Cold chain standards for vaccines

Information for immunisation providers including pharmacies, clinics and hospital services

As of 1 November 2024 Health New Zealand | Te Whatu Ora is continuing to review the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition) and the 2021 COVID-19 Vaccine Addendum along with resources to support Cold Chain.

Immunisation providers storing and/or administering vaccines must be familiar and comply with the following documents:

National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition) - Ministry of Health

COVID-19 Vaccine Addendum to National Standards June 2021

Cold chain management policy template - IMAC

Interim statement - Lifespan of pharmaceutical fridges for vaccine storage - October 2024 (PDF 69KB)

Immunisation providers storing and/or administering vaccines include, but are not limited to, the following:

general practices
hospital pharmacies/departments/wards
public health units
community pharmacies
corrections facilities
travel clinics
outreach immunisation services
occupational health services
accident and medical clinics
after-hours services.

National Standards

Aim: All people should have access to safe, effective vaccines from the most appropriate provider within their community. Public trust in the national immunisation programme is critical to its success, and a key component of this is robust storage and monitoring of vaccines at all points of the cold chain.

Objective: To ensure immunisation providers in New Zealand are enabled through the National Standards to store and transport vaccines within their required temperature range, from the point of manufacture through to when they are administered to an individual.

1. All immunisation providers must hold cold chain accreditation 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. IMAC has provided a cold chain policy template that providers can adapt and use for their facility (available from the Downloads section of this page).

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: Pharmaceutical fridges 10 years or older used to store vaccines can be used, provided continuous real-time temperature monitoring services with out-of-hours alarming and notification processes are in place and all other aspect of the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition) are complied with.

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 their offsite cold chain policy and equipment approved by the Immunisation Co-ordinator.

For details on meeting the standards, see the National Standards for Vaccine Storage and Transportation 2017 - Ministry of Health and Cold Chain resources.

If an immunisation provider fails to comply with the standards, its district or primary health organisation, medical officer of health or the Ministry will review its access to vaccines. Vaccine supply may also be suspended until the provider is able to meet the standards.

Cold Chain Accreditation

Cold Chain Accreditation (CCA) is an assessment tool used to assess an immunisation provider’s cold chain management practices and ensure that they meet the required 10 standards as outlined in the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017.

To achieve CCA, an immunisation provider must meet all the standards. The provider self-assessment provides the immunisation provider with an opportunity to self-review their practices.

All providers/clinics who store vaccines and/or offer immunisation services must achieve CCA, including (but not limited to) general practices, public health units, community pharmacies, travel clinics, emergency medical services, occupational health services, research units and hospital wards/clinics/departments/pharmacies. CCA is valid for up to three years based on the CCA reviewer’s findings.

The following forms have been developed to assist in the CCA process.

CCA Provider Self-Assessment Form – is to be completed by an immunisation provider and sent to the local immunisation coordinator or CCA reviewer prior to their CCA review. Immunisation providers should refer to the Cold Chain Management Policy template which covers all the areas of cold chain management required to achieve CCA.

CCA Immunisation Provider Review Form – is to be completed by the immunisation coordinator or CCA reviewer at the time of the immunisation providers CCA review.

Process for vaccines stored outside the +2°C to +8°C:

Quarantine the vaccines

Label and quarantine all the vaccines involved.
Ensure the vaccines are kept within the required temperature range of +2°C to +8°C. Seek alternative storage arrangements, if required, as per the provider’s cold chain policy.
Communicate with colleagues to ensure the vaccines are not used until further notice.
Document the incident.

Confirm and define the incident

Review the refrigerator temperature records and download information from the data logger to clarify the cold chain before this event.
Confirm current refrigerator temperatures.
Check the refrigerator’s service history to date.

Collect as much information as possible

What monitoring has taken place (maximum, minimum and/or current thermometer readings)?
For how long were the vaccines stored outside of the required +2°C to +8°C range (minutes, hours or days)?
Identify all vaccines stored in the refrigerator, the length of time they were stored, usual stock turnover and expiry dates.
Identify any previous events involving these vaccines where the temperature has gone outside the required+2°C to +8°C range.
Is it likely that any individuals received a compromised vaccine?

Contact your local immunisation coordinator

With all of the cold chain information available, work with the immunisation coordinator through to resolution.
Ensure that you fully document the incident and outcomes.

Refer to the section 6.4 of the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017.

National Review of Cold Chain Management Practices: Summary and Recommendations

In 2023 a Cold Chain Standards Review Group with representatives from Health New Zealand | Te Whatu Ora , Medicine Control and IMAC commenced a technical review of the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (2nd edition) and the 2021 COVID-19 Vaccines Addendum.

The purpose of the review was to combine the documents and ensure the standards are accessible and appropriate for the wide variety of vaccination providers now in Aotearoa.

The draft National Standards for Vaccine Storage and Transportation for Immunisation Providers 2023 went out for sector technical review from October 2023 to January 2024. The Cold Chain Standards Review Group incorporated feedback into the draft standards and implementation planning.

The Cold Chain Standards Review Group recommended the implementation plan is phased, and that a Cold Chain Standards Implementation Group is formed to lead the work. This is to ensure effective prioritisation of implementing all proposed changes.

In the interim, in response to requests from the sector, we are updating the standards and guidance on pharmaceutical fridges for vaccine storage being replaced at 10 years to reflect temperature monitoring services now in use. Phase one of the Cold Chain Standards implementation plan is issuing the Interim Statement on pharmaceutical fridges 10 years or older used for vaccine storage be used with continuous temperature monitoring services.

The further release of the updated National Standards for Vaccine Storage and Transportation for Immunisation Providers 2023 is under review.