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

Quality Management System

Marginal note:Organizational structure

42 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

43 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

• 44 (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

45 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

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

Marginal note:Donor identification code

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

Marginal note:Donation code

48 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

49 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

50 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

• 51 (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

52 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

53 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

54 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

55 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

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

Marginal note:Equipment — general requirements

57 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

58 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.

Errors and Accidents

Marginal note:System — investigation by establishment

59 An establishment must establish and maintain a system that allows for the identification, investigation and reporting of errors and accidents.

Marginal note:Error or accident by another establishment

• 60 (1) An establishment and a health professional that have reasonable grounds to believe that an error or accident by another establishment has occurred during the processing, distributing or importing of sperm or ova must immediately

  • (a) determine the donor identification codes and donation codes of the implicated sperm or ova;

  • (b) quarantine any implicated sperm or ova that are in their possession or control;

  • (c) notify the following:

    • (i) the establishment from which they received the implicated sperm or ova, and

    • (ii) in the case of an establishment, every establishment, health professional or recipient to which it distributed the implicated sperm or ova; and

  • (d) in the case of a primary establishment that has reasonable grounds to believe that the error or accident occurred during the processing of sperm and ova conducted on its behalf, initiate an investigation into the suspected error or accident.

• Marginal note:Contents of notice

  (2) The notice must include the following information:

  • (a) the donor identification code and the donation code associated with the implicated sperm or ova; and

  • (b) the reason for the belief that an error or accident has occurred.

• Marginal note:Action upon notice

  (3) An establishment or health professional that is notified under subparagraph (1)(c)(ii) or under this subsection must immediately

  • (a) quarantine all implicated sperm or ova in its possession or control; and

  • (b) in the case of an establishment, notify to the same effect every establishment, health professional and recipient to which it distributed the implicated sperm or ova.

• Marginal note:Written notice

  (4) If an establishment or a health professional gives a notice verbally under this section, that notice must be confirmed in writing within 24 hours after it is given.

Marginal note:Establishment or health professional — own error or accident

• 61 (1) An establishment and a health professional that have reasonable grounds to believe that an error or accident has occurred during the processing, distributing or importing of sperm or ova that they conducted must immediately

  • (a) determine the donor identification codes and the donation codes of the implicated sperm or ova;

  • (b) quarantine any implicated sperm or ova that are in their possession and control; and

  • (c) subject to subsection (2), initiate an investigation into the suspected error or accident.

• Marginal note:Exception

  (2) An establishment that conducts a processing activity on behalf of a primary establishment that has or previously had in its possession or control any implicated sperm or ova can request that the primary establishment conduct the investigation by providing a notice to them that contains the following information:

  • (a) the donor identification codes and donation codes of all implicated sperm or ova; and

  • (b) the reason for the belief that an error or accident has occurred.