Safety of Sperm and Ova Regulations

Safety of Sperm and Ova Regulations Whereas, pursuant to subsection 66(1) of the Assisted Human Reproduction Acta, the Minister of Health has laid a copy of the proposed Safety of Sperm and Ova Regulations before each House of Parliament, substantially in the annexed form; Therefore, Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to section 65b of the Assisted Human Reproduction Acta, makes the annexed Safety of Sperm and Ova Regulations. S.C. 2004, c. 2 S.C. 2012, c. 19, s. 737 Definitions The following definitions apply in these Regulations. accident means an unexpected event that is not attributable to a deviation from the standard operating procedures or applicable laws, including these Regulations and that could compromise human health and safety or the safety of sperm or ova. (accident) activity, in respect of sperm or ova, means any of the following activities: processing, which means performing the donor suitability assessment, obtaining the sperm or ova from a donor, preparing, identifying, testing, preserving, assessing quality, labelling, quarantining, or storing; distributing; and importing. (activité) adverse reaction means the unexpected presence of an infectious disease agent or the unexpected occurrence of an infectious disease in a recipient of sperm or ova or a child created from that sperm or those ova. (effet indésirable) Directive means the document entitled Technical Requirements for Conducting the Suitability Assessment of Sperm and Ova Donors, published by the Department of Health, as amended from time to time. (directive) donation code means the unique group of numbers, letters, symbols or a combination of any of them that identifies the sperm or ova donation. (code d’identification du don) donor identification code means the unique group of numbers, letters, symbols or a combination of any of them that is assigned to a donor. (code d’identification du donneur) donor suitability assessment means an assessment of a donor that is based on the following: donor screening; physical examination of the donor; and donor testing. (évaluation de l’admissibilité du donneur) error means a deviation from the standard operating procedures or applicable laws, including these Regulations, that could compromise human health and safety or the safety of sperm or ova. (manquement) establishment means a person, partnership, unincorporated entity or a part of any of them that conducts an activity but only includes a health professional if the health professional conducts an activity that is not referred to in the definition health professional. (établissement) health professional means a person who is authorized under the laws of a province to make use of sperm or ova in that province and who makes use of sperm or ova or distributes sperm to a recipient for their personal use; prepares, quarantines, labels or stores sperm or ova for the purpose of their use by that person; or prepares, quarantines, labels or stores sperm for the purpose of its distribution by that person to a recipient for their personal use. (professionnel de la santé) human health and safety means the health and safety of a recipient of sperm or ova or a child created from that sperm or those ova to the extent that their health and safety relate to the safety of the sperm or ova. (santé et sécurité humaines) medical director, in respect of a primary establishment, means a person who is authorized under the laws of the jurisdiction in which the primary establishment is situated to practise the profession of medicine and who is responsible for all medical and technical procedures carried out during the processing of sperm or ova. (directeur médical) primary establishment means an establishment that conducts all processing activities in respect of sperm or ova, whether it conducts them itself or another establishment conducts any of the activities on its behalf. (établissement principal) quarantine, with respect to sperm and ova, means the quarantine described in subsection 28(2) conducted by an establishment or a health professional. (mise en quarantaine) standard operating procedures means the component of a quality management system that comprises instructions that set out the processes applicable to the components of the system and to the activities carried out by an establishment. (procédures opérationnelles normalisées) Amendments to Directive The document referred to in the definition of Directive is deemed to be amended for the purposes of these Regulations if the amendment is not inconsistent with the purpose of reducing risks to human health and safety. Primary establishment — conformity of processing A primary establishment must ensure that sperm or ova are processed in accordance with these Regulations before distributing or making use of them. Primary establishment — activities on its behalf The primary establishment must ensure that every establishment that conducts any processing on its behalf meets the requirements of these Regulations. Establishment that imports An establishment that imports sperm or ova must ensure that the sperm or ova are processed by a primary establishment that is registered in accordance with these Regulations. Requirement to register — primary establishment A primary establishment that processes sperm or ova must be registered and may process sperm or ova, subject to any change under paragraph 11(1)(a), only in accordance with its registration. Application A primary establishment must submit an application for registration to the Minister, in the form established by the Minister, that contains the following information: the applicant’s name, telephone number, email address, postal address and, if different from the postal address, civic address; in the case of an applicant that previously conducted its activities under another name, either under these Regulations or the Processing and Distribution of Semen for Assisted Conception Regulations, that other name; the first name, last name, telephone number and email address of a person to contact for further information concerning the application and, if different, a person to contact in case of emergency; a statement indicating whether the applicant proposes to process sperm or ova; a list of the processing activities that the applicant proposes to conduct in each building and, if not already provided, the civic address of the respective buildings; a statement indicating whether the applicant proposes to have another establishment process sperm or ova on its behalf; and the name and civic address of any other establishment that the applicant proposes to have conduct any of the processing activities on its behalf, a list of the processing activities that are proposed to be conducted in each building and, if not already provided, the civic address of the respective buildings. Signature and attestation The application must be signed and dated by a senior executive officer; and include an attestation from that senior executive officer of the following: that the applicant has evidence demonstrating that it is able to meet the requirements of these Regulations, that any other establishment that is proposed to process sperm or ova on its behalf is able to meet the requirements of these Regulations, that all information submitted in support of the application is accurate and complete, and that the senior executive officer has the authority to bind the applicant. Additional documents and information The applicant must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any documents or information that the Minister considers necessary to complete the Minister’s review of the application. Registration number If the Minister determines, after reviewing an application for registration, that the information provided in the application is complete, the Minister must register the primary establishment and issue a registration number. Refusal The Minister may refuse to register an applicant if the Minister has reasonable grounds to believe that the applicant has submitted, in the application for registration, false, misleading, inaccurate or incomplete information; the applicant has not complied with subsection 5(3) or the documents and information that the applicant has provided under subsection 5(3) are not sufficient to complete the review of the application; or the Minister has reasonable grounds to believe that registering the primary establishment could compromise human health and safety or the safety of sperm or ova. Amendments — application A primary establishment that processes only one of sperm or ova and proposes to begin processing the other must, before doing so, submit an application to the Minister to amend its registration, in the form established by the Minister, that contains a description of the proposed amendment, as well as the information referred to in section 5 that is relevant to the proposed amendment. The primary establishment must provide to the Minister, on or before the date specified in the Minister’s written request to that effect, any documents or information that the Minister considers necessary to complete the Minister’s review of the application. Amendment If the Minister determines, after reviewing the application for the amendment to the registration, that the information provided in that application is complete, the Minister must amend the registration. The Minister may refuse to amend the registration of the primary establishment if the Minister has reasonable grounds to believe that the primary establishment has submitted, in the application for amendment, false, misleading, inaccurate or incomplete information; the primary establishment has not complied with subsection 8(3) or the documents and information that it has provided under subsection 8(3) are not sufficient to complete the review of the application; or the Minister has reasonable grounds to believe that the amendment of the registration could compromise human health and safety or the safety of sperm or ova. Notice to Minister A primary establishment must notify the Minister in writing, in the form established by the Minister, within 30 days after the day on which there is any change to the information provided in the application for registration — other than a change that is the subject of an application for an amendment to the registration — including the cessation of all activities with respect to either sperm or ova if the registration is for both sperm and ova; or the primary establishment has ceased all of its activities. Contents of notice The notice must contain the following information: the primary establishment’s name, telephone number, email address, postal address and, if different from the postal address, civic address; the primary establishment’s registration number; the date on which the change or cessation became effective; and in the case of cessation, details of the disposition of the sperm or ova that are in the possession or control of the primary establishment. The notice must that if the primary establishment has not ceased all of its activities, it has evidence demonstrating that it meets the requirements of these Regulations, that if the primary establishment has not ceased all of its activities, any other establishment that processes sperm or ova or is proposed to process sperm or ova on its behalf meets the requirements of these Regulations, that all information submitted in support of the notice is accurate and complete, and that the senior executive officer has the authority to bind the primary establishment. Update to registration The Minister must update the registration to reflect the notice. Suspension without notice The Minister may suspend, in whole or in part, without prior notice, a primary establishment’s registration, if the Minister has reasonable grounds to believe that human health and safety or the safety of the sperm or ova has been or could be compromised. Notice If the Minister suspends a registration, the Minister must send a notice to the primary establishment that gives the reasons for the suspension and its effective date; indicates that the primary establishment has an opportunity to be heard; and if applicable, indicates that corrective action must be taken by the primary establishment and the date by which it must do so. Action following suspension of registration On the suspension of its registration, the primary establishment must immediately notify every establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the reasons for its suspension, the effective date of the suspension and the parts of the registration that are the subject of the suspension. Action upon notice An establishment that has been notified under subsection (3) or under this subsection must immediately notify to the same effect any establishment, health professional or recipient to which it distributed the implicated sperm or ova. Written notice If the Minister or the establishment gives a notice verbally under this section, that notice must be confirmed in writing as soon as feasible. Reinstatement of registration The Minister must reinstate a registration, in whole or in part, if the primary establishment makes a request to the Minister, in the form established by the Minister, and provides evidence that demonstrates that the primary establishment has corrected the situation that gave rise to the suspension; or the situation that gave rise to the suspension did not exist. The reinstatement takes effect immediately after the Minister sends to the primary establishment a notice to that effect. Exception — compliance history The Minister may refuse to reinstate a primary establishment’s registration if its compliance history demonstrates an inability to consistently conduct its activities in accordance with these Regulations. Partial reinstatement If the Minister does not reinstate any part of a registration that was suspended, the Minister must remove that part of the registration. Cessation of activities The Minister must cancel a registration if the Minister receives a notice under section 11 that the primary establishment has ceased carrying out all of the activities that are the subject of its registration. Circumstances The Minister may cancel a registration in any of the following circumstances: the primary establishment has not provided the annual attestation that is required under section 20; the primary establishment has not complied with the requirements set out in section 21 to provide additional documents or information; any information provided by the primary establishment to the Minister in accordance with these Regulations proves to be false or misleading; the primary establishment fails to take corrective action, within the required period, in accordance with subsection (2) or paragraph 13(2)(c); the corrective action that was taken by the primary establishment in accordance with subsection (2) or paragraph 13(2)(c) has not corrected the situation that gave rise to a notice of suspension or cancellation of the registration; the registration has been suspended for a period of more than 12 months; the Minister has reasonable grounds to believe that the primary establishment does not meet the requirements of these Regulations. Before cancelling a registration, the Minister must send to the primary establishment a notice that gives the reasons for the proposed cancellation and its effective date; Action following cancellation of registration If the registration is cancelled under section 16, the primary establishment must immediately take the following action: cease carrying out all of the activities that are the subject of its registration; and notify any establishment, health professional or recipient to which it has distributed the implicated sperm or ova during the period specified in the notice of the cancellation and the effective date. An establishment that has been notified under paragraph (1)(b) or under this subsection must, in turn, immediately notify to the same effect any establishment, health professional or recipient to which it distributed the implicated sperm or ova. If an establishment gives a notice verbally under this section, that notice must be confirmed in writing within 24 hours after it is given. Notice before distribution or importation Before distributing or importing sperm or ova, an establishment must send to the Minister a notice, in the form established by the Minister, that contains the following information: the establishment’s name, telephone number, email address, postal address and, if different from the postal address, civic address; in the case of an establishment that previously conducted its activities under another name, either under these Regulations or the Processing and Distribution of Semen for Assisted Conception Regulations, that other name; the first name, last name, telephone number and email address of a person to contact for further information concerning the notice and, if different, a person to contact in case of emergency; a statement indicating whether the establishment proposes to distribute or import sperm or ova and the projected start date; the civic address of the buildings in which the establishment proposes to conduct the activities, if not already provided; and the name and registration number of each primary establishment that processes that sperm or those ova. that the establishment has evidence demonstrating that it is able to meet the requirements of these Regulations, that the senior executive officer has the authority to bind the establishment. Change or cessation An establishment that distributes or imports sperm or ova and makes any change to the information provided under section 18, including the cessation of distribution or importation, must send to the Minister, within 30 days after the day on which the change occurs, a notice, in the form established by the Minister, that contains the following information: the name of the establishment, telephone number, email address, postal address and, if different from the postal address, civic address; in the case of cessation, details of the disposition of the sperm or ova that are in the possession or control of the establishment. that the establishment has evidence, if it is still distributing or importing sperm or ova, demonstrating that it meets the requirements of these Regulations, April 1 A primary establishment and any other establishment that distributes or imports sperm or ova must send to the Minister, in the form established by the Minister, an annual attestation on or before April 1 of the calendar year following the year of registration or the year in which the notice of distribution or importation is sent; and on or before April 1 of each subsequent calendar year. The attestation must certify that the establishment has evidence demonstrating that it meets the requirements of these Regulations, in the case of a primary establishment, any other establishment that processes sperm or ova on its behalf meets the requirements of these Regulations, all information submitted in support of the attestation is accurate and complete, and the senior executive officer has the authority to bind the establishment. 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 assessment In order to determine whether a donor is suitable, a primary establishment must ensure that a donor suitability assessment is conducted. Donor screening An establishment that performs donor screening must do so in accordance with the requirements set out in the Directive under the heading “Donor Screening”. Physical examination 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”. Donor testing An establishment that performs donor testing must do so in accordance with the requirements set out in the Directive under the heading “Donor Testing”. Donor reassessment 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”. Determination of donor suitability 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. Donor unsuitability A primary establishment must ensure that its medical director determines a donor to be unsuitable if the donor meets any criteria set out in the Directive under the heading “Donor Exclusion”; or the donor suitability assessment is not complete. Summary document 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 the age of the donor; a statement that the donor suitability assessment and, if applicable, donor reassessment have been conducted in accordance with these Regulations; and the dates and results of the donor testing and the assessment of the risk of genetic disease transmission. Requirement 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 determined the donor to be suitable; and determined and documented that the sperm and ova can be released from quarantine. Segregation The establishment must quarantine the sperm and ova by clearly indicating that they are quarantined; segregating them from sperm and ova that are not quarantined; and ensuring that they are not distributed or used. Release from quarantine — exceptional access 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: 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 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. 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: the age of the donor, if known; the conditions that have been met; the dates and results of any donor screening, physical examination or donor testing; and the reasons the donor was determined to be unsuitable and a detailed explanation for each reason. Storage 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. Communication of risk 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: 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 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. 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 the donor and recipient know each other; and the health professional requests the sperm or ova from a primary establishment in the context of a directed donation. A primary establishment, in the context of a directed donation, must ensure that a donor suitability assessment is conducted. 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”. Physical examination of donor 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”. 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”. 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”. Review by primary establishment 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. A primary establishment must ensure that its medical director creates and signs a summary document that confirms the review and that contains a statement that the donor suitability assessment and, if applicable, donor reassessment have been conducted in accordance with these Regulations; the dates and results of the donor testing and the assessment of the risk of genetic disease transmission; and a list of any criteria set out in the Directive under the heading “Donor Exclusion” that have been met. Donor suitability assessment cannot be conducted 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 donation of sperm or ova has previously been obtained from the donor; the donor suitability assessment in respect of the donation was not conducted in accordance with these Regulations; and 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. Requirements — medical director The medical director must meet the following requirements: review any available medical information about the donor; review any available results of any donor screening, physical examination or donor testing that was previously conducted; unless it is not medically possible to do so, take appropriate measures to complete the donor suitability assessment; and create and sign a summary document that confirms the medical director’s review and that contains the age of the donor, the medical reasons for which another donation cannot be obtained or an explanation of the risk, the dates and results of any donor screening, physical examination or donor testing, a list of any criteria set out in the Directive under the heading “Donor Exclusion” that have been met, and 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. 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 confirmed the review of the donor suitability assessment and, if applicable, the donor reassessment; and 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. Before distributing or making use 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: 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 Risk reduction 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 to prevent contamination or cross-contamination; to prevent the transmission of an infectious disease; and to maintain the quality of the sperm or ova. Organizational structure An establishment must have an organizational structure that sets out the responsibility of management for all activities that it conducts and all measures that it takes in order to meet the requirements related to quality management. Components of system An establishment must, with respect to the activities that it conducts and the measures that it takes in order to meet the requirements related to quality management, establish and maintain a quality management system that includes the following components and must name an individual to be responsible for that system: standard operating procedures; a process control program that includes a system for verifying and validating any change to a process; a system that allows for process improvement and that includes complaint monitoring and the implementation of corrective and preventative actions including recalls; and a document control and records management system. Standard operating procedures The standard operating procedures must meet the following requirements: they are in a standardized format; they are approved by the individual responsible for the quality management system; they are easily accessible at each location where the relevant activities are conducted; all changes to them are approved by the individual responsible for the quality management system before they are implemented; and they are kept up-to-date. Review of procedures An establishment must review its standard operating procedures every two years or after either of the following events and every two years after that event: following any amendment to these Regulations; and when a deficiency in the standard operating procedures is revealed as a result of an investigation into an error, accident or adverse reaction or as a result of an internal audit. Internal audit An establishment must establish and maintain an internal audit system for quality management purposes and must carry out an internal audit every two years of the activities that it conducts to ensure that those activities comply with these Regulations and with its standard operating procedures, to be carried out by a person who is qualified to do so and who does not have direct responsibility for the activities being audited. Tracing system An establishment must establish and maintain a system for tracing sperm and ova. Donor identification code A primary establishment must ensure that a donor identification code is assigned to each donor. Donation code A primary establishment must ensure that a donation code is assigned to each donation of sperm and ova that indicates the date of the donation and links the donation to the donor. Establishment that labels An establishment that labels an immediate container of sperm or ova must establish and maintain a labelling control system; and ensure that the donor identification code and the donation code appear on the label in a clear and indelible manner. Label verification — primary establishment A primary establishment must ensure that the immediate container of sperm or ova is already labelled in accordance with the requirements of paragraph 49(b) and that it is accompanied by documentation that contains the following documents and information in English or French before distributing or making use of the sperm or ova: the donor identification code and the donation code; the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container; in the case of exceptional access, a statement that indicates that the donation is for exceptional access only; in the case of a directed donation, a statement that indicates that the donation is for directed donation only; the name of the primary establishment, its registration number and contact information; a copy of any summary document; and instructions for the handling and storage of the sperm or ova. Containers An establishment that distributes, imports or makes use of sperm or ova must verify the integrity of the immediate containers and the shipping containers as well as the accuracy and legibility of their labels; and ensure that the documentation that accompanies the immediate containers contains the following information in English or French: the donor identification code and the donation code, the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container, in the case of exceptional access, a statement that indicates that the donation is for exceptional access only, in the case of a directed donation, a statement that indicates that the donation is for directed donation only, the name of the primary establishment, its registration number and contact information, a copy of any summary document, and Shipping An establishment that ships sperm or ova must establish and maintain shipping standards; verify the integrity of the immediate containers and the shipping containers before shipping as well as the accuracy and legibility of their labels; and use shipping containers that are capable of resisting damage, maintaining the safety of the sperm or ova and maintaining adequate environmental conditions during shipping. 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. Qualified personnel In order to conduct its activities, an establishment must have sufficient personnel who are qualified by their education, training or experience to perform their respective tasks; and establish and maintain a program for the initial and ongoing training of personnel and for evaluating their competency. Facilities The facilities in which an establishment conducts its activities must be constructed and maintained in a manner that allows for the following: the carrying out of its activities; the cleaning, maintaining and disinfecting of the facilities in a way that prevents contamination and cross-contamination; and controlled access to all areas where its activities are conducted. Environmental control system An establishment must establish and maintain a system for controlling and monitoring appropriate environmental conditions for all facilities and areas in which activities are conducted; and periodically inspect those systems in order to verify that the systems function properly and must take any necessary corrective action. Program — procurement and maintenance An establishment must establish and maintain a program for procuring and maintaining all critical equipment, supplies and services. Equipment — general requirements An establishment must ensure that the critical equipment that it uses is cleaned and maintained and that, whenever applicable, it is qualified for its intended purpose; calibrated; disinfected or sterilized before each use; and requalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications. 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. System — investigation by establishment An establishment must establish and maintain a system that allows for the identification, investigation and reporting of errors and accidents. Error or accident by another establishment 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 determine the donor identification codes and donation codes of the implicated sperm or ova; quarantine any implicated sperm or ova that are in their possession or control; notify the following: the establishment from which they received the implicated sperm or ova, and in the case of an establishment, every establishment, health professional or recipient to which it distributed the implicated sperm or ova; and 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. The notice must include the following information: the donor identification code and the donation code associated with the implicated sperm or ova; and the reason for the belief that an error or accident has occurred. An establishment or health professional that is notified under subparagraph (1)(c)(ii) or under this subsection must immediately quarantine all implicated sperm or ova in its possession or control; and 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. 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. Establishment or health professional — own error or accident 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 determine the donor identification codes and the donation codes of the implicated sperm or ova; quarantine any implicated sperm or ova that are in their possession and control; and subject to subsection (2), initiate an investigation into the suspected error or accident. Exception 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: the donor identification codes and donation codes of all implicated sperm or ova; and Notice of investigation 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 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. An establishment or health professional that is notified under subsection (1) or under this subsection must immediately 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. 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. 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. Results of investigation 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. Action on receipt of notice 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. Release from quarantine 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. 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: 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 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: the condition that has been met; Preliminary and interim reports 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: 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 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 any new information with respect to the suspected error or accident, the progress of the investigation, and any measures taken during those 15 days to mitigate further risk. Final report 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: the results of the investigation; any corrective action taken; and details concerning the disposition of the implicated sperm or ova. An establishment must establish and maintain a system that allows for the identification, investigation and reporting of adverse reactions. Action to be taken An establishment and a health professional that have reasonable grounds to believe that an adverse reaction has occurred must immediately determine the donor identification codes and donation codes of any implicated sperm or ova in their possession; quarantine any of the implicated sperm or ova in their possession and control; and the primary establishment that processed the implicated sperm or ova, and if the sperm or ova were imported, the establishment that imported the sperm or ova. the donor identification code and the donation code of the implicated sperm or ova; a description of the adverse reaction; the name of any suspected infectious disease or disease agent, if known; and an explanation of how the safety of the implicated sperm or ova might have been compromised, if known. An establishment that is notified under subsection (1) or under this subsection must immediately quarantine any of the implicated sperm or ova that are in its possession or control; and notify to the same effect every establishment, health professional and recipient to which it distributed the implicated sperm or ova. Investigation On receipt of a notice, a primary establishment must immediately initiate an investigation into the adverse reaction. 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. 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. 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. 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: 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 the dates and results of any donor screening, physical examination or donor testing; 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: 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 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, any new information with respect to the adverse reaction, 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: General 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. Donor identification codes and donation codes 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. Retention period — general An establishment and a health professional must keep records for 10 years after their creation unless otherwise specified in these Regulations. Retention period — employees 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. Retention period — standard operating procedures 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. Processing A primary establishment must keep records that contain the following documents and information with respect to the sperm or ova it processes: the donor identification code and the donation code that appear on the label of each immediate container of sperm or ova; the number of immediate containers on which the same donation code appears; the type of donation, whether sperm or ova; the date of the donation; any documents and information with respect to the suitability of the donor; a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; and any information with respect to the disposition of the sperm or ova. Establishment to cooperate 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. Distribution and importation 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: the contact information for the establishment from which the establishment or health professional received the sperm or ova, if applicable; a copy of all documentation that is required under these Regulations to accompany the immediate container of the sperm or ova; 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 Making use 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: the contact information and registration number of the primary establishment that processed the sperm or ova; 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; any information that allows for the identification of the recipient; and 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. Retention period — processing, distribution, importation and making use 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. 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 any documents and information with respect to the investigation; 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 a copy of any reports sent to the Minister. Retention period 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. Record qualities Records containing documents and information must be complete and kept in a manner that allows them to be audited at any time. Information qualities The information must be accurate, legible and indelible. Storage of records 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. Primary establishment not registered 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. Duration Subsection (1) applies until the day on which the determination of the application submitted under section 5 is made. 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. Distribution or importation before coming into force of these Regulations — notice 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. Distribution or importation — requirements An establishment that, on or before the day on which these Regulations come into force, distributes or imports sperm or ova must ensure that the sperm or ova were processed in accordance with these Regulations by a primary establishment; and 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. Sperm obtained before these Regulations come into force 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 the sperm is processed, within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations, in accordance with those Regulations; or the sperm is the subject of a special access authorization under section 20 of those Regulations. Special access authorization 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. Immediate container 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. Documentation 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: the donation code; the name and business address of the processor within the meaning of the Processing and Distribution of Semen for Assisted Conception Regulations; 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 a copy of the special access authorization, if any. Records 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. [Amendments] The Processing and Distribution of Semen for Assisted Conception Regulations2 are repealed. SOR/96-254 Coming into force of section 10 of Act Subject to subsection (2), these Regulations come into force on the day on which section 10 of the Assisted Human Reproduction Act comes into force. 180th day Section 3 comes into force on the 180th day after the day on which section 10 of the Assisted Human Reproduction Act comes into force. [Note: Regulations, except section 3, in force February 4, 2020, section 3 in force August 2, 2020, see SI/2019-37.]