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Wisconsin Department of Health Services Vaccine Storage and Handling Update Jackie Nelson, Coordinator Vaccines for Children Program Wisconsin Division.

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Presentation on theme: "Wisconsin Department of Health Services Vaccine Storage and Handling Update Jackie Nelson, Coordinator Vaccines for Children Program Wisconsin Division."— Presentation transcript:

1 Wisconsin Department of Health Services Vaccine Storage and Handling Update Jackie Nelson, Coordinator Vaccines for Children Program Wisconsin Division of Public Health Immunization Program

2 Wisconsin Department of Health Services Why all the fuss over storage and handling? Whats in your storage unit?

3 Wisconsin Department of Health Services Number of Vaccines in the Routine Childhood Immunization Schedule 1985 (7)1995 (10)2005 (14 ) 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 Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio Measles Rubella Mumps Diphtheria Tetanus Pertussis Polio Hib (infant) Hepatitis B Varicella Pneumococcal Disease Influenza Meningococcal Hepatitis A HPV Rotavirus 2012 (16)

4 Wisconsin Department of Health Services 1 box of Varicella Private $ box of Varicella VFC $ Two boxes of Varicella $ Private Stock $ VFC Stock $ All vaccine in fridge $16, 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?

5 Wisconsin Department of Health Services Success of Immunization Strategies Dramatic decrease in vaccine preventable diseases o Tetanus, Haemophilus influenzae type b (Hib), Chicken Pox, Measles Eradication of many diseases in the US o Smallpox, Diphtheria, Polio

6 Wisconsin Department of Health Services Office of the Inspector General Report Study was conducted in April/May 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 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

10 Wisconsin Department of Health Services 1. Maintaining Recommended Storage Temperatures The Cold Chain – Vaccines must remain at proper temperatures o Manufacturer to distributor o Distributor to office/clinic o Office/clinic to patient

11 Wisconsin Department of Health Services 1. Maintaining Recommended Storage Temperatures 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 fluctuate o Water bottles should be placed in the unit to help stabilize temperature o Assure the door is always closed and sealed

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

13 Wisconsin Department of Health Services 1. Maintaining Recommended Storage Temperatures Frost build-up example

14 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

15 Wisconsin Department of Health Services 2. Vaccine Storage Requirements Home-style combination refrigerator/freezer is acceptable only if each compartment has a separate door o 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 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services 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 )

19 Wisconsin Department of Health Services 2. Vaccine Storage Requirements Always store vaccines in their original boxes Do not remove vaccine from box to place in separate storage containers

20 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

21 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services Traceable Certified Thermometer

24 Wisconsin Department of Health Services Example of Certification Form

25 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

27 Wisconsin Department of Health Services 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 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

29 Wisconsin Department of Health Services 5. Vaccine Rotation Before new supply of vaccine is ordered, check current supply and order enough vaccine to cover a 2 month period. Rotate stockshort 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 Wisconsin Department of Health Services Vaccine Storage and Handling 6 Focus Areas 1.Maintaining Recommended Storage Temperatures 2.Vaccine Storage Requirements 3.Temperature Monitoring 4.Vaccine Management 5.Vaccine Rotation 6.Common Errors

31 Wisconsin Department of Health Services 6. Common Errors Storage unit doors are not properly closed and sealed o 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 Wisconsin Department of Health Services 6. Common Errors Vaccine inventory expires o Order vaccines carefully to ensure vaccines do not expire Count inventory before ordering Order only a 2 month supply o Attempt to locate a VFC provider to transfer short dated vaccine before it expires o Do not store expired vaccines with unexpired vaccines

33 Wisconsin Department of Health Services 6. Common Errors Upon arrival, vaccines are not inspected and immediately stored o Inspect vaccines on arrival o Immediately unpack and store vaccines o If vaccines are damaged, contact the VFC program within one hour of receiving shipment o Lynette Hanson, or

34 Wisconsin Department of Health Services 6. Common Errors Improper handling of compromised vaccine o 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 o 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 o Use your emergency storage and handling plan to prevent vaccine from being compromised

35 Wisconsin Department of Health Services 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. Common Errors in Wisconsin

36 Wisconsin Department of Health Services 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 Common Errors in WI (cont)

37 Wisconsin Department of Health Services 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)

38 Wisconsin Department of Health Services 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!

39 Wisconsin Department of Health Services 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 o Jackie Nelson, State VFC Coordinator or

40 Wisconsin Department of Health Services 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, o Jackie Nelson,


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