The Ministry has reviewed the cold chain documents and the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 along with the Cold Chain Accreditation documentation.
Each provider/clinic or hospital department storing and/or administering vaccines must be familiar and compliant with the following documents:
- National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017
- Annual Cold Chain Management Record
- Cold chain management policy template (Word, 227 KB).
Providers/clinics/hospital departments 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.
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 (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: 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.
For the details on how providers can meet these 10 standards, see sections 2 to 7 of the National Standards for Vaccine Storage and Transportation 2017.
If an immunisation provider fails to comply with the standards, its district health board 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 Provider Self-Assessment Form (doc, 589KB)
- CCA Provider Self-Assessment Form (PDF, 122KB)
- Cold chain accreditation self-assessment form-formatted (DOC, 272 KB)
- Cold chain accreditation self-assessment form-formatted (PDF, 207 KB)
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.
- CCA Immunisation Provider Review Form (doc, 591KB)
- CCA Immunisation Provider Review Form (pdf, 140KB)
- Cold chain accreditation review for immunisation services-formatted (DOC, 288 KB)
- Cold chain accreditation review for immunisation services-formatted (PDF, 288 KB)
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 order to improve cold chain management, the Ministry of Health commissioned PricewaterhouseCoopers (PwC) to undertake a review of cold chain management practices. The summary and recommendations are available: National Review of Cold Chain Management Practices Summary (docx, 92 KB)
This review included appraisal of cold chain failure information and cold chain documentation (including international policy and practices), a provider survey and provider interviews.
The key findings and recommendations have been used by the Ministry of Health to inform the update of the previous National Guidelines for Vaccine Storage and Distribution 2012 and associated cold chain documents.