SOR-2007-118 Safety of Human Cells, Tissues and Organs for Transplantation Regulations

in the case of lymphohematopoietic cells, tissues and organs retrieved from live donors and of tissues retrieved from deceased donors, all donor testing results; and

in the case of fresh skin, islet cells and organs retrieved from deceased donors, the donor testing results that are necessary at the time of transplantation. (évaluation de l’admissibilité du donneur)

whether the donor has or ever had a transmissible disease or is or ever was infected with a transmissible disease agent;

donor compatibility; and

the degree of functionality of the cell, tissue or organ that is to be retrieved. (examen du donneur)

importation;

processing;

distribution; and

transplantation. (établissement)

in respect of a structural tissue, that the processing does not alter the original characteristics that are relevant to its claimed utility for reconstruction, repair or replacement; and

in respect of cells and nonstructural tissue, that the processing does not alter the biological characteristics that are relevant to their claimed utility. (manipulation minimale)

donor screening;

donor testing;

donor suitability assessment;

retrieval, except for organs and islet cells;

testing and measurements performed on the cells, tissues or organs after they are retrieved;

preparation for use in transplantation, except for organs;

preservation;

quarantine;

banking; and

packaging and labelling. (traitement)

the standard operating procedures;

records to demonstrate that the standard operating procedures have been implemented; and

audit processes to verify that the standard operating procedures are being implemented. (système d’assurance de la qualité)

their in-patient hospitalization or its prolongation;

persistent or significant disability or incapacity;

medical, dental or surgical intervention to preclude a persistent or significant disability or incapacity;

a life-threatening condition; and

death. (effet indésirable grave)

subject to paragraph (b), in the case of an organ from a deceased donor, the relevant organ donation organization;

in the case of adjunct vessels that are retrieved with an organ and not used immediately in the organ transplantation, the relevant tissue bank;

in the case of an organ from a living donor or lymphohematopoietic cells that are not banked, the relevant transplant establishment;

in the case of tissues or banked lymphohematopoietic cells, the relevant cell or tissue bank; and

in the case of islet cells, the establishment that prepares the cells for use in transplantation. (établissement central)

cells, tissues and organs that are for non-homologous use;

cells, tissues and organs that are for autologous use;

heart valves and dura mater;

tissues and cells — except for islet cells, and except for lymphohematopoietic cells that are derived from bone marrow, peripheral blood or cord blood — that have a systemic effect and depend on their metabolic activity for their primary function;

medical devices that contain cells or tissues and that are the subject of investigational testing involving human subjects under Part 3 of the Medical Devices Regulations;

cells, tissues and organs that are the subject of clinical trials under Division 5 of Part C of the Food and Drug Regulations;

Class IV medical devices that are regulated under the Medical Devices Regulations;

blood components, blood products and whole blood, except for cord blood and peripheral blood for use in lymphohematopoietic cell transplantation;

cells and tissues that are regulated under the Assisted Human Reproduction Act or any of its regulations.

the establishment’s name and civic address, and its postal address if different, and the name and telephone number of a person to contact for further information with respect to the application;

in the case of an establishment that previously carried out its activities under another name, that other name;

a description of the types of cells, tissues and organs that the establishment processes, distributes or imports;

a description of the types of processing, distribution or transplantation activities that the establishment carries out or for which it is responsible;

the period during which the establishment has been in operation; and

a statement dated and signed by the medical director or scientific director that certifies that the establishment is in compliance with these Regulations.

the application for registration contains false or misleading information;

the Minister receives a notice under section 13 that states that the establishment has ceased an activity;

the establishment has not complied with a request for additional information made under section 14; or

the Minister has reason to believe that the establishment is not in compliance with these Regulations or that the safety of cells, tissues or organs has been or could be compromised.

send a written notice to the establishment that sets out the reasons for the proposed cancellation and specifies the corrective action, if any, that the establishment must take and the time within which it must be taken; and

give the establishment an opportunity to be heard in writing with respect to the cancellation.

cease carrying out the activities that were authorized by the registration; and

notify the establishments to whom it has distributed a cell, tissue or organ or made a donor referral, during the period specified in the notice, of the cancellation, the reasons for the cancellation and the effective date.

the establishment’s name and civic address, and its postal address if different;

the establishment’s registration number;

the date on which the change or cessation became effective; and

in the case of the cessation of an activity, the disposition of the cells, tissues and organs in the establishment’s possession.

obtain the donor information and history in accordance with sections 12.2 and 12.3 of the general standard;

determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the general standard and in Annex E to that standard;

perform a physical examination of the donor in accordance with section 13.2 of the general standard; and

perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the general standard.

determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.2 of the tissue standard; and

perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.6 of the tissue standard.

obtain the donor information and history in accordance with sections 12.2.2.3, 12.2.2.4, 12.2.3.4 and 12.2.3.7 of the organ standard;

determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.2.2 of the organ standard;

perform the tests specified in sections 14.1.2 and 14.3.2 of the organ standard; and

perform appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard.

documentation of the donor suitability assessment according to the requirements of the jurisdiction where the assessment was performed;

documentation that the tests specified in sections 14.1.2 and 14.3.2 of the organ standard have been performed;

documentation that appropriate and effective tests for the diseases or disease agents specified in sections 14.2.6.3 and 14.2.6.6 of the organ standard have been performed; and

in the case of those of the tests for the diseases or disease agents specified in section 14.2.6.3 of the organ standard that must be performed before transplantation and the blood group test for ABO, a copy of the test results.

obtain the donor information and history in accordance with sections 12.2.2.2 and 12.2.2.3 of the lymphohematopoietic standard;

perform a physical examination of the donor in accordance with section 13.2 of the lymphohematopoietic standard;

determine that the donor is not unsuitable to donate on the basis of the contraindications or exclusion criteria set out in section 13.1.3 of the lymphohematopoietic standard;

perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard; and

perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard.

have documentation of the donor suitability assessment;

perform the tests specified in section 12.2.2.4 of the lymphohematopoietic standard;

perform appropriate and effective tests for the diseases or disease agents specified in section 14.2.3 of the lymphohematopoietic standard; and

determine that the donor is not unsuitable to donate on the basis of the exclusion criteria set out in section 13.1.3.4 of the lymphohematopoietic standard.

in Canada, if the testing is performed in Canada; or

in Canada or the United States, if the testing is performed outside Canada.

on the exterior label and in the package insert, the name of the establishment, its civic address and contact information; and

on the exterior label and in the package insert, the establishment’s registration number.

the donor is found to be suitable after completion of the donor suitability assessment;

except in the case of fresh skin, bacteriological test results are reviewed and found to be acceptable, if applicable; and

all processing records are reviewed for completeness and compliance with the standard operating procedures.

a cell, tissue or organ that has been determined safe for transplantation is not immediately available;

the transplant physician or dentist, based on their clinical judgement, authorizes the exceptional distribution; and

the transplant establishment obtains the informed consent of the recipient.

the name of the transplanted cell, tissue or organ;

the provisions of these Regulations with which the cell, tissue or organ is not in compliance at the time of its distribution;

the justification for the distribution that formed the basis for the transplant physician’s or dentist’s decision to authorize it;

the name of the source establishment that distributed the cell, tissue or organ;

the name of the transplant establishment and of the transplant physician or dentist who authorized the distribution; and

the time and date of the written authorization of the distribution and a copy of the authorization signed by the transplant physician or dentist.

determine the donor identification codes of all implicated cells, tissues and organs;

identify and quarantine any other implicated cells, tissues and organs in its possession; and

notify the following establishments:

the reasons for the establishment’s belief that the safety of cells, tissues or organs has been compromised;

an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

the donor identification codes of all implicated cells, tissues and organs; and

the name of any suspected transmissible disease or disease agent, if known.

quarantine any implicated cells, tissues and organs in its possession;

send a notice described in subsection (2) to all of the following establishments:

initiate an investigation into the suspected error or accident.

the reasons for its belief that the safety of the cells, tissues or organs has been compromised;

an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

the donor identification codes of all implicated cells, tissues and organs;

the name of any suspected transmissible disease or disease agent, if known; and

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.

quarantine all implicated cells, tissues and organs in its possession; and

forward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.

determine the donor identification codes of the transplanted cells, tissues or organs;

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

notify the following establishments:

a description of the adverse reaction;

the donor identification codes of all implicated cells, tissues and organs; and

the name of any suspected transmissible disease or disease agent, if known.

quarantine any implicated cells, tissues and organs in its possession;

send a notice described in subsection (2) to all of the following establishments:

initiate an investigation into the adverse reaction.

a description of the nature of the adverse reaction;

an explanation of how the safety of the implicated cells, tissues or organs may have been compromised, if known;

the donor identification codes of all implicated cells, tissues and organs;

the name of any suspected transmissible disease or disease agent, if known; and

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.

quarantine all implicated cells, tissues and organs in its possession; and

forward a copy of the notice to every establishment to which it distributed implicated cells, tissues or organs.

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

an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent.

within 24 hours after the start of the investigation, a preliminary report that includes all 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 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.

the results of the investigation;

the final disposition of the cells, tissues and organs that were the subject of the investigation and the reasons for that disposition; and

any corrective actions taken.

the establishment from which it receives the cells, tissues and organs; and

all establishments to which it distributes the cells, tissues and organs.

the donor identification code;

documentation showing completion of the donor suitability assessment;

a description of the cells, tissues and organs retrieved from the donor;

if applicable, the name of any source establishment from which it received a donor referral or to which it made a donor referral;

the name of the retrieval establishment;

documentation of all processing activities;

the notice of exceptional distribution, if any; and

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.

a description of the transplanted cells, tissues or organs;

the donor identification code;

the registration number of the source establishment;

the notice of exceptional distribution, if any, and confirmation that the donor suitability assessment was completed as required by section 42;

information that allows the identification of the recipient; and

documentation of any errors, accidents and adverse reactions and their investigation in connection with those cells, tissues or organs and any corrective action taken.

the records described in section 57;

the records described in section 59, except paragraph (h);

the records described in section 60, except paragraph (f); and

the record of destruction or other disposition of the cell, tissue or organ, if applicable.

the records described in paragraphs 59(h) and 60(f); and

reports of audits conducted under section 76, if applicable.

the carrying out of all of its activities;

the efficient cleaning, maintenance and disinfection of the facilities in a way that prevents contamination and cross-contamination;

appropriate monitoring and control of environmental and microbiological conditions in all areas where its activities are carried out; and

controlled access to all areas where its activities are carried out.

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.

be in a standardized format;

be approved by the medical director or scientific director;

be available for use at all locations where the relevant activities are carried out;

have any changes to the procedures approved by the medical director or scientific director before being implemented; and

be kept up-to-date.

any article that is referred to in subsection 23(2) of the Act;

any place where the inspector believes on reasonable grounds that any article referred to in paragraph (a) is processed; and

anything that the inspector believes on reasonable grounds is used or is capable of being used in the processing of any article referred to in paragraph (a).

a registered establishment; and

a transplant establishment that does not distribute cells or tissues.