1. Vaccine Cold Chain
Vaccines exposed to storage temperatures outside the manufacturer determined ranges may have reduced potency, creating limited protection and resulting in the re-vaccination of patients, loss of public confidence in vaccines and thousands of dollars in wasted vaccine. Proper storage and handling begins with an effective vaccine cold chain. A cold chain is a temperature-controlled supply chain that includes all vaccine-related equipment and procedures. Vaccines must be stored properly from the time they are manufactured until they are administered.
Potency (also known as viability) is reduced every time a vaccine is exposed to an improper condition. This includes overexposure to heat, cold, or light at any step in the cold chain. Proper vaccine storage and handling play critical roles in efforts to prevent vaccine-preventable diseases. Use this guide to ensure that your site’s storage and handling practices preserve the potency of the vaccines that you administer to your patients.
To protect the viability of the VFC/VFAAR vaccines stored at your site, they must be stored in the acceptable temperature ranges indicated below. The best way to ensure that the vaccine temperature is properly maintained is to ensure the following are in place at your site:
- Staff trained in proper vaccine storage and temperature monitoring.
- Appropriate and reliable vaccine storage units.
- 24/7 temperature monitoring with calibrated continuous temperature monitoring device (Provided by PDPH).
*** Ultra-low Temperature Range
-80 C to -60 C (-112 F to -76 F)
2. Staff and Training
Having staff that is trained on proper storage and handling procedures is vital to ensuring that your vaccine is viable when it is administered to patients. Ensure that your staff is prepared by:
- Providing annual training on proper storage and handling procedures for all staff involved in the receipt, management, administration, or transport of vaccines.
- Identifying two individuals to serve as the primary vaccine coordinator and back‐up vaccine coordinator. These individuals must complete all required Immunization Program trainings as directed by Immunization staff. The vaccine coordinators will oversee all vaccine management within the facility, including, but not limited to:
- Developing and maintaining the Vaccine Management Plan.
- Monitoring storage and handling and vaccine administration practices in the facility.
- Planning and overseeing vaccine ordering for the practice.
- Accounting for any vaccine that is deemed non‐viable.
- Ensuring and documenting annual vaccine management training for designated staff, as well as training new staff upon hire.
- Storing all required documentation for a minimum of three years.
- Serving as a point of contact for PDPH staff.
*Contact the immunization program as soon as possible when a change in vaccine coordinator occurs at your site.
3. Vaccine Storage and Temperature Monitoring Equipment
Vaccine Storage Units
Before you can store VFC/VFAAR vaccines in a given a unit, it must be monitored to ensure that it can maintain in range temperatures. To get your unit set-up contact TempCheck@phila.gov so that we can provide guidance on setting up the new unit and how to safeguard your vaccine during the transition. In this section, you will find information on acceptable storage units, relocating and storing vaccines inside a unit, maintaining a reliable unit, and using a temperature monitoring device.
Your vaccine storage unit is a key component in maintaining the vaccine cold chain at your practice.
Your vaccine storage units must:
- Consistently maintain storage temperature.
- Have enough space to properly store vaccines throughout the year including back to school and flu season.
- Have separate external doors for refrigerator and freezer.
- Have Do Not Unplug stickers at the outlet, on unit, and on the circuit breaker.
Recommended Storage Units:
- Standalone refrigerator
- Standalone freezer
- Pharmaceutical units
- Refrigerator in household combination refrigerator-freezer
- (PDPH expects to remove the recommendation of allowing refrigerators in combination units to be used for storage of vaccine)
Unacceptable Storage Units:
- Dorm-style units
- Freezer in household combination refrigerator-freezer
All units must be plugged directly into a dedicated wall outlet. Units cannot be plugged into:
- GFI/GFCI outlets (specialized outlets with a built-in breaker, may have reset buttons)
- Outlets that can be activated by a wall switch
- Extension cords, power strips, surge protectors
Ensure that the unit, plug, and circuit breaker on the electric panel are clearly labeled to prevent accidental loss of power.
Selecting a unit to store your vaccines in is an important decision. As a VFC/VFAAR provider, your site will often have several thousands of dollars of federally purchased vaccine in your unit. Purchasing a unit that is reliable and accurate up-front is a worthwhile investment, both in time and money, for your practice. The time needed to respond to out of range temperatures and the cost of reimbursement for wasted vaccines can be very burdensome for practices whose unit does not maintain in-range temperatures. To ensure that the unit that you are considering is the best option for your clinic, email our program at TempCheck@phila.gov so that we can offer insight on the units that are being considered based on other providers experiences with a brand, the typical supply on hand at your practice, and other considerations based on the CDC recommendations for storage units.
Unit Relocation Approval Process
Units that have been moved – from a location within the office or a location outside the office –may not be able to maintain temperatures in its new location for a variety of reasons. These include:
- Alteration of settings during the move.
- Changes in the temperature and/or air circulation in the new location.
- Damage to the unit during the move.
- Reliability of new outlet being used.
It can take up to seven (7) days to stabilize the temperature in a newly installed, moved or repaired storage unit.
Organizing and Storing Vaccine
The way that you store and organize the vaccine is an important part of protecting viability and preventing wastage.
- Place the Temperature probe in the center of the unit (the center of the center shelf).
- Use baskets, rubber bands and/or tags to organize the vaccine.
- Separate vaccines with similar names to avoid administration of the wrong vaccine (ie separate Dtap and TdaP).
- Clearly label the vaccine with the funding source (ex. VFC, VFAAR, Private).
- Vaccines must not be stored on the floor or on the doors of the unit.
- Store vaccine away from the unit’s internal air vent(s).
- Store vaccine 2-3 inches away from the unit walls.
- Place water bottles in your unit based on your unit type. For specifics on setting up your unit based on the unit type review these images:
Routine Maintenance of Storage Units
Storage units need regular maintenance to ensure proper operation. Conduct routine maintenance for all vaccine storage units and related equipment – such as generators, alarm systems, and back-up batteries – so that your equipment functions at maximum efficiency:
- Check seals and door hinges.
- Clean coils and other components per manufacturer direction.
- Defrost manual-defrost freezers.
- Clean the interior of each unit to discourage bacterial and fungal growth. (Do so quickly to minimize the risk of a temperature excursion).
- Test any backup generator quarterly and have it serviced annually.
Digital Data Loggers
Having a Digital Data Logger, or DDL, monitoring all federally funded vaccine while it is at your site is required for all sites participating in the VFC or VFAAR programs. A DDL is a thermometer that monitors and records the temperature of your vaccine storage unit 24 hours a day, 7 days a week.
Vaccines exposed to storage temperatures outside the recommended ranges may have reduced potency, creating limited protection and resulting in the re-vaccination of patients and thousands of dollars in wasted vaccine. If your vaccine storage unit goes out of range, the DDL will alert you, with an audible alarm, ensuring that your patients receive viable vaccine that gives them the protection they need. In the event of a temperature excursion, sites will be able to give vaccine manufacturers precise information regarding the temperature and length of excursion to assess the viability of the affected vaccine.
The buffered temperature probe is placed inside the center of your vaccine storage unit. Temperatures measured by a buffered probe match vaccine temperature more closely than those measured by standard thermometers, which tend to reflect only air temperature. It is the most accurate way to measure actual vaccine temperatures. The temperature in the unit is assessed and recorded by the DDL at regular intervals.
*** DDLs for Ultra-Cold Temperatures
DDLs using a buffered temperature probe provide the most accurate measurement of vaccine temperatures. However, many manufacturers use pure propylene glycol (freezing point -59° C) or a glycol mixture with a warmer freezing point. For accurate ultra-cold temperature monitoring, it is essential to use an air-probe or a probe designed specifically for ultra-cold temperatures with the DDL.
Philadelphia provides DDLs to monitor the units used to store VFC & VFAAR vaccines. If you want to use thermometers that you purchase yourself, they’ll need to be accurate within +/-1°F (+/-0.5°C) and have:
- a current and valid Certificate of Calibration (also known as a Report of Calibration)
- a probe that best reflects vaccine temperatures (e.g., a probe buffered with glycol, glass beads, sand, or Teflon®) placed in the center of the storage unit close to the vaccine
- a digital display that shows current, minimum, and maximum temperatures
- a low battery indicator
- a logging interval (or reading rate) that can be programmed by the user to measure and record temperatures no less frequently than every 10 minutes
- an audible alarm
Other Types of Thermometers
Many refrigerators come with a dial or built in thermometer. Some providers like to place this thermometer in the storage unit as a sort of “backup” to the Digital Data Loggers. Dial and Built-In thermometers are inaccurate and cannot be used to monitor temperatures. They do not meet the CDC’s temperature monitoring requirements. These thermometers cannot be used to record temperatures on your paper logs, or to confirm the accuracy of VFC digital data logger thermometers as they have not been calibrated, most do not contain glycol probes, and do not give you a digital reading of the temperature.
While some built-in thermometers might meet the CDC’s stringent requirements you must first contact TempCheck to verify suitability before using them to monitor the unit temperatures. In the event of an excursion, the VFC program will only accept readings from a PDPH approved thermometer.
Backup DDL thermometers are now stored at the Immunization program offices at 1101 Market Street, 12th floor. Call or email TempCheck at 215‐685-6777 or email@example.com when you need a back‐up thermometer to maintain the cold chain for your vaccines. Examples when to request of a back-up DDL include:
- Defrosting your freezer
- To monitor your unit after your vaccine and original DDL were moved to a back-up location
- To facilitate a planned vaccine transport
Storage units, especially freezers, can sometimes build up too much ice. When you need to defrost your VFC/VFAAR storage unit, TempCheck – our storage and handling coordinators – can help.
TempCheck will help you safely store the vaccine while you defrost the unit. Use this guide to plan your defrost. Review it when you plan a defrost, and consult it during the defrost process. If you have any questions, or if your vaccine is exposed to out-of-range temperatures during the defrost transport process, contact TempCheck at TempCheck@phila.gov as soon as possible.
How to defrost your storage unit:
Plan and Prepare
- Contact TempCheck to tell them that you are planning to defrost your unit. TempCheck will need to know when you plan to defrost, and where your back-up unit is. TempCheck will send you a backup DDL to monitor the back-up unit. Keep the packing material so you can send the DDL back to PDPH.
- Prepare the back-up DDL: Once you get the back-up DDL, temper the probe by putting it in your primary freezer. After 30 minutes, start up the DDL. Monitor temperatures for at least 1 hour. Alternatively, place the probe in your unit overnight and start the DDL the next morning.
- Move the vaccine: It’s time to move the vaccine. Leave the primary DDL in your primary unit while you defrost the primary unit.
- If your back-up unit is on-site: Move the vaccine and back-up DDL to your secondary unit.
Note the time.
- If your backup unit is off-site: using the emergency transport guide, set up a hard-sided
cooler for transport. Move the back-up DDL to the cooler. Place the probe in the middle. Move
the vaccine into the cooler. Note the time. Transport the vaccine directly to the back-up
location. Note the time the vaccine and DDL are moved into the back-up unit.
- If your back-up unit is on-site: Move the vaccine and back-up DDL to your secondary unit.
Defrosting Your Unit
- Note the time when you start defrosting your primary unit. The DDL will warm up, which will
probably trigger an alarm.
- Allow the ice in the unit to melt.
- Turn the freezer back on. Wait until the DDL shows that the temperature is back in the normal
- Transfer the vaccines back into the freezer, using the same transport protocol that you used to
move them to the back-up unit.
Dealing With the Data
- Download the data from both data loggers and email it to TempCheck@phila.gov.
- Include the following information in the email.
- When you took the vaccine out of the primary unit
- When you put the vaccine into the back-up unit
- When you started defrosting the primary unit
- When you took the vaccine out of the back-up unit
- When you put the vaccine back into the defrosted primary unit
- Reconnect the DDL and continue temperature monitoring as usual.
- Repackage the back-up DDL and send it back to PDPH.
5. Temperature Monitoring and Reporting
To ensure that the vaccine that is supplied to your site by the VFC and VFAAR programs is viable when administered to patients, consistent temperature monitoring is an important part of participating in the program. Our program requires sites to maintain active and passive monitoring. The active monitoring is recorded on the paper temperature logs. The passive monitoring is recorded by the DDL and reported to our program regularly. Both types of temperature files should be kept for at least 3 years.
Paper temperature logs
Checking on your unit daily provides an opportunity to inspect the storage unit, reorganize any misplaced vaccines, and remove any expired vaccines. The immunization program requires that sites check and record the following:
- Storage unit’s current temperature twice a day with the date and time (at the beginning and at the end of each clinic day)
- Minimum and maximum temperature at the start of each clinic day:
- To get the Min/Max, simply press the review/mark button on your VFC400 Digital Data Logger
- Press it one time and it will display the max temperature for the day
- Press it again to get the minimum temperature
- If you notice a temperature in the min/max that is outside of the acceptable range, please contact us at firstname.lastname@example.org
- The initials of the individual checking the temperature, and the time the temperatures were recorded
DDL Temperature files
The DDL monitors and records the temperature in your vaccine storage units. To ensure that the cold chain is being maintained at your site and that ordered vaccines can be stored safely, temperature files are routinely reported to our program. The DDL has a limited memory and must be downloaded every 28 -30 days to prevent gaps in the temperature data.
- Configure the DDL (Logtag) software on your computer (Click here for our Configuration Guide).
- Keep track of when you need to download. Use this guide to download and reconfigure the DDL.
- Report (submit) your temperature files. Find our Temperature Downloading and Reporting Guide here.
Downloading Your DDL Files?
Follow these two easy steps to submit your Digital Data Logger (DDL) files
- Upload the DDL green .CSV files to Clinic Tools on PhilaVax
- Email both the green .CSV files and yellow .LTD files to TempCheck@phila.gov
Following these two steps helps prevent delays in processing your order and helps
providers monitor vaccine temperatures. Together we can protect patients by ensuring
vaccines administered are viable. Providers that do not follow these steps will be suspended
from ordering vaccine until PDPH receives the DDL files, documenting that vaccines
were stored correctly.
If you received an error message when uploading your .CSV files into Clinic Tools,
please email the file to TempCheck@phila.gov
Reporting Temperature Data
Gaps refer to missing temperature monitoring data. They reflect periods of time for which we do not have data on the temperatures that your vaccine were exposed to. Gaps occur when the DDL is not recording the temperatures in your unit.
The DDLs can store 30 days worth of data. When you do not download, the DDL stops recording and:
- There is no way to know what temperatures are experienced by the vaccine during this period.
- The DDL alarm that indicates out-of-range temperatures are not triggered.
- Non-viable vaccines could inadvertently be administered to patients.
You can’t download too often, but you can download too late. Download and submit your DDL files:
- 28-30 days from your last download
- When placing an order
- When there is an alarm
- When you know you won’t be in the office, such as before a holiday weekend or before a vacation.
Failure to routinely submit temperature readings can delay future orders, and potentially lead to removal of any VFC/VFAAR vaccines currently held by your clinic.
6. Vaccine Transport
Vaccine transport refers to any time the vaccine needs to be moved from the primary units at the site to another location. The requirement for continuous temperature monitoring with a DDL extends to transport. Whenever the vaccine needs to be moved, a DDL needs to be with the vaccine. This can mean requesting a back-up DDL from the Immunization Program or moving the DDL from your primary unit with the vaccine. [Note: Vaccine can only be moved from a monitored storage unit to another monitored storage unit. If the receiving unit does not have at least seven (7) days of temps, then that unit is not ready to receive vaccines.]
VFC/VFAAR vaccine cannot be transported in a non-emergency situation without prior permission from the Immunization Program. Non-emergency situations include:
- Planned move
- New unit
- Planned loss of power
Contact our program for directions and assistance with non-emergency transport by emailing TempCheck@phila.gov.
To transport vaccine in an emergency, use your Vaccine Management Plan as a guide. It includes guidance for deciding when it’s time to move the vaccine and instructions for setting up a cooler to transport vaccine. Don’t wait for an emergency to learn what to do:
- Keep the plan up to date.
- Gather the supplies needed to transport the vaccine safely now.
- Store the supplies in a central location.
- Review the steps for responding to an emergency with all the staff at your site.
7. Emergency Vaccine Storage and Handling
Every VFC/VFAAR provider is required to identify two (2) off-site backup locations where they can move their vaccine in the event of power outages and equipment malfunctions. The address and contact information for the back-up locations should be recorded on the Vaccine Management Plan. Here is a list of approved and non-approved locations.
- Doctor’s offices freezer compartment of combination units
- Hospital Pharmacies
- Approved Unit at Another Clinic
- Personal Home Freezers
- Personal Deep Freezers
- Freezer Compartment of a Combination Unit
- Storage Containers with Dry Ice
8. Out of Range Temperatures: Excursions & Alarms
If vaccines experience an out-of-range temperature, they’re at risk of no longer being effective. If you observe out-of-range temperatures or have an alarm on your digital data logger, you must take action:
- Contact TempCheck immediately at TempCheck@phila.gov.
- Label exposed vaccine “do not use,” and store it under proper conditions as quickly as possible.
- Do not discard vaccines unless directed by the Philadelphia Immunization Program.
- Record the out-of-range temperatures and the room temperature in the “Action” area on the bottom of your paper temperature logs.
- Notify your vaccine coordinator or call the Philadelphia Immunization Program for guidance.
- Consult your Vaccine Management Plan.
- Document all action taken.
What does a DDL Alarm Sound Like?
Listen to a sample DDL alarm by clicking the “play” button below! If your web-client doesn’t support embedded audio you can download the MP3 file here.
For some storage unit excursions, the VFC program will require that you contact the vaccine manufacturers and complete an Excursion Response Form. This step is crucial, the form documents the vaccines viability. This information must come directly from the manufacturers and sites are required to provide a case number for each manufacturer. VFC staff will audit these forms. A new form is required every time you report an excursion event. The viability of the vaccine depends on several factors such as time, temperature, lot number, and vaccine type. In addition, the vaccine manufacturers are constantly testing their vaccines for viability. Recommendations may change depending on any new data they receive. DO NOT assume viability of vaccines, always contact the manufacturer.
9. VFC/VFAAR Vaccine Reimbursement Policy
Providers who are part of the Philadelphia VFC/VFAAR programs are held accountable for any vaccine supplied by the VFC/VFAAR programs, including reimbursement for vaccine wastage. Providers are expected to administer all vaccines ordered from the VFC/VFAAR programs. However, sometimes vaccines are unused because:
- Vaccine expires before administered. This could be a result of changes in patient enrollment or packaging restrictions forcing a practice to order a minimum of 10 doses even though they may only need a few doses (such as for Td or Pneumovax®).
- Vaccine is spoiled. Spoilage can occur if temperatures go out-of-range or vaccine is improperly stored.
- Vaccine is wasted. Wastage can occur if a vial is accidently broken or vaccine is drawn up and not administered. Vaccine in an open vial or syringe is considered wasted (if it is not viable).
VFC/VFAAR Policy Regarding Expired, Spoiled and Wasted Vaccines
The Philadelphia VFC/VFAAR program requires reimbursement for instances of spoiled vaccine due to negligence. This reimbursement will consist of dose-for-dose vaccine replacement at the private cost.
Expired, spoiled, and wasted vaccine is nonviable and must be reported to the Philadelphia VFC Program through the PhilaVax IIS within 30 days after expiration, spoilage or wastage. Use our guide to return any unopen non-viable vaccine at your site. To account for open non-viable vaccine, email DPHProviderHelp@phila.gov.
10. Key Points
- All VFC & VFAAR vaccine must be monitored by a DDL until it is administered. If you need to move the vaccine from your unit (due to a mechanical failure, power outage, etc) the DDL must be moved with the vaccine.
- Anything that could affect the viability of VFC &VFAAR vaccines must be reported to the Immunization program right away. This includes but is not limited to:
- Out of range temperatures and alarms
- Removal of the vaccine from the unit (not for vaccine administration)
- Transport of the vaccine
- Moving the vaccine to another units
- Power outage
- Purchasing a new unit
- Planned move
- Planned remodeling or other work that could disrupt power
Email (TempCheck@phila.gov) or call at 215-685-6777 about any storage and handling issues or changes with your VFC & VFAAR vaccine.