In 2017, the Centers for Disease Control and Prevention (CDC) changed the vaccine storage requirements for Vaccines for Children (VFC) program providers.
The reason behind this change is clear. Review and access to temperature logs are critical. Without them, you cannot determine whether vaccines are at the correct temperature.
Proper data logs are also essential for assessing a vaccine’s usability. If there is an extended temperature excursion, the vaccine is no longer viable.
The CDC’s requirements determine how providers conduct routine onsite storage of vaccines. They also provide guidelines for vaccine transportation, among other things.
The focus of this article is on the requirements for VFC data loggers as they apply to the VFC program.
The Vaccines for Children (VFC) Program
The Vaccines for Children (VFC) program helps parents afford vaccines for their children. This program gives all children a better chance of receiving recommended vaccinations on time.
The Advisory Committee on Immunization Practices (ACIP) recommends certain vaccines for children. Those are the ones included in the VFC program. The vaccines protect babies, younger children, and adolescents from 16 different diseases.
Office of Management and Budget (OMB) approves the funding for the VFC program. The Centers for Medicare & Medicaid Services (CMS) allocates the funds to the CDC.
The CDC buys the vaccines at a discounted price. Then, it distributes them to state health departments. They also distribute to territorial and local public health agencies. The agencies distribute the vaccines to public health clinics and private physicians’ offices. The vaccines are free to registered VFC providers.
VFC Data Loggers
Digital data loggers read and record vaccine temperatures on a continuous basis. They give providers accurate reporting of their vaccines’ temperatures over time. They log around the clock, even when the providers’ offices close.
Part of a data logger’s functionality includes alerts. Alerts notify clinic staff of any temperature excursions that occur during non-business hours. The can determine how long vaccines have been in out-of-range temperatures.
This type of vaccine temperature monitoring prevents vaccine losses due to undetermined excursions. It also provides an accurate vaccine storage temperature log. Logging data shows you how the unit’s temperature increases and decreases over time.
Another name for data loggers is “continuous temperature monitoring devices.”
Digital Data Logger Requirements for VFC Compliance
Providers enrolled in the VFC program must use a VFC-compliant data logger. They must use one in any freezer or refrigerator they use to store VFC-supplied vaccines.
Further, they must also have procedures that include at least one backup device. The backup must be available if the primary device fails or goes down for repair or calibration. All VFC data loggers must have a current certificate of calibration.
VFC Program Device Specifications for Digital Data Loggers
VFC providers must follow VFC device specifications from the California VFC program.
VFC data loggers must meet calibration and recalibration requirements. Devices must have a valid Certificate of Traceability and Calibration Testing. This certificate is also known as a Report of Calibration.
They must also meet the following requirements:
Digital data loggers must be accurate in their readings +/-1.0°F (+/-0.5°C).
VFC data loggers must be programmable to take readings at least once every 30 minutes.
The memory storage for all VFC data loggers should be large enough to hold 4000 readings or more.
Buffered Temperature Probe
A buffered probe comes with every device. It is the most precise way to measure vaccine temperature. VFC specifications dictate that you always use this feature. Probes can be detachable or embedded in a buffer.
Either one is acceptable as long as you can calibrate the temperature monitoring system. A buffered probe matches the vaccine temperature more so than a standard thermometer.
Standard thermometers tend to measure the air temperature around the vaccine. They don’t measure the temperature of the vaccine itself. The probe must be in a vial containing one of three materials.
It can be thermal buffer material, liquid material up to 60 mL, or loose media. Examples of thermal buffer liquid are ethanol, glycol, or glycerin.
Loose media examples are glass, sand, or glass bead. Finally, buffer material can be solid, such as aluminum or Teflon®.
VFC data loggers must have active external displays. The display must show the current, MIN, and MAX temperatures. The display must remain close to the vaccine temperature logs.
They must be close to the vaccine storage units as well. The display must also have a clear low-battery indicator.
The VFC data logger must have a programmable alarm. The audible or visual alarm signal when temperatures are out-of-range temperatures
Purchasing a VFC-Compliant Data Logger
There is a wide range of digital data loggers available that meet VFC requirements. Many have more features that would suit your facility’s needs better than the basic models.
VFC data loggers can be basic, stand-alone devices. Or, they can be far more sophisticated and come with enhanced functions.
The California VFC Program does not endorse any specific temperature monitoring system. As long as they meet the requirements, you can choose the model and features best for your facility’s needs.
Keep a list of the VFC requirements with you as you search for data loggers. This is the most practical guide to follow when purchasing digital data loggers.
Use the list as a checklist to ensure that the data loggers you buy meet all these requirements.
When You Are Ready to Buy VFC-Compliant Data Loggers
Are you ready to buy new or upgrade your VFC data loggers? If so, be sure to seek out a reputable medical equipment supply company.
Please contact us if you have any questions, as we have the knowledge and expertise to assist you.