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

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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

Marginal note: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.

• Marginal note: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.

• Marginal note: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.

• Marginal note: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.

Marginal note: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.

Personnel, Facilities, Equipment and Supplies

Personnel

Marginal note: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.

• Marginal note: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.

Facilities

Marginal note: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.

Equipment and Supplies

Marginal note: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.

Marginal note: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.

Marginal note: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.