In April and May of 2011, a group of analysts from the Office of the Inspector General of the United States of America, conducted an evaluation of 45 Vaccine For Children (VFC) program providers. The team was led by Holly Williams, and was formed to assess the storage conditions of vaccines distributed by the CDC to VFC providers, who were distributing the vaccines to children aged 18 and under, who were eligible under certain program conditions to receive disease fighting vaccines.
The assessment was carried out not like an FBI Mafia or FIFA raid, but more like an academic assessment. The group planned to test the storage conditions of 45 VFC providers, conduct interviews, and collect data. Once the two weeks were over, the team would make their recommendations to the CDC, and provide the results of their study.
What they found, was not good. 76% of the VFC providers surveyed had stored vaccines in unsafe temperature ranges for at least 5 cumulative hours, during a two week study. That 76% number may need a little time to sink in, but nonetheless is alarming to any lay-person. The 5 hours though need a bit of an explanation. Vaccines need to be kept cold to stay effective. Some need to be kept in refrigerators, others in freezers. During the course of this study, for the most part, they were. But for a cumulative 5 hours in over 3/4’s of the Vaccine Providers, they were out of acceptable temperature ranges. What’s the big deal? If a vaccine is stored outside of critical temperature ranges, it loses potency.
Which is a huge, huge problem for the health and well-being of our world.
What else did the report find? Here are a few more alarming statistics:
Each of the 45 providers recorded temperatures that differed from the Inspector General group’s independently measured temperatures.
In other words, the VFC providers were not using accurate (and thus most likely not using calibrated) data loggers or thermometers. Accuracy is if not the most pertinent, then one of the most pertinent issues in thermal measuring.
0 of the 45 VFC providers met all 10 categories of the VFC Operations Guide Requirements.
Those 10 requirements are: 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, and Vaccine Preparation.
The most failed category: Vaccine Storage Equipment, where 96% of VFC Providers failed to house their vaccines in proper refrigerators and/or freezers.
The least failed category: Vaccine Preparation, where only 2% of providers failed.
16 of 45 VFC Providers had expired vaccines, 13 of whom were storing them directly next to or within their unexpired vaccine supply.
Maybe the one thing worse than administering vaccines stored outside of proper temperature ranges: administering expired vaccines.
All in all, this report was essential, but alarming. The results were published a little over three years ago. Since then, vaccine providers (both VFC and non-VFC) on the whole have improved their vaccine storage practices immensely.
The CDC responded to the above report with new and more stringent recommendations, and now state and city VFC programs are following suit. Gone are the days of dorm style freezers, and chart recorders.
*NOTE: All information relayed, discussed, and analyzed above was taken from the Office of Inspector General, Report OEI-04-10-00430, ”Vaccine For Children Program: Vulnerabilities In Vaccine Management.” June, 2012. http://oig.hhs.gov/oei/reports/oei-04-10-00430.pdf.
Tags: Healthcare, vaccines