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

Regulations are current to 2020-10-05 and last amended on 2020-08-02. Previous Versions

Quality Management (continued)

Labelling and Storing (continued)

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.

Errors and Accidents

Marginal note:System — investigation by establishment

 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

  •  (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

  •  (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.

Marginal note:Notice of investigation

  •  (1) An establishment that initiates an investigation must immediately notify either the primary establishment that has or previously had in its possession or control any implicated sperm or ova and on whose behalf the processing activity was conducted or every establishment, health professional or recipient to which it distributed implicated sperm or ova and must include the following information in the notice:

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

    • (b) a description of the suspected error or accident and an explanation of how human health and safety or the safety of the sperm or ova might have been compromised.

  • Marginal note:Action upon notice

    (2) An establishment or health professional that is notified under subsection (1) 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 or recipient to which it distributed implicated sperm or ova.

  • Marginal note:Written notice

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

Marginal note:Requirement to cooperate

 An establishment and a health professional must, on request, provide to any establishment or health professional that is conducting an investigation any relevant documents or information in its possession in respect of implicated sperm or ova.

Marginal note:Results of investigation

  •  (1) An establishment that conducts an investigation must notify in writing either the primary establishment that has or previously had in its possession or control any implicated sperm or ova and on whose behalf the processing activity was conducted or every establishment, health professional or recipient to which it distributed implicated sperm or ova of the results of the investigation and of any action that is required to be taken.

  • Marginal note:Action on receipt of notice

    (2) An establishment that receives a notice under subsection (1) or a copy of such a notice under this subsection must send a copy of the notice to every establishment, health professional or recipient to which it distributed implicated sperm or ova.

 
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