Cold chain breach reporting

What is the Cold chain system?

Cold chain is the system of transporting or storing vaccines within the safe temperature range of +2°C to +8°C (strive for +5°C – the midway point). It begins when a vaccine is manufactured and continues through distribution, storage and transport until the vaccine is administered.

Immunisation providers must follow the principles of safe vaccine storage management to ensure that vaccines remain effective and potent. These principles are contained in the Cold chain management - provider resources.

Vaccines should be stored in a purpose-built vaccine refrigerator and kept in their original cardboard packaging to protect them from light exposure and temperature fluctuations. Vaccines must not be removed from their original packaging to increase refrigerator capacity.

What is a Cold chain breach?

A cold chain breach occurs when vaccines are exposed to temperatures outside the recommended storage range of +2°C to +8°C.

Note: A single temperature excursion, of up to +12°C for 15 minutes or less, such as during restocking or cleaning a purpose-built vaccine refrigerator, is not considered a cold chain breach. This exemption does not include temperature excursions <+2°C, which must always treated as a cold chain breach.

Cold chain breach reporting

Complete a Cold Chain Breach (CCB) Report Form if vaccines have been:

• Exposed to temperatures above +8°C.
• Exposed to temperatures below +2°C.
• Exposed to light after being removed from their original packaging and exposed to direct sunlight or ultraviolet (UV) light, including fluorescent light.

What to do following a cold chain breach

1. Isolate affected vaccines and place a sign on the refrigerator stating: 'Do not use or discard vaccines until further notice'.
2. Continue to store vaccines between +2°C and +8°C. Transfer vaccines to an alternate purpose-built vaccine refrigerator or temperature monitored cooler if required.
3. Download data logger records to determine the duration of the breach and temperatures reached. View the video on how to download temperature reports from a data logger on the Cold Chain Management Essentials video series page.
4. Assess affected vaccines by:
   • counting the number of doses exposed
   • identifying the vaccine brands affected
   • reviewing records for any previous cold chain breaches involving the same vaccines.
5. Complete the Cold Chain Breach Report Form as soon as possible. Submit a separate report for each affected vaccine refrigerator and include all required supporting documentation. View the video on how to fill out a Cold chain breach report form on the Cold Chain Management Essentials video series page.

6. Email the completed report and attachments to immunisation@health.vic.gov.au.
7. Await advice from the Victorian Department of Health before using or disposing of affected vaccines.
8. Investigate the cause of the breach and implement corrective actions to reduce the risk of recurrence.

For practical guidance on managing vaccine storage and cold chain breaches, refer to the Cold Chain Management Essentials video series page.

Resources

• Cold chain management essentials video series
• Cold chain management - provider resources
• National Vaccine Storage Guidelines ‘Strive for 5’ - Australian Government Department of Health, Disability and Ageing