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tissues or organs must keep a copy of every version of its standard operating procedures for 10 years after they are superseded by a new version.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.

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.

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) environmental and microbiological monitoring and control appropriate to the areas where its activities are carried out; and

• (d) controlled access to all areas where its activities are carried out.