At least one team member must have primary responsibility for cold chain management in the practice (refer to Criterion GP6.1 – Maintaining vaccine potency).
Cold Chain System
Definition:
The cold chain is the system of transporting and storing vaccines within the safe temperature range of +2°C and +8°C.
Vaccines are delicate biological products that become ineffective if not stored appropriately.
Cold Chain Management Requirements
Action on Temperature Variations:
Take appropriate action if the temperature is not stable or within the required range.
Essential Steps in Proper Cold Chain Management
Reliable Refrigerator:
Use a refrigerator capable of maintaining a stable temperature within the range of +2°C to +8°C.
Ensure the refrigerator is large enough to meet the practice’s storage needs and accommodate the frequency of vaccine orders.
Documented Processes:
Develop and implement clearly documented processes to maintain the cold chain.
Identify potential situations that could risk vaccine potency and establish appropriate management strategies.
Staff Training:
Ensure all practice staff handling vaccines receive ongoing training tailored to their roles and responsibilities.
Temperature Monitoring:
Monitor and record the maximum and minimum temperatures of refrigerators used to store vaccines at least twice a day.
Check and document the temperature before using any vaccines.
Temperature Variations:
Know the procedures for responding to temperature variations outside the recommended range of 2–8ºC, including reporting and documentation.
Cold Chain Breaches (CCB)
Handling CCB:
Isolate vaccines and place a ‘DO NOT USE’ sign on the fridge.
Continue to store vaccines between +2°C to +8°C.
The vaccines may need to be transferred to an alternate purpose built vaccine refrigerator or cooler if available, see below.
Do not discard any vaccines.
National Immunisation Program Vaccines:
Isolate affected vaccines and contact the Queensland Health Immunisation Program for advice.
Privately Purchased Vaccines:
Contact the manufacturer or supplier for guidance.
Reporting a CCB:
Complete a cold chain breach report form.
The person who noted the breach should complete the form.