HHS study of CDC’s Vaccines For Children Program shows 76% had problems.
When parents bring their children to the doctor’s office for vaccinations, they expect the treatment will protect them from the target diseases. A 2012 study by the U.S. Department of Health and Human Service’s (HHS) Inspector General’s office shows that this may not be the case. (Link to HHS Report)
The HHS studied the Center for Disease Control’s (CDC) Vaccines For Children (VFC) program. The proactive program provides free vaccinations to eligible children. In 2010 the $3.6 billion program served approximately 40 million children, distributing 82 million vaccine doses. VFC providers must meet certain requirements such as monitoring storagetemperatures and expiration dates to insure the vaccines are able to provide the desired protection against preventable diseases.
HHS used CDC data to audit 45 VFC providers, those that ordered a large number of vaccines in 2010. Site visits were used to interview personnel who coordinated the program at the medical practice location, and to observe vaccinemanagement practices over a two week period. The results showed a significant shortfall in compliance. Compliance categories specified by the program’s operation guide are as follows.
- Vaccine Storage Equipment
- Vaccine Storage Practices
- Temperature Monitoring
- Vaccine Storage and Handling Plans
- Vaccine Personnel
- Vaccine Waste
- Vaccine Security and Equipment Maintenance
- Vaccine Ordering and Inventory Management
- Receiving Vaccine Shipments
- Vaccine Preparation
The HHS report found that VFC vaccines stored by 76 percent of 45 providers were exposed to inappropriate temperatures. The authors note, “Although the majority of storage temperatures we independently measured during a 2-week period were within the required ranges, VFC vaccines stored by 76 percent—34 of 45—of the selected providers were exposed to inappropriate temperatures for at least 5 cumulative hours during that period.”
Most significantly, the authors found, “Sixteen of the thirty-four providers had both freezers and refrigerators that exposed VFC vaccines to temperatures outside the required ranges for 5 or more hours during the 2-week period. If the 34 providers’ freezer and refrigerator temperatures followed this same pattern for a year, these storage units could expose vaccines to inappropriate temperatures for at least 130 hours over 1 year. On the days of our site visits, the 34 providers had 9,173 VFC vaccine doses, worth approximately $368,820.” That is a significant number and while it does not mean that the vaccines were necessarily compromised, could lead to that conclusion and the need to revaccinate those receiving the doses. Parents who deal with children receiving injections can understand how this may not be news that is well received.
The report also notes, “Specifically, vaccines must be stored within the required temperature ranges from the time they are shipped from the manufacturer until they are administered by the provider. Providers must monitor all vaccine storage temperatures using a certified, calibrated thermometer to ensure that vaccines are not exposed to temperatures outside the required ranges. Additionally, to obtain a temperature reading that is representative of the storage unit, a thermometer must be placed in a central area inside each freezer and refrigerator used to store VFC vaccines.”
Using automatic temperature monitoring equipment to read and automatically record the temperatures on a daily or hourly basis can help vaccine and other medication providers establish conformity with compliance, but also helps to ensure optimum potency for provisioned doses. A device that can send email, SMS text or voice phone message alerts will help maintain the required control during hours of operation, but also during weekends and late hours when power outages may occur. In the end, a device that uses a cloud computing platform for data collection, sends alerts on user-defined limits, and stores the data in a format readily used for regulatory reporting is the ideal monitoring choice for vaccine storage purposes.