Understanding Health Canada Blood Regulations
The Health Canada Blood Regulations Guidance Document establishes the federal requirements for all establishments that collect, process, store, and distribute blood and blood components in Canada. These regulations ensure the safety and quality of Canada’s blood supply from collection through transfusion.
Regulatory Framework
The Blood Regulations work in conjunction with:
- Food and Drugs Act: Governing legislation
- CSA Z902: Technical standard for blood and blood components
- Good Manufacturing Practices (GMP): Quality requirements
Who Must Comply
These regulations apply to:
- Blood banks
- Hospital transfusion services
- Plasma collection centers
- Blood component manufacturers
- Cord blood banks
- Any establishment handling blood products
Storage Temperature Requirements
Health Canada specifies strict temperature requirements for each blood component:
Whole Blood and Red Blood Cells
- Temperature: 1°C to 6°C
- Storage: Validated blood bank refrigerators
- Monitoring: Continuous with alarms
Platelets
- Temperature: 20°C to 24°C
- Storage: Platelet incubators with agitation
- Monitoring: Continuous with alarms
Fresh Frozen Plasma (FFP)
- Temperature: -18°C or colder (-25°C or colder for extended storage)
- Storage: Blood bank freezers
- Monitoring: Continuous with alarms
Cryoprecipitate
- Temperature: -18°C or colder
- Storage: Blood bank freezers
- Monitoring: Continuous with alarms
ATEK provides monitoring solutions for all blood component storage requirements, with configurable alerts for each temperature range.
Temperature Monitoring Requirements
Health Canada requires comprehensive temperature monitoring:
Continuous Monitoring
- Storage equipment must have continuous temperature monitoring
- Systems must include audible and visual alarms
- Alarms must activate before temperatures reach unacceptable limits
Recording Requirements
- Temperature must be recorded at intervals not exceeding 4 hours
- Electronic continuous monitoring is preferred
- Records must be retained for traceability purposes
Alarm Response
- Alarm conditions must be investigated immediately
- Response procedures must be documented
- Corrective actions must be recorded
ATEK exceeds these requirements with:
- Temperature readings every 15 minutes
- Multi-channel alerting (SMS, email, phone)
- Permanent cloud-based data storage
- Automated excursion documentation
Establishment Licensing
Licence Requirements
Health Canada requires an Establishment Licence for:
- Blood collection
- Blood processing
- Blood component manufacturing
- Blood distribution
Application Process
Licence applications must include:
- Quality management system documentation
- Facility and equipment descriptions
- Standard operating procedures
- Personnel qualifications
- Temperature monitoring protocols
Inspections
Health Canada conducts inspections to verify:
- Compliance with Blood Regulations
- Adherence to CSA Z902 standards
- Quality management system effectiveness
- Temperature monitoring and documentation
ATEK documentation supports all aspects of the licensing process with comprehensive monitoring records and calibration certificates.
Quality Management System
Health Canada requires a documented quality management system covering:
Documentation
- Standard operating procedures
- Equipment maintenance records
- Personnel training records
- Temperature monitoring records
Process Controls
- Validated collection procedures
- Testing protocols
- Component preparation standards
- Storage and distribution controls
Traceability
- Donor identification
- Component labeling
- Distribution records
- Recipient documentation
Temperature Excursion Procedures
When temperature excursions occur:
- Immediate Response: Document the excursion and secure affected products
- Quarantine: Segregate affected blood products
- Assessment: Evaluate impact on product quality
- Decision: Determine if products can be released or must be discarded
- Documentation: Complete excursion report with all details
ATEK automatically captures all data needed for excursion assessment:
- Exact time the excursion began and ended
- Minimum and maximum temperatures during the event
- Duration of the temperature deviation
- Complete audit trail for regulatory review
How ATEK Supports Blood Regulations Compliance
Multi-Range Monitoring
ATEK monitors all blood storage temperatures:
- Refrigerated: 1°C to 6°C for red cells
- Room temperature: 20°C to 24°C for platelets
- Frozen: -18°C or colder for plasma
- Ultra-low: -65°C or colder for specialized storage
24/7 Alarmed Monitoring
When temperatures deviate from range, ATEK sends alerts via:
- SMS text message
- Email notification
- Phone call escalation
Alert recipients can be configured to match your facility’s response protocols.
Licence-Ready Documentation
ATEK maintains complete records for Health Canada inspections:
- Temperature logs with timestamps
- Calibration certificates
- Excursion reports with corrective actions
- Equipment monitoring history
Integration with Quality Systems
ATEK integrates with existing quality management systems:
- Automated data export
- API integration options
- Customizable reporting
- Validated monitoring platform