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 

For all COVID-19 vaccine cold chain breach information and action, see the Victorian COVID-19 vaccination guidelines.

First-time breach – reporting exceptions - you do not need to complete a CCB report form for vaccine that is:

less than 25°C and less than 6 hours

Actions required for first time breaches that are not reported:

You can continue to use government-supplied vaccines that have had a first time heat breach of less than 25°C for less than 6 hours, however you must take the following actions:

1. Determine and manage the cause of the breach: this may include a power outage, fridge breakdown, plug pulled out, door left open, vaccines left on bench. Where possible, address the cause to reduce the risk of the event recurring, for instance staff education, place a sign ‘Do not unplug vaccine fridge’ over power point, lock fridge door after use, service fridge annually or after break down, contact the fridge manufacturer about a door alarm or raising the front footings of fridge, get a battery back-up for power outage.
2. Document: record the date and duration of the breach and any actions taken
3. Mark vaccine boxes with a pen: 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.

Always complete the CCB report 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 below: Government-supplied vaccine only: Adacel (Example only) Total doses in stock:  15 Number of doses exposed to a first-time breach: 5 Number of doses, plus the total time for doses breached on more than one occasion (including the time of this breach):  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.