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.

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.