About cells, tissues and organs (CTO) inspections

Canada aims to minimize the potential health risks to those receiving human cell, tissue and organ (CTO) transplants. Learn how we conduct inspections of CTO establishments.

On this page

• CTO inspections
• What inspectors look for
• After a CTO inspection
• Inspection report cards
• For more information

CTO inspections

Canada monitors establishments that handle human organs and minimally manipulated cells and tissues to be used in transplantation.

In Canada, CTO establishments are regulated by the:

• Food and Drugs Act
• Safety of Human Cells, Tissues and Organs for Transplantation Regulations

This act and its CTO regulations allow us to:

• monitor CTO establishments, including source establishments
• assess whether an establishment is complying with its regulatory requirements

Any Canadian establishment governed by the CTO regulations may be inspected at any time by the federal government. This specifically includes those involved in:

• importing
• processing
• distribution

Processing of CTOs can include:

• donor:
  • testing
  • screening
  • suitability assessment
• banking
• quarantine
• preservation
• packaging and labelling
• retrieval (except in the case of organs and islet cells)
  • islets are tiny clusters of cells scattered throughout the pancreas
• preparation for use in transplantation (except for organs)
• testing and measurements performed on CTOs after they are retrieved

What does minimally manipulated mean?

Minimally manipulated means processing of:

• a structural tissue that does not change the original characteristics that are relevant to its intended use for:
  • repair
  • replacement
  • reconstruction
• cells and non-structural tissue that does not change the characteristics that are relevant to their intended use

Structural tissue includes:

• skin
• bone
• tendons
• cartilage
• ligaments

What is a source establishment?

Source establishments are responsible for processing CTOs and determining if they are safe for transplantation.

A CTO establishment is considered a source establishment if it:

• is a cell bank (for banked lymphohematopoietic cells)
  • lymphohematopoietic cells help with immune system function
• prepares cells for use in transplantation (for islet cells)
• is an organ donation organization (for organs from deceased donors)
• transplants organs from a living donor or lymphohematopoietic cells that are not banked
• is a tissue bank (for tissues or adjunct vessels retrieved with an organ but not used immediately in organ transplantation)
  • an adjunct vessel is any additional tissue connected to an organ, like a vein or artery

What inspectors look for

During an inspection, our inspectors:

• review the establishment’s:
  • records
  • procedures
  • documents
  • existing processes
• assess compliance

The different areas of compliance include:

• inventory
• processing
• distribution
• importation
• staff training
• use of critical supplies
• exceptional distribution
  • this is for when a compatible CTO is available and needed urgently but is not yet considered safe for use
    • a CTO that is not fully compliant must be authorized by a transplant physician with consent from the recipient
• equipment maintenance
• quality system assurance
• error, accident and adverse reaction investigation and reporting

Inspectors make “observations” when they note areas where the establishment is not meeting regulatory requirements. Each observation is classified by level of risk.  This is taken into consideration for the overall inspection rating.

After a CTO inspection

After completing an inspection, the inspector creates a report that:

• documents the findings
• communicates the observations to the establishment
• issues an overall inspection rating to the establishment

The overall rating indicates whether the establishment is compliant or non-compliant with the:

• Food and Drugs Act
• CTO regulations

The rating is based on observations noted by the inspector and includes:

• the number of observations
• risk level of each observation

Compliant rating

A compliant rating means the establishment is complying with the Food and Drugs Act and CTO regulations.

An establishment may receive a compliant rating even if a number of observations have been identified. This is because the rating also takes into consideration the level of risk.

Establishments will need to take corrective actions to address any observations.

Non-compliant rating

A non-compliant rating could mean that the establishment:

• has not shown that its activities comply with the Food and Drugs Act and CTO regulations
• will need to take immediate corrective actions

We may suspend or terminate an establishment’s registration in some cases.

Ongoing follow-up

Establishments must take corrective actions to address the observations either during the inspection or after it. They must provide us with a written corrective action plan for any observations identified, including target dates for completion.

We may conduct a follow-up inspection to make sure the corrective actions have been taken.

When needed, we will consider further enforcement actions, as outlined in the Compliance and Enforcement Policy (POL-0001).

Inspection report cards

Canada posts detailed report cards for our CTO inspections. Each report card summarizes the inspection observations and ratings:

• Drug and Health Product Inspections Database