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Processing and Distribution of Semen for Assisted Conception Regulations (SOR/96-254)

Regulations are current to 2020-01-27

PART 1General (continued)

[SOR/2000-410, s. 2]

Records

  •  (1) Every person who processes semen for distribution shall maintain the following records in respect of each donor:

    • (a) the date of each donation and the tests, screening and monitoring performed in respect of the donor, the dates and results of those measures and, if necessary, an interpretation of the results;

    • (b) in respect of each donation, the identification code marked on each container of the donor’s semen, and the number of containers having that identification code;

    • (c) if the processor is a physician who uses the donor’s semen in the performance of assisted conception,

      • (i) the identification code marked on each container of semen and a means to identify the patient on whom the assisted conception was performed, and

      • (ii) in the case of semen that is distributed in accordance with a special access authorization, the patient’s written consent to the use of the semen;

    • (d) if a container of the donor’s semen is distributed for further distribution, the name and business address of the person who received the container and the identification code marked on it;

    • (d.1) if a container of the donor’s semen is distributed in accordance with a special access authorization, a copy of the authorization; and

    • (e) in respect of each container of the donor’s semen that the processor destroys, the identification code marked on it and the reason for its destruction.

  • (2) Every person who processes semen for distribution shall establish and maintain written standard operating procedures to be followed in

    • (a) processing semen; and

    • (b) tracing semen in accordance with sections 15 to 18.

  • SOR/2000-410, s. 9

 Every person who distributes semen processed by another person shall keep the following records in respect of each container of that semen:

  • (a) the name and business address of the processor and the identification code marked on the container;

  • (b) if the distributor received the container of semen from a person other than the processor, the name and business address of that person;

  • (c) in the case of a container of semen that is in the person’s possession, other than one for which a special access authorization has been issued, the following evidence that the semen was processed in accordance with the requirements of these Regulations in force at the time the semen was distributed to the person, namely, the date that the semen was donated, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results;

  • (c.1) in the case of a container of semen that the person distributed before December 1, 2000, evidence that the semen was processed in accordance with the requirements of these Regulations in force at the time the person distributed the semen;

  • (c.2) in the case of a container of semen that the person distributes on or after December 1, 2000, other than one for which a special access authorization has been issued, the following evidence that the semen was processed in accordance with the requirements of these Regulations in force at the time the person distributes the semen, namely, the date that the semen was donated, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results;

  • (c.3) in the case of a container of semen for which a special access authorization has been issued,

    • (i) a copy of the authorization,

    • (ii) a copy of the declaration referred to in paragraph 19(2)(i), and

    • (iii) the date that the semen was donated, the tests performed in respect of the donor, the dates and results of the tests and, if necessary, an interpretation of the results;

  • (d) if the distributor is a physician who uses the semen in the performance of assisted conception,

    • (i) a means to identify the patient on whom the assisted conception was performed, and

    • (ii) in the case of semen that is distributed in accordance with a special access authorization, the patient’s written consent to the use of the semen;

  • (e) if the container of semen is distributed for further distribution, the name and business address of the person who received it;

  • (f) in respect of each container of semen that the distributor destroys, the reason for its destruction; and

  • (g) in respect of each container of semen that the processor collects under paragraph 16(2)(c) or (3)(c), the date of its collection.

  • SOR/2000-410, s. 10

Tracing of Semen

 Where a physician who performed assisted conception on a woman has reasonable grounds to believe that an infectious agent was transmitted to the woman through semen used in the performance of the assisted conception, the physician shall, without delay,

  • (a) stop the distribution of all containers of semen in the physician’s possession having the same identification codes as that of the semen used for the assisted conception; and

  • (b) provide a written report to each processor of the semen

    • (i) advising that semen that they processed may be contaminated by an infectious agent, and naming the agent, and

    • (ii) specifying the identification codes marked on the containers of that semen.

  •  (1) Where a processor receives a report under paragraph 14(b), or otherwise has reasonable grounds to believe that semen that the processor processed and distributed may be contaminated by an infectious agent, the processor shall, without delay,

    • (a) identify the donors of the semen and quarantine all semen from those donors that is in the processor’s possession;

    • (b) use all reasonable means to identify, and locate the business address of, each person who received for further distribution semen obtained from any of those donors;

    • (c) give to each of the following persons a written notice specifying the identification codes marked on the containers of the semen believed to be contaminated, naming the infectious agent and indicating that the semen must be quarantined pending the completion of an investigation or must be destroyed, namely

      • (i) any person to whom the processor distributed, for further distribution, containers of semen having the identification codes specified in the notice, and

      • (ii) any other person who the processor believes received, for further distribution, containers of that semen;

    • (d) notify the donors of the semen in writing that an investigation is being conducted to determine whether semen that they donated is contaminated by an infectious agent, and naming the agent; and

    • (e) conduct an investigation to determine whether any of the semen provided by those donors is contaminated by an infectious agent.

  • (1.1) Despite subsection (1), the processor of semen that has been distributed in accordance with a special access authorization is not required to take the measures specified in that subsection by reason only that

    • (a) a particular infectious agent, other than one referred to in column 1 of the table to subsection 20(1), was not tested for in accordance with the requirements of paragraphs 4(1)(b) and 9(1)(a) during the processing of the semen; or

    • (b) the semen was not processed in accordance with section 10.

  • (2) Every person who distributed semen that is subject to investigation under paragraph (1)(e) shall, at the request of the processor conducting the investigation, provide the name and business address of every person to whom the person distributed the semen for further distribution.

  • (3) Every processor who conducts an investigation shall provide the Minister with the following information at the following times:

    • (a) within three days after the start of the investigation, the name of the infectious agent with which the semen is believed to be contaminated, the number of donors who donated semen that is believed to be contaminated and the number of containers of semen attributable to each donor; and

    • (b) every 30 days after the start of the investigation, until the final report is provided, an update on the progress made in tracing the semen, including information as to the number of containers used, recovered, quarantined or destroyed, and the number of persons contacted.

  • SOR/2000-410, s. 11
  •  (1) Where the results of the investigation demonstrate that all or some of the semen is not contaminated by an infectious agent, the processor

    • (a) shall prepare a list specifying the identification codes marked on the containers of the semen that is not contaminated;

    • (b) shall notify each person referred to in paragraph 15(1)(c), in writing, that the containers having the identification codes specified in the list may be distributed; and

    • (c) may distribute the containers in the processor’s possession that have the identification codes specified in the list.

  • (2) Where the results of the investigation demonstrate that all or some of the semen is contaminated by an infectious agent, the processor shall

    • (a) prepare a list specifying the identification codes marked on the containers of the semen that is contaminated;

    • (b) notify each person referred to in paragraph 15(1)(c), in writing, that all quarantined containers having the identification codes specified in the list must be collected by the processor;

    • (c) collect and destroy the containers of semen referred to in paragraph (b); and

    • (d) destroy the containers of semen in quarantine under paragraph 15(1)(a) that have the identification codes specified in the list.

  • (3) Where the results of the investigation are inconclusive as to whether all or some of the semen is contaminated by an infectious agent, the processor shall

    • (a) prepare a list specifying the identification codes marked on the containers of that semen;

    • (b) notify each person referred to in paragraph 15(1)(c), in writing, either

      • (i) that all quarantined containers having the identification codes specified in the list must be destroyed or reserved for special access distribution, or

      • (ii) that all quarantined containers having the identification codes specified in the list must be destroyed, reserved for special access distribution or kept in quarantine until collected by the processor;

    • (c) if the person to whom the processor gave a notice under subparagraph (b)(ii) informs the processor that the person has chosen to have the processor collect the containers as proposed in the notice, collect those containers and destroy them or reserve them for special access distribution; and

    • (d) destroy the containers of semen in the processor’s possession having the identification codes specified in the list or reserve them for special access distribution.

  • SOR/2000-410, s. 12
 
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