GreatNorthCollective/greatnorth-canada-federal-laws-text huggingface dataset:
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 34
Quarantine — cells and tissues 34 (1) A source establishment must ensure that cells, except islet cells, and tissues are quarantined until all of the following processing activities are completed: (a) the donor is found to be suitable after completion of the donor suitability assessment; (b) except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; and (c) all processing records are reviewed for completeness and compliance with the standard operating procedures. Additional requirement — live donors of tissue (2) In addition to the requirements set out in subsection (1), the source establishment must quarantine tissues that are retrieved from live donors in accordance with section 17.2 of the tissue standard.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 35
Storage limits 35 An establishment that distributes cells, tissues or organs and that stores cells, tissues and adjunct vessels that were not used at the time of transplantation of the organ with which they were retrieved must observe scientifically based maximum storage periods.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 36
Storage location 36 An establishment that distributes cells, tissues or organs must store them in a location that has environmental conditions that maintain their safety and that is secure against the entry of unauthorized persons. SOR/2023-247, s. 11(E)
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 37
Storage during transportation 37 An establishment that ships cells, tissues or organs must ensure that they are stored during transportation in appropriate environmental conditions. SOR/2022-197, s. 14(E) SOR/2023-247, s. 11(E)
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 38
Segregation — tissues 38 An establishment that stores tissues must ensure that those that are intended for autologous use are segregated from those intended for allogeneic use.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 39
Segregation — transmissible disease agents and markers 39 An establishment that stores cells, tissues or organs must ensure that any of them that are untested or for which the results of tests on donor blood samples are positive or reactive for transmissible disease agents or markers or are unavailable are segregated from all other cells, tissues and organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 40
Conditions 40 A source establishment may distribute cells, tissues or organs that have not been determined safe for transplantation if all of the following conditions are met: (a) a cell, tissue or organ that has been determined safe for transplantation is not immediately available; (b) the transplant physician or dentist, based on their clinical judgement, authorizes the exceptional distribution; and (c) the transplant establishment obtains the informed consent of the recipient.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 41
Notice in source establishment’s records 41 (1) A source establishment that distributes cells, tissues or organs under section 40 must keep a copy of the notice of exceptional distribution in its records. Notice in transplant establishment’s records (2) The transplant establishment must keep a copy of the notice of exceptional distribution in its records. Contents of notice (3) A notice of exceptional distribution must contain all of the following information: (a) the name of the transplanted cell, tissue or organ; (b) the provisions of these Regulations with which the cell, tissue or organ is not in compliance at the time of its distribution; (c) the justification for the distribution that formed the basis for the transplant physician’s or dentist’s decision to authorize it; (d) the name of the source establishment that distributed the cell, tissue or organ; (e) the name of the transplant establishment and of the transplant physician or dentist who authorized the distribution; and (f) the time and date of the written authorization of the distribution and a copy of the authorization signed by the transplant physician or dentist.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 42
Follow-up 42 A source establishment that distributes a cell, tissue or organ under section 40 before the donor suitability assessment is complete must, after the distribution, complete the assessment, carry out any other appropriate follow-up testing and notify the relevant transplant establishment of the results.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 43
Required action 43 (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that the safety of a cell, tissue or organ that is or was in its possession has been compromised by the occurrence of an error or accident during processing must immediately take all of the following steps: (a) determine the donor identification codes of all implicated cells, tissues and organs; (b) identify and quarantine any other implicated cells, tissues and organs in its possession; and (c) notify the following establishments: (i) the relevant source establishment, and (ii) if the cells, tissues or organs were imported, the establishment that imported them. Exception — importers (2) If the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment. Contents of notice (3) The notice must include all of the following information: (a) the reasons for the establishment’s belief that the safety of cells, tissues or organs has been compromised; (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known; (c) the donor identification codes of all implicated cells, tissues and organs; and (d) the name of any suspected transmissible disease or disease agent, if known. Written notice (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 44
Action by source establishment 44 (1) A source establishment that has reasonable grounds to believe that the safety of cells, tissues or organs for whose processing it is responsible has been compromised by the occurrence of an error or accident during processing must immediately take all of the following actions: (a) quarantine any implicated cells, tissues and organs in its possession; (b) send a notice described in subsection (2) to all of the following establishments: (i) if the cells, tissues or organs were imported, the establishment that imported them, (ii) any source establishment from which it received the donor referral, if applicable, (iii) any source establishment to which it made a donor referral, if applicable, and (iv) any establishment to which it distributed implicated cells, tissues or organs; and (c) initiate an investigation into the suspected error or accident. Contents of notice (2) The notice must include all of the following information: (a) the reasons for its belief that the safety of the cells, tissues or organs has been compromised; (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known; (c) the donor identification codes of all implicated cells, tissues and organs; (d) the name of any suspected transmissible disease or disease agent, if known; and (e) a statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 45
When no investigation necessary 45 If, on receipt of a notice under subsection 43 (1), the source establishment does not have reasonable grounds to believe that an investigation is necessary, it must notify the establishment to that effect in writing and provide its reasons for the decision not to conduct an investigation.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 46
Action on receipt of notice 46 An establishment that is not a source establishment and that receives a notice under section 44 or a copy of such a notice under this section must immediately take both of the following actions: (a) quarantine all implicated cells, tissues and organs in its possession; and (b) forward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 47
Required action 47 (1) Subject to subsection (2), an establishment that is not a source establishment and that has reasonable grounds to believe that an unexpected adverse reaction has occurred must immediately take all of the following steps: (a) determine the donor identification codes of the transplanted cells, tissues or organs; (b) identify and quarantine any other cells, tissues and organs in its possession that could potentially cause an adverse reaction in the same way as the transplanted cells, tissues or organs; and (c) notify the following establishments: (i) the relevant source establishment, and (ii) if the cells, tissues or organs were imported, the establishment that imported them. Exception — importers (2) If the establishment that receives a notice under subsection (1) is the establishment that imported the implicated cells, tissues or organs, it only has to notify the source establishment. Contents of notice (3) The notice must include all of the following information: (a) a description of the adverse reaction; (b) the donor identification codes of all implicated cells, tissues and organs; and (c) the name of any suspected transmissible disease or disease agent, if known. Written notice (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 48
Action by source establishment 48 (1) A source establishment that has reasonable grounds to believe that an unexpected adverse reaction has occurred that involves cells, tissues or organs for whose processing it is responsible must immediately take all of the following actions: (a) quarantine any implicated cells, tissues and organs in its possession; (b) send a notice described in subsection (2) to all of the following establishments: (i) if the implicated cells, tissues or organs were imported, the establishment that imported them, (ii) any source establishment from which it received the donor referral, if applicable, (iii) any source establishment to which it made a donor referral, and (iv) any establishment to which it distributed implicated cells, tissues or organs; and (c) initiate an investigation into the adverse reaction. Contents of notice (2) The notice must include all of the following information: (a) a description of the nature of the adverse reaction; (b) an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known; (c) the donor identification codes of all implicated cells, tissues and organs; (d) the name of any suspected transmissible disease or disease agent, if known; and (e) a statement requiring all implicated cells, tissues and organs to be quarantined immediately and until further notice from the source establishment and specifying any other corrective action that must be taken.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 49
Action on receipt of notice 49 An establishment that is not a source establishment and that receives a notice under section 48 or a copy of such a notice under this section must immediately take both of the following actions: (a) quarantine all implicated cells, tissues and organs in its possession; and (b) forward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 50
Requirement to cooperate 50 An establishment must provide the source establishment that is conducting an investigation with any relevant information in its possession with respect to cells, tissues or organs that it distributed or transplanted.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 51
Reports to Minister 51 (1) A source establishment that is conducting an investigation into either of the following subject-matters must provide the Minister with the reports described in subsection (2): (a) a suspected error or accident that is identified after distribution of cells, tissues or organs that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent; and (b) an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent. Contents and timing (2) The reports must include the following information and be provided at the following times: (a) within 24 hours after the start of the investigation, a preliminary report that includes all 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 update on any new information about the suspected error or accident or serious adverse reaction, on the progress made in the investigation during those 15 days and on the steps taken to mitigate further risks.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 52
When investigation shows no contamination or compromise 52 (1) If the results of the investigation show that the implicated cells, tissues or organs are not contaminated or compromised, the source establishment must notify every establishment that was notified under section 44 or 48 to that effect in writing and that they may be released from quarantine. Forwarding of copies of notice (2) On receipt of a notice under subsection (1), an establishment that is not a source establishment must forward a copy of the notice to every establishment to whom it distributed implicated cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 53
When investigation inconclusive or shows contamination or compromise 53 (1) If the results of the investigation show that some or all of the implicated cells, tissues or organs are contaminated or compromised, or the results are inconclusive, the source establishment must notify every establishment that was notified under section 44 or 48 to that effect in writing and that they may not be released for distribution. Forwarding of copies of notice (2) On receipt of a notice under subsection (1), an establishment that is not a source establishment must forward a copy of the notice to every establishment to whom it distributed implicated cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 54
Final report to Minister 54 (1) On completion of an investigation , the source establishment must submit a detailed final report to the Minister that contains at least all of the following information: (a) the results of the investigation; (b) the final disposition of the cells, tissues and organs that were the subject of the investigation and the reasons for that disposition; and (c) any corrective actions taken. Summaries of final reports (2) The source establishment must send a summary of the final report to every establishment that was notified under section 44 or 48 . Forwarding of summaries (3) An establishment that receives a summary under subsection (2) must send a copy of it to every establishment to which it distributed implicated cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 55
Record quality 55 Records kept by an establishment must be accurate, complete, legible and indelible.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 56
Donor identification code — source establishment 56 (1) A source establishment must assign a donor identification code to each donor of a cell, tissue or organ for which it has responsibility. Donor identification code — all establishments (2) Every registered establishment and transplant establishment must ensure that the donor identification code is a component of its records system.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 57
Requirement 57 An establishment’s records must contain information with respect to all cells, tissues and organs that it processes, distributes, imports or transplants that identifies (a) the establishment from which it receives the cells, tissues and organs; and (b) all establishments to which it distributes the cells, tissues and organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 58
Shipping documents 58 An establishment’s records must include all shipping documents with respect to cells, tissues and organs that it ships to another establishment.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 59
Source establishment records 59 The source establishment must keep records with respect to cells, tissues and organs that it processes that contain at least all of the following information: (a) the donor identification code; (b) documentation showing completion of the donor suitability assessment; (c) a description of the cells, tissues and organs retrieved from the donor; (d) if applicable, the name of any source establishment from which it received a donor referral or to which it made a donor referral; (e) the name of the retrieval establishment; (f) documentation of all processing activities; (g) the notice of exceptional distribution, if any; and (h) documentation of any reported errors, accidents and adverse reactions and their investigation, if any, in connection with cells, tissues or organs retrieved from the donor that it banked or distributed and any corrective action taken.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 60
Transplant establishment records 60 The transplant establishment must keep records with respect to cells, tissues and organs that it transplants that contain at least all of the following information: (a) a description of the transplanted cells, tissues or organs; (b) the donor identification code; (c) the registration number of the source establishment; (d) the notice of exceptional distribution, if any, and confirmation that the donor suitability assessment was completed as required by section 42 ; (e) information that allows the identification of the recipient; and (f) documentation of any errors, accidents and adverse reactions and their investigation in connection with those cells, tissues or organs and any corrective action taken.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 61
Establishments to cooperate 61 An establishment must provide the source establishment and the transplant establishment with all of the information described in sections 59 and 60 , respectively, that it possesses to complete the establishment’s records.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 62
Retention — 10 years after transplantation 62 (1) An establishment must keep the following records for at least 10 years after the date of transplantation, if known, or for at least 10 years after the date of distribution, final disposition or expiry of the cell, tissue or organ, as the case may be, whichever is the latest: (a) the records described in section 57 ; (b) the records described in section 59 , except paragraph (h); (c) the records described in section 60 , except paragraph (f); and (d) the record of destruction or other disposition of the cell, tissue or organ, if applicable. Retention — 10 years after record creation (2) An establishment must keep the following records for 10 years after the date of their creation: (a) the records described in paragraphs 59 (h) and 60 (f); and (b) reports of audits conducted under section 76 , if applicable. Retention — employee records (3) An establishment that distributes cells, tissues or organs must keep records of the qualifications, training and competency of its employees for 10 years after the time an individual ceases to be an employee of the establishment. Retention — standard operating procedures (4) An establishment that distributes cells, tissues or organs must keep a copy of every version of its standard operating procedures for 10 years after they are superseded by a new version.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 63
Storage of records 63 An establishment that distributes cells, tissues or organs must store records in a location that has appropriate environmental conditions and that is secure against the entry of unauthorized persons.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 64
Sufficient number and qualifications 64 (1) An establishment that distributes cells, tissues or organs must have sufficient personnel who are qualified by education, training or experience to perform their respective tasks to carry out the establishment’s activities. Competency (2) An establishment that distributes cells, tissues or organs must have a system for the orientation and training, both initial and ongoing, of personnel and for the evaluation of their competency.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 65
Requirements 65 The facilities of an establishment that distributes cells, tissues or organs must be constructed and maintained to permit all of the following: (a) the carrying out of all of its activities; (b) the efficient cleaning, maintenance and disinfection of the facilities in a way that prevents contamination and cross-contamination; (c) appropriate monitoring and control of environmental and microbiological conditions in all areas where its activities are carried out; and (d) controlled access to all areas where its activities are carried out. SOR/2023-247, s. 12(E)
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 66
Requirements — equipment 66 An establishment that distributes cells, tissues or organs, in carrying out its processing and storage activities, must use equipment that is cleaned and maintained and, whenever applicable, (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 Human Cells, Tissues and Organs for Transplantation Regulations — 67
Requirements — storage equipment 67 An establishment that distributes cells, tissues or organs that uses equipment to store cells, tissues or adjunct vessels that are not used immediately in organ transplantation must ensure that the equipment maintains appropriate environmental conditions.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 68
Processing supplies 68 An establishment that processes cells, tissues or organs must use qualified supplies for those activities that could affect the safety of the cells, tissues or organs, and must store solutions, reagents and other supplies under appropriate environmental conditions.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 69
Cleaning supplies 69 An establishment that processes cells, tissues or organs must ensure that it uses supplies for cleaning, maintenance, disinfection or sterilization that do not react with, or that are not absorbable by, the cells, tissues or organs.
Safety of Human Cells, Tissues and Organs for Transplantation Regulations — 70
Application 70 Sections 71 to 76 apply only to establishments that distribute cells, tissues or organs.