Beginning January 1, 2018, all Vaccines for Children (VFC) providers will be mandated to meet new storage and handling requirements. Are you prepared?
Background: VFC and the Omnibus Budget Reconciliation Act (OBRA)
The VFC program was implemented to address a specific measles epidemic that occurred during 1989–1991. Over this three-year period, tens of thousands of cases of measles were reported, resulting in hundreds of deaths. Upon investigation, Centers for Disease Control and Prevention (CDC) discovered that more than 50 percent of children affected had not been immunized, despite having seen a health care provider.
Responding to this critical situation, Congress passed the Omnibus Budget Reconciliation Act (OBRA) in August 1993, which resulted in the creation of the Vaccines for Children program in October 1994. Known officially as section 1928 of the Social Security Act, VFC is an entitlement program—a right guaranteed by law—for eligible children ages 18 and younger.
VFC fulfills two important functions:
CDC buys vaccines at a discounted rate from manufacturers and distributes them at no charge to private physicians' offices, public health clinics, and other health care facilities enrolled as VFC providers.
VFC providers play the important role of safely storing these vaccines and administering them at no cost to eligible children.
The Challenges of VFC Implementation
Many partners and collaborating agencies work together with the goal of vaccinating VFC-eligible children with viable, properly handled vaccines. While this cooperative effort is a positive step forward, it also presents challenges to implementing a uniform, national set of standards. In short, each state has its own governance over its vaccine program and supply. Even the temperature monitoring best practices advocated by VFC and CDC are not enforced at the state-level. For companies that operate in multiple states, the logistical burden to meet different requirements can be a challenge.
Successful implementation of the VFC program requires close collaboration with people just like you. Other programs and agencies that contribute to the program's success include:
Centers for Disease Control and Prevention (CDC)
Centers for Medicare and Medicaid Services (CMS)
State Medicaid agencies
Health Resources and Services Administration (HRSA)
Indian Health Service (IHS)
National, state, and local organizations representing the private health care sector
State, local, and territorial immunization programs.
What Are the New VFC Standards?
Depending on the state, some of the following standards are required, while others are only recommended:
Refrigerator and freezer units must include a continuous temperature monitoring device capable of displaying current, minimum and maximum temperatures in Fahrenheit or Celsius with an accuracy of +/- 1.0° F (+/- 0.5° C).
The digital display must be on a device outside of the storage unit to allow reading temperatures easily without opening the storage unit door.
Users must be able to program a continuous logging interval or reading rate every 30 minutes (every 15 minutes is recommended).
Logs should be able to download data digitally to a computer or website.
Units must have a programmable alarm system with visual and audible alerts for all out-of-range (OOR) temperature thresholds. System should also have a low-battery indicator.
A detachable probe encased in a biosafe buffered material is required (a glycol-encased probe is highly recommended).
Memory capacity must be able to store a minimum of 4,000 readings without recording over old data when the log is full.
Units and displays must have current NIST certification and be calibrated per manufacturer's recommendations or at least every two years by an accredited laboratory.
VFC Temperature Monitoring Equipment Requirements
As is evident in the new standards, routine review of and access to temperature data are critical for determining whether a vaccine has been properly stored, and more importantly, whether it can be administered if it was actually involved in a temperature excursion. That means no later than January 1, 2018, all VFC providers must use continuous temperature monitoring devices within units that store vaccines to be administered to VFC-eligible children. To meet VFC program requirements, these devices must also be equipped with:
Capacity for continuous monitoring
Active display easily read outside the unit
Recording of data that can be routinely downloaded
Providers without the mandate’s requirements in place on January 1, 2018, will be suspended from ordering vaccines via VFC programs. Fortunately, TempAlert devices have all of the required capabilities that meet the 2018 VFC mandate. Please contact us to find a solution that meets your needs.