Cold chain breach reporting

All immunisation providers should follow the principles of safe vaccine storage management to ensure that clients receive effective and potent vaccines. The principles are contained in the National vaccine storage guidelines: strive for 5.

Cold chain is the system of transporting or storing vaccine within the safe temperature range of 2°C to 8°C (strive for 5°C – the midway point).

A cold chain breach is exposure of vaccines to temperatures outside the recommended range of 2°C to 8°C, excluding fluctuations up to 12°C lasting no longer than 15 minutes when restocking, cleaning the fridge or stock taking.

Cold chain breach reporting – standard procedure 

Single-event breach – reporting exceptions

You do not need to complete a cold chain breach report for vaccine that is exposed, on a single occasion, to a temperature of up to 25°C for less than 6 hours (for example, during a power outage), excluding a freeze breach.

You can continue to use government-supplied vaccines that have been breached in this single-event scenario. However, you must take the following actions:

1. Determine the cause of the breach and, where possible, address this to reduce the risk of the event recurring.
2. Record the date and duration of the breach and any actions taken.
3. Identify the vaccine exposed to a single-event breach by marking it with a pen so you can identify it if the same vaccine is breached a second time.

All other breaches

Before completing the Cold chain breach report form for all other breaches, take the following steps and have the information at hand:

1. Identify the current vaccine stock that was previously breached - know the timeframe for the previous breach(es)
2. Know the temperature of the breach(es).
3. Determine the timeframe for the breach by
   – reading the timeframe on the data logger (should be set to read at 5 minutely intervals)
   – for power outages, contacting the power company supplier to discuss the timeframe
   – asking a neighbour if the power was out and the timeframe
   – speaking with relevant staff which may include the cleaner or a tradesperson
   – checking when the fridge temperature was last recorded.
4. For mechanical problems arrange for the fridge to be fixed as soon as possible, while awaiting breach advice.

Reporting all other breaches

Use the Cold chain breach report form to report all other breaches such as:

• freeze breach
• heat breach greater than or equal to 6 hours
• heat breach greater than or equal to 25°C
• vaccines breached on more than one occasion.

The following steps should be taken for any of the above cold chain breach scenarios: 

1. Isolate the vaccines and place a sign on the vaccine fridge 'Do not use or discard vaccines until further notice'.
2. Determine the cause of the breach and, where possible, address this to reduce the risk of the event recurring.
3. Complete the Cold chain breach report form as soon as possible and  email or fax to the Immunisation Section.
4. Await advice about what to do with each vaccine. If you need urgent advice contact the Immunisation Section by telephone.

For urgent advice, contact the Immunisation Section.