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Criterion 5.3.2 - Vaccine potency

Our practice has appropriate processes that maintain the potency of vaccines.

Explanation

The success of any vaccination program depends on the potency of vaccines when they are administered. The essential reference for this criterion is the current published edition of the NHMRC guidelines The Australian immunisation handbook⁵¹ which outlines exactly what a practice needs to do in relation to cold chain management. It is important that practices follow the current published edition of these NHMRC guidelines in relation to cold chain management and monitoring during storage, use, transfer and disposal of vaccines. The Australian immunisation handbook is available online at www.immunise.health.gov.au.

The most common problems that practices face in maintaining the potency of vaccines are:

• monitoring the maximum and minimum temperature of refrigerators in which vaccines are stored on a daily basis when the practice is open, and
• knowing what to do if the temperature of the refrigerator falls below or exceeds the acceptable range.

Safe vaccine storage may be achieved using domestic refrigerators if appropriate safeguards are in place; for example, the use of 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 in which to place stored vaccines.

Standards relating to cold chain management change from time to time and there are a number of bodies that make recommendations. The NHMRC recommendations, however, are seen as the authoritative advice on this practice process. If the NHMRC makes a change to its recommendations (such as recommending the use of refrigerators designed specifically for vaccine storage) then the RACGP will advocate on behalf of the profession for funds to implement such a recommendation.

Indicators

1. our practice can demonstrate how our practice's cold chain management processes meet the current published edition of the NHMRC guidelines (direct observation).
2. our GP(s) and staff can describe how the process used for cold chain management meets the current published edition of the NHMRC guidelines (interview).
3. our practice has a documented policy for cold chain management procedures in accordance with the current published edition of the NHMRC guidelines (document review).

Publication Date: 17 August 2007
Authorised By: Standards