into an error, accident or adverse reaction or as a result of an internal audit.

Marginal note:Internal audit

 An establishment must establish and maintain an internal audit system for quality management purposes and must carry out an internal audit every two years of the activities that it conducts to ensure that those activities comply with these Regulations and with its standard operating procedures, to be carried out by a person who is qualified to do so and who does not have direct responsibility for the activities being audited.

Tracing and Identifying

Marginal note:Tracing system

 An establishment must establish and maintain a system for tracing sperm and ova.

Marginal note:Donor identification code

 A primary establishment must ensure that a donor identification code is assigned to each donor.

Marginal note:Donation code

 A primary establishment must ensure that a donation code is assigned to each donation of sperm and ova that indicates the date of the donation and links the donation to the donor.

Labelling and Storing

Marginal note:Establishment that labels

 An establishment that labels an immediate container of sperm or ova must

  • (a) establish and maintain a labelling control system; and

  • (b) ensure that the donor identification code and the donation code appear on the label in a clear and indelible manner.

Marginal note:Label verification — primary establishment

 A primary establishment must ensure that the immediate container of sperm or ova is already labelled in accordance with the requirements of paragraph 49(b) and that it is accompanied by documentation that contains the following documents and information in English or French before distributing or making use of the sperm or ova:

  • (a) the donor identification code and the donation code;

  • (b) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container;

  • (c) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only;

  • (d) in the case of a directed donation, a statement that indicates that the donation is for directed donation only;

  • (e) the name of the primary establishment, its registration number and contact information;

  • (f) a copy of any summary document; and

  • (g) instructions for the handling and storage of the sperm or ova.

Marginal note:Containers

  •  (1) An establishment that distributes, imports or makes use of sperm or ova must

    • (a) verify the integrity of the immediate containers and the shipping containers as well as the accuracy and legibility of their labels; and

    • (b) ensure that the documentation that accompanies the immediate containers contains the following information in English or French:

      • (i) the donor identification code and the donation code,

      • (ii) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container,

      • (iii) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only,

      • (iv) in the case of a directed donation, a statement that indicates that the donation is for directed donation only,

      • (v) the name of the primary establishment, its registration number and contact information,

      • (vi) a copy of any summary document, and

      • (vii) instructions for the handling and storage of the sperm or ova.

  • Marginal note:Shipping

    (2) An establishment that ships sperm or ova must

    • (a) establish and maintain shipping standards;

    • (b) verify the integrity of the immediate containers and the shipping containers before shipping as well as the accuracy and legibility of their labels; and

    • (c) use shipping containers that are capable of resisting damage, maintaining the safety of the sperm or ova and maintaining adequate environmental conditions during shipping.

Marginal note:Storage

 An establishment that stores sperm or ova must establish and maintain standards for acceptable storage temperature ranges and ensure that sperm and ova are stored at a temperature within that range.

Personnel, Facilities, Equipment and Supplies

Marginal note:Qualified personnel

 In order to conduct its activities, an establishment must

  • (a) have sufficient personnel who are qualified by their education, training or experience to perform their respective tasks; and

  • (b) establish and maintain a program for the initial and ongoing training of personnel and for evaluating their competency.

Marginal note:Facilities

 The facilities in which an establishment conducts its activities must be constructed and maintained in a manner that allows for the following:

  • (a) the carrying out of its activities;

  • (b) the cleaning, maintaining and disinfecting of the facilities in a way that prevents contamination and cross-contamination; and

  • (c) controlled access to all areas where its activities are conducted.

Marginal note:Environmental control system

 An establishment must

  • (a) establish and maintain a system for controlling and monitoring appropriate environmental conditions for all facilities and areas in which activities are conducted; and

  • (b) periodically inspect those systems in order to verify that the systems function properly and must take any necessary corrective action.

Marginal note:Program — procurement and maintenance

 An establishment must establish and maintain a program for procuring and maintaining all critical equipment, supplies and services.

Marginal note:Equipment — general requirements

 An establishment must ensure that the critical equipment that it uses is cleaned and maintained and that, whenever applicable, it is

  • (a) qualified for its intended purpose;

  • (b) calibrated;

  • (c) disinfected or sterilized before each use; and

  • (d) requalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications.

Marginal note:Supplies

 An establishment must ensure that the critical supplies that it uses are qualified or validated, as applicable, for their intended use and that they are stored under appropriate environmental conditions.

 
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