1. Vaccine Storage and Handling Update
Jackie Nelson, Coordinator
Vaccines for Children Program
Wisconsin Division of Public Health
Immunization Program
Introduce state staff, Thank You for the Oppurtunity

2. Why all the fuss over storage and handling?
What’s in your storage unit?
So I know many of you have seen me a lot over the last several months and you may be asking, why all the fuss over the vaccine storage and handling. Let me tell you why. 2

3. Number of Vaccines in the Routine Childhood Immunization Schedule
1985 (7)
1995 (10)
2005 (14)
2012 (16)
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib (infant)
Hepatitis B
Varicella
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib (infant)
Hepatitis B
Varicella
Pneumococcal Disease
Influenza
Meningococcal
Hepatitis A
Measles
Rubella
Mumps
Diphtheria
Tetanus
Pertussis
Polio
Hib (infant)
Hepatitis B
Varicella
Pneumococcal Disease
Influenza
Meningococcal
Hepatitis A
HPV
Rotavirus
Because the practice of immunization has truly become a science over the last 25 years from 7 in 1985 to 10 in 1995 to 14 in 2005 to 16 in So no wonder the administration, storage and handling has become so complicated and so very important. How many of you have seen any of these diseases? Probably not many because of the successes of our collective immunization efforts. 3

4. How much money is in your storage unit?
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
1 box of Varicella Private $870.95
1 box of Varicella
VFC $724.90
Two boxes of Varicella $
Private Stock $
VFC Stock $
All vaccine in fridge $16,227.20 4

5. Success of Immunization Strategies
Dramatic decrease in vaccine preventable diseases
Tetanus, Haemophilus influenzae type b (Hib), Chicken Pox, Measles
Eradication of many diseases in the US
Smallpox, Diphtheria, Polio
We have had a lot of successes with reducing or eliminating many debilitating VPD’s. Infact, the World Health Organization has said that immunizations has been one of the greatest public health interventions next to clean drinking water, of rhe centry. So thank you to all of you who have had even the slightest role in vaccinating and protecting our children and now many adults. We have done so well at decreasing VPD that many parents and health professional have never seen many of these diseases. This is a good thing, a very good thing but it makes our job alittle harder. Now our challenge is in maintaining high immunization rates with safe and effective vaccines. We know that when vaccine is not properly stored or handled there is a possibilty the vaccine will loose it potency nd effectivness. This is where the provider comes in. Asyou recive vaccine in your practices are responsible for protecting it so that it when it is adminsitered it does what it is supposed to do. Additionally, vaccine is very expensive any wher from whether it is provided to you from the state VFC program or privatley purchased. The cost per dose of vaccine can range from $9 for 1 dose of Hep B to $120 for everyone of the 3 dose series of HPV. We all have a responsibilty to protect the vaccine and frankly that is why I am here today. You probably have heard that we ae looking at a pretty significant vaccine loss here at your facility and we would like to take that experience and make it a learning oppurtuity. So the remining of this presentation with focus on the quidelines of proper storage and handling of all vaccine. ovawe will review some of the have to assure that the vaccine that our children are receiving provided the optimal amount ojk

6. 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

7. 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.

8. 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.

9. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

10. 1. Maintaining Recommended Storage Temperatures
The “Cold Chain” – Vaccines must remain at proper temperatures
Manufacturer to distributor
Distributor to office/clinic
Office/clinic to patient

11. 1. Maintaining Recommended Storage Temperatures
Vaccines stored in the refrigerator
Temperature range is 35-46º F (2-8º C)
Store in middle of unit with air flow around vaccines to keep from freezing
Frequent opening may cause temperatures to fluctuate
Water bottles should be placed in the unit to help stabilize temperature
Assure the door is always closed and sealed

12. 1. Maintaining Recommended Storage Temperatures
Vaccines stored in the freezer
Temperature range is 5ºF (-15ºC) or colder
Do not allow frost/ice build-up to take place
Ensure door remains closed and sealed
Ice packs should be placed in the unit to help stabilize temperature
Check all vaccines to ensure you do not exceed “thaw” times
Do not refreeze vaccine
Add ice pack under Varicella vaccine

13. 1. Maintaining Recommended Storage Temperatures
Frost build-up example

14. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

15. 2. Vaccine Storage Requirements
Home-style combination refrigerator/freezer is acceptable only if each compartment has a separate door
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

16. 2. Vaccine Storage Requirements
Unacceptable storage unit with 1 door for fridge and freezer access
Permitted storage unit with separate doors
Separate controls highly recommended

17. 2. Vaccine Storage Requirements
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

18. 2. Vaccine Storage Requirements
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)
Must be big enough to hold largest inventory- think about flu season

19. 2. Vaccine Storage Requirements
Always store vaccines in their original boxes
Do not remove vaccine from box to place in separate storage containers
Store vaccine in their boxes. DO NOT DO THIS!!

20. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

21. 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

22. 3. Temperature Monitoring
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 ( )
Keep logs for 3 years

23. Traceable Certified Thermometer

24. Example of Certification Form

25. 3. Temperature Monitoring
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

26. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

27. 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

28. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

29. 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

30. Vaccine Storage and Handling 6 Focus Areas
Maintaining Recommended Storage Temperatures
Vaccine Storage Requirements
Temperature Monitoring
Vaccine Management
Vaccine Rotation
Common Errors
So for the remainder of the presentation today we will be focusing on these 6 very important areas.

31. 6. Common Errors Storage unit doors are not properly closed and sealed
Check 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

32. 6. Common Errors Vaccine inventory expires
Order vaccines carefully to ensure vaccines do not expire
Count inventory before ordering
Order only a 2 month supply
Attempt to locate a VFC provider to transfer short dated vaccine before it expires
Do not store expired vaccines with unexpired vaccines

33. 6. Common Errors
Upon arrival, vaccines are not inspected and immediately stored
Inspect vaccines on arrival
Immediately unpack and store vaccines
If vaccines are damaged, contact the VFC program within one hour of receiving shipment
Lynette Hanson, or
It is imperative that vaccines are checked immediately upon arrival. If the damaged vaccine or the error on the order is not reported by us within an hour after receipt at your facility, McKesson is not under any obligation to replace the order.

34. 6. Common Errors Improper handling of compromised vaccine
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 determined
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
Use your emergency storage and handling plan to prevent vaccine from being compromised
It is a requirement of the Vaccines for Children Program that you have an Emergency Plan in place so vaccine can be moved to another location if warranted.

35. Common Errors in Wisconsin
In 2010, the most common errors found during
VFC 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.

36. Common Errors in WI (cont)
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 least
one 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

37. 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.

38. 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!
Take home message,

39. 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:
Wisconsin Immunization Program
Jackie Nelson, State VFC Coordinator or

40. 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.
Jane Dunbar,
Jackie Nelson,