Criterion 5.3.2 Vaccine potency
Our health service has appropriate processes to maintain the potency of vaccines.
► A. Our health service can demonstrate how our cold chain management processes conform to the current published edition of the NHMRC National Vaccine Storage Guidelines (direct observation).
► B. Our staff can describe how the process our health service uses for cold chain management conforms to the current published edition of the NHMRC National Vaccine Storage Guidelines (interview).
► C. Our health service has a documented policy for cold chain management procedures that conforms to the current published edition of the NHMRC National Vaccine Storage Guidelines (document review).
The success of any vaccination program depends on the potency of vaccines when they are administered. The essential references for this criterion are the current published edition of the NHMRC Australian Immunisation Handbook60 and the National Vaccine Storage Guidelines which outline exactly what a health service needs to do in relation to cold chain management. It is important that health services follow established protocols for cold chain management and monitoring during the storage, use, transfer and disposal of vaccines. These references are available online at www.immunise.health.gov.au.
The most common problems faced in maintaining the potency of vaccines are:
- on a daily basis when the health service is open, monitoring the maximum and minimum temperature of refrigerators in which vaccines are stored
- knowing what to do if the temperature of the refrigerator falls below or exceeds the acceptable range.
Vaccines should be stored in an appropriate refrigerator. Safe vaccine storage may be achieved using domestic refrigerators if appropriate safeguards are in place, such as a combination of the following:
- a temperature probe placed in the vicinity of stored vaccines
- staff taking the correct action when out of range temperatures are recorded
- the use of trays for storing vaccines.
Although standards relating to cold chain management change from time to time and there are a number of bodies that make recommendations on this process, the NHMRC recommendations are seen as the authoritative advice.