Manual for Compliant Vaccine Temperature Monitoring

Vaccine distribution is far more than administering a vaccine to a patient. From the manufacturer to the medical professional who handles the vaccine, every step of the process must be properly handled.

One of the primary considerations is how a medical facility must store the vaccines. Some vaccines require refrigeration, while others require cold storage or ultracold storage. The vaccines must be stored at a stable temperature in order to preserve their potency.

Medical facilities must use vaccine temperature monitoring to keep vaccines stored in optimal conditions. Failure to do so can have a range of negative consequences.

Impacts Of Improper Vaccine Storage

A common mistake made by medical facilities is related to vaccine temperature storage. This could be due either to storing the vaccine at the wrong temperature, issues with temperature in transit, or temperature fluctuations within a storage container.

Improper storage compromises the integrity and effectiveness of the vaccine. Patients who receive these vaccines will not be properly protected against the diseases. This leaves them vulnerable to illness and able to pass it to others.

In addition, the vaccine may become so ineffective that it cannot be used. Or the individuals who obtained a vaccine stored at an improper temperature may have to receive a notification and be re-vaccinated. Either of these scenarios would be costly for the medical facility.

It is critical that medical facilities store vaccines according to CDC compliance standards. This includes both vaccines that require refrigeration and those that need to remain frozen. The facility must have the proper equipment and procedures in place to both store and monitor the vaccines.

Vaccine Cold Chain

Vaccines are incredibly sensitive to fluctuations in temperature. The vaccine cold chain is a network of storage and transportation that moves the vaccine from its origin to its destination. This includes the manufacturer, national storage facilities, regional hospitals, health centers, and outreach programs. 

At every step along the vaccine’s route, there is a risk for exposure to the improper temperature. Whether too hot or too cold, this can cause the active ingredients to degrade. The challenge is to ensure the proper transportation, containers, and monitoring for the vaccines.

The CDC emphasizes that the vaccine cold chain depends on three main elements:

• Well-trained staff, including a vaccine coordinator
• Reliable storage and temperature monitoring equipment
• Accurate vaccine inventory management

A breakdown in any of these elements poses a risk to the vaccine itself and the public’s confidence in the vaccine. The CDC recommends that each facility develops and maintains clearly written, detailed, and up-to-date storage and handling operating procedures. Protocols should include how to handle emergencies, such as power outages or natural disasters.

Compliance with CDC Vaccine Temperature Monitoring Devices

To ensure that vaccines are stored at the correct temperature, the CDC recommends each storage unit have a temperature monitoring device (TMD). Furthermore, the CDC recommends using a “digital data logger” (DDL). A DDL provides the most accurate storage unit temperature information, including if the unit has been outside the recommended temperature range.

Guidelines for DDL devices are as follows:

1. A detachable probe that best reflects vaccine temperatures
2. Alarm for out-of-range temperatures
3. Low-battery indicator
4. Current, minimum, and maximum temperature display
5. Recommended uncertainty of +/-0.5° C (+/-1° F)
6. Logging interval (or reading rate) that the user can program to measure and record temperatures at least every 30 minutes
7. Use DDLs with a current and valid Certificate of Calibration Testing.

CDC Recommendations for Vaccine Storage

For each vaccine storage location, the vaccine coordinator must oversee several logistical and operational considerations. This ensures that as the vaccines pass through each stage of the cold chain, they are properly handled.

Receiving the Vaccines

Only trained staff should receive vaccines. The staff should inspect the delivery immediately for any evidence of damage. The temperature monitoring device should have its output reviewed and the results documented.

The vaccine coordinator should confirm receipt of the shipment within the allowable time and if there were any discrepancies in the contents. Full inventory of the shipment should be recorded.

Refrigerators/Freezers for Vaccine Storage

The CDC recommends that refrigerators and freezers for vaccines be stand-alone units. Studies have shown that stand-alone units maintain temperatures better than refrigerator/freezer combos.

The size of the unit should be appropriate for the number of vaccines it needs to store, though the sizes can vary from counter-top to large, pharmaceutical-grade.

The refrigerator or freezer must be able to maintain its temperature throughout the year. It should be dedicated to the storage of vaccines and not used for other purposes.

Placement of the Storage Unit

The storage unit should be placed in an area with good air circulation. The room should be well-ventilated so the device can maintain proper cooling. There should be at least four inches between the unit and the wall, and the motor of the unit should not be covered.

Monitoring of the Storage Unit

As mentioned, the CDC requires a temperature monitoring device (TMD) for each unit. The placement of the device is important for proper monitoring. The device should be placed in the middle of the unit, away from any walls, ceiling, door, or floor.

Allow the unit time to have the temperature stabilized before storing any vaccines. An ongoing log of the temperature monitoring should be recorded, and the CDC recommends temperature monitoring at least two times per day.

The Right Technology for Vaccine Temperature Monitoring

Effective vaccine temperature monitoring is essential to vaccine delivery. With stringent requirements from the CDC, your facility will want to ensure that you are compliant and that your temperature monitoring is manageable.

Our Vaccine Monitoring Cloud System is CDC compliant and offers continuous temperature monitoring via app or computer. You can receive immediate alerts for potential issues via email, text message, and more. Contact us today to learn more.