Clinical governance standard

CG12 – Maintaining vaccine potency


      1. CG12 – Maintaining vaccine potency

CG12 | Maintaining vaccine potency


Consumer expectation statement: I expect that this practice stores and delivers vaccines safely and effectively in line with current guidelines.

CG12.A The practice has a written, practice-specific policy that outlines its cold chain processes.

The practice:

  • maintains a cold chain management policy and procedure that is:
  • has a record of all monitoring of vaccine refrigerators, including the temperature.

CG12.B The practice has at least one member of the practice team who has primary responsibility for cold chain management in the practice.

The practice:

  • has a member of the practice with primary responsibility for cold chain management, which includes ensuring the practice complies with the current edition of the National vaccine storage guidelines: Strive for 5
  • ensures the responsible member of the practice team has had appropriate training in cold chain management and understands their role
  • informs members of the practice team who is responsible for cold chain management
  • has a process to delegate cold chain management when the member of the practice team with primary responsibility is unavailable.


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 temperature ranges recommended in the National vaccine storage guidelines: Strive for 5.

The practice maintains vaccine potency by having a current cold chain management policy and a person responsible for cold chain management.


The practice’s cold chain policy needs to be based on the current edition of the National vaccine storage guidelines: Strive for 5. To keep their cold chain policy current, the practice could:

  • subscribe to updates from federal and state or territory health departments about cold chain requirements and public health alerts
  • conduct regular quality improvement activities related to cold chain management.


The practice’s cold chain management policy is an operational document and needs to be reviewed for currency every two years (see criterion F1.E).


The practice needs to nominate a member of the practice team to take responsibility for, and to have authority and accountability of, cold chain management in the practice.

All members of the practice need to know which member of the practice team has primary responsibility for cold chain management so they can seek advice and support from this person if they have any questions about vaccine storage and supply.

The responsible person could:

  • discuss the cold chain management policy in team meetings
  • create a template to make monitoring and recording of refrigerator temperatures easier
  • create a roster for monitoring cold chain compliance
  • include education about cold chain management in induction and ongoing training for the practice team
  • conduct an audit of vaccine storage to determine whether it complies with the National vaccine storage guidelines: Strive for 5.


Maintaining patient confidence in the safety and quality of vaccine handling is an important aspect of immunisation care. While the practice’s cold chain policy is a documented operational procedure, communication with patients about vaccine storage and handling needs to be transparent and reassuring, rather than procedural or technical.

The practice could:

  • display a short statement (for example, in the waiting room, in treatment rooms, on the practice website) that the practice adheres to national guidelines relating to cold chain management
  • inform patients, if they ask, that vaccines are stored and managed according to best practice cold chain procedures
  • include a brief explanation in patient information materials (for example, immunisation brochures and consent forms) that vaccines are stored under strict temperature-controlled conditions to ensure their safety and effectiveness.
 

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