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

Marginal note:Preliminary and interim reports

75 A primary establishment that is conducting an investigation into 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 adverse reaction 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 the following information,

  • (i) any new information with respect to the adverse reaction,

  • (ii) the progress of the investigation, and

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

Marginal note:Final report

76 A primary establishment 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.

Records

Marginal note:General

• 77 (1) An establishment and a health professional must keep records that contain all the documents and information required under these Regulations and all other records that demonstrate that they meet the requirements of these Regulations.

• Marginal note:Donor identification codes and donation codes

  (2) An establishment and a health professional must ensure that the donor identification code and the donation code are components of all of their records that relate to the processing, distribution, importation or making use of sperm or ova.

Marginal note:Retention period — general

• 78 (1) An establishment and a health professional must keep records for 10 years after their creation unless otherwise specified in these Regulations.

• Marginal note:Retention period — employees

  (2) An establishment must keep records containing records of the qualifications, training and competency of its employees for 10 years after the day on which an individual ceases to be an employee of the establishment.

• Marginal note:Retention period — standard operating procedures

  (3) An establishment must keep a copy of every version of its standard operating procedures for 10 years after the day on which they are superseded by a new version.

Marginal note:Processing

• 79 (1) A primary establishment must keep records that contain the following documents and information with respect to the sperm or ova it processes:

  • (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;

  • (b) the number of immediate containers on which the same donation code appears;

  • (c) the type of donation, whether sperm or ova;

  • (d) the date of the donation;

  • (e) any documents and information with respect to the suitability of the donor;

  • (f) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; and

  • (g) any information with respect to the disposition of the sperm or ova.

• Marginal note:Establishment to cooperate

  (2) An establishment that processes sperm or ova on behalf of a primary establishment must provide to the primary establishment all of the documents and information that it possesses to update the primary establishment’s records.

Marginal note:Distribution and importation

80 An establishment that distributes or imports sperm or ova and a health professional who distributes sperm to a recipient for their personal use must keep records that contain the following documents and information with respect to that sperm or those ova:

• (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;

• (b) the number of immediate containers on which the same donation code appears;

• (c) the contact information for the establishment from which the establishment or health professional received the sperm or ova, if applicable;

• (d) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova;

• (e) the contact information for each establishment, health professional or recipient to which the establishment or health professional distributes the sperm or ova, if applicable; and

• (f) any information with respect to the disposition of the sperm or ova.

Marginal note:Making use

• 81 (1) An establishment and a health professional must keep records that contain the following documents and information with respect to the sperm or ova of which it makes use:

  • (a) the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova;

  • (b) the number of immediate containers on which the same donation code appears;

  • (c) the contact information and registration number of the primary establishment that processed the sperm or ova;

  • (d) if applicable, the contact information for the establishment from which the establishment or health professional received the sperm or ova, if they were not received from a primary establishment;

  • (e) a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova;

  • (f) any information that allows for the identification of the recipient; and

  • (g) any information with respect to the disposition of the sperm or ova.

• Marginal note:Establishment to cooperate

  (2) An establishment must provide to the establishment and health professional all of the documents and information that it possesses to update the establishment and health professional’s records.

Marginal note:Retention period — processing, distribution, importation and making use

82 An establishment and a health professional must keep records in respect of each immediate container of sperm or ova for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm or ova.

Marginal note:Investigation

• 83 (1) An establishment or health professional that has conducted or received a notice of an investigation respecting an accident, error or adverse reaction must keep records that contain

  • (a) any documents and information with respect to the investigation;

  • (b) any notices that were received and copies of those that were sent and a list of all the establishments, health professionals or recipients to which they were sent; and

  • (c) a copy of any reports sent to the Minister.

• Marginal note:Retention period

  (2) An establishment and a health professional must keep records for a period of 10 years after the date of the last recording in that record.

Marginal note:Record qualities

• 84 (1) Records containing documents and information must be complete and kept in a manner that allows them to be audited at any time.

• Marginal note:Information qualities

  (2) The information must be accurate, legible and indelible.

Marginal note:Storage of records

85 An establishment and a health professional must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.

Transitional Provisions

Marginal note:Primary establishment not registered

• 86 (1) A primary establishment that, before the day on which these Regulations come into force, processes sperm or ova may, despite section 4, continue to do so without having been registered, if it submits an application for registration under section 5 within 90 days after that day.

• Marginal note:Duration

  (2) Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made.

Marginal note:Registration number

87 Despite paragraphs 11(2)(b), 18(1)(f) and 50(e), subparagraph 51(1)(b)(v) and paragraph 81(1)(c), a primary establishment’s registration number does not have to be provided before the 180th day after the day on which these Regulations come into force.

Marginal note:Distribution or importation before coming into force of these Regulations — notice

88 An establishment that, before the day on which these Regulations come into force, distributes or imports sperm or ova may continue to do so, despite section 18, if it sends a notice to the Minister that meets the requirements of that section within 90 days after that day.

Marginal note:Distribution or importation — requirements

• 89 (1) An establishment that, on or before the day on which these Regulations come into force, distributes or imports sperm or ova must ensure that

  • (a) the sperm or ova were processed in accordance with these Regulations by a primary establishment; and

  • (b) the primary establishment has submitted an application for registration under section 5 within 90 days after the day on which these Regulations come into force.

• Marginal note:Duration

  (2) Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made.

Marginal note:Sperm obtained before these Regulations come into force

• 90 (1) This section applies to sperm that is obtained before the day on which these Regulations come into force and that may be distributed, imported and used — despite the requirements set out in sections 22 to 40 – only if

  • (a) the sperm is processed, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations, in accordance with those Regulations; or

  • (b) the sperm is the subject of a special access authorization under section 20 of those Regulations.

• Marginal note:Special access authorization

  (2) Despite subsection (1), sperm that is the subject of a special access authorization may only be distributed and used for the purpose for which the authorization is granted.

• Marginal note:Immediate container

  (3) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the identification code, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations, appears in a clear and indelible manner on the label of the immediate container.

• Marginal note:Documentation

  (4) Before distributing or making use of the sperm, an establishment and a health professional must ensure that the immediate container of sperm is accompanied by documentation that contains the following information in English or French:

  • (a) the donation code;

  • (b) the name and business address of the processor within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations;

  • (c) the date of the donation, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results; and

  • (d) a copy of the special access authorization, if any.

Marginal note:Records

91 An establishment and a health professional must keep records of all documents and information as required under the Processing and Distribution of Semen for Assisted Conception Regulations, in respect of each immediate container of sperm, unless otherwise required by these Regulations, for a period of 10 years after the day on which they distribute, make use of or effect the disposition of the sperm.