TVFC Guidelines for Vaccine Storage and Handling
Vaccines supplied by the state represent taxpayers' dollars, and each clinic that participates in the Texas Vaccines for Children Program (TVFC) must commit to protecting the vaccine so that we can continue to provide a safe, effective product to the children of Texas. The TVFC has the additional burden of proving to the Commissioner of Health, the state legislature, and the Centers for Disease Control and Prevention (as well as other organizations) that the vaccines are being used in a cost-effective manner.
There are three basic elements needed to assure that vaccines are handled properly: the right equipment, well-trained people, and standard operating procedures.
To be sure that vaccines are kept at the correct temperatures, you need a refrigerator, a freezer, and two thermometers, preferably with maximum-minimum temperature recording capability. An alarm system and a back-up generator also may be appropriate for larger clinics.
The refrigerator compartment should maintain temperatures between 2°-8°C (36°-46°F). Since it should never reach temperatures below 0°C (32°F), set the temperature mid-range, about 5°C (40°F) to provide the best safety margin.
The freezer compartment should maintain temperatures at or below -15°C (5°F). It should never reach temperatures above 0°C (32°F). You will get the most useful information about actual storage temperatures from maximum-minimum thermometers. You will want one for the refrigerator and one for the freezer.
High volume clinics may find separate refrigerators and freezers useful. But most clinics find a standard "kitchen" side-by-side or top-freezer unit to be sufficient. Frost-free freezers are acceptable. "Bar" units or dormitory-style units are not recommended, and state-supplied varicella vaccine should never be stored in one.
If your refrigerator is new or newly repaired, allow time to adjust it. Check the instructions carefully, before adjusting the temperature control settings, then make sure temperatures do not change overnight. Sometimes manufacturers recommend resetting the controls in summer and winter. If so, post instructions about this on the door.
Plug guards are an effective tool to prevent the accidental unplugging of equipment. The TVFC has purchased enough plug guards to serve all current public and private providers. As soon as they are received, they will be shipped to vaccine depots statewide, to be distributed with vaccine orders. Signs warning staff to not unplug the refrigerator are available from the Immunization Division, Literature and Forms Section.
It is a good idea to identify sufficient, alternative space to store vaccines and maintain the "cold chain" during any period when your refrigerator is out of service.
It is important that vaccines be kept at the proper temperature at all times. Frequently opening the door interrupts the cold chain and can result in a cumulative loss of vaccine potency over time. Storing food, sodas, or patient specimens in the same refrigerator should be avoided.
Just because a refrigerator/freezer is plugged in and running does not mean that everything is fine and your vaccines are safe. No refrigerator is perfect and accidents will happen. Plugs get disconnected, power outages occur, and equipment can fail. So it is a good idea to take a few extra precautions to ensure the quality and effectiveness of your vaccines, not to mention the financial investment. Following are some basic tips:
- Check and record on a chart the internal temperatures. Think about the temperature; is it within the acceptable temperature range?
- Storing extra ice packs along the walls, back, and in the door racks of the freezer compartment helps keep a steady temperature during automatic defrosting cycles. It also provides additional reserves of cold in the event of a power failure.
- Storing a couple of large water bottles against the inside walls or in door racks of the refrigerator, helps maintain a stable temperature and again, provides extra reserves of cold in the event of a power failure.
- Never store vaccines in the doors because the temperatures are not as stable as in the body of the refrigerator or freezer.
- Stack vaccines with enough room for the air and the cold to circulate.
Vaccine security depends on the knowledge and habits of the clinic staff. It is a good idea if one trained person is designated to be "in-charge," to ensure that vaccines are handled and stored properly. It is also good to have a designated back-up person. Establishing a set of procedures for both daily and emergency situations helps assure the continued viability of the vaccines. All individuals responsible for vaccines should be familiar with the correct storage temperatures and handling conditions for the various vaccines. It does not do any good to record the temperature of the refrigerator daily if the person recording the temperature is not aware that a temperature above 8°C (46°F) is too high. When staff changes, ensure that new employees receive all necessary training. Proper training not only helps in determining if vaccines may have been spoiled and should not be used, but also guards against discarding vaccines needlessly.
The TVFC strongly recommends that clinics have written procedures for the storage and handling of vaccines. Clearly written procedures help prevent mistakes. The written procedures should begin with ordering vaccines and end with the administration of the vaccines.
Keeping too much vaccine in your inventory increases the risk of vaccines reaching their expiration dates. Additionally, too much stock increases the loss if the refrigerator fails. When ordering vaccines, please refer to your monthly C-5 forms: Number of Doses Administered (11KB, :03). Not only should you consider the monthly reports immediately preceding the current order, but also look at the monthly reports from the same time, one year ago. Order only the amount of vaccine you will need for a 60-90 day time-frame.
Be sure to look for vaccine shipments and open them as soon as possible after they arrive. Check a copy of your order against the packing sheet. If there are any discrepancies, contact your supplier immediately. Check the expiration dates on the vaccines you have received. Always use the shortest-dated vaccines first! Then place the vaccines in the appropriate storage compartment.
OPV must be stored in the freezer. OPV can be thawed and refrozen up to 10 times if it is always kept at 8°C (46°F) or colder, and the cumulative time of the thaw periods is less than 24 hours. If it is thawed for more than 24 hours, it must be used within 30 days. OPV sometimes changes color, but it is still viable as long as it is maintained to these instructions. Keep OPV away from the defrost mechanism.
Varicella vaccine must be kept at -15°C (5°F) and must be used within 30 minutes after reconstitution. It cannot be refrozen. If varicella has been thawed, but has not been reconstituted, the vaccine must be used within 72 hours as long as the vaccine is stored at 8°C (46°F) or colder.
MMR vaccine may either be stored frozen or refrigerated. MMR is sensitive to light and should not be left out in the light.
Other vaccines (DT, Td, DTaP, Hep A/B, IPV, and Hib) are stored in the refrigerator, and should never be frozen.
Diluents may be stored in the door of the refrigerator, and provide extra insulation much like bottles of water. It is preferred that diluents for MMR and varicella vaccines be stored cool, because warm diluent might inactivate those vaccines. Diluents should not be frozen, especially those containing adjuvant.
At the end of each month, count your inventory and pay special attention to the expiration dates of your vaccines. For any vaccine that will expire within 60 days, if you will be able to use it, no problem. If you will not be able to use it all, call your supplier immediately. In most cases, it can be moved to another clinic where it will be used before it expires.
Remember, the monthly form C-5, Number of Doses Administered by Age Groups (11KB, :03) is a vital tool to help you properly store and handle TVFC vaccines. Please do not simply record the information on the form – THINK about what the information means, and take appropriate action. Vaccines are money, and every dose wasted is like throwing money away. Negligent handling of TVFC vaccines may result in your clinic being billed for the dollar value of the vaccines lost.
Refrigerator Warning Sign
Texas Vaccines for Children Program (TVFC) purchase vaccines with state and federal funding. The TVFC providers participating in the program must commit to proper storage & handling of these vaccines. A guide to storage & handling is available to you from the Texas Department of Health or your vaccine distribution depot. The emergency event plan reviews actions to be taken in case of disasters, power failures, and vaccine loss.
Precautions should be taken to avoid vaccine loss stored in your refrigerator/freezer. Vaccine orders should be placed in the appropriate compartments of the refrigerator upon arrival. Every clinic participating in the program must have a designated emergency vaccine storage site assigned to them to store vaccine in the event of a disaster or power failure. An emergency vaccine storage site should be equipped with a back-up generator in case there is no electrical power. Arrangements should be coordinated with your vaccine depot to locate a vaccine emergency storage site to prevent the loss of vaccines. The vaccine depot should be contacted in the event that you expect vaccine could be lost. Listed below are a few preventions that require vaccine be moved to an emergency vaccine storage site.
Vaccines must be moved as soon as possible to your vaccine depot or a designated emergency storage site if any of these catastrophic situations apply.
- Hurricanes, tornados, severe flooding, or a strong thunder storm where power loss could occur
- Power outage for more than 24 hours
- Construction/repairs of your clinic that might involve electrical power to be off
"Your best judgement should be used to prevent vaccine losses."
Vaccine Protection Plan:
If one of these emergency events occurs, take the following steps to protect your vaccine:
- Call your vaccine depot and emergency storage site, inform them of the situation you are experiencing, that vaccine will be moved.
- Fill out transfer form of all vaccine in the refrigerator that will be moved. List on form the exact number of doses by vaccine type.
- Refrigerated Vaccine: must be packed and stored to maintain an internal temperature between 35° to 46° degrees Fahrenheit.
- Paper bag vaccines, include copy of transfer form and label bags with your clinic name, contact person and phone number. Transport them in a styrofoam box with cold packs, except varicella. Be careful not to mix vaccines that belong in the refrigerator with those that belong in the freezer. Varicella instructions are listed below.
- Varicella: must be transported in dry ice. If dry ice is not available, you must coordinate with the vaccine depot, the transportation of your varicella vaccine. Varicella vaccine must be packed in dry ice to maintain an internal temperature at or below -15° Centigrade (+5° Fahrenheit). Varicella should not be thawed-out. If this occurs contact Merck at 1-800-9-VARIVAX for further instructions on usage.
- Transport all vaccines to the emergency storage site. Vaccines should be taken out of styrofoam box and placed in the appropriate refrigerator compartments, but not taken out of the paper bag which identifies your clinic.
- Vaccines should be picked up when it is safe to return to the clinic and the procedures above should be followed in retrieving and transporting the vaccine.
"Remember your vaccine depot can provide you with assistance in packaging the vaccine for transport from one designation to another."
Vaccine loss should be reported immediately to your vaccine depot or to Central Office Pharmacy. You should not discard nor remove your vaccine until you have been instructed. This information is needed when calling to report a loss due to power failure, improper refrigeration or vaccine left out of the refrigerator:
- Obtain the present refrigerator temperature recording form (#C-105).
- Record the temperature of your refrigerator and freezer and have it available. (Close refrigerator doors to avoid further temperature loss.)
- Call your vaccine depot distribution site and provide them with information on what has happened, how long, and vaccine type(s). Follow instructions on use or returning loss/damaged vaccine.
- Remember to fill out transfer form of all loss/damaged vaccine. List on form the exact number of doses by vaccine type.
- A letter of explanation must accompany the damaged vaccine from the medical director of the clinic explaining what happened and the precautions that the clinic will take to prevent this from reoccurring.
- Vaccines loss must be reported on the clinic's monthly biological report for the month that it occurred.
"Your clinic's coffee room refrigerator or home storage of vaccines is not allowed."
Proceed to Section 4. Immunizations: Guidelines and General Recommendations