Vaccine regulations, specifically for Vaccine for Children (VFC) providers, are updated more frequently than most industry regulations that Dickson comes into contact with. The Center for Disease Control (CDC), State Vaccination Programs, Local Health Departments, and VFC program all have a stake in the storage practices vaccine providers must adhere to. We made a list of some important regulation trends in the vaccine storage world, and what they will mean for vaccine providers in the near future.
Continuous Monitoring vs Manual Recording
This is a bit of a prediction, but data loggers will soon take over as the primary means of keeping track of the temperatures that vaccines are stored in. The antiquated logging sheets that vaccine providers have been using for ages are on their way out. We assume that the transition to data loggers will go from ”recommendations” to ”requirements” within the next few years. How can vaccine providers be prepared for the potential transition? Stay one step ahead and get more knowledge about data loggers now. Features such as Wi-Fi connectivity, alarms, and sensor types will influence future data logger purchases. Be sure to do a little research before you buy.
-58 to 5F and 35 to 46F
Keep them separate. The temperature ranges for frozen and refrigerated vaccines are nothing new, but the emphasis that vaccines should never move from the fridge to freezer is new. We've analyzed a lot of the CDC’s literature, and regulations created today differ from past regulations in the increase in the amount of times vaccines (except for MMR) are stressed to never move from the fridge to the freezer when the vaccine’s environment was compromised. Our best guess is that CDC auditors found that clinics would stick a vaccine meant for the refrigerator into the freezer to cool it down more quickly if it was left in an unstable environment for too long. So to vaccine coordinators, be mindful of this, and alert your staff to stop trying to cover up past mistakes.
Consequences for VFC’s
"You will pay" summarizes a message that the CDC and local immunization programs have begun to voice on a consistent basis in the last year. For VFC providers, compromised vaccines that are no longer usable are really, really bad for the hospital or clinic’s bottom line. Many times, if the failure falls on the clinic, the clinic has to pay for those lost vaccines. Thus, it puts even more emphasis (and pressure) on vaccine providers to store vaccines at the proper temperature, and also prove that the vaccines were stored at the proper temperature with hard data. All vaccine coordinators should know how much a refrigerator full of compromised vaccines will cost them (it can be over $20,000), and stress to their staff the importance of proper temperature management and thorough documentation.
The CDC led off their most recent Vaccine Storage Toolkit with an explanation of the cold chain, and how essential it was for vaccine providers to maintain their place in the cold chain to ensure that vaccines are properly distributed. In this leading section, an infographic shows the vaccine manufacturing and distribution process, with providers making up the final portion of that chain. Next, they provide a list of essential resources for vaccine coordinators, and stressed the importance of directly contacting vaccine manufacturers and immunization programs with questions or issues as they arise. Keep your place in the cold chain secure, and do it with the help from other links in the chain.
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