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Develop and adhere to a
Routine Vaccine Storage and Handling Plan. |
All healthcare providers who administer vaccines should evaluate their cold chain procedures to ensure that vaccine storage and handling guidelines are being followed. Each office should develop and adhere to a detailed written Routine Vaccine Storage and Handling Plan. This plan should include all aspects of routine vaccine management, from ordering vaccines and controlling inventory to storing vaccines and monitoring storage conditions. A written plan will help vaccine providers stay organized and will provide quality assurance of proper vaccine management.
Each office needs an Emergency Vaccine Retrieval and Storage Plan. |
In addition, each office should have a detailed written Emergency Vaccine Retrieval and Storage Plan in the event of refrigerator or freezer malfunctions, power failures, natural disasters, or other emergencies that might compromise appropriate vaccine storage conditions. Establishing a set of written plans for both daily and emergency situations helps assure the continued viability of vaccines. These plans should be easily accessible to staff and should be kept near the vaccine storage unit(s).
Many components of the routine and emergency plans will be the same for every practice but some of the details may vary depending on local policies. Consult your agency or local or state health department immunization program, as appropriate for your situation, for any special instructions.
Routine Vaccine Storage and Handling Plan |
Whenever there is a question about the integrity of the vaccine, follow your state health department immunization program policy and contact either the manufacturer’s quality control office or the immunization program for guidance. |
The
information below is provided as a guideline for developing a Routine
Vaccine Storage and Handling Plan for the protection and
maintenance of your vaccine
supply. You may also use the Routine Vaccine Storage and Handling Plan Worksheet in the Resources section to help organize your plan. Consult your agency, local health department, or state health department immunization program, as appropriate for your situation, for any special
instructions or forms. Whenever there is a question about the integrity of the vaccine, follow your state health department immunization program policy and contact either the manufacturer’s quality control office or the immunization program for guidance.
Each Routine Vaccine Storage and Handling Plan should include the following information:
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Up-to-date contact information |
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For the primary and backup vaccine coordinators who are responsible for routine vaccine storage and handling (see the section on Vaccine Personnel) |
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For the
state or local health department immunization program (see State
Immunization Program Contact Information in the Resources section)
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For the
manufacturers of the vaccines in your inventory (Manufacturer
Quality Control Office Telephone Numbers in the Resources section)
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For the refrigerator and freezer maintenance and repair company(s) |
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For the vaccine storage unit alarm company (if applicable) |
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For the sources of packing materials and certified calibrated thermometers |
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Descriptions
of the roles and responsibilities of the primary and backup vaccine
coordinators (see the section on Vaccine
Personnel) |
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Summaries
of the storage requirements for each vaccine and diluent in your
inventory (see the sections on Vaccine
Storage Practices and Selected Biologicals) |
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Protocols for vaccine storage unit temperature monitoring (see the section on Temperature Monitoring and Thermometers in the Vaccine Storage Equipment section) |
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Protocols for vaccine storage equipment maintenance (see the section on Vaccine Storage Equipment) |
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Protocols
for the correct placement of vaccine within storage units
(see Vaccine Storage
Locations and Positioning in the section on Vaccine Storage
Practices) |
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Protocols for responding to vaccine storage and handling problems (see the section on Storage Troubleshooting) |
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Protocols for vaccine inventory management (contact your state health department immunization program for details and see the section on Vaccine Inventory Management for general guidelines) |
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Protocols
for transporting and receiving vaccine shipments (contact
your state health department immunization program for details and
see the section on
Vaccine Shipments and Maintaining
the Cold Chain During Transport in the Resources section for
general guidelines) |
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Policies for preparing vaccine for administration (see the section on Vaccine Preparation and Disposal) |
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Protocols for proper disposal of vaccines and supplies (contact your state health department immunization program for details and see the section on Vaccine Preparation and Disposal for general guidelines) |
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Samples of the forms used in your vaccination program (contact your state health department immunization program for details and see the Resources section —e.g., temperature logs, stock records, tally sheets) |
Keep
your Routine Vaccine Storage and Handling Plan in a prominent and easily
accessible location near the vaccine storage units. Also establish a checklist
of procedures and post it on all vaccine storage units (see Checklist
for Safe Vaccine Handling and Storage in
the Resources section).
All
staff members who administer or handle vaccines in any way should be familiar
with the Routine Vaccine Storage and Handling Plan (see Training
in the Vaccine Personnel section).
Staff members should be familiar with the Routine Vaccine Storage and Handling Plan. |
Emergency Vaccine Retrieval and Storage Plan |
General Guidelines
To
protect the vaccine inventory and to minimize potential monetary loss,
every facility that stores vaccine should have a written Emergency Vaccine
Retrieval and Storage Plan. Various situations may compromise vaccine
storage conditions, such as equipment failures, power outages, or natural
disasters. The Emergency Vaccine Retrieval and Storage Plan should provide
up-to-date information regarding procedures to follow to protect and/or
retrieve vaccines as quickly as possible when a potentially compromising
situation occurs. Post the Emergency Vaccine Retrieval and Storage Plan
on or near the vaccine storage equipment. Ensure that all staff (current
and new) read the plan and understand it. Also ensure that janitorial
and security staff are aware of the plan and know the procedures to follow
to notify designated personnel about any problems with the vaccine storage
equipment. Review and update the contact lists in the plan quarterly;
review and update the entire plan annually.
When state officials, local officials, or providers have reasonable cause to believe that weather conditions, natural disasters, or other emergencies might disrupt power or flood any office where vaccine is stored, emergency procedures should be implemented in advance of the event.
Whenever there is a question about the integrity of the vaccine, follow your state health department immunization program policy and contact either the manufacturer’s quality control office or the immunization program for guidance. |
The
information below is provided as a guideline for developing an Emergency
Vaccine Retrieval and Storage Plan for the protection of vaccine inventories
before and during emergency situations. You may also use the Emergency
Vaccine Retrieval and Storage Plan Worksheet and the Emergency
Response Worksheet in the Resources section to help organize your
response. Consult your agency, local health department, or state health
department immunization program, as appropriate for your situation, for
any special instructions or forms. Whenever there is a question about
the integrity of the vaccine, follow your state health department immunization
program policy and contact either the manufacturer’s quality control office
or the immunization program for guidance.
Advance Preparations
Well in advance of any emergency situation you should have the following personnel, equipment, information, and protocols in place:
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Designated
primary and backup vaccine coordinators with emergency contact information.
Record this information in the Emergency
Vaccine Retrieval and Storage Plan Worksheet found in the Resources
section. In addition to their routine vaccine storage and handling
duties (see the section on Vaccine Personnel
for details), the primary and backup vaccine coordinators should: |
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Monitor
the operation of the vaccine storage equipment and systems; |
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Track
inclement weather conditions; |
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Set
up and maintain a monitoring/notification system during times of inclement
weather or other conditions that might cause a power outage (a continuous-monitoring
temperature alarm/notification system should be considered, especially
for practices with large inventories); |
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Ensure
the appropriate handling of the vaccine during a disaster or power
outage; |
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Ensure
24-hour access to the building and vaccine storage unit(s); and |
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Ensure
that sufficient fuel is on hand to continuously run the generator
for at least 72 hours if the facility has a backup generator. |
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Emergency
staff contact list in order of contact preference. Determine
whether all or certain persons on the list should be contacted in
the event of a vaccine storage emergency or if the first person reached
is sufficient. Include the primary and backup vaccine coordinators
on the list. Record the names (in order) and contact information in
the Emergency
Vaccine Retrieval and Storage Plan Worksheet. |
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Vaccine
storage unit specifications. For each vaccine storage unit
in your facility, identify the type of unit (e.g., refrigerator, freezer,
combination refrigerator/freezer), the brand name, the model number,
and the serial number. Record this information in the Emergency
Vaccine Retrieval and Storage Plan Worksheet. These specifications
may be useful for the repair company. |
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Alternate
vaccine storage facility or facilities. Establish working
agreements with at least one alternate storage facility with a backup
generator where vaccine can be appropriately stored and monitored
for the interim (e.g., hospital, long-term care facility, state depot,
Red Cross, fire station, packing plant). Make advance arrangements
with the facility(s)
to store your vaccine when weather predictions call for inclement
conditions (e.g., tornadoes, hurricanes, ice, severe snowstorms),
when your vaccine storage equipment cannot be repaired, or when the
power cannot be restored before the vaccine storage unit temperature
rises above the recommended range. Record the name of the alternate
facility(s), the name of the contact person(s), and the telephone
number(s) in the Emergency
Vaccine Retrieval and Storage Plan Worksheet. |
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Establish at least one alternate storage facility where vaccine
can be appropriately stored and monitored. This facility should
have a backup generator. |
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Written
protocols, vehicles, and drivers for transporting vaccine to and from
the alternate vaccine storage facility. |
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If
the vaccine can be moved to the alternate facility before the vaccine
storage temperature rises above the recommended range, it may be transported
in insulated containers or coolers within ordinary vehicles inside
the passenger compartment (not in the trunk because temperatures cannot
be controlled inside the trunk). Make advance arrangements for a primary
and backup vehicle and driver and record the contact information in
the Emergency
Vaccine Retrieval and Storage Plan Worksheet. |
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When
transporting vaccine in ordinary vehicles
use the passenger compartment—not the trunk. |
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If
the location is far away or if you have a large quantity of vaccine,
consider renting a refrigerated truck to transport the vaccine. In
this case, joining with other practices to reduce costs may be advantageous
if a refrigerated truck rental is necessary. Make advance arrangements
with a local refrigeration company and an alternate and record the
contact information in the Emergency
Vaccine Retrieval and Storage Plan Worksheet. |
A refrigerated truck can be used to transport
vaccine. |
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Develop
written protocols for transporting vaccine to and from the alternate
vaccine storage facility.
– Establish how
to load the vehicle.
– Have preselected routes to take (and alternate routes if
necessary).
– Determine the estimated time en route. |
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Written
instructions for entering your facility and vaccine storage spaces
in an emergency if the building is closed or if it is after hours.
These instructions should include the building security/after-hours
access procedure, a floor diagram and the locations of the following:
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Doors |
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Flashlights |
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Spare
batteries |
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Light
switches |
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Keys |
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Locks |
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Alarms
(including instructions for use) |
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Circuit
breakers |
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Packing
materials |
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Appropriate
packing materials to safely transport or temporarily store vaccine.
These materials may include insulated containers, refrigerated/frozen
packs, and dry ice (depending on the type of vaccine—see
Written protocol for vaccine
packing in this section, Maintaining
the Cold Chain During Transport in the Resources
section, Chart
of Refrigerated/Frozen Pack Needs for Different Climates in
the Resources section
for general guidelines). In situations where an alternate vaccine
storage facility with a backup generator cannot be identified within
a reasonable distance, maintain the appropriate packing materials
to temporarily and safely store vaccine at your facility. Record the
names and contact information for sources of these materials in the
Emergency
Vaccine Retrieval and Storage Plan Worksheet. |
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Insulated containers. |
Refrigerated/frozen packs. |
Dry Ice. |
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Prioritized
vaccine packing list. Make a written list of which vaccines
to pack first in an emergency. Contact your state or local health
department immunization program for advice on prioritization. If it
is not possible to pack and transport all your vaccines, use your
prioritized vaccine packing list to determine the types and amounts
of vaccine to save. |
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Written
protocol for vaccine packing. Each facility should develop
its own standard operating procedures (SOPs) for packing vaccine.
These instructions should be readily available for staff unfamiliar
with vaccine packing procedures. Key steps that should be reflected
in all SOPs are: |
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Open
the refrigerator and/or freezer doors only when absolutely necessary
and only after you have made all preparations for packing and moving
the vaccine to the alternate storage facility. |
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Use
properly insulated containers to transport the vaccine. These containers
should be validated to ensure that they are capable of maintaining
the vaccine at the correct temperatures. You may use the shipping
containers the vaccines arrived in from the manufacturer. Alternatively,
you 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. |
Refrigerated
vaccines: |
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Pack
the refrigerated vaccines first, using enough refrigerated/frozen
packs to maintain the cold chain. The number and placement of refrigerated/frozen
packs inside the container will depend on container size and outside
temperature. For detailed instructions, see Chart
of Refrigerated/Frozen Pack Needs for Different Climates in the
Resources section. |
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Be
sure to place an insulating barrier (e.g., bubble wrap, crumpled brown
packing paper, Styrofoam™ peanuts) between the refrigerated/frozen
packs and the vaccines to prevent accidental freezing. The contents
of the container should be layered as follows: refrigerated/frozen
packs, barrier, vaccine, thermometer or temperature monitor, another
layer of barrier, and additional refrigerated/frozen packs. |
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Use
properly placed thermometers near the vaccine to assess whether the
cold chain has been broken. The thermometer should be placed next
to the vaccine and should not come in contact with the refrigerated/frozen
packs. |
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Attach
labels to the outside of the container to clearly identify the contents
as being valuable and fragile vaccines. |
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Record
vaccine type(s), quantity, date, time, and originating facility on
a label on the outside of the container. |
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Document
the vaccine storage unit temperature at the time the vaccine is removed
for transport. |
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Place bubble wrap,
crumpled brown packing paper, or Styrofoam™ peanuts between
the refrigerated/frozen packs and the vaccines. |
Place the thermometer next to the
vaccine but not in contact with the refrigerated/frozen packs. |
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Attach appropriate labels to the outside of the container. |
Frozen vaccines: |
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Pack
the frozen vaccines last, using a separate insulated container. Remove
combined measles, mumps, rubella, and varicella vaccine (MMRV); varicella
vaccine; and zoster vaccine from the freezer and pack with dry ice
immediately before they are to be transported. At least 6 pounds of
dry ice should be used in the container to maintain the vaccines in
their frozen state. |
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Attach labels to the outside of the container to clearly identify the contents as being valuable and fragile vaccines. |
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Record vaccine type(s), quantity, date, time, and originating facility on a label on the outside of the container. |
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Document the vaccine storage unit temperature at the time the vaccine is removed for transport. |
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Use
properly insulated
containers to transport vaccine.
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Dry
ice should be used during transport to maintain vaccines in their
frozen states. |
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Temperatures inside the storage units should be monitored and recorded at least twice a day for as long as vaccine is stored in this location. |
Written protocol for appropriately storing vaccine at the alternate vaccine storage facility. Combined measles, mumps, rubella, and varicella vaccine (MMRV); varicella vaccine; and zoster vaccine should be stored in the freezer at 5°F (–15°C) or colder. Other vaccines should be stored in the refrigerator at 35° to >46°F (2° to 8°C). There should be adequate cold air circulation around the vaccines. Each alternate vaccine storage unit should have a functioning certified calibrated thermometer in each compartment. Temperatures inside the storage units should be monitored and recorded at least twice a day for as long as vaccine is stored this location (see the sections on Vaccine Storage Practices and Temperature Monitoring for further details).
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Up-to-date
list of Manufacturer
Quality Control Office Telephone Numbers. An example
may be found in the Resources section. |
Emergency Actions
The following emergency procedures should be implemented in advance of the event if possible. If you have no warning and the emergency event is already occurring or has already occurred, you should still follow these procedures. Consult your agency, local health department, or state health department immunization program, as appropriate for your situation, for any special instructions. Whenever there is a question about the integrity of the vaccine, follow your state health department immunization program policy and contact either the manufacturer’s quality control office or the immunization program for guidance.
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