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

Marginal note: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.

Marginal note: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.

Exceptional Distribution

Marginal note: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.

Marginal note: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.

• Marginal note:Notice in transplant establishment’s records

  (2) The transplant establishment must keep a copy of the notice of exceptional distribution in its records.

• Marginal note: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.

Marginal note: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.

Error, Accident and Adverse Reaction Investigation and Reporting

Errors and Accidents

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note:Written notice

  (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Marginal note: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.

Adverse Reactions

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note:Written notice

  (4) If the notice is given verbally, a confirmatory written notice must be sent as soon as possible afterwards.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

Investigations and Reporting

Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Records

Marginal note:Record quality

55 Records kept by an establishment must be accurate, complete, legible and indelible.

Marginal note: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.

• Marginal note: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.