Prepare your practice: NSW Health cold chain audits

Local public health units (PHUs) on behalf of NSW Health continue to conduct random cold chain audits of all immunisation providers including general practices, pharmacies and RACFs.

All immunisation providers responsible for ordering, receiving, storing and administering government funded vaccines on the NIP must understand and adhere to the principles of vaccine management and storage, as set out in National Vaccine Storage Guidelines: Strive for 5.

In addition to the national guidelines, immunisation providers in NSW are required to adhere to the NSW state requirements for cold chain management and vaccine storage.

Equipment

• Vaccine storage: providers are required to have a vaccine specific fridge, a data logger, and min/max thermometer to continuously monitor refrigerator temperatures.
• Alternative storage for vaccines: in addition, providers are required to have a cooler to store vaccines in the event of a fridge malfunction or power outage. Ensure cooler is large enough to accommodate all vaccines, ice packs, bubble-wrap, and a data logger or min/max thermometer.

Equipment maintenance

• Vaccine fridge: must be serviced annually (within the last 12 months);
• Data logger: change battery and check accuracy according to the manufacturer’s recommendation
• Min/max thermometer: change battery and check accuracy (via ‘slush test’) at least every 12 months

Temperature monitoring

• Vaccines must always be stored at temperatures between 2°C and 8°C, , with the ideal storage temperature being 5°C – hence the phrase ‘Strive for 5’.
• Min/max thermometer temperatures must be checked and recorded twice daily. Record minimum, maximum and current temperatures on a chart/logbook and reset thermometer after each recording.
• Data loggers must be set to record temperatures at 5-minute intervals. Data must be downloaded and checked at least once a week to ensure temperatures have stayed within the acceptable range of 2°C to 8°C.

Reporting

• Cold chain breach: any temperature variations outside the acceptable range of 2°C to 8°C must be reported to the Public Health Unit (with the exception of a temperature deviation of up to 12°C for less than 15 minutes).
• Light exposure breach:  vaccines must be stored inside their original cardboard packaging to protect against exposure to light. Any vaccines which have been exposed to light must be reported to the Public Health Unit.
• Temperature deviations between 8°C to 12°C for less than 15 minutes are not considered cold chain breaches, however all temperature deviations must be documented on the Vaccine storage trouble sheet.

Documentation & training

• A vaccine storage self-audit must be completed annually and records retained for audit purposes.
• All temperature records must be kept and retained according to medico-legal requirements.
• At least two staff members must hold a certificate of completion of the NSW Vaccine Storage and Cold Chain Management online learning module. It is best practice for all staff to complete the training.

Policies & procedures

• All clinics that store and administer vaccines must have documented policies, procedures and protocols in place, and regular orientation, education or training sessions for staff.
• A vaccine management protocol must be in place for ordering, receiving, storing and administering vaccines.
• A cold chain breach protocol is required to promptly identify and manage cold chain breaches. This will help minimise the risk of administering ineffective vaccines to patients.
• A power failure protocol is required to help reduce vaccine loss in the event of a power failure. Clinics should practise implementing protocol to ensure that the plan will work in a real power failure situation.

Further information

• CESPHN – Cold chain management webpage, contact us on immunisation@cesphn.com.au if you need further assistance
• National Vaccine Storage Guidelines – Strive for 5
• NSW Health – Cold Chain Toolkit
• NSW Health – Safe Vaccine Storage Checklist
• NSW Health Website – Vaccine storage and cold chain management