Best practices and VFC program compliant data loggers
The Centers for Disease Control and Prevention (CDC) places a high importance on data loggers for medical refrigerators and lab freezers. A data logger, sometimes referred to as a thermal recorder, monitors the temperature of the cold storage unit where vaccines are kept. Maintaining a stable temperature within the medical refrigerator is critical to preserving the integrity of the vaccines in your healthcare practice.
The storage unit in your practice may contain thousands of dollars worth of vaccines, but that could all go to waste if the temperature does not remain stable. We’ve outlined some temperature monitoring practices, along with the requirements for the CDC’s Vaccines for Children (VFC) program providers, so you can be sure your vaccines are safely stored and you are compliant with VFC temperature monitoring regulations.
Best Practices for Monitoring Vaccine Temperatures
About three million lives are protected every year by vaccines, but unfortunately hundreds of thousands of lives are lost due to vaccine instability. One factor that causes vaccine instability is storing the vaccine at the incorrect temperature.
The system used to distribute and preserve vaccines is called the “cold chain.” Beginning with the cold storage unit at the manufacturing facility, the chain extends through transporting of the vaccine and at the provider’s office before ending once the vaccine is administered to the patient. If at any point the “cold chain” is broken, the vaccine can become ineffective. Using temperature monitoring best practices can prevent the cold chain being broken in your healthcare practice.
Assess Temperatures in New Units Before Storing Vaccines
To ensure your new freezer or refrigerator is working properly, it is best practice to record the temperatures in the unit for several days before placing any vaccines in the unit. You’ll want to record the minimum and maximum temperature each workday. Once you have recorded temperatures for at least two days in the recommended range, your unit can be used for vaccine storage. For safe vaccine storage, refrigerators should maintain temperatures between 2° C and 8° C (36° F and 46° F). Lab Freezers should maintain temperatures between -50° C and -15° C (-58° F and +5° F).
Routinely record minimum and maximum temperatures
At the beginning of each work day, personnel should record the cold storage unit’s minimum and maximum temperatures. In addition to the temperature readings, the data on the entry log should include the date, time, name of person recording the temperature, and any actions taken if a temperature excursion occurred. If a temperature check was missed, the entry on the log should be left blank.
Invest in a Digital Data Logger
The CDC requires every vaccine storage unit to have a thermal monitoring device. Though they recommend more specifically a digital data logger (DDL). Since digital data loggers continuously record temperatures, they provide the most accurate temperature information, including details on how long a unit has been operating outside the recommended temperature range. The frequency of temperature readings, alarms and low battery indicators are also benefits of digital data loggers.
Information recorded by a digital data logger can be downloaded to a computer or accessed through the manufacturer’s website via a portal. The reviewing and analyzing of temperature data should be done at least weekly to monitor trends and ensure vaccines have not been exposed to out-of-range temperatures. The CDC recommends keeping this data for up to three years. Check with your state and local health agency to see if they have further requirements for saving a backlog of vaccine temperature data.
Data Logger Requirements for VFC Compliance
As mentioned above, using a data logger to continually assess cold storage temperatures is considered best practice and recommended by the CDC. As of January 2020, the VFC program went a step further and now requires all providers to use continuous temperature monitoring devices, or data loggers, in all refrigerators and freezers that house vaccines that will be administered to VFC-eligible children. They also require providers to have a back-up device on hand, in the event that the current device is out of commission.
To meet the VFC program requirements, you’ll want to make sure that the data logger used in your practice meets the following requirements.
Buffered Temperature Probe Equipped
A buffered temperature probe is designed to simulate the temperature of the vaccines within the cold storage unit, rather than the temperature of the air within the refrigerator. Acceptable buffer materials include glycol, glass beads, sand, or Teflon.
The data logger must have an active temperature display that can be easily read by personnel. Current, minimum, and maximum temperatures must be displayed, as well as a low battery indicator.
The ability to continuously monitor and record data that can be downloaded to a computer for review is not only a requirement, but is helpful and convenient for employees, rather than having to manually record temperatures. Downloading data should be done routinely.
There must be an alarm that visually or audibly triggers when out-of-range temperature readings occur. These are also known as “temperature excursions”.
Accurate Readings at Scheduled Intervals
The data logger must take accurate readings within +/- .5 C° (or one 1° F). The recommended maximum logging interval of every 30 minutes should be programmed by personnel.
A Certificate of Calibration
Calibration testing is done to ensure the accuracy of a data loggers readings meets nationally accepted standards. A Report of Calibration or Certificate of Calibration should be issued by an appropriate entity every one to two years, or as recommended by the manufacturer.
Purchasing A Data Logger
Whether your practice is administering private vaccines, or public vaccines through the VFC program, following vaccine temperature monitoring best practices and using a compliant data logger is important. At K2 Scientific, we can provide you with monitoring systems that protect your expensive vaccines. Our LogTag UTRED30 Wireless Vaccine Temperature Monitoring System and TandD Vaccine Temperature Monitoring Systems are calibration certified and VFC compliant giving you peace of mind that your vaccines are protected.