Health Canada Blood Regulations Resources
When: In 2014, the Health Canada Blood Regulations were legislated.
Why: The Blood Regulations are intended to promote the protection of Canadian blood donors and recipients by ensuring the safety of both blood and blood products. All establishments that store and transfuse blood must meet specific requirements described in the Blood Regulations.
How: To ensure compliance with these regulations, Health Canada (HC) monitors and inspects both registered and non-registered establishments that handle blood and blood products.
In 2015, HC inspectors began visiting registered sites in Ontario to perform inspections; the schedule was expanded in 2018 to include non-registered sites. The inspections typically involve the review of a sites:
- Documentation (training, competency, internal audits, maintenance, annual summary report)
- Procedures and processes related to:
- Storage,
- Labelling,
- Distribution,
- Record keeping,
- Transforming of blood and blood products.
Upon completion of the HC inspection, an Exit Notice provides the inspector’s findings and observations. Observations in most cases are non-conformances, which are assigned a risk factor to demonstrate how the current practice is affecting potential patient safety outcomes. An overall inspection rating of Compliant or Non-Compliant is issued to the site. Sites will need to take corrective action(s) to address all Observations.
Non-Registered Site
Any site that stores, distributes (redistributes), and labels blood components must comply with the Blood Regulations.
Registered Site
Any site that has additional processes to transform blood components (e.g., pools, washes, irradiates) or that has a pre-assessed donor program must be registered with Health Canada under the Blood Regulations.
Note: establishments that only pool cryoprecipitate are referred to as non-registered sites.
The following documents support TML’s in developing their internal audit program under the Blood Regulations.
Registered - Internal audits are required to be performed every two years at minimum, on all regulated activities under the Blood Regulations. The audit intervals should be specified in hospital operating procedures.
Non-Registered – Internal audits are a component of TML’s quality management system, which include assessments of activities and processes it performs. Non-registered TML’s should conduct risk assessments to determine the frequency that audits to the processes which relate to regulated activities under the Blood Regulations.