About blood inspections

Canada aims to protect the safety of Canadian blood donors and recipients. This is done by monitoring and inspecting establishments that handle blood. Learn how we conduct these inspections.

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Blood inspections

Canada monitors establishments that handle blood collected for transfusion or for further manufacturing into a drug for human use. This includes activities such as:

  • storing
  • labelling
  • importing
  • processing
  • distributing
  • transforming (the washing, pooling or irradiation done after the blood is determined safe for transfusion)

In Canada, blood establishments are regulated by the Food and Drugs Act and Blood Regulations.

This act and the Blood Regulations allow us to:

  • monitor blood establishments
  • assess whether an establishment is complying with its regulatory requirements

Any establishment governed by the Blood Regulations may be inspected at any time by the federal government. This includes the licensed and registered blood establishments.

What is a blood establishment licence?

An establishment must have a blood establishment licence to:

  • import blood for transfusion
  • process allogeneic blood, which is blood collected from one person for transfusion into another person

What is a blood establishment registration?

An establishment must be registered with the federal government if it:

  • transforms blood
  • has a pre-assessed donor program
    • this program takes donor blood in an emergency before the testing is completed
    • donors are subject to routine blood testing, including infectious disease testing every 3 months
  • processes autologous blood, which is blood collected from one person for transfusion into that same person at a later time

Establishments conducting regulated activities under the Blood Regulations are to comply with all relevant sections.

Blood inspections for foreign sites

A Canadian blood establishment may contract out any of its activities to a foreign establishment, such as testing.

Foreign establishments conducting activities on behalf of a Canadian establishment must comply with Canadian regulatory requirements set out in the Blood Regulations.

We rely on inspections undertaken by trusted international regulatory partners and perform paper-based reviews of the information to make our own regulatory decisions.

What inspectors look for

During an inspection, our inspectors:

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

The different areas of compliance include:

  • storage
  • labelling
  • distribution
  • record keeping
  • processing, which means any of the following activities:
    • donor suitability assessment
    • collection
    • testing
    • blood component preparation
  • transformation

In addition, we also assess:

  • exceptional distribution
    • this is used in emergency transfusion situations where:
      • allogeneic blood that has been determined safe for distribution is not immediately available
      • the recipient's physician requests the blood for use in emergency treatment
  • personnel, facilities, equipment and supplies
  • operating procedures and the quality management system
  • error, accident and adverse reaction monitoring, 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.

After a blood 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 and Blood Regulations.

The rating is based on:

  • the number of observations noted by the inspector
  • risk level of each observation

Compliant rating

A compliant rating means the establishment is complying with the Food and Drugs Act and Blood 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 means that the establishment:

  • has not shown that its activities comply with the Food and Drugs Act and Blood Regulations
  • needs to take immediate corrective actions

We may take action when a risk to the health and safety of Canadians is identified. This can include:

  • cancelling the establishment's registration
  • suspending or cancelling the establishment's licence

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 enforcement actions, as outlined in the Compliance and Enforcement Policy (POL-0001).

Inspection report cards

We post detailed report cards for blood inspections. Each report card summarizes the inspection observations and ratings:

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