Cold Chain Breach

A cold chain breach is when vaccines are exposed to:
- Temperatures below +2°C
- Temperatures above +8°C
Exception:
- +8°C to +12°C for ≤15 minutes is considered a minor deviation, not a breach
- Any exposure < +2°C is always a breach, regardless of duration
Importance:
- Vaccines are biological products that degrade when improperly stored
- Exposure to freezing, heat, or light can render vaccines ineffective

🔹 PREVENTION: How to Maintain the Cold Chain

Purpose-built vaccine refrigerators are essential
Features must include:
- Built-in temperature monitoring system
- Digital external temperature display
- Safety mechanisms to prevent temperature fluctuation
Domestic fridges are not suitable due to instability in temperature zones

Manual checks (recorded):
- Twice daily:
  - Before first use
  - End of day
- Record minimum, maximum, and current temperatures
Visual checks (not recorded):
- Each time the fridge is opened
- Quickly verify current temperature remains within range

A data logger continuously records fridge temperature over time
Best practice:
- Preset to log at 5-minute intervals
- Download at least weekly or as per manufacturer’s advice
- Retain logged data for audit purposes
May be:
- Inbuilt into the fridge
- Standalone and installed manually

Ensure:
- Away from direct sunlight
- In rooms with stable ambient temperature
- Free airflow around back and sides
- Fridge is not overcrowded; avoid blocking internal vents

Isolate the affected vaccines immediately
- Label clearly: “Do Not Use”
- Prevent further distribution or administration
Transfer vaccines if required:
- If fridge cannot maintain +2°C to +8°C, move to pre-prepared cooler with ice bricks and temperature monitoring
- Use guidelines from Strive for 5 Section 9.3 for cooler packing technique

Review the data logger:
- Note lowest/highest temp reached
- Note duration of exposure
If no data logger:
- Assume breach duration is from last time fridge was checked to current display reading

All cold chain breaches must be reported
- Publicly funded vaccines:
  - Report to state/territory public health unit (e.g. NSW Health, VIC Health)
- Privately purchased vaccines:
  - Report to the vaccine manufacturer for stability and usability advice
Do not discard vaccines until official advice is received

If vaccines are deemed viable:
- Document:
  - Any revised expiry dates
  - Cumulative cold chain exposure
  - Attach notes to vials/boxes as needed
If deemed non-viable:
- Must be disposed of safely
- Do not return to stock
- Replace with new vaccines (report for resupply if funded)

A general practice:
- Could not provide proof of compliant cold chain from April 2019 to January 2023
- Result:
  - 1,600 patients recalled for re-vaccination
  - Included personalised catch-up programs for children ≤5 years old

Cost and resource diversion:
- Staff redeployed to:
  - Audit cold chain history
  - Contact affected patients
  - Re-schedule vaccines
Vaccine wastage:
- All affected stock must be destroyed, regardless of supply constraints
Public health risk:
- Patients may have received ineffective vaccines
- Leads to suboptimal immunity
Media and trust issues:
- Breaches may become media headlines
- Undermines public confidence in vaccination programs
- Potential rise in vaccine hesitancy