Wisconsin Department of Health Services Vaccine Storage and Handling Update Jackie Nelson,...

Wisconsin Department of Health Services

Vaccine Storage and Handling Update

Jackie Nelson, CoordinatorVaccines for Children Program

Wisconsin Division of Public Health

Immunization Program


Why all the fuss over storage and handling?

What’s in your storage unit?


Number of Vaccines in the Routine

Childhood Immunization Schedule1985 (7) 1995

(10)2005 (14)

MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant) Hepatitis BVaricellaPneumococcal DiseaseInfluenzaMeningococcalHepatitis A

MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant) Hepatitis BVaricella

MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolio

MeaslesRubellaMumpsDiphtheriaTetanusPertussisPolioHib (infant) Hepatitis BVaricellaPneumococcal DiseaseInfluenzaMeningococcalHepatitis AHPVRotavirus

2012 (16)


1 box of Varicella Private $870.95

1 box of Varicella

VFC $724.90

Two boxes of Varicella

$1595.85

Private Stock$8293.65

VFC Stock $6337.70

All vaccine in fridge $16,227.20

The cost of one box of each vaccine that is universally recommended for children & adolescents by purchase source

Vaccines included:DTaP (Infanrix), HepB (Engerix), Comvax,Hib (pedvax), Rotavirus (Rotatech,)PCV13,e- IPV, Flu, MMR, Varicella, HepA (Vaqta), MCV (menactra), Tdap (Boostrix), HPV (Gardasil), Kinrix, Pediarix, Pentacel

How much money is in your storage unit?


Success of Immunization Strategies

• Dramatic decrease in vaccine preventable diseaseso Tetanus, Haemophilus influenzae type b

(Hib), Chicken Pox, Measles

• Eradication of many diseases in the USo Smallpox, Diphtheria, Polio


Office of the Inspector General Report

• Study was conducted in April/May 2011

• 45 VFC providers from the 5 largest Grantees

• Completed a site visit which included interviews with staff, observation of vaccine management, 2 week study of temps and final interview with grantee staff


What did they find?

• 76% of the 45 selected providers had temperatures out of range during the two week period.

• 16 of 45 providers had expired vaccines in their refrigerators.

• 0 of 45 providers met the vaccine management requirements in the 8 required areas.


What Does it Mean to Me?

• CDC will be coming out with more strict requirements on vaccine storage and handling.

• Thermometers should be the type that are fluid filled in glycol.

• Site visits need to be more focused.


Vaccine Storage and Handling 6 Focus Areas

1. Maintaining Recommended Storage Temperatures

2. Vaccine Storage Requirements3. Temperature Monitoring 4. Vaccine Management5. Vaccine Rotation6. Common Errors



• The “Cold Chain” – Vaccines must remain at proper temperaturesoManufacturer to distributoroDistributor to office/clinicoOffice/clinic to patient



• Vaccines stored in the refrigerator o Temperature range is 35-46º F (2-8º C)o Store in middle of unit with air flow

around vaccines to keep from freezing o Frequent opening may cause

temperatures to fluctuateoWater bottles should be placed in the

unit to help stabilize temperature oAssure the door is always closed and

sealed



• Vaccines stored in the freezero Temperature range is 5ºF (-15ºC) or

colderoDo not allow frost/ice build-up to take

placeo Ensure door remains closed and

sealedo Ice packs should be placed in the unit

to help stabilize temperatureoCheck all vaccines to ensure you do

not exceed “thaw” timesoDo not refreeze vaccine



Frost build-up example




2. Vaccine Storage Requirements

3. Temperature Monitoring 4. Vaccine Management5. Vaccine Rotation6. Common Errors



• Home-style combination refrigerator/freezer is acceptable only if each compartment has a separate dooro Separate controls are highly

recommended, but not required• Refrigerators without freezers and

stand-alone freezers usually perform better, e.g. pharmaceutical type

• Units must maintain required temperatures year-round



• Unacceptable storage unit with 1 door for fridge and freezer access

• Permitted storage unit with separate doors

• Separate controls highly recommended



• Do not store vaccine near cold air outlet from the freezer

• Store vaccine centrally in the refrigerator and never in the door or vegetable bins

• Must allow 2 inches in between the walls of the unit and the vaccine boxes



• Expired vaccine must be removed from units containing unexpired vaccine

• Unit must be big enough to hold largest inventory

• Unit must be dedicated to the storage of biologics (no food or beverages)



• Always store vaccines in their original boxes

• Do not remove vaccine from box to place in separate storage containers


3. Temperature Monitoring

• Measure temp of refrigerator and freezer twice daily (am and pm) with a certified, calibrated thermometer

• Thermometers should be certified by the National Institute of Standards and Technology (NIST) and calibrated regularly

• Thermometers should be placed next to the vaccine in a central location in the storage unit

• If temperature is out of range, immediately report to supervisor and record corrective action

• Take additional temperature measurements to ensure that temps are again within range



• Record temperature of refrigerator and freezer twice daily (first thing in the morning and at the end of the day) on temperature log

• Review temp logs at least weekly

• Fax temperature logs monthly to the Wisconsin Division of Public Health (608.267.9493)

• Keep logs for 3 years


Traceable Certified Thermometer


Example of Certification Form



• One person should be assigned the primary responsibility of measuring and recording temperatures

• A back up person should be assigned in case the primary individual is unavailable

• All staff working with vaccines should be familiar with proper temperature monitoring and recording


4. Vaccine Management

• State Supplied vaccine must be ordered through the Wisconsin Immunization Registry (WIR)

• Count and record current inventory before ordering vaccines through WIR (doses, lot # and expiration date)

• Vaccines are shipped Monday through Wednesday

• Immediately upon arrival, place vaccine in appropriate storage units

• If there is a problem with the vaccine order report it to the VFC program within one hour of vaccine receipt


5. Vaccine Rotation

• Before new supply of vaccine is ordered, check current supply and order enough vaccine to cover a 2 month period.

• Rotate stock—short dated vaccines should be used first.

• Attempt to locate a VFC provider to transfer short dated vaccine before it expires.

• After three attempts and you still need assistance, contact Jane Dunbar at 715-365-2709.


6. Common ErrorsStorage unit doors are not properly closed and sealed

oCheck refrigerator and freezer doors frequently When the clinic opens Close if left open during the day; check

temps if found open Check before going home for the day Check on last business day of the week

(e.g. Friday night) before clinic closes for weekend

Check first thing on Monday morning


6. Common Errors

• Vaccine inventory expiresoOrder vaccines carefully to ensure

vaccines do not expire Count inventory before ordering Order only a 2 month supply

oAttempt to locate a VFC provider to transfer short dated vaccine before it expires

oDo not store expired vaccines with unexpired vaccines


6. Common Errors

• Upon arrival, vaccines are not inspected and immediately storedo Inspect vaccines on arrivalo Immediately unpack and store vaccineso If vaccines are damaged, contact the

VFC program within one hour of receiving shipment

o Lynette Hanson, 608-267-5148 or [email protected]


6. Common Errors• Improper handling of compromised

vaccineo If state supplied vaccine is compromised

you must call the WI Immunization Program for guidance Do not throw away compromised vaccine Do not use compromised vaccine until the

viability of the vaccine has been determinedo In the event of a power outage, if you

are able to determine the duration will only be for a short time, do not remove vaccine and keep the door closed until power is restored

oUse your emergency storage and handling plan to prevent vaccine from being compromised


In 2010, the most common errors found duringVFC Site Visits were:

• Providers recorded temperatures in the gray area (out of range) of the temperature chart and did not do anything to address the problem.• Approximately 17 sites had non working thermometers in their refrigerator units.

Common Errors in Wisconsin


• 70 providers (out of 300) (public and private) did not have written procedures in all 8 required areas which include emergency response.

-Designation of primary vaccine coordinator and at leastone backup staff-Proper vaccine storage and handling written plan-Vaccine Shipping (includes receiving and transport)-Procedures for vaccine relocation in the event of an emergency-Has the emergency plan been reviewed and updated in

the past year-Vaccine ordering-Inventory control (stock rotation)-Vaccine wastage

Common Errors in WI (cont)


• Providers did not have certified/calibrated

thermometers in their vaccine refrigerators and those that did have calibrated thermometers were unable to produce the certificate.

Common Errors in WI (cont)


Take Home Messages

• Improperly stored vaccines lose their efficacy and will not protect against disease

• Expired vaccines may not protect patients

• Do not administer improperly stored or expired vaccines

• Notify the Wisconsin Immunization Program if vaccine has been improperly stored or compromised in any way!


Resources for additional information on vaccine storage

and handling• Package inserts (can be found at

immunize.org)• Vaccine manufacturers• Pink Book – CDC text on Vaccines• Red Book – AAP text on vaccines• CDC website: www.cdc.gov/nip• Wisconsin Immunization Program

o Jackie Nelson, State VFC Coordinator 608.266.1506 or email [email protected]

http://www.cdc.gov/nip

mailto:[email protected]


Thank You for All You Do to Protect Our Children and

Communities

• For additional information on vaccine preventable diseases, please contact the Wisconsin Immunization Program.o Jane Dunbar, 715-365-2709o Jackie Nelson, 608-266-1506

Wisconsin Department of Health Services Vaccine Storage and Handling Update Jackie Nelson,...

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