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How to Manage the MnVFC Program
Have and maintain appropriate vaccine refrigerator/freezer(s) to store vaccine.
Safeguard the power supply to storage units.
Use a continuous temperature monitoring device that has a current and valid Certificate of Calibration to monitor temperatures in each storage unit.
Place the temperature probe in the center of the storage unit with the vaccine.
Have one backup continuous temperature monitoring device with a current and valid Certificate of Calibration readily available for each MnVFC site.
Vaccine storage units
Storage units, in order of preference, are:
- Purpose-built or pharmaceutical/medical-grade units, including doorless and dispensing units.
- Vaccine storage units that conform to National Sanitation Foundation (NSF)/ American National Standards Institute (ANSI) Standard 456 (which have been tested rigorously to be used for the storage of vaccines).
- Stand-alone refrigerator and freezer units—these units can vary in size from a compact, under-the-counter style to a large, stand-alone, pharmaceutical-grade storage unit.
- Household combination refrigerator/freezer unit, using only the refrigerator compartment to store vaccines. Store frozen vaccine in a stand-alone freezer. Household combination units will need to be replaced with option #1, #2, or #3 above in the following situations:
- When purchasing new storage unit equipment (e.g., unit stops functioning, etc.).
- Vaccine loss due to storage unit failure.
- Newly enrolled sites are required to store vaccine in a pharmaceutical unit (combo or stand-alone), stand-alone refrigerator or stand-alone freezer.
- Dormitory units (i.e., combination refrigerator/freezers with one exterior door) are not allowed for storing MnVFC vaccines. Vaccine stored in this type of unit are considered unusable due to a significant risk of freezing vaccine.
Features and use of vaccine storage units
- Must be able to maintain required vaccine storage temperatures:
- Refrigerator between 36°F and 46°F (between 2°C and 8°C), aim for 40°F (5°C).
- Freezer between -58°F and +5°F (between -50°C and -15°C), aim for 0°F (-18°C).
- Ultra-cold freezer between -130°F and -76°F (between -90°C and -60°C).
- Must be large enough to hold the year’s largest inventory, for example, the back-to-school rush or the flu season, based on how many doses of vaccines you order annually.
- Must have sufficient room to store water bottles in the refrigerator and frozen water bottles in the freezer to help stabilize the temperature.
- Note: Water bottles are recommended for household-grade units and are not recommended for use with the majority of pharmaceutical-grade and purpose-built units. For such units, follow the manufacturer’s guidance.
- Must have room for air to circulate so the proper temperature range is maintained. Should be used only for vaccines or other medical supplies. Storage of food and beverage is not recommended in vaccine storage units. A limited supply of Pedialyte or juice for patient use is acceptable, ideally on the top shelf or bottom of the unit.
- Sharing a storage unit with your lab is not recommended because of possible contamination of the vaccine and an increase in temperature fluctuations due to increased frequency of the door opening. If you must store vaccines in a unit that contains lab specimens, store the specimens on a shelf below the vaccines.
- Must be repaired or replaced immediately if there are mechanical problems.
- Before using a unit for vaccine storage, check and record the minimum and maximum temperatures each workday. Once you have two consecutive days of temperature recorded within the recommended range, your unit is stable and ready for use:
- Refrigerator units may require two to seven days to stabilize and maintain temperatures within the recommended range.
- Freezer units may take two to three days to stabilize and maintain temperatures within the recommended range.
Safeguard the power supply
- Do not use ground fault interrupter (GFI) outlets, extension cords, or power strips.
- Plug in only one storage unit per electrical outlet.
- Make sure the storage unit is plugged into an outlet where it cannot be accidentally unplugged. An outlet that has an electrical plug with a safety lock is ideal. If your building has auxiliary power, use the outlet supplied by that system.
- You must label storage unit and electrical outlets with “Do Not Unplug” stickers. Order stickers for free on Order Printed Immunization Materials (www.health.state.mn.us/people/immunize/ ordermat.html).
- Fuse box and/or circuit breakers for vaccine storage units must be labeled with “WARNING” stickers to prevent any disruption of the power to vaccine storage units. Order stickers for free on Order Printed Immunization Materials (www.health.state.mn.us/people/immunize/ordermat. html).
- In larger sites, we encourage you to have a backup power system as a source of backup power in case of an emergency. You may also want to install an alert system to notify appropriate personnel of a power outage.
- If you have a backup power system, it should be tested quarterly and receive annual maintenance.
Continuous temperature monitoring devices
- There are two categories of continuous temperature monitoring devices: data loggers and continuous temperature monitoring systems. Technology for these devices and systems is evolving.
- Data loggers: A portable measurement instrument that can be programmed to record temperatures at preset intervals. They are capable of recording and storing thousands of temperature readings that can then be retrieved, viewed, and evaluated.
- Continuous temperature monitoring systems: A system that provides information on temperatures for multiple vaccine storage units throughout a clinic or system, recorded at preset intervals. It transmits real-time data to a computer and has the ability to alert multiple people via text and/or email. There should be a written procedure to address who is notified when out-of-range temperatures occur and how the contact list is updated. Use a continuous temperature monitoring device with a current and valid Certificate of Calibration (in each storage unit).
- Thermometers are not allowed for monitoring MnVFC vaccine.
Features of continuous temperature monitoring devices
- Required features:
- A temperature probe placed in the center of the storage unit with the vaccine.
- In a pharmaceutical unit, placement of the probe in other locations may be suitable because pharmaceutical units maintain more consistent temperatures throughout the unit.
- Continuous monitoring and recording capabilities to track and record temperatures over time.
- The capacity to routinely download/save temperature data to an electronic file or folder (recommended at least weekly).
- Temperature (current, minimum, and maximum) display that is easily read from outside the unit, including on a computer monitor.
- A probe in buffered material (e.g., biosafe glycol) is required.
- A temperature probe placed in the center of the storage unit with the vaccine.
- Recommended features:
- Alarm for out-of-range temperatures.
- Accuracy within +/-1°F (+/- 0.5°C).
- Low battery indicator.
- User programmable logging intervals (e.g., the user can set how often the device records the temperature) recommended at intervals of 15 minutes and no more than 30 minutes.
Backup continuous temperature monitoring device
Each MnVFC site must have access to at least one readily available backup continuous temperature monitoring device that has a valid Certificate of Calibration and meets the above requirements. Backup DDLs are usually maintained on site.
- Use this device in case your main continuous temperature monitoring device is not working properly, or current equipment requires calibration testing.
- The Certificate of Calibration for the backup device should have a different calibration date than the main continuous temperature monitoring devices at the site unless you have onsite calibrations performed all on the same day.
- Use the backup device if you need to transport vaccine.
Certitifificate of Calibratition
Calibration of continuous temperature monitoring devices must be performed at a minimum of every two to three years from the last calibration testing date or more frequently if recommended by the manufacturer. If no expiration date is listed on the certificate, the device must be recalibrated every two years. All continuous temperature monitoring devices will “drift” over time, and normal use can impact their accuracy. Therefore, all devices require recalibration. To be considered “valid,” a Certificate of Calibration must have the following required elements:
- Model/device name or number.
- Serial number.
- Date of calibration.
- Whether the instrument passed or failed testing (or instrument in tolerance).
- Recommended element: Documented uncertainty (recommended uncertainty = ± 0.5°C / ± 1.0°F). If the DDL is no longer accurate within these parameters, it must be replaced; adjusting the DDL is not recommended.
- To determine if a certificate of calibration testing was issued by an appropriate entity, check to see if the certificate indicates one or more of these items:
- Conforms to ISO 17025.
- Performed by an ILAC/MRA Signatory body accredited laboratory. You can review this list of the ILAC MRA and Signatories.
- Traceable to the standards maintained by NIST.
- Meets specifications and testing requirements for the American Society for Testing and Materials (ASTM) Standard E2877 tolerance Class F (≤ 0.5°C) or better.
- Includes reference to another acceptable accuracy validation method, such as comparison to other traceable reference standards or tests at thermometric fixed points.
- Note: CDC recommends that certifications be issued for the entire monitoring unit (detachable probe, data logger, etc.) and not individual certificates for each component.
Properly receive and store vaccine and diluents.
On site staff record minimum and maximum temperatures for each storage unit at the start of each clinic day.
Take immediate action on out-of-range temperatures.
Receive vaccine shipments
- Appropriate staff must be on site to receive vaccine shipments at least one day per week other than Monday.
- If you receive a shipment outside of your shipping window, call McKesson or Merck (depending on the vaccine) to report.
- You must check the condition of all vaccines and diluents immediately when they arrive.
- Open vaccine packages immediately and store at appropriate temperatures.
- Inspect the vaccine and packaging for damage.
- Compare the vaccine received with the packing list. Report any discrepancies to the MnVFC program inbox at health.mnvfc@state.mn.us.
- Check expiration dates and put vaccines and diluents with the earliest expiration date in front to be used first.
- Check that the vaccine has remained in the correct temperature range.
- Check the cold chain monitor for any indication of a temperature excursion in refrigerated vaccine shipments from McKesson. If the vaccine shipment is compromised in any way, the provider must contact McKesson Specialty Customer Care immediately at 1-877-TEMP123 (1-877-836-7123). It is critical that McKesson Specialty Customer Care be contacted within two hours of the vaccine arrival.
- For shipments from Merck, use the date on the packing list to determine how long the vaccine was in transit. Merck will send your vaccine in a small shipping container that is qualified for two days in transit, or a larger shipping container qualified for four days in transit. See the shipping container insert to confirm approved number of days. If vaccine has been in transit for longer than the approved number of days, or you have any concerns about the condition of the vaccine, call Merck immediately at 1-800-672-6372. Document on your packing slips and/or inventory logs the date and time the shipment was received, packing material condition, and temperature indicator status. Keep this documentation for at least three years.
- If you receive vaccine with an expiration date of six months or less, call the MnVFC program for guidance.
- MMRV and varicella must be shipped directly to all sites.
Store vaccine
- Vaccine packaging:
- Keep vaccine or diluent in their original packaging to:
- Protect them from light.
- Help prevent medication errors by making labels easier to read.
- Provide additional protection in case of an out-of-range temperature, power outage, door left open, or mechanical failure.
- Simplify managing your vaccine inventory.
- Keep vaccine or diluent in their original packaging to:
- Organizing storage unit:
- Store vaccine and diluents with enough space for cold air circulation.
- Store vaccine and diluents in the middle of the compartment, two to three inches away from walls, ceiling, floor, door, and cold air vent. The temperature near the floor and walls of the unit differs from that in the middle of the compartment and the cold air vent can freeze refrigerated vaccines.
- Use open trays and baskets to organize vaccines.
- Clearly label each container with the vaccine type.
- Separate stock sites must separate MnVFC vaccine and diluent from private vaccine and other public stock (if applicable).
- Do not store “look-alike” and “sound-alike” vaccines and diluents next to each other (e.g., Tdap and DTaP, HepA and HepB and Hib).
- Do not store vaccine or diluent in the door or drawers of the refrigerator or freezer.
- Never store diluents in the freezer.
- For vaccine or diluent stored in a household combination refrigerator/freezer:
- You cannot store vaccine in the freezer section of a combination household unit.
- For vaccine stored in the refrigerator section, do not use the top shelf for storing vaccine because the cold air vent blowing from the freezer may freeze vaccine located there. If you must use the top shelf of this type of unit, place water bottles underneath the cold air vent to prevent vaccine from being stored there.
- Do not store food or beverages in the refrigerator or freezer because frequent opening of doors can lead to temperature variations that may affect vaccine viability. There is also a risk of contaminating vaccines.
- Water bottles:
- Water bottles are especially important in household units. They are not recommended for use in all purpose-built or pharmaceutical-grade units (refer to manufacturer guidance).Store water bottles in the doors, on the floor, and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently. Water bottles in the refrigerator help stabilize temperatures.
- Add or subtract water bottles one at a time to prevent temperature fluctuations.
- Too many water bottles in the door can prevent the door from closing tightly.
- Mark water bottles “Do Not Drink.”
- Water bottles are especially important in household units. They are not recommended for use in all purpose-built or pharmaceutical-grade units (refer to manufacturer guidance).Store water bottles in the doors, on the floor, and near the cold air vent in the refrigerator and frozen water bottles in the freezer to help maintain a stable temperature if there is a power failure and when the door is opened frequently. Water bottles in the refrigerator help stabilize temperatures.
Monitor and document temperatures
- Temperature monitoring and documentation requirements.
- Record for each storage unit at the start of each workday that the clinic is open:
- Minimum (lowest) and maximum (highest) temperature to the first decimal point for the previous 24-hour period.
- Date and time.
- Name or initials of on-site staff reviewing and recording the min/max temperatures.
- Temperatures can be recorded either electronically or on a paper temperature log. Record actual temperatures and do not record alarm settings.
- Based on the type of continuous temperature monitoring device in use, the min/max may or may not need to be reset. Follow the manufacturer’s instructions specific to your device.
- Review storage unit temperature readings weekly for out-of-range temperatures or changes in temperature trends that might require action (e.g., adjusting unit temperature or repairing/replacing storage or continuous temperature monitoring equipment).
- Record for each storage unit at the start of each workday that the clinic is open:
- Temperature monitoring best practices.
- Record current temperatures in each storage unit twice each day.
- View temperatures throughout the day and take immediate action on out-of-range temperatures.
- Document any actions taken on out-of-range temperatures.
- Check that:
- Probe is located in the center of the unit with the vaccine, unless manufacturer advises differently.
- Vaccines are in their original boxes.
- Vaccines are stored away from the walls, floor, or vents.
- Vaccine is not stored in the door or in the drawers.
- The door of the unit is tightly closed.
- Paper logs note when site is closed and missed readings are left blank.
- A copy of your temperature logs/reports may be requested by the MnVFC program to check temperature control or to assist in troubleshooting issues.
Move vaccine immediately for refrigerated vaccine that is less than 2 degrees Celsius (36 degrees Fahrenheit) and follow action steps for out-of-range temperatures. Vaccines exposed to freezing temperatures for even a brief time may become nonviable (unusable).
Take immediate action on out-of-range temperatures and excursions
When your continuous temperature monitoring device is reading a temperature that falls outside the recommended range, it is considered an excursion or out-of-range temperature. Vaccines exposed to out-of-range temperatures may become nonviable (unusable, especially if frozen).
Be aware that open multidose vials and refrigerated MMR vaccine are especially sensitive to out of range temperatures. Confirm viability with vaccine manufacturer(s) with every excursion even if the temperature stabilized within 30 minutes.
Vaccine must be stored within the following temperature ranges:
- Refrigerator between 36°F and 46°F (between 2°C and 8°C), aim for 40°F (5°C).
- Freezer between -58°F and +5°F (between -50°C and -15°C), aim for 0°F (-18°C).
- Ultra-cold freezer between -130°F and -76°F (between -90°C and -60°C).
- All the following incidents must be reported to the MnVFC program:
- Refrigerated vaccine reached a temperature less than 2°C (36°F) for any amount of time.
- The temperature of the fridge or freezer unit was too warm and did not stabilize in the correct range within 30 minutes.
- Any out-of-range temperature that happened in any unit storing open multi-dose vials (MDVs) or refrigerated MMR vaccines for any amount of time.
- Vaccine was stored improperly in a way that led to the vaccine sitting at an out-of-range temperature for 30 minutes or more.
- Report the temperature excursion to the MnVFC program by completing the MnVFC and UUAV Temperature Excursion Form, and our staff will follow-up with you on next steps.
- If you find an out-of-range temperature, take immediate action:
- Determine the problem. Attempt to fix the cause, if possible. It might be easily corrected (e.g., door not shut, power outage, unit malfunction).
- Adjust the storage unit’s temperature, if necessary.
- Report the excursion to the vaccine coordinator or backup vaccine coordinator, if available.
- Monitor the temperature. If the temperature is too warm and doesn’t stabilize in the correct range within 30 minutes, follow these action steps:
- Stop using the vaccine.
- Mark the vaccine “Do Not Use” so no one administers it.
- Move the vaccine to a storage unit that is maintaining the correct temperature.
- Collect the lot numbers, expiration dates, storage unit temperatures, the room temperature, and the time the unit was out-of-range.
- Evaluate the temperature log (download data or review CTM information) to determine the length of time the storage unit was out of range and how high/low the temperature got.
- Determine if any of this vaccine was involved in a previous storage and handling mishap or temperature excursion incident.
- Call the vaccine manufacturer(s) and ask to speak to a medical consultant or quality assurance staff. Manufacturer contact information is available on Immunize.org: Vaccine Manufacturers.
- Report the temperature excursion to the MnVFC program by completing the MnVFC and UUAV Temperature Excursion Form, and our staff will follow-up with you on next steps.
- Document your actions. You can use the Temperature Excursion Incident Log, the Temperature Excursion Incident Checklist, or your own site’s form to document out-of-range temperatures and actions taken. Keep these logs for three years.
- Replacement method sites with a temperature excursion that results in a large amount of nonviable vaccine are asked to contact the MnVFC program for information on how to replace vaccine.
- When an out-of-range temperature incident occurs, the MnVFC program may hold your vaccine orders until all issues are resolved.
- Separate stock sites with MnVFC vaccine that is determined to be nonviable must report it to MDH.
- Vaccine that is expired or exposed to out-of-range temperatures and is in its original vial or pre-filled syringe can be returned to McKesson Specialty Distribution within six months of expiration. Open multi-dose vials determined to be nonviable should be discarded per your site’s policy.
- Return or dispose of privately purchased nonviable vaccine per your site’s policy.
More detailed information about receiving and storing vaccine
Take monthly vaccine inventory, order only the amount of vaccine you need, rotate stock, and transfer vaccine that is nearing expiration to other sites to prevent wasting vaccine.
Keep privately purchased vaccine separate from MnVFC vaccine.
Avoid borrowing between your public and private vaccine stocks; however, if it is necessary, complete all of the fields on the borrowing report.
Report all MnVFC vaccine that becomes nonviable or lost to MDH.
Return all spoiled or expired vaccine in its original vial or pre-filled syringe to McKesson Distribution within six months of expiration.
Manage inventory
- Physical inventory of your MnVFC vaccine should be done weekly and must be done at least monthly and before placing a vaccine order.
- Record the number of doses, lot numbers, and expiration dates.
- Rotate your vaccine stock so vaccine due to expire first is in front.
- Vaccine must be rotated every week or when a new shipment comes in (whichever happens more frequently).
- Keep vaccine in the original packaging to make managing inventory easier.
Order the amount of vaccine you actually need
- Place an order when you have a four-week supply of vaccine remaining to ensure that you have enough vaccine to allow for any potential delays.
- Place smaller, more frequent orders to minimize the amount of vaccine loss if an incident occurs during shipment or in the vaccine storage unit.
- It is an expectation that enrolled sites will order vaccine at least every 12 months.
- If your site does not order vaccine in the twelve-month period, MnVFC staff may follow-up with you to discuss the reason behind the lack of ordering.
- Order vaccine online through the Minnesota Immunization Information Connection (MIIC).
- If your site is not set up for ordering in MIIC, contact the MIIC Help Desk at health.miichelp@ state.mn.us.
- You must include current storage unit temperatures with each order.
- Provide doses on hand, lot number, and expiration date of all public vaccine in stock (MnVFC and UUAV, if applicable) with each MDH vaccine order.
- You can print out the doses on hand page and bring it to your storage unit to collect your doses on hand information.
Track your MnVFC vaccine orders in MIIC
- In MIIC, select View Vaccine Management to track the shipment status of your MnVFC vaccine orders.
- Influenza vaccine product requests can also be tracked under Manage Special Vaccine Event in MIIC.
- Go to Vaccine Ordering and Management in MIIC for a detailed guide on how to create and view the shipping status of your MnVFC vaccine orders in MIIC.
Keep privately purchased vaccine separate from MnVFC vaccine
- MnVFC vaccine must only be used for MnVFC-eligible patients.
- Select the dose from the MnVFC supply when you see a patient who is eligible for MnVFC vaccine.
- Mark the MnVFC boxes or vials and/or keep them in a clearly marked open tray or basket.
Transferring vaccine
- Transferring vaccine occurs when a MnVFC site is unable to use vaccine before its expiration date and is transferred to another MnVFC-enrolled site to avoid wastage.
- You are responsible for transferring any vaccine you will be unable to use to another MnVFC site.
- Once a site has been identified, call them to make sure they can use the vaccine, have space to store it, and someone will be there to receive it.
- If you are unable to locate another MnVFC site that can take your vaccine, call the MnVFC program and we will help you find a home for it.
- If you have frozen vaccines (MMRV and varicella) that will expire within three months that you cannot use, call the MnVFC program for guidance.
- Only full, sealed vials or unopened pre-filled syringes can be transferred.
- Report all MnVFC vaccine that is transferred to another site using the Vaccine Transfer Record.
- Keep one copy, enclose one copy with the vaccine, and send one copy to the MnVFC program.
- Whether you are sending or receiving a vaccine transfer, you must keep your copy of the Vaccine Transfer Record for three years.
- Follow CDC and manufacturer specifications for maintaining the recommended temperature range (between 36°F and 46°F or between 2°C and 8°C ) during transport of vaccine. Guidance for packing and transporting vaccine is available in Packing Vaccines for Transport during Emergencies (PDF).
- You must use a continuous temperature monitoring device with a valid Certificate of Calibration.
Borrowing vaccine
- Borrowing occurs when a provider borrows vaccine from MnVFC stock to administer to a patient not eligible for the program, or when a provider borrows vaccine from private stock to use on MnVFC-eligible patients.
- This should be a rare, unplanned occurrence.
- Borrowing is approved only in these instances:
- Lack of vaccine stock due to delayed or spoiled shipments.
- Vaccine expiring soon will be lost if not used. Providers with a small, privately insured patient population can use this option to administer short-dated, privately purchased vaccine to a VFCeligible child and replace it with a longer-dated, VFC dose.
- New staff calculated ordering intervals incorrectly, leading to a lack of either private or public vaccine stock.
- VFC seasonal influenza vaccine stock is not yet available. Private seasonal influenza vaccine stock may be borrowed for VFC-eligible children and replaced when VFC vaccine becomes available. This one-directional borrowing is unique to seasonal influenza vaccine.
- Use the Vaccine Borrowing Report to document every time MnVFC vaccine is borrowed to administer to a non- eligible patient or when private stock is used for a MnVFC-eligible child.
- Document the vaccine type borrowed, vaccine stock used, patient’s name and date of birth, date the dose was administered, why the vaccine was borrowed, and the date the vaccine was replaced.
- Keep a copy of the Vaccine Borrowing Report for three years.
Manage nonviable vaccine
- All nonviable MDH vaccine must be reported to MDH. We recommend you report wastage on a monthly basis. Vaccine that is expired or exposed to out-of-range temperatures and is in its original, unopened vial or pre-filled syringe should be returned to McKesson Specialty Distribution within six months of expiration.
- There are two categories of nonviable vaccine: Returned and wasted.
- Returned: This is nonviable vaccine in its original, unopened vial or syringe. Examples of vaccine that should be reported for return include:
- Expired vaccine. Note: Do not return vaccine as “expired vaccine” before its expiration date, including influenza vaccine, unless it was short dated by the manufacturer.
- Vaccine that is recalled by the manufacturer.
- Vaccine that is nonviable due to exposure to out-of-range temperatures.
- Wasted: This is nonviable vaccine that should not be returned and should be properly disposed of according to your policy. Examples of vaccine that should be reported as wastage include:
- Vaccine drawn into the syringe but not administered.
- Vaccine in open vial but doses not administered.
- Compromised vial (e.g., due to a drop causing damage to vial integrity or sterility), broken vial, or lost vial.
- Returned: This is nonviable vaccine in its original, unopened vial or syringe. Examples of vaccine that should be reported for return include:
- How to report nonviable MDH vaccine:
- MIIC online Reporting Nonviable MDH Vaccine to MIIC (PDF).
- Keep nonviable vaccine documentation for three years (if you report nonviable vaccine via MIIC, you do not need to keep a paper copy).
- Once you have determined vaccine is nonviable, remove it from your storage unit and mark it “Do Not Use” to avoid unintentional use.
- For multiple dose vials, refer to the product’s package insert regarding the expiration and beyond use date. Package inserts for vaccines can be found on IAC’s Package Inserts & FDA Product Approvals.
- If you report vaccine for return, you will receive an email with shipping labels from “UPS Quantum View [pkginfo@ups.com].”
Take monthly vaccine inventory, order only the amount of vaccine you need, rotate stock, and transfer vaccine that is nearing expiration to other sites to prevent wasting vaccine.
Manage inventory
- Rotate your vaccine stock so vaccine due to expire first is in front.
- Vaccine must be rotated every week or when a new shipment comes in (whichever happens more frequently).
- Keep vaccine in the original packaging to make managing inventory easier.
Track and order MnVFC vaccine based on administration data
- Develop policies and procedures related to how your site operationalizes the replacement method of vaccine management.
- The vaccine coordinator or designee will run a monthly report that shows doses of private vaccine given to MnVFC-eligible children. Analyze the vaccine administration data to track doses and determine your MnVFC vaccine order. Every dose administered must be documented to determine the number of doses needed to order.
- The preferred report to use is the Doses Administered by Eligibility Report (DAER) (PDF) in MIIC.
- Another option is to run your own report (e.g., through electronic health record or billing data, etc.), but to use this option, you must periodically compare your data to make sure it aligns with the DAER.
- When providers have administered the minimum order amount of a given vaccine to MnVFCeligible patients, they may place an order to replenish those privately purchased doses. MnVFC vaccine ordered must replace doses previously administered to MnVFC-eligible patients; vaccine ordered cannot exceed the number of doses given.
- For example, you can only order polio after administering 10 doses of polio to MnVFC-eligible patients. If you have administered 12 doses of polio you can order 10 doses now and after you administer eight more doses you can order an additional 10 doses.
- Order the same vaccine type that was administered to MnVFC-eligible patients.
- For example, if patients have received Infanrix vaccine, you can replace the doses with any of the DTaP vaccines regardless of presentation or brand. You are not able to replace those doses with a different vaccine like Hepatitis A or a combination vaccine like DTaP-HepB-IPV.
- It is an expectation that enrolled sites will order vaccine at least every 12 months.
- If your site does not order vaccine in a twelve-month period, MnVFC staff may follow-up with you to discuss the reason behind the lack of ordering.
- Order vaccine online through the Minnesota Immunization Information Connection (MIIC).
- If your site is not set up for ordering in MIIC, contact the MIIC Help Desk at health.miichelp@ state.mn.us.
- You must include current storage unit temperatures with each order.
Track your MnVFC vaccine orders in MIIC
- In MIIC, select View Vaccine Management to track the shipment status of your MnVFC vaccine orders.
- Influenza vaccine product requests can also be tracked under Manage Special Vaccine event in MIIC.
- Visit Vaccine Ordering and Management in MIIC for a detailed guide on how to create and view the shipping status of your MnVFC vaccine orders in MIIC.
Transferring vaccine
- If you want to receive MnVFC vaccine from a site that is not within your system, you need to have administered at least as many doses of that type of vaccine to MnVFC-eligible children. These will count as doses from the MnVFC program in the same way as doses ordered from MDH.
- Only full, sealed vials or unopened pre-filled syringes can be transferred.
- If you want to send vaccine to another site, identify a site, call them to make sure they can use the vaccine, have space to store it, and someone will be there to receive it.
- Report all MnVFC vaccine that is transferred to another site using the Vaccine Transfer Record.
- Keep one copy, enclose one copy with the vaccine, and send one copy to the MnVFC program.
- Whether you are sending or receiving a vaccine transfer, you must keep your copy of the Vaccine Transfer Record for three years.
- Follow CDC and manufacturer specifications for maintaining the recommended temperature range (between 36°F and 46°F or between 2°C and 8°C) during transport of vaccine.
- Guidance for packing and transporting vaccine is available in Packing Vaccines for Transport during Emergencies (PDF).
- You must use a continuous temperature monitoring device with a valid Certificate of Calibration.
Manage nonviable vaccine
- All nonviable MDH vaccine must be reported to MDH. We recommend you report wastage on a monthly basis. Vaccine that is expired or exposed to out-of-range temperatures and is in its original, unopened vial or pre-filled syringe can be returned to McKesson Specialty Distribution within six months of expiration.
- There are two categories of nonviable vaccine: Returned and wasted.
- Returned: This is nonviable vaccine in its original, unopened vial or syringe. Examples of vaccine that should be reported for return include:
- Expired vaccine.
- Note: Do not return vaccine as “expired vaccine” before its expiration date, including influenza vaccine, unless it was short dated by the manufacturer.
- Vaccine that is recalled by the manufacturer.
- Vaccine that is nonviable due to exposure to out-of-range temperatures.
- Wasted: This is nonviable vaccine that should not be returned and should be properly disposed of according to your policy. Examples of vaccine that should be reported as wastage include:
- Vaccine drawn into the syringe but not administered.
- Vaccine in open vial but doses not administered.
- Compromised vial (e.g., due to a drop causing damage to vial integrity or sterility), broken vial, or lost vial.
- Returned: This is nonviable vaccine in its original, unopened vial or syringe. Examples of vaccine that should be reported for return include:
- How to report nonviable MDH vaccine:
- MIIC online: Reporting Nonviable MDH Vaccine to MIIC (PDF).
- If you report vaccine for return, you will receive an email with shipping labels from “UPS Quantum View [pkginfo@ups.com]”.
- MIIC online: Reporting Nonviable MDH Vaccine to MIIC (PDF).
- Keep nonviable vaccine documentation for three years. (If you report non-viable vaccine via MIIC, you do not need to keep a paper copy).
- Once you have determined vaccine is nonviable, remove it from your storage unit and mark it “Do Not Use” to avoid unintentional use.
- For multiple dose vials, refer to the product’s package insert regarding the expiration and beyonduse date. Package inserts for vaccines can be found on IAC’s Package Inserts & FDA Product Approvals.
Develop and clearly post an anaphylaxis protocol.
Ensure staff are properly trained on your anaphylaxis protocol to respond to an emergency related to vaccine administration.
An anaphylaxis protocol must be clearly posted in the area where vaccines are administered. For an example of a protocol, review Medical Management of Vaccine Reactions in Children and Teens in a Community Setting (PDF) and Medical Management of Vaccine Reactions in Adults in a Community Setting (PDF) from Immunize.org.
- The protocol must be reviewed at least every three years and signed and dated by your medical provider.
- All staff who administer vaccines should maintain current emergency response skills:
- Know the signs of anaphylaxis and be currently certified in cardiopulmonary resuscitation (CPR).
- Review the protocol with all staff that administer vaccine and care for patients who receive vaccine – both when they are hired and each year after that.
- Emergency supplies must be readily available where vaccines are administered. On a monthly basis, assign staff to check that emergency supplies have not expired and to replenish supplies after an anaphylaxis event has occurred.
- Provider should plan for the availability of at least three doses of epinephrine CDC: Preventing and Managing Adverse Reactions.
- Assign a staff member to submit a report to Vaccine Adverse Event Reporting System (VAERS) in the event of an adverse reaction following vaccine administration.