Vaccines for Children (VFC) & Vaccine Storage
 
Vaccines for Children (VFC) & Vaccine Storage
Are you using digital data loggers? How about household refrigerator/freezers? How can you be confident that your vaccines haven’t been compromised? The Centers for Disease Control and Prevention (CDC) Vaccine Storage & Handling Toolkit aims to provide guidance on these and other questions. Published in 2014, the Toolkit discusses Vaccine Cold Chain, Transportation, Storage and Handling Plans, Temperature Monitoring Equipment, Best Practices and more. More recently, the CDC released new requirements for all Vaccines for Children (VFC) suppliers, tightening restrictions on VFC storage.

Vaccine Cold Chain
To maintain and distribute vaccines in optimal condition, your cold chain process is heavily dependent upon reliable transportation and storage equipment. Exposure to any conditions inappropriate for the vaccine can affect the potency, and while some vaccines will show physical evidence of inappropriate storage, appearance is not a reliable indicator. Immediate corrective action must be taken to correct an inappropriate condition.

To protect your assets, Mesa now offers cold chain monitoring services through Infitrak, a recent Mesa acquisition. From data logging and asset monitoring, to temperature and transport mapping, qualification, validation and package design and testing, we are there with you every step of the way. Feel confident that your vaccines haven’t been compromised with accurate, reliable asset monitoring.

Storage and Handling Plans
If you are using household combination refrigerator/freezers, please note that per the new CDC guidelines, these will no longer be allowable for VFC storage. For refrigerator-only and freezer-only units, general recommendations include developing a Routine Vaccine Storage and Handling Plan and an Emergency Vaccine Retrieval and Storage Plan, with annual updates. If you are a VFC provider, you are advised to contact your immunization program for their guidance on these plans.

The following are VFC vaccine storage guidelines to note:
  • Maintain proper refrigerator and freezer temperatures
  • Do not place food or beverage in the unit
  • Do not place vaccines on the doors, the floor, or in drawers
  • Group vaccines by type
  • Place a NIST-certified calibrated probe in the center next to vaccines
Resources on proper vaccine storage and handling are available through the CDC, including:
Temperature Monitoring Equipment
We mentioned that the CDC will require NIST-certified calibrated probes in the center of storage units by your vaccines. For proper environment monitoring, you will be required to:
  • Review and record storage unit temperature readings at least 2 times a day, and minimum and maximum temperatures once each morning.
  • Use the digital data logger to store and record temperatures at regular intervals for 24-hour monitoring.
  • Have a digital display for the data logger for reading outside of the storage unit.
  • Maintain temperature data and document any malfunctions or outages.
We have highlighted the primary requirements from this Toolkit and direct Mesa solutions for you in our Blog, Solutions for Maintaining Compliance with the New CDC Vaccine Requirements.

Please note, as of January 1, 2017*, the following recommendations will be requirements for all VFC providers in order to maintain compliance with the CDC:
  1. All VFC providers must have certified calibrated digital data loggers for continuous temperature monitoring for each VFC storage unit and back-up thermometer.
  2. Household combination refrigerator/freezers will no longer be allowable for the storage of VFC vaccines.
*Mesa recommends checking with your state authorities for confirmation of when these requirements will be mandated at your facility.

Failure to meet these requirements may result in a citation under public record. Our Mesa representatives are available to discuss any questions you may have regarding the new requirements, and how we can help you prepare for these changes. Please contact us today.



Mesa Monitoring's Suite of Service Options
Did you know your Continuous Monitoring System (CMS) needs regular maintenance after ‘System Go Live’? To help ensure compliance and maintain proper working order of your CMS, we are happy to offer a full suite of service options:
  • Validation Services
  • Calibration Services
  • Mappings
  • Annual Service, Calibration, PM and Data Migration
  • Dedicated Project Management
  • 24/7 Help Desk
Further detailed information on our service options is available on MesaMonitoring.com. Please contact a Mesa Representative to discuss how we can continue to help at your facility.


Recent Blog - On-Site Spares & Emergency Parts
Establishing an inventory of on-site spares and emergency parts is important to minimize potential downtime. Select parts or components may have a long procurement lead time, and there may also be times during the year when your Continuous Monitoring (CM) manufacturer is not able to process orders. Contact your supplier for recommendations and incorporate the procedures into your...

How To Contact Mesa Monitoring
Please visit us at monitoring.mesalabs.com, or choose from the following suggested points of contact:
General Inquiries and Purchase Orders /
Inside Sales and Admin
303-565-2724
monitoring@mesalabs.com
Service Agreements /
Service Contract Administrator – TJ Crane
303-565-2724 Ext. 10437
tcrane@mesalabs.com
Parts and On-Site Service Quotations Territory Sales Representative
monitoringsales@mesalabs.com
Technical Support 303-565-2724, Dial 4

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Mesa Monitoring, 12100 W. 6th Avenue, Lakewood, CO 80228