Vaccines are fragile, biological substances. They can become less effective or even destroyed if they are exposed to temperatures outside the recommended storage range — between +2°C and +8°C.
This 'cold chain' begins when the vaccine is made and ends when the vaccine is administered.
You must keep vaccines within the safe temperature range while storing or transporting them. The Royal Australian College of General Practitioners’ Standards for general practices (5th edition) recommends guidance in:
- the current edition of the National Vaccine Storage Guidelines: Strive for 5
- the current online edition of the Australian Immunisation Handbook
The National Vaccine Storage Guidelines: Strive for 5 promotes best practice in vaccine storage. Refer to the guidelines to ensure that equipment and procedures are in place.
Cold chain breaches
Do not use vaccines exposed to temperatures below +2°C or above +8°C without getting further advice. Do not discard these vaccines. For National Immunisation Program vaccines, isolate them and contact state or territory health authorities for advice. For privately purchased vaccines contact the manufacturer or supplier.
Recommendations for discarding vaccines may change between health authorities and manufacturers.
Do not discard any vaccines until you get advice.
Essential steps in proper cold chain management
To be confident that you are maintaining vaccines' potency, practices must:
- have a reliable refrigerator capable of maintaining a stable temperature. Ensure the fridge is big enough for the practice’s storage needs and how frequently you order vaccines
- develop clearly documented processes to maintain the cold chain. This may include identifying potential situations that risk vaccine potency and implementing appropriate management strategies
- ensure that all practice staff handling vaccines receive ongoing training that is appropriate for the responsibilities of their role
- monitor and record the maximum and minimum temperature of refrigerators used to store vaccines at least once a day and before using any vaccines
- know what to do (including reporting and documentation) if the refrigerator temperature varied outside the recommended range of 2–8ºC
Store vaccines in an appropriate refrigerator. If the practice is using a domestic refrigerator, you’ll need to make certain modifications to reduce the risk of storage problems. The National Vaccine Storage Guidelines: Strive for 5 sets out these modifications.
Note that guidelines do not recommend cyclic defrost and bar refrigerators because they produce wide changes in internal temperatures.
Data loggers are small electronic devices that continuously measure temperatures and keep a record of the results. They can help you verify cold chain efficacy and do a quality control check of the vaccine refrigerator temperatures. They require computer software to download the readings. Some vaccine refrigerators have data loggers inbuilt in them. If not, you can buy an external data logger.
Data loggers are useful to determine and record:
- how accurate the refrigerator's thermometer is
- if the temperature fluctuated and how long the refrigerator stayed at this temperature
- potential cooler or warmer areas within the refrigerator — areas which may not be suitable for vaccine storage
Naming who is responsible
Nominate a member of the practice team to:
- manage the cold chain
- comply with cold chain management guidelines
The practice must clearly state the role and responsibilities within a position description and give appropriate training. Another staff member should be trained as back-up when the responsible person is not at work.
Routine self-auditing helps to ensure that the practice is giving potent vaccines. The appendix of the National Vaccine Storage Guidelines: Strive for 5 contains a self-audit example.
Always prepare vaccines in line with the manufacturer’s instructions. You find these in the product information provided with the vaccine or on the TGA website. Be vigilant about correctly preparing vaccines that need to be reconstituted before administration.
The Australian Immunisation Handbook has comprehensive information about the equipment needed to prepare vaccines.
Handling and administering vaccines
All immunisation providers should be familiar with the handling and disposal of sharps. The Australian guidelines for the prevention and control of infection in healthcare sets out how to do this.
Only suitably trained and qualified people can administer vaccines. See your state or territory website for accredited vaccination training courses for nurses.
The Australian Immunisation Handbook has comprehensive information about vaccine procedures, including pre-vaccination, administration and post-vaccination care. It includes details on:
- route of administration
- recommended injection sites