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
• exposure to light as vaccine has been removed from the packet and the glass fridge door allows light to penetrate.

Cold chain breach reporting – standard procedure 

First-time breach – reporting exceptions

You do not need to complete a cold chain breach report for vaccine that is exposed for the first time 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 for the first time. 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.

Complete the form when the vaccines in the fridge have been:

	Exposed to a heat breach greater than or equal to 25°C Exposed to a heat breach greater than or equal to 6 hours Breached on more than 1 occasion
	Exposed to temperatures less than or equal to 0˚C
	Exposed to light as vaccine has been removed from the packet and the glass fridge door allows light to penetrate.

Prepare the required information to complete the form

	How long did the breach last? Download the data logger* and calculate the hours and minutes the temperature showed 9⁰C and over. Record timeframe on page 1 of the form. *If the data logger is not working, estimate the time the fridge was outside of 2⁰C to 8⁰C such as: Contact the power company supplier to discuss the power outage timeframe Read the last time the fridge showed it was within the acceptable range and calculate the time from that point Ask a neighbour the timeframe the power was out Speak with relevant staff which may include the cleaner or a tradesperson Do not submit manual or data logger temperature recordings.
	Count the number of doses in stock at the time of the breach for all Government supplied vaccines, record this in the second column of page 2, of the form.
	Complete the table on page 2 of the form using this example.  Government-supplied vaccine only  Total doses in stock  Number of doses exposed to a first-time breach  Number of doses, plus the total time for doses breached on more than one occasion (including the time of this breach)  Adacel (Example only)  15  5  5 x 6 hours, 5 x 7 hours

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. Download and complete the Cold chain breach report form as soon as possible and  email to the Immunisation Section.
4. Await advice about what to do with each vaccine.