Cells, Tissues and Organs

The Safety of Human Cells, Tissues and Organs for Transplantation Regulations (CTO Regulations or Regulations) contain safety requirements with respect to processing; storage; record keeping; distribution; importation; error, accident and adverse reaction investigation and reporting. Processing includes donor screening, donor testing, donor suitability assessment, retrieval (except in the case of organs and islet cells), testing and measurements performed on the cells, tissues or organs (CTO) after they are retrieved, preparation for use in transplantation (except for organs), preservation, quarantine, banking, packaging and labelling. These Regulations are intended to result in improved protection of the health and safety of Canadian transplant recipients

The CTO Regulations require that source establishment and establishments that distribute or import cells, tissues or organs register with Health Canada. Establishments that only retrieve CTO, only import for transplant, or only transplant do not have to register.

Furthermore, based on the CTO Regulations, source establishments are to report to Health Canada suspected errors and accidents that are identified after distribution of CTO that could lead to a serious adverse reaction involving the transmission of an infectious disease or disease agent, or an unexpected serious adverse reaction that is thought to involve the transmission of an infectious disease or disease agent. The error and accident preliminary investigation report form is provided below.

Reports

• Summary Report of Inspections of Cells, Tissues and Organs Establishments Conducted from August 2009 to June 2012 [2013-01-16]
• Summary Report: Stakeholder Consultation Workbook for the Cells, Tissues and Organs (CTO) Programs Inspection Strategy [2012-11-21]

Regulations

• Safety of Human Cells, Tissues and Organs Regulations (CTO Regulations)
• Canadian Standards Association (CSA)

Guides and Policies

• Inspection Policy for Cells, Tissues and Organs Establishments (POL-0057) [2017-03-15]
• Guidance on Classification of Observations for Inspection of Cells, Tissues and Organs Establishments (GUI-0101) [2017-03-15]
• Guidance Document for Cell, Tissue and Organ Establishments - Safety of Human Cells, Tissues and Organs for Transplantation
• Guidance Document for Source Establishments - Reporting Adverse Reactions to Human Cells, Tissues and Organs

Forms

• Human Cells, Tissues and Organs (CTO) for Transplantation Registration Application Form (FRM-0171)
• Human Cells, Tissues and Organs for Transplantation - Error or Accident Preliminary Investigation Report Form (FRM-0172)

Registration

• List of Registered Cells, Tissues and Organs (CTO) Establishments

Compliance Promotion

• Thinking about banking your child’s cord blood?