A cold chain is a process that ensures vaccines are continuously stored at the required vaccine storage temperature (usually between +2°C to +8°C) from the time of manufacture to the point of administration. Maintenance of cold chain is required at all times, including while vaccines are stored in chilly bins for transport and during off-site vaccination clinics.
Why is maintaining the cold chain important?
Vaccines are delicate biological substances. If exposed to temperatures above or below those recommended, vaccines may be irreversibly damaged and cannot be relied upon to provide the expected level of protection against the disease/s that they were designed to prevent. The greatest risk to vaccine viability during storage in chilly bins is the risk of exposure to temperatures that are too cold, as this may have an immediate effect on the potency of a vaccine.
Requirements for all immunisation providers
In New Zealand immunisation service providers must adhere to the following standards:
- Achieve current Cold Chain Accreditation or Cold Chain Compliance before offering an immunisation programme
- All relevant clinical staff must ensure continuity of the cold chain
- Have a cold chain policy
- Have a stock management process that ensures they are not over or under-stocked
- Use a pharmaceutical refrigerator for vaccine storage
- Have two systems for monitoring vaccine storage temperatures
- Have an emergency cold chain process and equipment for ensuring safe temporary storage of vaccines if a power outage occurs or a refrigerator fails
- All equipment used for storing, transporting and monitoring vaccines must be fit for the purpose, appropriately maintained and tested
- Documentation associated with vaccine temperature monitoring must be kept for a minimum of 10 years
- Equipment for off-site immunisation clinics, if they offer this service, must be trialled
Checking the temperature before opening the vaccine refrigerator
- The refrigerator temperature is monitored by a data logger
- The minimum and maximum refrigerator temperatures are recorded daily
- The temperature recording chart is checked for variations in temperature before using the vaccines
- The minimum/maximum temperature recording chart is stored near the refrigerator to facilitate checking each time vaccines are taken out of the refrigerator
- Temperature records are kept for a minimum of 10 years, as per Health (Retention of Health Information) Regulations, 1996
- All relevant clinical staff know how to download, save files and review the data logger recordings weekly or earlier when required
- Appropriate immediate action is taken when temperature readings fall outside the required +2°C to +8°C range and this is documented
- Monitor ambient room temperature.
Expectations of provider staff for the vaccine cold chain
- Providers must nominate at least two people to hold responsibility for vaccine storage and temperature monitoring
- Vaccinators require knowledge of the cold chain process and must ensure the vaccines they administer have been stored correctly
- All clinical staff must read, understand, and comply, with the provider’s cold chain policy so they can take appropriate action if the cold chain is not maintained