Understanding PHAC National Vaccine Guidelines
The National Vaccine Storage and Handling Guidelines for Immunization Providers, published by the Public Health Agency of Canada (PHAC), establish the federal standard for vaccine cold chain management. These guidelines ensure vaccines maintain their potency from manufacturer to patient across all Canadian provinces and territories.
Key Storage Requirements
PHAC cold chain requirements include:
- Refrigerated Vaccines: +2°C to +8°C
- Target Temperature: +5°C provides optimal safety margin
- Frozen Vaccines: -15°C or colder
- Monitoring Frequency: Minimum twice daily (start and end of workday)
- Documentation: Complete temperature logs with min/max readings
Purpose-Built vs Domestic Refrigerators
PHAC recommends purpose-built pharmaceutical refrigerators because they:
- Maintain more stable temperatures
- Have uniform air circulation
- Feature digital temperature controls
- Include audible/visual alarms
Domestic refrigerators may be used if they meet specific requirements, but require more careful monitoring and placement of vaccines away from walls, vents, and the door.
Cold Chain Breach Procedures
When temperature excursions occur, PHAC requires a systematic response:
- Immediate Documentation: Record the incident details including duration and temperature readings
- Vaccine Segregation: Mark affected vaccines “DO NOT USE” and store separately
- Contact Public Health: Consult your regional public health authority before discarding
- Complete Incident Report: Document all actions taken and outcome
ATEK automatically captures all data needed for incident reporting:
- 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
Required Written Protocols
1. Routine Vaccine Storage and Handling
PHAC requires written procedures for day-to-day operations:
- Receiving and inspecting vaccine shipments
- Proper storage placement and organization
- Inventory management and rotation
- Regular temperature monitoring and documentation
2. Urgent Vaccine Storage and Handling
Facilities must have procedures for:
- Power outages (planned and unplanned)
- Equipment malfunction or failure
- Natural disasters or facility emergencies
- After-hours response protocols
3. Management of Inappropriate Vaccine Storage Conditions
Documented procedures for temperature excursions:
- Immediate response steps
- Documentation requirements
- Contact information for public health authority
- Decision tree for vaccine disposition
How ATEK Supports PHAC Compliance
Continuous Monitoring
ATEK monitors vaccine storage temperatures every 15 minutes, far exceeding the twice-daily minimum. This provides:
- Early warning of developing problems
- Complete temperature history
- Evidence of continuous compliance
- Data for trend analysis
Immediate Alerts
When temperatures approach or exceed limits, ATEK sends alerts via:
- SMS text message
- Email notification
- Phone call escalation
Alert recipients can be configured to match your facility’s chain of responsibility, ensuring the vaccine coordinator and backup delegate receive appropriate notifications.
Documentation Ready for Inspections
ATEK maintains complete records for public health audits:
- Temperature logs with timestamps
- Calibration certificates
- Excursion reports with corrective actions
- Equipment maintenance records
Equipment Requirements
PHAC specifies requirements for vaccine storage equipment:
Refrigerator Standards
- Purpose-built pharmaceutical refrigerators preferred
- Domestic refrigerators acceptable if meeting specifications
- No door storage of vaccines
- Dedicated vaccine-only units required
- Adequate capacity for vaccine inventory
Temperature Monitoring Devices
- Digital display showing current temperature
- Min/max temperature recording
- Valid calibration certificate
- Downloadable data capability
- Placement in central area of storage unit
ATEK sensors meet all PHAC temperature monitoring requirements and provide additional features including wireless connectivity, cloud storage, and automated reporting.
Training Requirements
PHAC mandates that all personnel handling vaccines receive:
- Initial training on cold chain management
- Annual refresher training
- Documentation of training completion
- Access to written procedures and guidelines
ATEK’s user-friendly dashboard supports training requirements by providing intuitive access to monitoring data, alert management, and compliance reporting.