Stop! Do not use! - Responding to a cold chain breach

The national vaccine storage guidelines (Strive for 5) provide a framework on how to safely manage the ‘cold chain’ - a system of storing and transporting vaccines within the safe temperature zone of +2°C to +8°C. Vaccines that are frozen, allowed to get too warm, or directly exposed to light need to be managed appropriately to ensure vaccine efficacy is preserved.

What is a cold chain breach?

A cold chain breach occurs when a vaccine is exposed to temperatures below +2°C, or above +8°C.

Minor temperature deviations are acceptable for temperatures between +8°C and +12°C, if the deviation occurred for 15 minutes or less. All temperature excursions below +2°C are a cold chain breach.

Preserving the cold chain

The Strive for 5 guidelines provide advice on how to preserve the cold chain. Practices should have purpose-built vaccine fridges, with inbuilt temperature monitoring, external temperature displays, and safety features that prevent temperature fluctuations.

Fridges need to have their temperature (minimum, maximum and current) checked and recorded twice a day; before the fridge is opened for the first time that day, and at the end of the day. Users of vaccine fridges should check the fridge temperature routinely each time the fridge is opened (the temperature does not need to be recorded every time).

A data logger is a small device that can measure ambient fridge temperatures at preset intervals over a period of time. This allows for close monitoring of the cold chain. While these can be purchased separately to a vaccine fridge, some purpose-built vaccine fridges have an inbuilt data logger.

Data loggers should be preset to record temperatures at five-minute intervals and downloaded on at least a weekly basis (or as recommended by the manufacturer).

Practices should consider the placement of vaccine fridges carefully, and ensure the fridge is placed out of direct sunlight, in an area with steady ambient temperatures. Vaccine fridges should be positioned to allow adequate air flow around the backs and sides of the fridge.

What should we do in the event of a cold chain breach?

A cold chain breach must be promptly managed to prevent patients receiving potentially ineffective vaccines. Breached vaccines must be immediately isolated and labelled ‘do not use’.

Vaccines that cannot be stored at a safe temperature while the breach is being managed should be transferred to temporary monitored vaccine storage, such as a prepared cooler. Coolers can be prepared as per s.9.3 of the Strive for 5 guidelines.

When the vaccines are safely isolated, the temperature and length of the cold chain breach must be determined; this information can be found on the data logger.

If the information cannot be retrieved from the data logger, the cold chain breach is presumed to have occurred from the last documented time the vaccine fridge was checked, to the temperature that is shown on the fridge’s external temperature display.

All cold chain breaches must be reported to determine whether vaccines are still safe to be used, or whether they need to be discarded. Publicly funded vaccine breaches can be reported in accordance with local state or territory public health requirements. Breached privately funded vaccines can be reported to the manufacturer, who will provide advice on how to manage breached vaccines.

If vaccines can be saved, any changes to expiry dates or information about cumulative exposure should be documented on the vaccine packaging.

What happens if we don’t report a cold chain breach?

Unreported cold chain breaches can have significant consequences for practices, health professionals, patients and the community. It was reported in 2023, that a practice in NSW was unable to provide evidence that vaccines were consistently stored at the correct temperature from April 2019 to January 2023.

As a result, approximately 1600 patients needed to be recalled for revaccination, which included the development of individualised catch-up vaccination programs for children who were aged five years and under.

Large scale patient recalls such as these are expensive, time-consuming and diminish limited vaccine resources. Practice resources are diverted into managing the breach, with practice staff required to manage vaccine resources, ensuring cold chain equipment is serviced and working effectively, and contacting affected patients.

Public health units work closely with practices to ensure all patients receive accurate advice and develop appropriate catch immunisation schedules for those who need it. Vaccine supplies are limited, however breached vaccines must be destroyed and replaced with new stock.

Most importantly, patients who receive affected vaccines are left with inadequate protection against vaccine preventable disease. Media reporting on large scale breaches can undermine public trust and confidence in vaccination programs, leading to scaremongering campaigns on social media and lower immunisation rates.

Early detection and good management of cold chain breaches protects patient safety and vaccine program integrity.

If you experience a breach, or you require advice on cold chain management, contact our Medico-legal Advisory Services team.