On behalf of NSW Health, local Public Health Units (PHUs) may carry out random vaccine storage and cold chain audits on immunisation providers, including general practices and pharmacies, to ensure compliance with the National Vaccine Storage Guidelines: Strive for 5 and the NSW Health cold chain mandatory requirements.
To access government-funded National Immunisation Program (NIP) vaccines, immunisation providers must comply with both the National guidelines and NSW requirements. Non-compliance may result in the pharmacy losing access to NIP vaccines and can lead to a regulatory notification.
All immunisation providers involved with ordering, receiving, storing and administering government-funded vaccines must understand and adhere to the principles of vaccine storage and cold chain management.
Mandatory cold chain requirements
For a pharmacy to be compliant with cold chain mandatory requirements, pharmacists must ensure:
- Vaccines are stored between 2°C and 8°C in a purpose-built vaccine refrigerator.
- The vaccine fridge has been serviced within the last 12 months, and servicing is maintained annually.
- A data logger device is present and functioning in each vaccine refrigerator. In addition:
- the data logger must be set to record temperatures at 5-minute intervals; and
- the data logging report must be downloaded, reviewed and saved once a week.
- Vaccine refrigerator temperatures (current, minimum and maximum) are manually monitored and recorded twice a day followed by thermometer reset.
- At least two staff members must have successfully completed the NSW Vaccine Storage and Cold Chain Management online learning module – however it is recommended for all staff to complete the training.
- All temperature records must be kept and retained according to medico-legal requirements.
- Any variations outside of the acceptable range of 2°C to 8°C (i.e. a cold chain breaches) are immediately reported to the local Public Health Unit, with the exception of brief excursions up to 12°C for less than 15 minutes.
- NIP stock is not shared with other pharmacies. This is because you cannot determine if the other pharmacy is compliant with cold chain management best practices or if a “stop” has been placed on their Vaccine Account Number (VAN).
- NIP stock is not administered to patients who do not meet the NIP eligibility criteria e.g. using an NIP influenza vaccine to vaccinate someone who isn’t NIP-eligible and charging them an administration fee.
- The National Vaccine Storage Guidelines: Strive for 5 Appendix 2- Vaccine Storage Self Audit is conducted annually.
- Vaccines are not removed from the original cardboard packaging under any circumstance, as they may lose potency if exposed to light.
Additional requirements
- Protocols are in place for managing a cold chain breach and staff are aware of and familiar with this.
- Protocols are in place for ordering and receiving vaccines and staff are aware of and familiar with these, i.e. Vaccine Management Protocol as per Strive for 5 Appendix 1.
Proprietors should report any areas of non-compliance highlighted during a NSW Health cold chain audit to their business insurer.
Pharmacists can reach out to their local Primary Health Network (PHN) or local Public Health Unit (PHU) for further immunisation-related or cold chain management support and education.
Resources
- NSW Health Cold Chain Toolkit for Immunisation Providers
- NSW Health Safe Vaccine Storage Checklist
- NSW Health Vaccine Storage and Cold Chain Management
- PDL Guide to Medicines by Injection
PDL members can call 1300 854 838 for advice and incident support from one of our Professional Officers.
