Cold chain management

Cold chain management protocols are followed by all stakeholders to safely transport and store vaccines within the temperature range of +2°C to +8°C (strive for 5°C – the optimum temperature).

 Most vaccines lose effectiveness if they:

• freeze
• get too warm
• are exposed to direct sunlight or ultraviolet (UV) light, including fluorescent light.

The National vaccine storage guidelines: Strive for 5 (external site) is a valuable resource which explains cold chain management protocols clearly. Immunisation providers should understand, follow, and establish these guidelines within their premises to ensure that staff are trained, and their patients receive effective vaccines. 

When government-funded vaccines are involved in a potential wastage incident, the incident must be immediately reported to the WA Department of Health.

Report a cold chain breach

Report any cold chain breach (CCB) incident to the WA Department of Health when government-funded vaccines are exposed:

• to temperatures below +2°C or above +8°C. This does not include temperature deviations or excursions in which the temperature reaches a maximum of up to +12°C for 15 minutes or less. Any deviation below +2°C must always be reported.
• to light (such as removal from packaging; light penetrates through a glass fridge door).

Cold chain breach protocol

Follow the cold chain breach (CCB) protocol steps:

1. Immediately isolate the affected vaccines and mark as ‘DO NOT USE’.
2. DO NOT DISCARD ANY VACCINES.
3. Keep vaccines refrigerated between +2°C and +8°C.
4. Be prepared to transfer the affected vaccines into temporary monitored vaccine storage.
5. If your site is located outside of the metropolitan area, please use the cold chain breach (CCB) and vaccine wastage form (PDF 281KB) to report the breach to your WA Health Regional Immunisation Coordinator (RIC) (HealthyWA) For metropolitan areas, please use the cold chain breach and vaccine wastage form (RedCap).
6. If the breach involves private vaccines, contact the manufacturer.
7. If the breach occurs during transport from Onelink, refer to the relevant section at vaccine ordering.
8. Take steps to correct the problem and to prevent it from recurring.
9. Your RIC can guide you, including on how to undertake a cold chain self-audit.

Cold chain information required

When completing the relevant cold chain breach (CCB) and vaccine wastage form (PDF or RedCap version), you need to include: 

• vaccine product(s) and dose quantities
• if vaccine(s) were involved in prior breaches
• date(s) and duration of the breach (hours and/or minutes)
• if vaccines involved in the breach were inadvertently administered to patients
• temperature range of the breach (minimum and maximum temperatures)
• your data logger results for the period(s) of the breach in a table view (pdf or '.csv' format) in 5 minute intervals
• your contact details so you (or other staff) can be contacted in a timely manner

Breach assessment

Your RIC may require additional information: 

• the brand and size of the refrigerator in which the vaccines are stored 
• cold chain audit details, such as when the date the refrigerator was last serviced or if there are any maintenance issues
• the expiry date of the vaccines
• if vaccines are wet or soggy, or where they were positioned in the fridge(s) when the breach occurred
• your data logger results in a graph view
• your daily temperature monitor chart in a pdf format
• steps you have taken for improvements or to prevent recurrences and may offer advice.

Your RIC will advise whether vaccines are safe to retain or should be discarded.

Remember:

• if you are advised to discard vaccines, remove the vaccines from your fridge and discard according to your medical waste procedure
• your RIC will record the wastage as a cold chain breach – do not enter a new wastage incident for the discarded vaccines, even if the vaccines are about to expire
• keep a record of the incident near your fridge(s) for future reference
• contact your RIC if you require assistance
• refer to the National vaccine storage guidelines – Strive for 5. (external site)

Report a vaccine expiry

To report a wastage incident due to vaccine expiry, user error, or another reason, refer to the information within the vaccine incident report form (external site).

Refer to vaccine ordering for further information or contact your Public Health Unit.

Transport monitors

Each Onelink delivery has a Sensitech TagAlert® cold chain monitor to electronically record the vaccine temperature during transport.

Each TagAlert® monitor accurately ensures cold chain management for the delivery of vaccines, and:

• has four temperature and time-out-of-range alarm limits
• is fully tested before the order leaves the warehouse
• alarms if a breach occurs during transport from the Onelink warehouse to your premises
• has a validation certificate for 12 months

Follow the important ‘Receive and store’ steps on the vaccine ordering webpage upon delivery of vaccines at your premises.