Questions & Answers
Storage & Handling - Vaccine Storage
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Questions

General information

  1. What is Cold Chain Management?
  2. What is proper vaccine storage and handling?
  3. Who is USAMMA/DOC?
  4. How can USAMMA/DOC be reached?
  5. Who is DLA Troop Support?
  6. What vaccine storage and handling training should immunization departments implement?
  7. Where can additional storage and handling information guidelines be found?

Vaccine Storage Equipment

  1. Can a dormitory style refrigerator be used to permanently store vaccines?
  2. Is there a DoD policy requiring certain vaccine storage equipment to be purchased?
  3. What are the general requirements for the type of refrigerator, freezer, or combined refrigerator/freezer unit used to store vaccines?
  4. How can you stabilize temperatures in the refrigerator?
  5. How can you stabilize temperatures in the freezer?
  6. What are the requirements for the vaccine storage room?
  7. What regular maintenance should be conducted on vaccine storage equipment?
  8. Can I use a combination household style refrigerator/freezer to store vaccines?

Temperature Monitoring

  1. What type of thermometer is best for measuring temperatures in a vaccine storage unit?
  2. Where within the vaccine storage unit should the thermometer be placed?
  3. How often should temperatures be recorded for refrigerator and freezer compartments where vaccines are stored? And how should you document temperatures?
  4. Who should adjust the temperature of a vaccine storage unit?
  5. How often should I set the digital date logger to measure temperature?
  6. Do twice daily physical temperature checks need to occur if a data logger and/or alarm system is in place?
  7. How long should temperature logs be maintained?
  8. Should I have a digital data logger along with a thermometer in the vaccine storage unit?
Answers

General information

  1. What is Cold Chain Management?
    Cold Chain Management is the process of preparing temperature-sensitive medical products (TSMP) for shipment utilizing standardized systems and procedures, ensuring that required temps are maintained throughout the supply chain, and the validation that those conditions are met during all phases of distribution until delivery.

  2. What is proper vaccine storage and handling?
    Vaccines are stored, shipped, and handled according to pharmaceutical manufacturers' instruction as outlined in the product's package insert or other guidance. Failure to adhere to recommended specifications for proper storage and handling temperatures may reduce vaccine potency, resulting in an inadequate immune response and inadequate protection against the vaccine preventable disease.

  3. Who is USAMMA/DOC?
    United States Army Medical Material Agency/Distribution Operation Center (USAMMA/DOC) is the DoD agency responsible for the management, coordination, and execution of distribution services. Specifically, the packing and storage of Temperature Sensitive Medical Products (TSMPs) requiring refrigeration or other special handling requirements while maintaining close in-transit visibility in support of our internal and external customers. The DOC operates under the clinical and technical direction of USAMMA's Pharmacy Consultant who is also the Deputy Director for Distribution Operations of the Immunization Healthcare Branch.

  4. How can USAMMA/DOC be reached?

    For vaccines and temperature sensitive product questions contact USAMMA /DOC during the hours of 0700-1700 EST at phone: 301-619-4318, 1197, 4198/ DSN: 343-4318, 1197, 4198/Fax: 301-619-4468; after hours call: 301-676-1184, 301-676-0857, or 301-256-8072 for urgent issues only.

    NIPR E-mail: USAMMADOC@amedd.army.mil.

    For more information go to the following website: http://www.usamma.army.mil/cold_chain_management.cfm



  5. Who is DLA Troop Support?
    Defense Logistics Agency-Troop Support (DLA-TS) provides United States armed services members with food, clothing, textiles, medicines, medical equipment, and construction supplies and equipment. The pharmaceutical division offers most vaccines for purchase by eligible DoD customers.

    More information can be found at the following website: https://www.troopsupport.dla.mil/

  6. What vaccine storage and handling training should immunization departments implement?
    All staff members who administer vaccines should be trained during orientation and annually about the importance of vaccine cold chain management and storage/handling practices. In addition, they should be familiar with the correct storage temperatures for the various vaccines and procedures for what to do if the temperature is out-of-range, i.e., power outage, equipment failure, etc.

  7. Where can additional storage and handling information guidelines be found?
    The IHB website has a webpage dedicated to vaccine storage and handling, www.vaccines.mil/STORAGE_and_HANDLING , which includes tools and products to help you build quality storage and handling practices. The CDC also has a vaccine storage and handling webpage,www.cdc.gov/vaccines/recs/storage/default.htm, that includes numerous resources including forms, checklists, posters, and guidelines on proper vaccine storage and handling.

Vaccine Storage Equipment

  1. Can a dormitory style refrigerator be used to permanently store vaccines?
    CDC does not recommend the use of dormitory-style or bar-style combined refrigerator/freezers for ANY vaccine storage.

  2. Is there a DoD policy requiring certain vaccine storage equipment to be purchased?
    No, clinics should follow guidance for appropriate storage equipment as outlined by the Centers for Disease Control and Prevention (CDC), Advisory Committee on Immunization Practices (ACIP), National Center for Immunization and Respiratory Diseases (NCIRD), or service policies.

  3. What are the general requirements for the type of refrigerator, freezer, or combined refrigerator/freezer unit used to store vaccines?
    CDC strongly recommends the use of stand-alone refrigerators and stand-alone freezer units, meaning a self-contained unit that only refrigerates or freezes and is suitable for vaccine storage. These units can vary in size, from compact, under-the-counter style to a large, stand-alone, pharmaceutical grade storage unit. The characteristics of a recommended storage unit include: enough room to store the year's largest inventory without crowding and sufficient room to store water bottles in the refrigerator and frozen coolant packs in the freezer to stabilize the temperature and minimize temperature fluctuations that can impact vaccine potency. In addition, frost-free or automatic defrost cycle units are preferred.

  4. How can you stabilize temperatures in the refrigerator?
    You can help stabilize and maintain the temperature in the refrigerator by adding buffers such as at least two or three large containers of water placed against the inside walls and in the door racks. The addition of water bottles (not gel packs) reduces the risk of freezing due to the tremendous latent heat released from water prior to freezing. Not only will water bottles help maintain an even temperature they also help keep the temperatures stable in the event of a power failure.



  5. How can you stabilize temperatures in the freezer?
    You can help stabilize and maintain the temperature in the freezer by adding buffers such as frozen packs along the walls, back, and bottom of the freezer compartment and inside the racks of the freezer door.

  6. What are the requirements for the vaccine storage room?
    Good air circulation around the vaccine storage unit is essential for proper heat exchange and cooling functions. The unit should be placed in a well-ventilated room and should have space around the sides and top. If the room temperature is too hot it is recommended that a small AC portal unit or extra ventilation vents are added to ensure room temperature remains stable and does not cause the refrigerator/freezer temperatures to shift outside of normal range.

  7. What regular maintenance should be conducted on vaccine storage equipment?
    Users should conduct regular maintenance tasks that can be divided into daily, weekly, monthly and periodic actions such as: on a daily basis check the temps and ensure the storage unit doors are closed; on a weekly basis defrost the freezer; on a monthly basis clean the coils and motor, clean the storage unit compartments, and check the door seals; and periodically check/clean the drain pan. Facilities should maintain a logbook which contains records indicating the serial numbers of each piece of equipment, the date each piece of equipment was installed, the dates of any routine maintenance tasks (such as cleaning), the dates of any repairs or servicing, and the name of the person performing each of these tasks. This logbook is also an ideal place to keep the instructions that came with the equipment.

  8. Can I use a combination household style refrigerator/freezer to store vaccines?
    CDC recommends the use of stand-alone units as a best practice. An alternative to stand-alone units is to use only the refrigerator compartment of a combination household refrigerator/freezer unit to store refrigerated vaccines and to be very careful not to use the top shelf if the vent from the freezer opens there. A separate stand-alone freezer should then be used to store frozen vaccines; this is because the freezer compartment of a combined house-hold unit should not be used for vaccine storage if the refrigerator unit is being used for that purpose. The usual house-hold single-condenser combination refrigerator/freezer units are less capable of simultaneously maintaining proper storage temperatures in the refrigerator and freezer compartments. These refrigerators are cooled by venting cold freezer air into the refrigerated section – thus there is a real risk of freezing vaccine near the cooling vents.

Temperature Monitoring

  1. What type of thermometer is best for measuring temperatures in a vaccine storage unit?
    CDC recommends the use of a digital thermometer with a biosafe glycol-encased probe or a similar temperature buffered probe that will more closely approximate the measure of liquid temperature. A temperature buffer enables a thermometer probe to more closely match the temperature changes experienced by stored vaccine. Examples of temperature buffers are a probe inserted into a glycol-filled vial or one inserted into glass beads. To ensure validity of temperature measurements, only calibrated thermometers with a certificate of Traceability and Calibration should be used.

  2. Where within the vaccine storage unit should the thermometer be placed?
    In the refrigerator, it is important that the glycol-encased or similar temperature buffered probes be placed in close proximity to the vaccines being stored. Proper placement is very important since it helps the staff to most accurately identify the actual vaccine vial temperatures and to take appropriate corrective actions quickly if necessary.

  3. How often should temperatures be recorded for refrigerator and freezer compartments where vaccines are stored? And how should you document temperatures?
    Temperatures inside refrigerator and freezer compartments should be measured and recorded on a temperature log a minimum of at least twice a day (the room temperature should also be recorded on the log); once at the start of the day and a second time before the area is closed whether or not you have an alarm system installed. Army immunization areas must record the temperature a minimum of 4 times per day. Immediate action must be taken if the temperature is outside the recommended range for either compartment.

  4. Who should adjust the temperature of a vaccine storage unit?
    Only the primary or backup vaccine coordinator should adjust the temperature of a vaccine storage unit. Limiting access to the thermostat reduces the risk that the temperatures will be adjusted inappropriately. A warning sign should be posted on the storage unit that says, "Do not adjust refrigerator or freezer temperature controls. Notify (insert name) if adjustments are necessary".

  5. How often should I set the digital date logger to measure temperature?
    CDC's interim recommendation is to set the digital data logger to measure every 15 minutes. If you wish to set the data logger to measure temperature more frequently or if the manufacturer recommends a more frequent setting, that is acceptable. CDC is currently working with the National Institute of Standards and Technology (NIST) to evaluate the most efficient and effective settings for digital data logger temperature measurements.

  6. Do twice daily physical temperature checks need to occur if a data logger and/or alarm system is in place?
    Yes. CDC still recommends documenting twice daily temperature checks even with a continuous data logger and/or alarm system because twice daily checks will give you a better indication of any problem with your storage units function. Relying solely on alarms can lead to complacency and inappropriate temps may not be discovered in a timely manner (e.g., alarm battery failure). DoD has had many vaccine losses due to failure of alarm or call systems that were not being physically checked, these losses could have been avoided if someone was physically checking the temperatures.

  7. How long should temperature logs be maintained?
    Temperature logs should be kept for 3 years or per service/local policy. Archived temperature logs can show how well the vaccine storage unit is working overtime and can be used to determine when a unit may need adjustment, maintenance, or replacement, such as when temperatures are consistently at the limit or sometimes beyond the limit of the recommended temperature range.

  8. Should I have a digital data logger along with a thermometer in the vaccine storage unit?
    Yes. CDC's interim guidance suggests the use of digital data loggers with detachable probes that allow the reading of temperatures without opening the door and record & store temperature information at frequent programmable intervals for 24 hour temperature monitoring rather than non-continuous temperature monitoring.