How to Perform a Self-Audit Before a Vaccine Storage Regulatory Audit
By Mike Blazes, CEO and champion, Control Company
Vaccine storage is vital to maintaining the accuracy and efficacy of the vaccines administered today. Whether it be in a doctor’s office, medical research facility, hospital or outpatient clinic, vaccine storage requires reliable monitoring to verify the correct temperature and environmental conditions. Vaccines can be ruined due to careless handling, and without proper monitoring could be administered ineffective. Regulatory organizations perform standard audits to examine procedures for vaccine storage. To ensure your storage methods meet required guidelines, follow these five steps.
- Timing Before you even begin the storage methods of vaccines, establish a schedule for ordering, whatever type of vaccines it might be. For instance, vaccinations for the flu season can begin as early as August. If you are a healthcare provider, determine when you will begin to administer the vaccine and build out a calendar from that point. Vaccines have a shelf life, and their efficacy diminishes beyond it; ordering a supply of vaccines to sit on the shelf for an extended period won’t bode well.
- Establish protocol From ordering the vaccines to accepting delivery to handling the vaccines for distribution, you must have a comprehensive plan for each step to maintain the integrity of the vaccines. You should also designate specific personnel to handle this process. Too many people involved can result in damage to the vaccines. Have this plan visible within the area that the vaccines are stored so there is a visual degree of accountability apparent to anyone entering the environment where the vaccines are stored.
- Refrigeration Where you store the vaccines is probably the most critical aspect of this process. Not only do you need to ensure adequate space for the volume of vaccines, but you need to make sure there is a reliable refrigerator or cooling system, minimum and maximum temperatures; maintain the internal and external environment of the storage facility and the environment it sits in, say a closet or storage room; and send 24 hour monitoring alerts if there are issues that arise like a power outage or surge, a door left open or an issue with internal temperature control.
- Storing your vaccines You’ve ordered your vaccines, and they are delivered. Before you begin to store them, be aware of the amount of space you have allotted for this. You cannot have a crowded storage area; that can result in a temperature variance. Vaccines need space. It is best to place the vaccines in the center of the refrigerator, away from walls or vents; do not place them on the doors or in bins. You want to be sure the vaccines reside in the area that will have the most accurate temperature. Keep the vaccines in their original packing with the date facing forward. Be sure to have a monitoring log for tracking every vaccine order that comes in and out of your facility.
- Distribution Transporting vaccines can be a delicate endeavor as you are removing the vaccines from a stable environment to what is hopefully another stable and portable environment. Distribution requires each of the previous steps’ guidelines only in a portable manner. Things to consider in distribution are the type of container used to store the vaccines; the monitoring mechanism used to ensure the temperature within; the amount of space needed to store the vaccines; the handling of the vaccines from one storage container to the next; the timing of the delivery from point A to point B.
Like all the previous steps, one of the most critical aspects of vaccines storage remains accountability. A comprehensive step-by-step process with specially trained designated personnel as well as an accurate and continuous temperature monitoring system is necessary to ensure the integrity of the vaccines. A digital data logger with a cloud-based system will ensure the process and provide ongoing documentation necessary to maintain guidelines for vaccine storage.