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

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.

Marginal note:Notice of investigation

• 62 (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

63 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

• 64 (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.

Marginal note:Release from quarantine

65 An establishment or health professional that quarantines implicated sperm or ova must continue to do so until the results of the investigation reveal that the safety of the implicated sperm or ova is not compromised.

Marginal note:Release from quarantine — exceptional access

• 66 (1) Despite section 65, an establishment and a health professional may release sperm or ova from quarantine if the establishment or health professional 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 part 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 establishment or health professional that is responsible for the quarantine must create and sign a summary document that contains the following information:

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

  • (b) the condition that has been met;

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

  • (d) 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: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.

Marginal note:Preliminary and interim reports

67 The establishment or health professional that conducts an investigation into a suspected error or accident that could lead to an adverse reaction must send the following reports to the Minister, in the form established by the Minister, at the following times:

• (a) within 72 hours after the start of the investigation, a preliminary report that includes a detailed description of the suspected error or accident and any relevant information that is available at that time; and

• (b) within 15 days after the start of the investigation and every 15 days after that until the final report is made, an interim report that contains

  • (i) any new information with respect to the suspected error or accident,

  • (ii) the progress of the investigation, and

  • (iii) any measures taken during those 15 days to mitigate further risk.

Marginal note:Final report

68 An establishment or health professional that conducts an investigation into a suspected error or accident that could lead to an adverse reaction must send, within 72 hours of completing the investigation, a detailed final report to the Minister, in the form established by the Minister, that contains the following information:

• (a) the results of the investigation;

• (b) any corrective action taken; and

• (c) details concerning the disposition of the implicated sperm or ova.

Adverse Reactions

Marginal note:System — investigation by establishment

69 An establishment must establish and maintain a system that allows for the identification, investigation and reporting of adverse reactions.

Marginal note:Action to be taken

• 70 (1) An establishment and a health professional that have reasonable grounds to believe that an adverse reaction has occurred must immediately

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

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

  • (c) notify the following:

    • (i) the primary establishment that processed the implicated sperm or ova, and

    • (ii) if the sperm or ova were imported, the establishment that imported the sperm or ova.

• Marginal note:Contents of notice

  (2) The notice must include the following information:

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

  • (b) a description of the adverse reaction;

  • (c) the name of any suspected infectious disease or disease agent, if known; and

  • (d) an explanation of how the safety of the implicated sperm or ova might have been compromised, if known.

• Marginal note:Action upon notice

  (3) An establishment that is notified under subsection (1) or under this subsection must immediately

  • (a) quarantine any of the implicated sperm or ova that are in its possession or control; and

  • (b) 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, the notice must be confirmed in writing within 24 hours after it is given.

Marginal note:Investigation

• 71 (1) On receipt of a notice, a primary establishment must immediately initiate an investigation into the adverse reaction.

• Marginal note:Requirement to cooperate

  (2) An establishment and a health professional must, on request, provide to any primary establishment 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

• 72 (1) A primary establishment that conducts an investigation must notify in writing 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 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.

Marginal note:Release from quarantine

73 An establishment or health professional that quarantines implicated sperm or ova must continue to do so until the results of the investigation reveal that the safety of the implicated sperm or ova is not compromised.

Marginal note:Release from quarantine — exceptional access

• 74 (1) Despite section 73, an establishment and a health professional may release sperm or ova from quarantine if the establishment or health professional 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 part 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 establishment or health professional that is responsible for the quarantine must create and sign a summary document that contains the following information:

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

  • (b) the condition that has been met;

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

  • (d) a description of the adverse reaction;

  • (e) the name of any suspected infectious disease or disease agent, if known; and

  • (f) an explanation of how the safety of the implicated sperm or ova might have been compromised, if known.

• 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.