The message below was sent to DHB Portfolio Managers by HealthCERT and this is important information for aged care providers.
Dear DHB HOP Portfolio Managers
The Ministry of Health has been notified of an event where influenza vaccines were compromised by exposure to temperatures outside the required storage range of +2˚C to +8˚C. These vaccines were given to residents in an Aged Residential Care (ARC) facility and they have been offered re-vaccination. This is of concern as this age group is vulnerable to the complications associated with influenza.
This event has brought to both the Ministry’s and the affected DHB’s attention that some ARC facilities are storing vaccines on-site (i.e. influenza vaccine) and are not aware of the requirements for vaccine storage.
We understand that most ARC facilities do not store vaccines on-site and the vaccinating health professional brings the vaccines with them ensuring they are stored at the required temperature range (this includes vaccine temperature monitoring). For those facilities who offer their own vaccination service, by using an authorised vaccinator, they are required to maintain safe vaccine storage conditions at all times.
We have been working with HealthCERT and provided an update in the May 2017 (Issue 19) HealthCERT Bulletin which can be found on the Ministry of Health website at: http://www.health.govt.nz/our-work/regulation-health-and-disability-system/certification-health-care-services/healthcert-bulletin
Who can administer vaccines
Influenza vaccines, like all vaccines, are prescription medicines and can only be administered by a registered nurse when there is a valid prescription or standing order, or if the registered nurse is an authorised vaccinator working in accordance with an approved immunisation programme. Information about the authorisation process and a local programme can be found in Appendix 4 of the Immunisation Handbook
The cold chain is the system of transporting and storing vaccines within the required temperature range. All vaccines must be stored between +2˚C to +8˚C at all times (this is part of the cold chain). Due to the delicate nature of vaccines they can become ineffective when exposed to temperatures outside this range. All immunisation providers, which includes ARC facilities storing influenza vaccines for administration to residents or staff, are required to go through a process of Cold Chain Accreditation (CCA). CCA is an assessment tool used by a trained assessor to ensure that the provider’s cold chain management practices and processes meet the National Standards for Vaccine Storage and Transportation for Immunisation Providers 2017 (the Standards). This should be undertaken prior to the storage of any vaccines.
Vaccine cold chain equipment requirements include:
- storing the vaccines in a pharmaceutical refrigerator (domestic refrigerators are not acceptable),
- monitoring the refrigerator temperature using a
- digital minimum/maximum thermometer (the minimum and maximum temperature must be recorded every day the facility is open),
- temperature data logger (this is required to be downloaded at least weekly and in response to any daily minimum/maximum temperatures that are recorded outside the +2˚C to +8˚C range),
- having a chilly bin, insulation material, ice packs and monitoring equipment for use in the event of power or equipment failure.
Each facility is also required to have an up-to-date policy related to cold chain management.
The Standards can be found on the Ministry’s website and contain more information and details on the equipment and monitoring requirements.
There is also more information about cold chain management on the Ministry’s cold chain page
If you have any questions regarding cold chain management or you would like more information please contact your local Immunisation/Cold Chain Coordinator, you will find their details on the Immunisation Advisory Centres website
We would appreciate if you could please follow up with your ARC providers to:
– check if they are offering and storing vaccines
– if yes are they aware of the requirements under the National Standards and have they achieved CCA and has undergone the authorised vaccinator process?
– if not, can they please contact their local immunisation coordinator to discuss their cold chain management.
If you have any queries please email the Ministry’s Immunisation Team at [email protected]