Cold Chain Protocol - Vaccines and Biologics

6.  Temperature Monitoring

Relevant Reference Materials:

6.1.  Temperature Monitoring by Assigned Personnel

Regular and accurate temperature monitoring is imperative to ensure that the products have been stored at the manufacturer’s recommended storage temperatures. Refrigerators that contain vaccines or biologics must have an appropriate temperature monitoring device.

Required Actions for Daily Temperature Monitoring:
  1. Take the fridge(s) and room temperature twice daily (including units with continuous temperature monitoring and recording devices), first thing in the morning and again at the end of the clinic day.

  2. If staff do not work on the weekends some options to consider are:
    a.   Train any security that is on site, if available, to conduct the temperatures on non-work days.
    b.   Use a continuous temperature monitoring device (data logger) as it can better indicate the time and length of any exposures.
    c.   Have the refrigerator(s) hooked up to a central alarm system that will go off when temperatures are outside of the set temperatures. Designated staff or security would be required to assess the situation if an alarm goes off and know the steps required to protect the vaccines and biologics.

  3. Document temperatures on a temperature log (Resource 3: Temperature Log for Vaccines and Biologics), including the:
    •     Current refrigerator temperature
    •     Minimum temperature since last reading
    •     Maximum temperature since last reading
    •     Room temperature (to establish effect of ambient temperatures on storage)
          Note: If a temperature reading is missed, the log entry should remain blank.

  4. Take immediate action when the temperature in the fridge is outside the recommended range or if there is an equipment or power failure. Actions taken should be recorded (Resource 4: Storage Trouble Shooting Record).
The Vaccine Coordinator or back-up will:
  1. Review the Temperature Log for Vaccines and Biologics weekly to ensure proper storage temperatures are being maintained.

  2. Review the Temperature Log for Vaccines and Biologics and Vaccine Storage Trouble Shooting Records monthly to note trends in storage temperatures and potential storage issues.

  3. Keep the Temperature Log for Vaccines and Biologics and Vaccine Storage Trouble Shooting Records for a period of three (3) years (to monitor historical and seasonal patterns).
To help prevent substantial losses of vaccines and biologics facilities storing large inventories should install continuous monitoring temperature alarm systems with round-the-clock notification to appropriate personnel.

Communicable Disease Control (CDC)
Public Health
Manitoba Health

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