Cold chain management

A cold chain breach occurs when vaccine temperatures occur outside the recommended range of +2 to +8 °C during vaccine storage or transport.

As a condition to receiving government-funded vaccines, the cold chain management protocol must be followed in accordance with the National Vaccine Storage Guidelines – Strive for 5 (external site) for transporting and storing vaccines.

Providers must immediately advise their WA Health public health unit (HealthyWA) when a cold chain breach occurs and seek thermal stability advice for other incidents where government-funded vaccines are involved.

Cold chain breach and wastage reporting

Providers should follow the WA cold chain protocol (PDF 60KB) then use the process within the table below to report the incident or wastage where government-funded vaccines are affected.

Incident type Reporting process
Cold Chain Breach (CCB) Cold Chain Breach and Vaccine Wastage Form (PDF 127KB)
Vaccine Expiry* Vaccine Expiry Report Form (Government-Funded Vaccines only) (external site)

*Pharmacist-Administered Influenza Vaccination Program for Older Adults, Fluad® Quad is the only product distributed that requires reporting.

Cold chain monitoring during vaccine transport

From 20 September 2021, each vaccine delivery has a Sensitech TagAlert® cold chain monitor to electronically record the vaccine temperature during transport.

The TagAlert® has four temperature and time-out-of-range alarm limits. An alarm is triggered if a heat or freeze breach occurs during transport from the warehouse to the immunisation provider/service.

Providers or practice staff must immediately check the TagAlert® in every vaccine box upon delivery.

TagAlert® screen Indicator and action
‘OK’ is displayed on screen

 TagAlert OK screen
Vaccine is safe to use. Promptly unpack and refrigerate vaccines immediately. Discard the single-use TagAlert®.

Alarm – black box over the ‘OK’ and numbers 1, 2, 3, or 4 appear

TagAlert 1234 screen

An alarm has been triggered. Isolate the vaccine in the fridge, call Onelink for advice. Only discard TagAlert® after receiving advice from Onelink.

TagAlert® hardware – accuracy and validation

TagAlert® is an accurate validation of cold chain management for the delivery of vaccines:

  • the TagAlert® is subjected to a one-point accuracy test before it is shipped to the customer
  • the TagAlert® is validated for 12 months and has a certificate of validation
  • Sensitech (manufacturer of TagAlert®) is a world-leading provider of cold chain solutions.

Resources

More information

Last reviewed: 06-10-2021
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Public Health