GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Safety of Sperm and Ova Regulations — 44
Standard operating procedures 44 (1) The standard operating procedures must meet the following requirements: (a) they are in a standardized format; (b) they are approved by the individual responsible for the quality management system; (c) they are easily accessible at each location where the relevant activities are conducted; (d) all changes to them are approved by the individual responsible for the quality management system before they are implemented; and (e) they are kept up-to-date. Review of procedures (2) 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: (a) following any amendment to these Regulations; and (b) 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.
Safety of Sperm and Ova Regulations — 45
Internal audit 45 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.
Safety of Sperm and Ova Regulations — 46
Tracing system 46 An establishment must establish and maintain a system for tracing sperm and ova.
Safety of Sperm and Ova Regulations — 47
Donor identification code 47 A primary establishment must ensure that a donor identification code is assigned to each donor.
Safety of Sperm and Ova Regulations — 48
Donation code 48 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.
Safety of Sperm and Ova Regulations — 49
Establishment that labels 49 An establishment that labels an immediate container of sperm or ova must (a) establish and maintain a labelling control system; and (b) ensure that the donor identification code and the donation code appear on the label in a clear and indelible manner.
Safety of Sperm and Ova Regulations — 50
Label verification — primary establishment 50 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: (a) the donor identification code and the donation code; (b) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container; (c) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only; (d) in the case of a directed donation, a statement that indicates that the donation is for directed donation only; (e) the name of the primary establishment, its registration number and contact information; (f) a copy of any summary document; and (g) instructions for the handling and storage of the sperm or ova.
Safety of Sperm and Ova Regulations — 51
Containers 51 (1) An establishment that distributes, imports or makes use of sperm or ova must (a) verify the integrity of the immediate containers and the shipping containers as well as the accuracy and legibility of their labels; and (b) ensure that the documentation that accompanies the immediate containers contains the following information in English or French: (i) the donor identification code and the donation code, (ii) the type of content, whether sperm or ova, unless this information already appears on the label of the immediate container, (iii) in the case of exceptional access, a statement that indicates that the donation is for exceptional access only, (iv) in the case of a directed donation, a statement that indicates that the donation is for directed donation only, (v) the name of the primary establishment, its registration number and contact information, (vi) a copy of any summary document, and (vii) instructions for the handling and storage of the sperm or ova. Shipping (2) An establishment that ships sperm or ova must (a) establish and maintain shipping standards; (b) verify the integrity of the immediate containers and the shipping containers before shipping as well as the accuracy and legibility of their labels; and (c) use shipping containers that are capable of resisting damage, maintaining the safety of the sperm or ova and maintaining adequate environmental conditions during shipping.
Safety of Sperm and Ova Regulations — 52
Storage 52 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.
Safety of Sperm and Ova Regulations — 53
Qualified personnel 53 In order to conduct its activities, an establishment must (a) have sufficient personnel who are qualified by their education, training or experience to perform their respective tasks; and (b) establish and maintain a program for the initial and ongoing training of personnel and for evaluating their competency.
Safety of Sperm and Ova Regulations — 54
Facilities 54 The facilities in which an establishment conducts its activities must be constructed and maintained in a manner that allows for the following: (a) the carrying out of its activities; (b) the cleaning, maintaining and disinfecting of the facilities in a way that prevents contamination and cross-contamination; and (c) controlled access to all areas where its activities are conducted.
Safety of Sperm and Ova Regulations — 55
Environmental control system 55 An establishment must (a) establish and maintain a system for controlling and monitoring appropriate environmental conditions for all facilities and areas in which activities are conducted; and (b) periodically inspect those systems in order to verify that the systems function properly and must take any necessary corrective action.
Safety of Sperm and Ova Regulations — 56
Program — procurement and maintenance 56 An establishment must establish and maintain a program for procuring and maintaining all critical equipment, supplies and services.
Safety of Sperm and Ova Regulations — 57
Equipment — general requirements 57 An establishment must ensure that the critical equipment that it uses is cleaned and maintained and that, whenever applicable, it is (a) qualified for its intended purpose; (b) calibrated; (c) disinfected or sterilized before each use; and (d) requalified or recalibrated, as appropriate, after any repair or change is made to it that results in a change to its specifications.
Safety of Sperm and Ova Regulations — 58
Supplies 58 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.
Safety of Sperm and Ova Regulations — 59
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.
Safety of Sperm and Ova Regulations — 60
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. 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. 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. 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.
Safety of Sperm and Ova Regulations — 61
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. 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.
Safety of Sperm and Ova Regulations — 62
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. 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. 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.
Safety of Sperm and Ova Regulations — 63
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.
Safety of Sperm and Ova Regulations — 64
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. 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.
Safety of Sperm and Ova Regulations — 65
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.
Safety of Sperm and Ova Regulations — 66
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. 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. 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. 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.
Safety of Sperm and Ova Regulations — 67
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.
Safety of Sperm and Ova Regulations — 68
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.
Safety of Sperm and Ova Regulations — 69
System — investigation by establishment 69 An establishment must establish and maintain a system that allows for the identification, investigation and reporting of adverse reactions.
Safety of Sperm and Ova Regulations — 70
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. 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. 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. 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.
Safety of Sperm and Ova Regulations — 71
Investigation 71 (1) On receipt of a notice, a primary establishment must immediately initiate an investigation into the adverse reaction. 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.
Safety of Sperm and Ova Regulations — 72
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. 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.
Safety of Sperm and Ova Regulations — 73
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.
Safety of Sperm and Ova Regulations — 74
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. 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. 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. 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.
Safety of Sperm and Ova Regulations — 75
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.
Safety of Sperm and Ova Regulations — 76
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.