VACCINE STORAGE AND HANDLING · document these vaccines on the Vaccine Return and Waste Form, the...

VACCINE STORAGE AND HANDLING Bureau of Immunization-Vaccines for Children Program

MODULE

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_________________________________________________________________ Florida VFC Provider Handbook Revision Date: June 2009

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_________________________________________________________________ Florida VFC Provider Handbook M-5-A Vaccine Management Revision Date: June 2009

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MODULE 5-A – Vaccine Storage and Handling: Vaccine Management Requirements

An important responsibility of the providers is to work with the VFC Program to develop and implement accurate but simple plans for routine and emergency vaccine management. Refer to Appendix 5 for a sample of an emergency storage and handling plan.

All providers must meet the following requirements in order to participate in the VFC Program:

A. Vaccine Coordinators: Designate one staff member to be the primary vaccine coordinator, and at least one back-up vaccine coordinator who is able to perform the vaccine storage and handling responsibilities in the event that the primary coordinator is unavailable. These positions will be responsible for some key requirements and will provide oversight for all vaccine management within the office.

The primary and back-up vaccine coordinators are responsible for training other staff who are responsible for administering vaccines or who may be required to transport vaccine in an emergency, following the office's vaccine storage and handling plan. The provider should keep a simple log sheet with the staff member's name and date of training. The primary vaccine coordinator and/or back-up staff should be the VFC contacts for the office, as documented on all of the VFC Program forms.

1. The primary and back-up vaccine coordinators must be responsible for the following vaccine management activities:

a. Conduct a monthly vaccine inventory and monitor vaccine usage.

b. Adjust the temperature of the vaccine storage unit.

c. Document the temperature on the Temperature Log for Vaccines Form for each storage unit.

d. The primary and back-up vaccine coordinators should monitor temperature logs when they are recording daily vaccine temperatures.

e. Rotate vaccine stock by placing vaccines with shorter expiration dates in front of those with longer expiration dates.


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f. Remove and label expired or unserviceable vaccine to avoid inadvertent administration.

g. Save at least two empty shipping containers, which McKesson Specialty uses to ship vaccines, to return expired or unserviceable vaccines for excise tax credit to the centralized vaccine distributor. Providers no longer have to return empty shipping containers to McKesson Specialty. Recycle them through the local recycling programs.

h. Under no circumstances should providers return syringes filled but not used, syringes (with or without needles), open vials, or any multidose vial from which providers have withdrawn doses. Providers must dispose of these items according to usual medical biosafety procedures.

i. Document expired or unserviceable vaccines on the Vaccine Return and Waste Form, the Vaccine Report Form, and the Vaccine Inventory Balance Sheet.

j. Contact the VFC Program staff at (800) 483-2543 three months prior to the vaccine expiration date to arrange transfer of the vaccine.

k. Store vaccines that require refrigeration in the middle of the refrigerator compartment, away from coils, walls, floor, and cold air vent.

l. Store vaccines that require freezer storage in the middle of the freezer compartment, away from the walls and coils.

m. Space vaccines to allow for cold air circulation around them.

n. Label and separate private vaccines from VFC vaccines.

B. Storage and Handling Plans: Providers may develop their own written routine and emergency storage and handling plans, or use the storage and handling templates for customization (see Appendix 5).

1. The routine vaccine storage and handling plan and the emergency plan should address the following aspects of vaccine management in the event of refrigerator or freezer malfunctions, power failures, natural disasters, or other emergencies that might compromise appropriate vaccine storage conditions:

a. Contact information of the person(s) responsible for preparing and transporting vaccine.


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b. A plan on how the person responsible for preparing and transporting vaccine will be notified that vaccine needs to be moved.

c. Identify the location that will receive vaccine.

d. A plan on how the receiving location will be notified of transport.

e. A plan on how to pack vaccine for transport.

f. Worksheet to document vaccine impacted by power or equipment failure.

g. List of primary and secondary staff who will perform these functions.

At a minimum, providers must review and update the emergency plan annually, or when there is a change in staff that has specific responsibilities in the emergency plan. The BOI and VFC Program staff may request a copy of the emergency plan for review and evaluation.

C. Vaccine Storage Equipment: Providers must have appropriate vaccine storage equipment that can maintain proper temperature conditions. Refrigerators or freezers used for vaccine storage must comply with the following requirements:

1. The provider must have temperature-monitored, alarm-equipped, stand-alone refrigerators with separate doors for freezer and refrigerator compartments. The refrigerator units should maintain the recommended temperature ranges between 35° to 46°F (2° to 8°C) and should have a separate freezer compartment with a separate exterior door.

2. The freezer compartment should maintain an average temperature of 5°F (-15°C) or colder. A combination refrigerator/freezer unit sold for home use is acceptable for vaccine storage.

3. Be large enough to hold the year's largest inventory.

4. Have working thermometers (certified in accordance with the National Institute of Standards and Technology (NIST) or the American Society for Testing and Materials (ASTM) standards) placed in a central area inside each storage compartment.


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5. Be dedicated to the storage of vaccines. Food and beverages must not be stored in a vaccine storage unit because this practice results in frequent opening of the door and destabilization of the temperature.

NOTE: The Florida VFC Program does not approve dormitory-style refrigerators for VFC vaccine storage. A dormitory-style refrigerator is defined as a small combination refrigerator/freezer unit that is outfitted with one external door, an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator, and is void of a temperature alarm device. Its temperature control sensor reacts to the temperature of the evaporator, rather than the general air in the storage compartment. When the compressor is on, the evaporator cools to lower the temperature in the refrigerator, in most cases to below 0°C.

D. Temperature Monitoring: Temperature monitoring should be the responsibility of the primary and back-up vaccine coordinators. If other staff must monitor temperatures, train these individuals on how to respond to and document actions taken when temperatures are outside the appropriate range.

1. Post a Fahrenheit or Celsius Temperature Log for Vaccines Form on the storage unit door or in a readily accessible place.

2. Record refrigerator/freezer temperatures on the Temperature Log for Vaccines Form twice a day (beginning and end), ensuring that refrigerator temperature ranges are between 35° to 46°F (2° to 8°C). Keep the freezer temperature 5°F or lower (-15°C or colder). Monitoring and recording temperatures twice a day is required, even if a continuous graphing/recording thermometer or a digital data logger is used.

3. Correct improper vaccine storage conditions immediately, including inappropriate exposure to light or storage temperatures outside the recommended ranges. Document the actions taken on the Emergency Response Plan Form (Sample) (see Appendix 5).

4. Maintain and store the completed Temperature Log for Vaccines Form for three years. The BOI field staff will review this form when they conduct on-site visits.

5. Monitor vaccine storage temperatures by using a minimum/maximum thermometer or continuous recording thermometer both in the refrigerator and freezer. Follow the


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manufacturer’s recommended schedule for recalibration of the certified thermometers.

E. Vaccine Shipments:

1. Immediately check the vaccine cold chain monitors when vaccine arrives at the office or clinic.

2. If upon the arrival of the vaccine shipment there is a vaccine-viability concern (i.e., if the monitor is not activated or if there is damage to the package), contact a McKesson Specialty representative at (877) 836-7123 within the contractual two-hour window.

3. Develop a policy with protocols and procedures for maintaining the vaccine cold chain during transport to off-site clinics or emergency storage locations. You can access the CDC storage and handling guidelines, Maintaining the Cold Chain During Transport, at http://www.immunize.org/catg.d/p3049.pdf.

F. Action Plan/Vaccine Wastage: What to do if a power failure occurs, staff left the refrigerator door open, the temperature was too cold or too hot, the refrigerator plug was pulled, or in any other situation that would cause improper storage conditions:

1. Implement written procedures for reporting and responding to vaccine losses.

2. Close the door and/or plug in the refrigerator/freezer.

3. Record the current temperature of the refrigerator/freezer on the Temperature Log for Vaccines Form. Return refrigerator/freezer to acceptable temperature ranges and monitor temperatures on an hourly basis.

4. Store the vaccines at appropriate temperatures in a refrigerator/freezer that is working properly. Do not throw out the affected vaccines.

5. Contact the manufacturer(s) (see Appendix 5) and the VFC Program for guidance.

6. Separate the potentially compromised vaccines to prevent inadvertent administration, and label with “DO NOT USE”, until the provider receives a response from the vaccine manufacturer indicating that the vaccine is still potent.


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7. Do not discard any vaccine, unless directed to do so by the vaccine manufacturer or the VFC Program representative.

8. If directed to discard any vaccine, return the vaccines (except syringes that you filled but did not use, syringes (with or without needles), open vials or any multidose vial from which some doses have been withdrawn) to McKesson Specialty in the recyclable insulated vaccine containers, in which the vaccines were originally shipped.

9. To ensure accountability for expired or unserviceable vaccines, document these vaccines on the Vaccine Return and Waste Form, the Vaccine Report Form, and the Vaccine Inventory Balance Sheet.

10. Fax a copy of the Vaccine Return and Waste Form to the VFC Program at (850) 245-4734.

11. Include a copy of the Vaccine Return and Waste Form with all expired or unserviceable vaccines in the shipping container.

12. If you do not have a postage-paid shipping label, contact a VFC Program representative at (800) 483-2543 to request a label.

Vaccine Security and Equipment Maintenance

Safeguard the electrical supply to the refrigerator and post warning notices at both the electrical outlet and the circuit breaker to prevent accidental disconnection of power.

A. Plug the refrigerator into an outlet in a restricted access area.

B. Label the refrigerator, electrical outlets, fuses, and circuit breakers on the power circuit with information that clearly identifies the perishable nature of vaccines and the immediate steps the provider will take in case of interruption of power. Contact the VFC Program at (800) 483-2543 to request “DO NOT UNPLUG” stickers.

C. Limit access to the vaccine supply to authorized personnel only.

D. Install locks on refrigerators and, if possible, the electrical plug.

E. Safeguard public vaccines by providing facility security, such as temperature alarms and restricted access to vaccine storage and handling areas.


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F. Provide a source of back-up power (generators) and a security system to alert appropriate personnel in the event of a power outage. If the provider’s building has auxiliary power, use the outlet supplied by that system.

G. Test back-up generators quarterly and maintain back-up generators at least annually (check manufacturer specifications for test procedures and maintenance schedules).


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Florida State Health Online Tracking System (Florida SHOTS)

The Florida SHOTS helps ensure that the required immunization records for childcare centers and school attendance are easy to locate, children’s immunizations are up to date, prevents unnecessary duplicative immunization, and consolidates immunization records from multiple healthcare providers. The benefits of the registry are:

A. Produces the legal immunization record (DH Form 680) required for school and daycare center attendance.

B. Consolidates immunization records from all providers into one record per patient.

C. Immunization information is accessible 24 hours a day, seven days a week.

D. The immunization tracking software never has to be downloaded or upgraded on your computer.

E. Provides reliable immunization history for any child.

F. Identifies patient’s previously reported contraindications.

G. Provides definitive information, reminders, recalls on immunizations that are due or overdue, and reduces paperwork.

H. Generates immunization reports for managed care organizations.

I. Provides current recommendations, information, and new vaccines.

For more information about the Florida SHOTS Program, call the toll-free telephone number at (877) 888-SHOT or send an email to [email protected].

________________________________________________________________ Florida VFC Provider Handbook M-5-B Vaccine Management Revision Date: June 2009

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MODULE 5-B – Vaccine Storage and Handling: Vaccine Storage Equipment

The Florida VFC Program does not approve dormitory-style refrigerators for VFC vaccine storage. A dormitory-style refrigerator is defined as a small combination refrigerator/freezer unit that is outfitted with one external door, an evaporator plate (cooling coil), which is usually located inside an icemaker compartment (freezer) within the refrigerator, and is void of a temperature alarm device. Its temperature control sensor reacts to the temperature of the evaporator, rather than the general air in the storage compartment. When the compressor is on, the evaporator cools to lower the temperature in the refrigerator, in most cases to below 0°C.

Dormitory-style refrigerators place vaccine at a high risk of freezing. These types of units cannot reliably regulate temperatures to keep vaccines within the recommended range. Vaccine storage units should be temperature-monitored, alarm-equipped, stand-alone refrigerators and stand-alone freezers.

Any stand-alone refrigerator or freezer used to store VFC vaccine must:

• Be able to maintain required vaccine storage temperatures year-round.

• Be large enough to hold the year’s largest vaccine inventory.

• Have a certified, calibrated thermometer inside each storage compartment.

• Be dedicated to the storage of vaccines. Food and beverages must not be stored in a vaccine storage unit.

No piece of vaccine storage equipment is infallible. At some point, equipment failure will occur because of a power failure, breakdown, or normal wear and tear. Vaccine security requires that providers should anticipate these failures, and that back-up equipment and back-up plans be available (see Appendix 5 for sample plan).

Facilities storing large vaccine inventories may want to consider installing continuous monitoring temperature alarm systems to help prevent substantial financial loss if the temperatures in their storage units exceed the recommended ranges. Even if the alarm systems are used, providers still must check and record the refrigerator and the freezer temperatures twice a day.

Patients receiving vaccine with decreased potency caused by improper storage conditions may not be fully protected against vaccine-preventable disease. The


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General Recommendations on Immunization, the Advisory Committee on Immunization Practices (ACIP), and the American Academy of Family Physicians (AAFP), states that providers should not count mishandled vaccine doses as valid doses and providers should repeat vaccination, unless serologic testing indicates a response to the vaccine. Recalling patients to repeat vaccine doses because vaccine has been stored improperly can damage public confidence in vaccines and in the provider’s practice.

• Recommended Refrigerator and Freezer Temperature Range: The provider must have temperature-monitored, alarm-equipped, stand-alone refrigerators and freezers. The refrigerator units should maintain the recommended temperature ranges of 35° to 46°F (2° to 8°C).

The freezer compartment should maintain an average temperature of 5°F (-15°C) or colder. A combination refrigerator/freezer unit sold for home use is acceptable for vaccine storage. It should have a separate exterior freezer door.

Store each vaccine in its proper location (see Figure 1) for the best safety margin. Store water bottles in the refrigerator and frozen packs in the freezer to stabilize the temperature.

Thermometers that provide continuous recording or minimum/maximum temperatures are preferred because they are the best indicators of temperature fluctuations outside of the recommended ranges. Adequate thermometers for monitoring temperatures are discussed in detail in Module 5-C.

• Opening the Door: Limit the number of times the vaccine storage unit doors are opened and avoid letting the doors stand open unnecessarily. This affects the temperature in the unit and exposes the vaccines to light (which can affect the potency of HPV, MMR, MMRV, rotavirus, varicella,

Store each vaccine in its proper location (Figure 1).


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and zoster vaccines). Frequently check the doors throughout the day to ensure they are tightly closed.

• Vegetable Bins: Remove the vegetable bins from the refrigerator. This will provide extra space to store containers of water to stabilize the temperature. Additionally, it will eliminate the temptation to use the bins for storage of food, beverages, or vaccines. Vaccines should never be stored near the floor of the refrigerator in the vegetable bins because the temperature in this area is different from that in the body of the refrigerator.

• Food and Beverages: Never store food or beverages inside the vaccine refrigerator or freezer. This practice results in frequent opening of the storage unit door and greater chance for temperature instability and excessive exposure to light. It may also result in spills and contamination inside the compartment.

Medications and Other Biologic Products: Other medications and biologic products should not be stored inside the vaccine storage unit. If there is no other choice, these products must be stored below the vaccines on a different shelf. This prevents contamination of the vaccines should other products spill, and reduces the likelihood of medication errors. More information regarding vaccine storage and handling is available at the CDC’s website at http://www2a.cdc.gov/vaccines/ed/shtoolkit/pages/storage_practices.htm#NonVaccine_Products.

_________________________________________________________________ Florida VFC Provider Handbook M-5-C Vaccine Management Revision Date: June 2009

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MODULE 5-C – Vaccine Storage and Handling: Thermometers

The use of trade names and commercial sources in this section is for identification only, and does not imply endorsement by the U.S. Department of Health and Human Services (DHHS), the U.S. Public Health Service (PHS), Centers for Disease Control and Prevention (CDC), Florida Department of Health, or the Florida Bureau of Immunization.

Certified-calibrated Thermometers

The National Center for Immunization and Respiratory Diseases, Centers for Disease Control and Prevention recommends using only certified-calibrated thermometers for measuring vaccine storage unit temperatures. Thermometers are a requirement for VFC providers. The manufacturer calibrates all thermometers during manufacturing, and gives them a temperature scale. Certified-calibrated thermometers undergo a second individual calibration against a reference standard from an appropriate agency, such as the National Institute of Standards and Technology (NIST), or a laboratory recognized by NIST. Calibration can be traceable to NIST using the American Society for Testing and Materials (ASTM) methods for the calibration process. Calibrated thermometers receive a certificate indicating successful completion of this process. The provider will receive a copy of the certificate when they purchase the instrument. This certificate is different from the manufacturer’s warranty; save this important document. Certified-calibrated thermometers are available through laboratory and scientific supply companies (see Appendix 5).

Avoid using thermometers that are not certified; a thermometer costing a few dollars is not worth the risk of damaging thousands of dollars of vaccine because of inaccurate readings. In the long run, it is better to invest in a more expensive but reliable certified-calibrated thermometer because it is more cost-effective.

Thermometers that provide continuous recording of minimum/maximum temperatures are preferred because they are the best indicators of temperature fluctuations outside of the recommended ranges.

Types of Certified-calibrated Thermometers

To ensure that refrigerators and freezers are maintaining the proper temperatures for vaccine storage, each compartment should have a certified-calibrated thermometer and the provider should check and record the temperature twice a day on the Temperature Log for Vaccines Form. There are several types of thermometers to monitor the temperatures within vaccine storage units.


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Certified-calibrated Thermometers

Most information/Highest cost <—————> Least information/

Lowest cost

Extent of data Continuous recording

Minimum/maximumtemperature

reading

Single point reading

Types Chart recorders,

electronic data loggers

Fluid-filled, some digital

Fluid-filled, some digital, bi-metal stem

Any of the various types of thermometers in this section are adequate for monitoring temperatures inside vaccine storage units. However, thermometers that provide continuous recording or minimum/maximum temperatures are preferred because they are the best indicators of temperature fluctuations outside of the recommended ranges. Providers should take immediate action when the refrigerator/freezer temperatures are out of the recommended range.

A. Fluid-filled Biosafe Liquid Thermometers

Fluid-filled biosafe liquid (bottle) thermometers consist of two parts:

1. The first part is a glass bulb connected to a glass tube, with a numbered scale printed along the tube. Inside the tube is a liquid (usually mercury or colored alcohol) that rises and falls as the temperature changes in the immediate area of the bulb.

2. The second part is a bottle containing a biosafe liquid, such as glycol. The glass bulb is immersed in the liquid. The liquid provides a buffer around the bulb, so that the reading does not fluctuate when the providers open or close the refrigerator or freezer door. Fluid-filled biosafe liquid thermometers are available in refrigerator and in freezer models. Some models may come with a magnet designed to attach the thermometer to the refrigerator or freezer wall. This is not the correct placement for a thermometer used in vaccine storage. Place the thermometer in the center of the refrigerator/freezer compartment with the vaccine.

Fluid-filled biosafe liquid thermometers can be difficult to read and can render inaccurate temperatures if the liquid column separates. This may be correctable; consult the manufacturer for detailed instructions for reuniting the liquid column.

Fluid-filled biosafe liquid thermometer.


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B. Minimum/Maximum and Digital Thermometers

Minimum/maximum thermometers are available in fluid-filled and digital forms. They show the current temperature and the minimum and maximum temperatures achieved. Providers can detect temperature fluctuations outside the recommended range by referring to the minimum and maximum temperature readings.

Digital thermometers display Fahrenheit and/or Celsius temperatures on a screen. Some have optional features, including a display of the minimum and maximum temperatures, a temperature alarm that can be set to ring at a specified temperature, or a temperature probe.

Minimum/maximum digital thermometer.

Digital thermometer with

standard probe.

Digital thermometer with

biosafe liquid-encased probe.

C. Digital Data Loggers

Digital data loggers are miniature, battery-operated, electronic devices programmed to record temperatures at intervals throughout the day, with the frequency of reading set by the user. They are capable of recording hundreds or even thousands of individual temperature readings.

Digital data loggers come with special software, which providers install on a computer. This software allows the user to set the frequency of the temperature readings, download data from the device, and calculate temperature averages, minimums, and maximums. In order to review the temperature history, the user must download data from the digital data logger on a regular basis. Providers must manually check and record temperatures twice a day. They can also use a second certified thermometer for these manual temperature checks.

Some data loggers may have an audible alarm to alert the user to out-of-range temperature conditions. Other data loggers may have external

Minimum/maximum

Thermometers.


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lights that alert the user to out-of-range temperature events; a green light indicates temperatures have remained in range and a red light indicates temperatures are out of range. If a data logger's alarm activates or displays a red light, follow the action plan outlined in Module 5-A. Providers may also use digital data loggers in vaccine transport.

D. Chart Temperature Recorders

Chart recorders consist of a graph wheel with replaceable graph paper and ink pens. The pens mark the temperature on the graph paper continually as the wheel turns. The graph paper has a Fahrenheit or Celsius scale on it and the temperature is read where the ink line falls on the scale. Providers should change the graph paper when it completes a full circle, usually weekly, and record the date on the graph paper when they remove/change the graph paper. Providers should keep old graphs as a permanent record of the performance of the vaccine storage unit. In a certified chart recorder, the certification applies only to the temperature sensor used by the recording pen.

Providers should record only the specific reading from the graphing wheel when they check the temperatures twice a day. Some chart recorders have temperature probes. Probes are available in two forms: a standard probe and a biosafe liquid-encased probe. Place the biosafe liquid-encased probes in the center of the compartment and suspend the standard probes.

Chart recorders are more difficult to read than digital thermometers because they require interpretation of the temperature graph. These are the only thermometers that record the current temperature, the minimum and maximum temperatures, and the continuous changes in temperature through time. Providers can detect temperature fluctuations outside the recommended ranges by referring to the minimum and maximum temperature readings.

Chart recorder. Graph paper— two-degree increments.

Graph paper—range.


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E. Bi-metal Stem Thermometers

Bi-metal stem thermometers are typically circular in shape, with a needle anchored in the center that points to one or two numbered scales (Fahrenheit and/or Celsius) located around the perimeter of the dial. The temperature is indicated by where the needle points on the scale. These thermometers may be difficult to read. When reading the thermometer, the face should be vertical and your eyes should be level with the center of the dial. Certified bi-metal stem thermometers are quite accurate, but they only indicate the temperature at the time they are read. They do not indicate the changes in temperature over time or the minimum/maximum temperatures achieved. Therefore, providers may not detect temperature fluctuations outside the recommended range.

F. Other Thermometers—NOT RECOMMENDED

Do not use thermometers that are not certified-calibrated thermometers. Uncertified thermometers or dial-type household refrigerator/freezer thermometers are not accurate enough to risk losing expensive vaccine. Generally, thermometers obtained in hardware and appliance stores are not certified instruments. These thermometers monitor temperatures for domestic food storage.

Thermometer Placement

Place the thermometer in the center of the compartment, away from the coils, walls, floor, and fan, in order to obtain a true reading of the temperature (see Figure 2).

Fluid-filled biosafe liquid thermometer in freezer.

Chart recorder in refrigerator.

Proper placement of thermometers in compartments (Figure 2).

Bi-metal stem thermometer.


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In the refrigerator, place the thermometer on the middle shelf, adjacent to the vaccine, or hanging down from the upper shelf. In the freezer, suspend the thermometer from the ceiling of the compartment or place on a box or some other item, so that it is in the middle of the compartment, off the floor. If the thermometer indicates a temperature outside the recommended range, check that the thermometer is appropriately situated.

Thermometer Maintenance and Recertification

Certified-calibrated thermometers require periodic recertification and recalibration in order to remain accurate. Contact the manufacturer for instructions regarding recalibration procedures. When choosing a certified-calibrated thermometer, consider the cost and frequency of required recalibration. Recalibration costs will vary by manufacturer, model, and type of thermometer. Keep documentation of recertification and recalibration as part of the office records.

The National Center for Immunization and Respiratory Diseases recommends adhering to the recalibration schedule recommended by the manufacturer.

_________________________________________________________________ Florida VFC Provider Handbook M-5-D Vaccine Management Revision Date: June 2009

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MODULE 5-D – Vaccine Storage and Handling: Vaccine Transfers

Vaccine transfers between providers can occur only after receiving approval from a VFC Program representative. A VFC provider may transfer a vaccine to another VFC provider within three months of the expiration date. Do not transfer opened vials. It is the provider’s responsibility to ship or transfer the vaccine safely and correctly. If the cold chain is broken and the vaccine becomes unserviceable, the VFC Program may charge providers for the cost of the vaccine.

The VFC Program does not recommend transferring varicella-containing vaccines to another provider or location because of storage temperature requirements.

Keep some of the original shipping coolers or cold packs for vaccine transfers or returns. The provider must complete the Vaccine Transfer Form (see Appendix 4).

Vaccine Transfer Form

The provider transporting the vaccines will complete the Vaccine Transfer Form. The provider receiving the vaccines should sign, date, and fax a copy of the Vaccine Transfer Form to the VFC Program at (850) 245-4734. The provider receiving the vaccine is responsible for all VFC vaccines in their possession and must ensure all vaccines are stored properly upon receipt.

How to Complete the Vaccine Transfer Form

• Name of the Person Responsible for Preparing and Transporting the Vaccine(s): The name of the person packing the vaccines in the insulated container.

• PIN: The PIN is the six-digit Provider Identification Number assigned by the VFC Program. The PIN appears on the packing slips that accompany the vaccine shipments.

• Telephone Number: A telephone number where the VFC Program can reach the person responsible for preparing and transporting the vaccine(s).

• Name of the Provider Receiving the Vaccine(s): Name of the person receiving the vaccine transfer.


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• PIN: The PIN is the six-digit Provider Identification Number assigned by the VFC Program.

• Telephone Number: A telephone number where the VFC Program can reach the person receiving the vaccine transfer.

Record specific information in these columns:

• Column 1 (Name of the Vaccine): A list of each of the vaccines transferred.

• Column 2 (Record Refrigerator Temperature): The person responsible for preparing and transporting the vaccines will record the refrigerator unit temperature before transporting the vaccine.

• Column 3 (Record Cooler Temperatures): The person responsible for preparing and transporting the vaccines will document the temperature in the insulated container before transporting the vaccines. The person receiving the vaccines will record the temperatures in the vaccine-insulated containers upon arrival to make sure the temperature range is within the acceptable range.

• Column 4 (Vaccine Expiration Date): The date the vaccine(s) expire(s).

• Column 5 (Manufacturer and Lot Number): The name of the vaccine manufacturer and the lot number.

• Column 6 (Number of Vaccine Doses): Number of vaccine doses transferred.

Vaccine Returns

The VFC Program requires providers to return expired and unserviceable vaccines to McKesson Specialty, the VFC Program centralized vaccine distributor. EXCEPTION: Under no circumstances should providers return syringes filled but not used, syringes (with or without needles), open vials, or any multidose vial from which providers have withdrawn doses. Providers must dispose of them according to usual medical biosafety procedures.

Providers should:

• Contact a VFC Program representative at (800) 483-2543 prior to returning any vaccines.

• Fax a completed Vaccine Return and Waste Form to the VFC Program at (850) 245-4734.


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• Place the original copy of the Vaccine Return and Waste Form in the recyclable insulated container with the unserviceable vaccines.

• Return the expired or unserviceable vaccines to McKesson Specialty in the recyclable insulated containers to facilitate their return via United Postal Service (UPS). No ice is necessary since the vaccine is unserviceable.

• If the provider does not have a postage-paid shipping label, they should contact the VFC Program at (800) 483-2543 to request one.

How to Complete the Vaccine Return and Waste Form

• Name of the Provider Returning the Vaccine(s): The provider will use the same facility name used for enrollment in the VFC Program. The facility name appears on the packing slips that accompany the vaccine shipments. If the facility name has changed, notify the VFC Program in writing. Complete the Additional Information Form (see Appendix 4) and the Vaccine Return and Waste Form and fax them to the VFC Program at (850) 245-4734.

• PIN: The PIN is the six-digit Provider Identification Number assigned by the VFC Program. The PIN appears on the packing slips that accompany the vaccine shipments.

• Person Completing the Form: The name of the person completing the form is important in case we have questions regarding the vaccine return.

• Telephone Number: A telephone number where the VFC Program can reach the person responsible for returning the vaccine(s).

• Column A (Date of Incident): The date the vaccine(s) became unserviceable.

• Column B (Name of the Vaccine): The name of each of the returned vaccines.

• Column C (Vaccine Manufacturer): The name of each vaccine manufacturer.

• Column D (Lot Number): The lot number which appears on the label of the vaccine vial.

• Column E (Expiration Date): The date the vaccine(s) expired.

• Column F (Number of Doses): The number of doses of each vaccine.


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• Column G (Return/Reason Code): The provider will write a code for the reason they returned the vaccine.

Return and Waste Reason Codes:

1. Expired: The date by which the vaccine or diluent should be used.

2. Wasted: Dropped vial/Broken vial.

3. Wasted: Drawn-up but not administered.

4. Spoiled: Proper refrigeration/freezer temperature not maintained.

5. Spoiled: Vaccine not refrigerated or stored properly upon receipt.

6. Spoiled: Refrigeration/mechanical failure.

7. Unusable: Natural disaster/power outage.

8. Unusable: Lost or damaged in transit to provider.

• Incident Report and Remedial Actions Taken: The provider will give a detailed explanation as to why the vaccine(s) became unserviceable and the remedial actions taken to prevent a recurrence (attach additional sheets, if necessary).

_________________________________________________________________ Florida VFC Provider Handbook M-5-E Vaccine Management Revision Date: June 2009

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MODULE 5-E – Vaccine Storage and Handling: Packing Vaccine for Transport to Off-site Activities

All public and private providers enrolled in the Vaccines for Children (VFC) Program are responsible for the proper maintenance of their vaccine inventories. When the providers transport vaccines from their clinic to another location they should follow proper vaccine transportation procedures to ensure protection of the vaccine supply. To facilitate mass immunization clinics at these locations, the VFC Program is allowing providers to transport vaccines that are required for school and child care only.

Providers should complete and fax the Special Vaccine Order Form for Off-Site Immunization Activities (Appendix 4) to the VFC Program at (850) 245-4734, 2 to 3 weeks prior to the planned school immunization activity. This will allow sufficient time for the VFC Program to process, and for McKesson Specialty to deliver the vaccine. This form is also available on our website at http://www.immunizeflorida.org/vfc/forms.htm.

Healthcare providers and staff are responsible for maintaining vaccine quality from the time a shipment arrives until the moment they administer a vaccine dose. The following are general guidelines for packing vaccine when transporting to off-site activities like health fairs and immunization clinics:

A. Use properly insulated containers to transport vaccine. The individual responsible to transport the vaccines should ensure these containers are capable of maintaining the vaccine at the correct temperatures. The provider may use the shipping containers the vaccines arrived in from McKesson Specialty. Alternatively, the provider may use hard-sided plastic insulated containers or Styrofoam™ coolers with at least 2-inch thick walls. Thin-walled Styrofoam™ coolers, such as those purchased at grocery stores to hold beverages, are not acceptable.

B. Pack enough refrigerated/frozen packs to maintain the cold chain. Do not use loose or bagged ice. The number and placement of refrigerated/frozen packs inside the container will depend on container size and outside temperature.

C. Pack vaccines in their original packaging. Do not remove vaccine vials from boxes, and do not draw up vaccine in advance.

D. Use a properly placed thermometer near the vaccine but not in contact with the frozen packs.


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E. In hot climates and summer seasons, keep the insulated containers in the air-conditioned interior of the car during transport, rather than in the trunk.

Refrigerated/frozen packs.

Place bubble wrap, crumpled

brown packing paper, or Styrofoam™ peanuts between the refrigerated/frozen packs and the

vaccines.

Place a thermometer next to the vaccine but not in contact with the

refrigerated/frozen packs.

Label the outside of the cooler containers to clearly identify the contents as being valuable and fragile vaccines. Below are some examples of labels the provider can attach to the coolers.

What to do After the Off-site Activity is Over

The designated staff will unpack, check, and immediately store the vaccines at the recommended temperature ranges of 35° to 46°F (2° to 8°C); and the freezer temperature of 5°F (-15°C) or colder when they return to the clinic from the off-site activity. The designated staff will fax a copy of the Cooler Temperature Log (Appendix 4) to the VFC Program at (850) 245-4734.

If the designated staff has suspicion of a cold chain failure or evidence of vaccine exposure to temperatures outside the recommended temperature range, the staff should immediately notify the primary vaccine coordinator. If the primary vaccine coordinator is not available, the staff should report the problem to the immediate supervisor. The designated staff, the primary vaccine coordinator, or the immediate supervisor should follow these steps:


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A. Store the potentially compromised vaccines under appropriate conditions in a properly functioning refrigerator/freezer.

B. Separate the potentially compromised vaccines, and label “DO NOT USE”, to prevent inadvertent administration, until the vaccine manufacturer(s) determine the integrity and potency of the vaccines.

C. Contact the manufacturer(s) and the VFC Program for guidance.

D. Do not discard any vaccine unless directed to do so by the vaccine manufacturer(s) or the VFC Program staff.

E. If the vaccine becomes unserviceable, account for these doses on the Vaccine Return and Waste Form and follow the VFC Program vaccine return procedures (see Module 5-D).

VACCINE STORAGE AND HANDLING · document these vaccines on the Vaccine Return and Waste Form, the...

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