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

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.

Marginal note: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.

Quality Assurance System

General

Marginal note:Application

70 Sections 71 to 76 apply only to establishments that distribute cells, tissues or organs.

Marginal note:Quality assurance system required

71 An establishment must ensure that it has a quality assurance system in place that complies with the requirements of these Regulations for all activities that it carries out.

Standard Operating Procedures

Marginal note:Standard operating procedures required

72 An establishment must have standard operating procedures with respect to the safety of cells, tissues and organs for all activities that it carries out.

Marginal note:Requirements

73 The standard operating procedures must meet all of the following requirements:

• (a) be in a standardized format;

• (b) be approved by the medical director or scientific director;

• (c) be available for use at all locations where the relevant activities are carried out;

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

• (e) be kept up-to-date.

Marginal note:Routine review

• 74 (1) An establishment must review its standard operating procedures every two years and again after any amendment to these Regulations.

• Marginal note:Supplementary review

  (2) An establishment that receives a summary of a final report of an error, accident or adverse reaction investigation or the report of an audit either of which reveals a deficiency in a standard operating procedure must review that procedure.

Marginal note:Records of compliance

75 An establishment must keep records that demonstrate that it has implemented its standard operating procedures.

Marginal note:Audits

76 An establishment must conduct an audit every two years of the activities that it carries out to verify that those activities comply with these Regulations and with its standard operating procedures, by a person who does not have direct responsibility for the activities being audited.

Powers of Inspectors

Marginal note:Taking photographs

77 An inspector may, in the administration of these Regulations, take photographs of any of the following:

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

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

• (c) 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).

Transitional Provision

Marginal note:Processed within 5 years before registration

• 78 (1) Subject to subsection (2), the following establishments may import, distribute or transplant, as the case may be, cells and tissues that were processed within five years before the day on which these Regulations are registered:

  • (a) a registered establishment; and

  • (b) a transplant establishment that does not distribute cells or tissues.

• Marginal note:Prohibition

  (2) An establishment may not import, distribute or transplant, as the case may be, cells or tissues under subsection (1) unless the requirements of subsection 56(2) and section 57 are met.

Coming into Force

Marginal note:Six months after registration

• Footnote ^*79 (1) These Regulations, except subsection 26(1), come into force six months after the day on which they are registered.

• Marginal note:Exception

  (2) Subsection 26(1) comes into force one year after the day on which these Regulations are registered.

• Marginal note:Transitional provision

  (3) Section 78 ceases to be in force five years after the day on which these Regulations are registered.

• Return to footnote ^*[Note: Regulations, except subsection 26(1), in force December 8, 2007; Subsection 26(1) in force June 8, 2008.]