Cold Chain Management

A cold chain breach (CCB) occurs when a vaccine is exposed to:

• any temperatures below +2°C
• any temperatures above +12°C
• temperatures between +8°C to +12°C for 15 minutes or more

ACTION: all cold chain breaches must be reported to Public Health Unit

A temperature deviation occurs when a vaccine is exposed to:

• temperatures between +8°C to +12°C for less than 15 minutes
• a temperature deviation is not considered a cold chain breach

ACTION: all temperature deviations must be documented in the ‘Corrective Action’ table

Steps to take following a cold chain breach:

1. Isolate vaccines and place a ‘DO NOT USE’ sign on the fridge.
2. Continue to store vaccines between +2°C to +8°C
3. Do not discard any government-funded vaccines.
4. Download and review the data logger report – assess the temperature and duration of breach. If there is a power outage, do not remove the data logger until the power is resumed; this ensures that all temperatures out of range are logged.
5. Report to your local PHU:

   South Eastern Sydney Local Health District:
   Complete online reporting form – see SAMPLE

   Sydney Local Health District:
   Complete PDF reporting form and email to SLHD-Immunisation@health.nsw.gov.au

6. If transferring vaccines to a vaccine cooler (e.g., Esky), please do so as per Section 8 of the  National Vaccine Storage Guidelines, Strive for 5. Record temperatures for all eskys on the Vaccine Cooler Temperature Chart.
7. Refer to the NSW Cold Chain Breach Protocol.

The PHU provides healthcare providers with advice and information on immunisation, excluding travel vaccinations.

• Follow up reports of adverse reactions to vaccinations which medical practitioners and hospitals are required to notify under the Public Health Act 2010.
• Assess reported cold chain breaches.
• Provide advice on vaccine viability following temperature excursions.
• Determine whether affected vaccines can continue to be used, require quarantine, or must be discarded.
• Support providers during power outages and emergency situations.
• Provide education and guidance on best practice vaccine management.

Contact your local PHU for advice if:

• Vaccines have been exposed to CCB or exposed to light.
• A refrigerator failure or malfunction has occurred.
• A power outage has affected vaccine storage.
• You require advice regarding a cold chain incident.
• Clinical advice including catch up vaccinations.
• Vaccine administration errors.
• Adverse events following immunisation (AEFI).

South Eastern Sydney Local Health District (SESLHD):

• Email: seslhd-publichealthunit-immteam@health.nsw.gov.au
• Phone: (02) 9382 8333 or 1300 066 055 during business hours

Sydney Local Health District (SLHD):

• Email: SLHD-Immunisation@health.nsw.gov.au
• Phone: (02) 9515 9420 or 1300 066 055 during business hours

Random vaccine storage audits are conducted by NSW Health Public Health Units. Non-compliance to guidelines will result in suspension of your Vaccine Account Number (VAN). Compliance audits will include checking:

• Correct vaccine storage and cold chain management protocol.
• Adherence to staff training requirements (completion of online Cold Chain Training Module).
• All vaccines administered are reported to the Australian Immunisation Register (AIR).

In the event of a power outage or fridge malfunction, vaccination providers must have a clear plan to salvage NIP vaccines and prevent vaccine wastage.

• Appendix 7 – Checklist for Managing a Power Failure – Strive for 5
• How to pack a cooler – NSW Health Strive for 5
• Temperature monitoring chart for esky/cooler – NSW Health

For outreach immunisation clinics, vaccination providers must have a clear process for transporting vaccines:

• Appendix 6 – Checklist: Mobile and emergency storage – Strive for 5
• How to pack a cooler – NSW Health Strive for 5
• Temperature monitoring chart for esky/cooler – NSW Health

Refer to the Strive for 5 Guidelines, Section 6 for guidance on Vaccine Specific Fridges.

• Vaccine specific fridge examples

• HLP MediTemp min/max thermometer – CESPHN user guide
• Annual maintenance of portable min/max thermometers -Ice Slurry/Slush test

What is a data logger? – CESPHN Information Sheet

Data loggers are essential for vaccine storage monitoring and may be integrated into a purpose-built vaccine refrigerator or used as a portable device. Wireless data loggers are recommended and should record temperatures at least every five minutes, with reports reviewed regularly weekly.