Once you get approved to be able to offer COVID-19 vaccines to your patients, there is one big issue that you must face before the vaccines arrive at your door. TEMPERATURE.
The two most predominantly available vaccines must be freezing cold. The Pfizer vaccine must be kept colder than it gets in Antarctica (minus 70 degrees Celsius). The Moderna vaccine only requires a temperature similar to a regular freezer (minus 20 degrees Celsius). Any out-of-range temperature reading requires immediate action from you and your staff.
Accordingly, in order to offer the vaccines to your patients, you’ll need a plan to address “temperature excursions.” This is the Center for Disease Control and Prevention’s (CDC) term for “any temperature reading outside the manufacturer’s recommended range” in your storage unit. This is important because if you do not store your vaccines at the proper temperature, they can lose potency and effectiveness and are no longer viable.
Note: On February 27, 2021, the FDA reported that it issued an emergency use authorization (EUA) to Janssen for the third COVID-19 vaccine. This vaccine must be stored at 36°F to 46°F and protected from light. The Janssen COVID-19 vaccine can’t be frozen; however, it can be stored between (47°F to 77°F) for up to 12 hours. For more information on the proper handling of this new vaccine, see the Janssen COVID-19 Vaccine EUA Fact Sheet for Healthcare Providers on the FDA website: https://www.fda.gov/media/146304/download
COVID-19 Vaccine Cold Chain Rules: Monitoring Devices
You certainly don’t want to end up in the unenviable position of having to discard numerous vials of COVID-19 vaccines. Unfortunately, this is very possible, unless you plan ahead.
There are four choices for monitoring freezer or refrigerator temperatures:
- Manual Thermometers are the easiest and least expensive method for monitoring freezer and fridge temperatures. With this method, you must designate a member of your team to visit each cold storage unit at least twice per day and record the temperature readings. The challenge with this option is that if something goes wrong outside of the two times the temperature is checked, you will never know.
- Chart Recorders keep a continuous record of temperatures. In use for decades, they are reliable, inexpensive and easy to use. Charts can be saved and filed for a comprehensive temperature record, which can help if you ever get audited.
- Data Loggers track and store temperature readings digitally. They offer continuous monitoring of unit temperatures and can be set to alarm if temperatures fluctuate. Data loggers can be expensive but have the advantages of continuous monitoring and data storage.
- Wireless Monitoring Devices continuously monitor the temperature of your refrigeration unit and notify you if it changes. Depending on the device you choose, features may include:
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- Sending you temperature updates via your cell phone or email
- Ability to change temperature from anywhere
- Keeps a log of temperature fluctuations that you can access
- Web interface that provides you historical information and settings
- Cell phone and email notifications based on your specification of temperature fluctuation, lost power or even loss of internet connection
WARNING: Be sure to research your remote monitoring device for hidden fees or subscriptions. Several devices require that you sign up for a subscription to get the benefit of remote monitoring, while others don’t. COVID-19 Vaccine Cold Chain Rules.
Note: For more information on vaccine storage, you can refer to the Center for Disease Control (CDC’s) Vaccine Storage and Handling Toolkit (cdc.gov). You’ll find complete guidance on how to handle a temperature excursion on page 34 of the toolkit. CO
Ensuring you closely manage the temperature of your COVID-19 vaccines is just one piece of the complicated puzzle this pandemic has brought to your practice. You can get the help you need to master the management, regulatory and reimbursement issues related COVID-19 with a variety of expert-led online training sessions designed to help your practice succeed.
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