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

Marginal note:Additional documents and information

21 An establishment must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any additional relevant documents or information to demonstrate that the activities it conducts are in compliance with these Regulations.

Donor Suitability

Regular Process

Donor Suitability Assessment and Determination

Marginal note:Donor suitability assessment

22 In order to determine whether a donor is suitable, a primary establishment must ensure that a donor suitability assessment is conducted.

Marginal note:Donor screening

23 An establishment that performs donor screening must do so in accordance with the requirements set out in the Directive under the heading “Donor Screening”.

Marginal note:Physical examination

24 An establishment that performs physical examinations on donors must do so in accordance with the requirements set out in the Directive under the heading “Physical Examination”.

Marginal note:Donor testing

25 An establishment that performs donor testing must do so in accordance with the requirements set out in the Directive under the heading “Donor Testing”.

Marginal note:Donor reassessment

26 In order to determine whether a repeat donor is suitable, a primary establishment must ensure that the donor is reassessed in accordance with the requirements set out in the Directive under the heading “Donor Reassessment”.

Marginal note:Determination of donor suitability

• 27 (1) A primary establishment must ensure that its medical director determines whether a donor is suitable by reviewing the information obtained from the donor suitability assessment and, if applicable, from the donor reassessment.

• Marginal note:Donor unsuitability

  (2) A primary establishment must ensure that its medical director determines a donor to be unsuitable if

  • (a) the donor meets any criteria set out in the Directive under the heading “Donor Exclusion”; or

  • (b) the donor suitability assessment is not complete.

• Marginal note:Summary document

  (3) If a donor has been determined to be suitable, the primary establishment must ensure that its medical director creates and signs a summary document that confirms this determination 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; and

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

Quarantine

Marginal note:Requirement

• 28 (1) An establishment must quarantine all sperm and ova that it processes in the manner set out in subsection (2) until the medical director of the primary establishment that is responsible for the quarantine of that sperm and those ova has

  • (a) determined the donor to be suitable; and

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

• Marginal note:Segregation

  (2) The establishment must quarantine the sperm and ova by

  • (a) clearly indicating that they are quarantined;

  • (b) segregating them from sperm and ova that are not quarantined; and

  • (c) ensuring that they are not distributed or used.

Marginal note:Release from quarantine — exceptional access

• 29 (1) Despite paragraph 28(1)(a), an establishment may release sperm or ova from quarantine if the primary establishment that is responsible for their quarantine receives a request from a health professional for exceptional access to that sperm or those ova and if one of the following conditions is met:

  • (a) the recipient has previously been exposed to sperm or ova from that donor and the risk profile of the requested sperm or ova, based on the results of any part of the donor suitability assessment, is at least equivalent to the risk profile of the sperm or ova to which the recipient has previously been exposed, based on the results of any of the donor suitability assessment that was conducted at that time; or

  • (b) sperm or ova from that donor have previously been used to create a child for an individual or a couple and the requested sperm or ova are to be used for the purpose of creating another child for that individual or couple.

• Marginal note:Summary document

  (2) Before the sperm or ova are released from quarantine, the primary establishment must ensure that its medical director creates and signs a summary document that contains the following information:

  • (a) the age of the donor, if known;

  • (b) the conditions that have been met;

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

  • (d) the reasons the donor was determined to be unsuitable and a detailed explanation for each reason.

• Marginal note:Storage

  (3) An establishment and a health professional must ensure that sperm or ova that are in their possession or control and are intended for exceptional access are segregated from sperm and ova that are not intended for exceptional access.

• Marginal note:Communication of risk

  (4) A health professional must meet the following requirements before making use of the sperm or ova or distributing the 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 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.

Directed Donation Process

Donor Suitability Assessment and Confirmation

Marginal note:Application

30 Despite sections 22 to 29, the requirements set out in sections 31 to 40 with respect to sperm or ova that are intended for directed donation may instead be met if

• (a) the donor and recipient know each other; and

• (b) the health professional requests the sperm or ova from a primary establishment in the context of a directed donation.

Marginal note:Donor suitability assessment

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

Marginal note:Donor screening

32 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

33 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

34 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

35 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

• 36 (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

• 37 (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

38 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

39 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

40 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

41 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.