Vaccine storage and cold chain management

What is the cold chain?

Cold chain is a system of transporting and storing vaccines within the safe temperature range of +2C to +8C.

Cold chain begins from the moment a vaccine is manufactured and continues through to the state or territory vaccine distribution centre, immunisation service provider and ends when the vaccine is administered to the patient.

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Vaccine storage

Policy directiveVaccines are sensitive medicines that must be protected from light and temperature fluctuations outside of 2°C to 8°C.

All immunisation providers responsible for ordering, storing, receiving and administering vaccines must understand the principles of vaccine storage and cold chain management.

The National Vaccine Storage Guidelines: Strive for 5 provide best practice guidelines for storing vaccines and managing the cold chain. Resources are available from the National Vaccine Storage resource collection.

The NSW Health Vaccine Storage and Cold Chain Management Policy provides mandatory requirements for the storage and management of vaccines in NSW public facilities. The policy directive includes a Vaccine Refrigerator Protocol for public facilities.

The Cold Chain Toolkit and Safe Vaccine Storage Checklist are available to support all immunisation providers.

Vaccines must be protected from the light

Vaccines may lose potency if exposed to direct sunlight or ultraviolet (UV) light, including fluorescent light. If a vaccine loses potency it may become less effective in providing protection against vaccine preventable diseases.

To protect vaccines from light exposure they must be stored in the purpose-built vaccine refrigerator inside their original cardboard packaging. Vaccines must not be removed from the original cardboard packaging to increase refrigerator capacity.

The original cardboard packaging ensures vaccines are protected against:

  • exposure to sunlight and ultraviolet (UV) light or fluorescent light
  • temperature fluctuations
  • possible breach of sterility
  • tampering
  • vaccine administration errors

Purpose built vaccine refrigerators must have capacity to store 1 months’ supply of government funded and private vaccine stock (if required).

Consider the volume of vaccines you store during peak times. You may require additional vaccine storage capacity to meet demand during the influenza season, consider hiring or purchasing additional purpose-built refrigerator.

Reporting a light-exposure breach

If you become aware of vaccines which have been exposed to light:

  1. Label the vaccines ‘Do not use’ and isolate them from other vaccines
  2. Use the Cold Chain Breach and Vaccine Wastage Form to report all light exposure breaches to your local public health unit on 1300 066 055.
  3. Include information about how long the vaccines have been stored outside of their original cardboard packaging and if patients were vaccinated with potentially light affected vaccines.

Cold chain management

All vaccines must be stored within the recommended temperature range of +2°C to +8°C at all times. Maintaining the cold chain is important to ensure that effective and potent vaccines are administered to patients.

Vaccine Storage and Cold Chain Management online training moduleImmunisation providers are responsible for ensuring all staff are trained in vaccine storage and cold chain management. The NSW Health Vaccine Storage and Cold Chain Management online training module should be used to facilitate staff education to equip staff to effectively manage the cold chain.

  • A certificate of completion is awarded at the end of the module and a copy should be saved in practice records.
  • For continued access to government-funded vaccines, at least two staff members who manages vaccines must successfully complete the NSW Health Vaccine Storage and Cold Chain Management online learning module. The certificate of completion for this module must be kept on file for review when requested by NSW Health.
  • It is recommended that all staff responsible for cold chain management in facilities should complete the module. This includes staff that manage, transport or administer vaccines and may include GPs, pharmacists, administrative staff and nurses.
  • Staff working in NSW public facilities should refer to the Vaccine Storage and Cold Chain Management Policy for mandatory training requirements

Vaccine storage self-audit

A vaccine storage self-audit must be completed every 12 months and more frequently where there have been problems with:

  • equipment or
  • cold chain breaches.

The following tools are available to complete the audit:

Please contact your local public health unit on 1300 066 055 to discuss any concerns following the audit.

NSW Health cold chain audits for all immunisation providers

Local public health units may carry out vaccine storage and cold chain audits on immunisation providers to ensure compliance with the National Vaccine Storage Guidelines: Strive for 5 and the NSW Health cold chain mandatory requirements.


Mandatory requirementsRefer to
Vaccine storage Vaccines must be stored in a purpose built vaccine fridge (PBVF). Domestic refrigerators must not be used for vaccine storage Section 3: Types of refrigerators for vaccine storage
Vaccine monitoringPurpose built vaccine refrigerators must be continuously monitored using a data loggerSection 4: Vaccine temperature monitoring devices
Temperature recordingFridge temperatures should be checked twice daily, both minimum and maximum followed by resetting the fridgeAppendix 5: Twice daily temperature monitoring chart of vaccines stored in vaccine refrigerators
Education and trainingAt least two staff members must have successfully completed the NSW Health Vaccine Storage and Cold Chain Management online learning module to order vaccines It is however recommended that all staff complete the online learning moduleThe NSW Health online learning module
Vaccine storage auditsNSW Health will be conducting random cold chain audits of all immunisation providers including general practices and pharmacies. This is to ensure compliance with vaccine storage and staff training requirementsImmunisation providers will be required to submit evidence that demonstrates:
  • the practice is compliant with vaccine storage and temperature monitoring requirements outlined in the National Guidelines
  • that at least two staff members have completed the NSW Health online cold chain learning module.

Managing a cold chain breach

A cold chain breach occurs when vaccine storage temperatures:

  • have been outside of the recommended range of +2°C to +8°C during storage or transport.
  • Excursions of >8°C to up to 12°C for no longer than 15 minutes may occur whilst restocking the refrigerator and are acceptable.

Immunisation providers must report all cold chain breaches to their local public health unit.

  1. Isolate vaccines and place a ‘DO NOT USE’ sign on the fridge.
  2. The vaccines may need to be transferred to an alternate if another purpose-built vaccine refrigerator is available, whilst attempting to continue to store vaccines between +2°C to +8°C. If this is not an option, leave vaccines in the affected fridge and keep fridge door closed.
  3. Place ‘DO NOT USE’ sign on vaccine fridge door.
  4. Do not discard any vaccines.
  5. Download and review the data logging report to assess the duration of the breach and temperature the refrigerator reached. Do not remove the data logger until the power is resumed (if power failure), this ensures that all temperatures out of range are logged.
  6. Complete the Cold Chain Breach and Vaccine Wastage Reporting Form and contact your local public health unit on 1300 066 055 as soon as possible during business hours to report the breach. If the breach occurs after hours, keep vaccines isolated until the next business day.
  7. If transferring vaccines to a vaccine cooler (e.g. Esky), please do so as per the Section 9 in the National Vaccine Storage Guidelines, Strive for 5. Record temperatures for all eskys on the Vaccine Cooler Temperature Chart.
  8. Refer to the NSW Cold Chain Breach Protocol.

Ordering and receiving vaccines

Immunisation providers are responsible for:

  • ordering vaccines and maintaining appropriate levels of stock to meet vaccination program requirements while not exceeding the capacity of the refrigerator (Immunisation providers should aim for one routine vaccine order per facility per month)
  • ensuring that stock is rotated when receiving new stock to prevent wastage of vaccines nearing expiry.

When receiving a vaccine delivery it is important to confirm that the cold chain has been maintained during transport and the integrity of the vaccines has not been compromised.

Before accepting the delivery and transferring the vaccines to a dedicated vaccine refrigerator, check the cold chain monitors and record the check on the vaccine minimum/maximum temperature chart.

If the cold chain monitor(s) has activated contact the NSW Vaccine Centre immediately on 1300 656 132.

While awaiting advice, the vaccines must be:

  • placed in the refrigerator
  • isolated and
  • labelled ‘do not use’.

Frequently asked questions (FAQs) relating to NSW Health cold chain mandatory requirements.

Who do the mandatory requirements apply to?

The mandatory requirements outlined in The National Vaccine Storage Guidelines 'Strive for 5' (3rd edition) 2019 apply to ALL immunisation providers in NSW who access government funded vaccines. This includes, general practitioners, pharmacies, residential aged care facilities, Aboriginal Medical Services and all NSW Health facilities, including child and family health and community centres.

I store vaccines in a domestic fridge, do I need to purchase a purpose-built vaccine refrigerator?

Yes, all immunisation providers accessing government funded vaccines must be storing vaccines in a purpose-built vaccine refrigerator.

Is there a government funding scheme to assist immunisation providers with the cost of purchasing a purpose-built vaccine refrigerator?

No, there is no government funding scheme for purpose-built vaccine refrigerators.

Is the battery-operated thermometer the same as a data logger?

No, please refer Section 4 Vaccine temperature monitoring devices of The National Vaccine Storage Guidelines 'Strive for 5' (3rd edition) 2019.

Why do I need a data logger when I already check my fridge temperatures twice daily?

Please refer Section 4 Vaccine temperature monitoring devices of The National Vaccine Storage Guidelines 'Strive for 5' (3rd edition) 2019. Data loggers provide 24/7 monitoring of your fridge. They are extremely useful to determine the duration of exposure of vaccines to out of range temperatures.

Does NSW Health audit immunisation providers to ensure their cold chain practices align with the National Vaccine Storage Guidelines ‘Strive for 5’ (3rd edition)?

Yes, local public health units may carry out vaccine storage and cold chain audits on immunisation providers to ensure they are compliant.

I am concerned that my practice does not meet the requirements of the National Vaccine Storage Guidelines, Strive for 5 (3rd edition) 2019. What should I do?

Contact your local public health unit on 1300 066 055 for further information and advice.

Does everyone in my practice have to complete the NSW Health cold chain training module?

At least two staff members must successfully complete the NSW Health Vaccine Storage and Cold Chain Management on-line learning module to continue to receive government-funded vaccines. However, it is strongly recommended that all persons responsible for ordering, storing, receiving and administering vaccines complete the on-line training module to ensure they understand the principles of vaccine storage. All staff should be competent in vaccine management in the event the person responsible for vaccine storage and the back-up person are away or in the event of an emergency or power failure.

The NSW Health cold chain training module is not working?

You must have Adobe flash player installed in your computer. If it is still not working you may need to select a different web browser (e.g. Google Chrome), you may also need to clear all cache if you are still having issues, please contact your local public health unit on 1300 066 055.

At the completion of the NSW Health cold chain training module there is a link to order vaccine temperature charts. However the link to: “where can I access a NSW Health approved vaccine fridge temperature chart?” is not working.

A vaccine fridge temperature monitoring chart is available from the National Vaccine Storage resource collection.

Resources



Current as at: Friday 11 October 2024
Contact page owner: Immunisation