Criterion GP6.1 – Maintaining vaccine potency

Why this is important

The success of any vaccination program depends on the potency of vaccines when they are administered to patients. To maintain their potency, vaccines need to be transported and stored within the temperature range of 2–8°C. As vaccines are delicate biological products, they become ineffective if they are not transported and stored within this temperature range.

Meeting this Criterion

Nominating a person with primary responsibility

Your practice must nominate a team member to take responsibility for cold chain management and compliance with cold chain management guidelines.

The team member responsible for cold chain management must be trained so they have the knowledge and skills required to ensure that vaccines remain potent.

All members of the practice team must know which team member has primary responsibility for cold chain management so they can seek advice and support from this person in order to ensure vaccine potency.

Your practice needs to have a process for this person to hand over to another designated and trained team member when they are unavailable.

Your practice’s quality assurance and risk management processes can include self-auditing of your practice’s cold chain management.

Choosing a refrigerator

Your practice must store vaccines in a reliable refrigerator. Purpose-built vaccine refrigerators are specifically designed to store vaccines between +2°C and +8°C, and are the only type of refrigerator recommended for storing vaccines.

Do not use cyclic defrost or bar refrigerators because their internal temperatures fluctuate considerably.

Domestic refrigerators (including bar fridges) are not built or designed to store vaccines and must not be used for vaccine storage. Refer to your state or territory health department for further advice.

Monitoring the refrigerator’s temperature

Your practice must:

• monitor and record the minimum and maximum temperatures of refrigerators in which any vaccine is stored at least twice a day on each day the practice is open (ideally at the beginning and end of the day)
• view and consider the current temperature every time a refrigerator storing a vaccine is opened
• take appropriate action if the temperature is not stable or within the required range.

Data loggers or digital thermometers in refrigerators

Your practice can use data loggers or digital thermometers to verify the efficacy of your cold chain and to conduct quality control checks of the temperature of refrigerators storing vaccines. Data loggers are small electronic devices that continuously measure temperatures, with the data uploaded to computer software so you can view and monitor the results. Some vaccine refrigerators come with inbuilt data loggers, but you can also purchase an external data logger if necessary.

Data loggers will help you identify and record:

• the accuracy of the thermometer
• temperature fluctuations inside the refrigerator, including the duration of the fluctuations
• areas in the refrigerator that are potentially too cool or too warm to store vaccines.

Cold chain management

To be confident of the potency of vaccines stored in your practice, you must:

• document and follow routine processes to maintain the cold chain, identify risks to the potency of vaccines (such as a loss of power), and implement appropriate strategies to manage this risk
• provide all members of the practice team who handle vaccines with ongoing education which is appropriate to their level of responsibility and forms part of their professional development
• be aware of what action is required if the temperature of the refrigerator has not been maintained within the required range.

Self-auditing

Your practice could conduct a self-audit of your cold chain management every 12 months as part of your routine quality assurance and risk management process in order to ensure you only administer potent vaccines. An example of a self-audit is contained in the National vaccine storage guidelines: Strive for 5.

Meeting each Indicator

GP6.1 A Our practice has at least one team member who has primary responsibility for cold chain management in the practice.

You must:

You could:

• include education about cold chain management in induction and ongoing training for the practice team.

GP6.1 B The team member who has primary responsibility for cold chain management ensures that the process used complies with the current edition of the National vaccine storage guidelines: Strive for 5.

You must:

You could:

• conduct an audit of vaccine storage to determine whether it complies with the National vaccine guidelines: Strive for 5.

GP6.1 C The team member who has primary responsibility for cold chain management reviews the following processes to ensure potency of our vaccine stock:

• Ordering and stock rotation protocols
• Maintenance of equipment
• Annual audit of our vaccine storage procedures
• Continuity of the cold chain, including the handover process between designated members of the practice team
• Accuracy of our digital vaccine refrigerator thermometer

You must:

You could:

• create a template to make monitoring and recording of refrigerator temperatures easier.
• create a roster for monitoring cold chain compliance.

GP6.1 D Our practice has a written, practice-specific policy that outlines our cold chain processes.

You must:

You could:

• review the cold chain management policy once a year
• discuss the cold chain management policy in team meetings.