The National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 are available on the Ministry of Health website. The document describes the standards and outlines the requirements for providers to achieve the standards.
The 2017 standards supersede the National Guidelines for Vaccine Storage and Distribution 2012 and the cold chain information in the Immunisation Handbook 2014. The Cold Chain Self-Assessment and Immunisation Provider Review, Cold Chain Management Policy Template, and Annual Cold Chain Management Guide and Record are currently being updated to reflect the 2017 standards.
Aim: To improve the health of all New Zealanders by protecting them from vaccine preventable diseases through an effective immunisation programme.
Objective: To ensure immunisation providers in New Zealand safely store and transport vaccines, following the 10 standards below to ensure all vaccines administrated are safe and effective.
1. All immunisation providers must hold cold chain accreditation or cold chain compliance before offering an immunisation programme.
2. All clinical staff must ensure continuity of the cold chain. They must also:
- be competent in all aspects of vaccine storage and transportation to ensure that vaccines are kept within the required +2°C to +8°C temperature range at all times
- take appropriate action when the cold chain is not maintained
- take responsibility for ensuring that the vaccines they administer have been correctly stored
- have read and understood, and comply with, the provider’s cold chain policy.
3. All immunisation providers must have a cold chain policy that contains the required information outlined in section 6.1. The Ministry of Health has provided a cold chain policy template that providers can adapt and use for their facility.
4. All immunisation providers must have a stock management process that ensures they are not over- or under-stocked.
5. All immunisation providers must use one or more pharmaceutical refrigerators for vaccine storage that:
- store only medicines and vaccines
- are appropriately maintained and serviced
- contain only vaccines and medicines stored in their original packaging and properly spaced within the pharmaceutical refrigerator.
Note: All pharmaceutical refrigerators have a limited life span, usually around 10 years. Immunisation providers are expected to actively plan for replacement and replace their refrigerator after 10 years rather than wait until the refrigerator fails to maintain temperature.
6. All immunisation providers must have two systems for monitoring the temperature that vaccines are being stored at:
- a daily check device that records the minimum and maximum temperatures reached – for example, an inbuilt refrigerator monitor or digital minimum/maximum thermometer
- a weekly check device that records the temperature at least every 10 minutes – for example, a data logger. Every week the provider then downloads and reviews this information, takes appropriate action and stores the week’s information.
7. All providers must have a cold chain process and equipment for ensuring safe temporary storage of vaccines if a power outage occurs or a refrigerator fails.
8. All equipment used for storing, transporting and monitoring vaccines must be fit for the purpose, and appropriately maintained and tested. As part of this maintenance and testing, providers must:
- arrange for annual servicing of the pharmaceutical refrigerators
- trial and test the capacity of their portable storage equipment.
9. All documentation associated with vaccine temperature monitoring must be kept for at least 10 years. This includes:
- the daily minimum and maximum temperature recordings
- the weekly data logger downloads
- temperature recordings from vaccines transported and stored in chilly bins
- any actions taken when a cold chain breach, excursion or failure occurs.
10. All immunisation providers who offer offsite immunisation clinics – for example, occupational health, school-based immunisation programmes and outreach immunisation services – must have appropriate and tested equipment for this purpose.