Vaccines are fragile, biological substances that can become less effective or destroyed if exposed to temperatures outside the recommended storage range of between +2°C and +8°C. Health professionals responsible for the administration of vaccines must follow appropriate procedures and processes to ensure vaccine storage as per the National Vaccine Storage Guidelines: Strive for 5.
The guideline promotes best practice in vaccine storage and contains information and advice for vaccine storage management. Immunisation providers must refer to the guideline to ensure that satisfactory equipment and procedures are in place before commencing.
The 'cold chain' is the system of transporting and storing vaccines within the safe temperature range of +2°C to +8°C. The cold chain begins with vaccine manufacture and ends with vaccine administration vaccination services.
See the following information regarding ordering vaccines:
- Receiving vaccine deliveries
- Responding to a cold chain breach
- Alternative vaccine storage in the event of power failure
- Vaccine storage self-audit
Staff responsible for vaccine cold chain management will:
- accept and sign for the vaccines from the courier;
- if transported by esky/cooler, check all cold chain monitors (CCM) and if a monitor is activated contact Vaccine Distribution Centre on (08) 7425 7139 immediately;
- promptly transfer vaccines to a monitored vaccine fridge, ensuring individual vaccines are NOT removed from their original packaging;
- check expiry dates and ensure vaccines with the shortest dates are placed at the front to be used first;
- read and record fridge temperature
- update stock records with details including vaccine brand, doses, batch number and expiry dates.
A 'cold chain breach' has occurred if vaccine storage temperatures have been outside the recommended range of +2°C to +8°C. It excludes excursions up to +12°C, lasting no longer than 15 minutes.
What to do when vaccines have been stored outside the recommended range
When Government funded vaccines have been stored outside the recommended range:
- Isolate vaccines and place a ‘DO NOT USE VACCINES’ sign on the fridge. Communicate this information to all staff.
- Do not use and do not discard any of the vaccines unless directed by SA Health’s Immunisation Section.
- Contact SA Health's Immunisation Section on 1300 232 272 as soon as possible during business hours. The Immunisation Section will request specific information on:
- time and date of the cold chain breach
- the circumstances of the cold chain breach
- fridge type used for vaccine storage
- the number and type of vaccines stored on each shelf
- the minimum, maximum and current temperatures
- the status of the cold chain monitors, and
- vaccines that may have previously had exposure to a cold chain breach
During widespread power outages, complete the Cold Chain Breach Report — National Immunisation Program Form (PDF 434KB) when directed by the Immunisation Section.
- Document all action taken on the reverse side of the vaccine fridge temperature chart.
For other vaccines not included in government funded programs, health professionals are advised to contact the vaccine manufacturer for advice.
Do you have a back-up plan and storage equipment if a power failure occurs?
Alternative vaccine storage in the event of a power failure may include any of the following:
More information on back-up plans, see the Cold Chain Back-up Plan (PDF 178KB).
Off-site monitored fridge
If you are planning to use a monitored fridge off-site (for example, local hospital) ensure an agreement has been put in place with the relevant organisation prior to the event. Also consider that this organisation may also be affected by a power failure.
If you plan to use an esky or cooler to store vaccines during a power failure the
following equipment will be necessary:
- appropriate size esky or cooler to accommodate all vaccines
- ice packs or gels
- insulating material e.g. polystyrene chips, bubble wrap, shredded paper
- minimum/maximum thermometer (available from the Immunisation Section)
- freeze sensitive monitor (available from the Immunisation Section)
Pack the esky or cooler according to the National Vaccine Storage Guidelines, Strive for Five.
Continue to closely monitor the temperature of vaccines whilst stored in the
esky or cooler. Once power has been restored ensure the fridge temperature has returned to 2°C to 8°C prior to returning vaccines.
A vaccine storage self-audit must be carried out at least once every 12 months, and more frequently where there have been problems with equipment or cold chain breaches.
Self-auditing is an important part of routine quality assurance and risk management processes. It enables staff to have confidence that they are administering a safe and effective vaccine.
A vaccine storage self-audit checklist is available in Appendix 2 of the National Vaccine Storage Guidelines: Strive for 5.
The SA Health Immunisation Section also conducts random vaccine storage documentation audits.
For further information contact the Vaccine Distribution Centre on (08) 87425 7139.