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 Public Health Unit supports immunisation providers with advice and information on government-funded vaccines. Core responsibilities of Public Health Units:

• Cold chain breach management: Investigating reports of cold chain breaches for NIP and state-funded vaccines and provide advice on vaccine viability and revaccination.
• Adverse event surveillance: Receiving, managing, and following up mandatory notifications of adverse events following immunisation (AEFIs) under the Public Health Act 2010.
• Clinical advice: Providing guidance regarding complex catch-up schedules, vaccine administration errors, revaccination advice, and patient eligibility.
• Vaccine Account management: Assessing new account applications and providing information and support related to ordering and receiving NIP vaccine stock.
• Cold chain education and guidance: Supporting providers during power outages and emergency situations, and providing 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:

• Documentation of annual Vaccine storage self-audit.
• Documentation of annual fridge service.
• Documentation of fridge temperature monitoring:
  • Twice daily min/max temperature records
  • Weekly data logger reports
• Correct vaccine storage and cold chain management protocols.
• 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

Fridge service

Fridge must be serviced every 12 months to ensure that it is in good working order. as outlined in Strive for 5, Section 3.9

Purpose-built vaccine refrigerators (PBVR)

For guidance on Vaccine Specific Fridges, refer to:

• Strive for 5, Section 3
• Vaccine specific fridge examples

• HLP MediTemp min/max thermometer – CESPHN user guide
• Annual maintenance of portable min/max thermometers – NSW Health
• How to check the accuracy of a thermometer (‘slush test’) – Strive for 5 (4th edition)

Data loggers are mandatory for vaccine temperature monitoring and should record temperatures every 5 minutes, with reports reviewed weekly.

Wireless data loggers are recommended and may be either be a portable device or integrated into a purpose-built vaccine refrigerator.

What is a data logger? – CESPHN Information Sheet