1. Practical Strategies to Prevent Vaccine Storage and Handling Errors
Teresa A. Anderson, DDS, MPH
Consultant
Deborah L. Wexler, MD
Executive Director
Immunization Action Coalition
National Immunization Conference
Washington, DC, March 30, 2011
coalition
immunization action
immunize.org

2. With thanks to Donna Weaver, RN, MN and Patricia Beckenhaupt, RN, MS, MPH National Center for Immunization and Respiratory Diseases, CDC
coalition
immunization action
immunize.org

3. Vaccine Storage and Handling
Vaccines are fragile and must be kept at recommended temperatures at all times. Some also must be protected from light.
Stock must be stored to avoid mix-ups of vaccines and diluents and to ensure expired or wrong vaccine or diluent is not used.
Once removed from storage, vaccines should be used promptly. Reconstituted vaccines have specific time limits for use.
It is better to NOT VACCINATE than to administer a dose of vaccine that has been mishandled, has expired, or is the wrong vaccine.

4. The results of storage and handling errors
If the error is recognized:
You may lose money (potentially a lot)
You may need to revaccinate anyone who received a dose of compromised/wrong vaccine
You may have to explain to irate parents why their children must repeat vaccine doses
The media might find out and provide your practice with negative publicity
If the error is not discovered, patients may be unknowingly susceptible to serious diseases.
CDC and IAC receive many phone calls and s from providers who have made errors. I will be sharing some examples along the way.
A Michigan study found that a typical pediatric practice had $12,000 worth of vaccines in storage. It has been estimated that improper storage and handling costs the VFC program more than $20 million each year.

5. This presentation will cover…
Developing comprehensive written vaccine storage and handling guidelines
Storing vaccines correctly to protect your expensive investment
Handling vaccines

6. Developing vaccine storage & handling guidelines
Develop written guidelines for standard and emergency vaccine storage and handling
Assign and train primary and back-up vaccine storage and handling (S&H) managers
Make sure all staff are familiar with your practice’s policies and procedures. This may include janitorial, security, reception, and mail staff.
Janitorial staff—E.g., so they don’t unplug refrigerator to vacuum. So they know to contact the vax manager if there is an after-hours problem.
Security personnel—notifying you of power outage, let you in building for emergency after-hours vaccine retrieval
Mail and reception staff—promptly handling shipment of vaccines to maintain the cold chain. Packages that contain vaccine should be opened immediately.

7. “… the majority of medical errors do not result from the individual recklessness or the actions of a particular group—this is not a ‘bad apple’ problem. More commonly, errors are caused by faulty systems, processes, and conditions that lead people to make mistakes or fail to prevent them. Thus, mistakes can best be prevented by designing the health system at all levels to make it safer--to make it harder for people to do something wrong and easier for them to do it right.”
According to this IOM report, at least 44,000 people, and perhaps as many as 98,000 people die in hospitals each year as a result of medical errors. Vaccination errors are not usually as deadly as surgical errors, but they are still serious and can be prevented. And they are common, especially as more vaccines become available and the schedule gets more complex.
From “To Err Is Human: Building a Safer Health System,” 1999 IOM report

8. Develop written vaccine S&H guidelines
Having everything in writing keeps everyone on the same figurative and literal page and helps avoid errors.
Develop written vaccine S&H guidelines
Develop plans and policies for both standard and emergency situations

9. Sample checklist of resources for routine vaccine S&H plan
Up-to-date contact info for: site S&H vax managers, state and/or local health dept IZ program, vaccine manufacturers, refrigerator and freezer maintenance & repair companies, sources for supplies (packing material, thermometers, etc.)
Descriptions of the roles & responsibilities of S&H vax managers
Summaries of the storage requirements for each vaccine & diluent in your inventory
Protocols for vaccine storage unit temp monitoring
Protocols for vaccine storage equipment maintenance
Protocols for vaccine inventory management
All this information (including related forms) is included in CDC’s online Toolkit for Vaccine Handling and Storage. The toolkit is under revision and currently unavailable, but we will provide information about it at the end of this presentation.

10. Sample checklist of resources for routine vaccine S&H plan (cont)
Protocols for the correct placement of vaccines within storage units
Protocols for responding to vaccine S&H problems
Protocols for receiving vaccine shipments
Protocols for transferring vaccine offsite (if applicable)
Policies for preparing for vaccine administration
Protocols for proper disposal of vaccine containers and supplies
Samples of the forms used in your vaccination program

11. You also need to develop a Vaccine Emergency Plan
Situations that may compromise vaccine storage conditions include equipment failures, power outages, and natural disasters.
When state officials or providers have reasonable cause to believe the weather conditions, natural disasters, or other emergencies might disrupt power or flood any office where vaccine is store, emergency procedures should be implemented in advance of the event.

12. Every clinic should have a written Emergency Vaccine Retrieval & Storage Plan that identifies a refrigerator and freezer with a back-up generator in which to store vaccine in the event of a power outage or natural disaster. Check with your state health department first. Consider contacting a local hospital or similar facility to be your back-up location if you should need it. The plan should also include emergency contact info, protocols for transporting vaccine, instructions for entering building after hours, etc.
Again, much more detail in CDC’s toolkit

13. Vaccine Storage and Handling Manager
Assign S&H responsibilities to two persons: a primary person and his/her backup
Provide training to both
These managers should be familiar with all aspects of vaccine storage and handling, including knowing how to handle vaccines when they arrive, how to properly record refrigerator and freezer temperatures, and what to do in case of an equipment problem or power outage.

14. Vaccine Storage Use the right kind of storage units
Store all vaccines appropriately (freezer or refrigerator)
Place vaccines in the most temp-stable spots within units
Do not store food or other medical supplies with vaccines
Use only calibrated thermometers that are certified for accuracy
Monitor & record refrigerator & freezer temps at least 2x/day
Take immediate action for out-of-range temps
Maintain temperature logs for at least 3 years
Prevent errors by using warning signs

15. Use the right kind of storage units
Stand-alone refrigerators and stand-alone freezers are best at maintaining required temperatures.
A combination refrigerator/freezer unit is acceptable for vaccines (but not optimal) IF the refrigerator and freezer compartments each have a separate external door.
Small single-door refrigerator-freezer units should not be used for vaccine storage storage.
VFC still allows for use of dorm-style combo units for temporary storage of small quantities of refrigerated (not frozen) vaccines. However, CDC does NOT recommend storing vaccines in such a unit, even for a short time. Based on research published in December 2009, the National Institute of Standards and Technology (NIST) concluded that “the dorm-style refrigerator is NOT recommended for vaccine storage under any circumstance.”  In performance testing, the dormitory-style refrigerator demonstrated consistently unacceptable performance, regardless of where the vaccine was placed inside the unit. 
Reasons:
Too hard to regulate temperature
Easy to freeze vaccine if near the top
Can forget to take out

16. Store all vaccine appropriately in the refrigerator or freezer
MMR*, MMRV, Zoster, Varicella
REFRIGERATOR
All vaccines but the above
(*MMR can be stored in either refrigerator or freezer)
These vaccines may be damaged by by freezing.
They can tolerate short times out of of of the refrigerator.
DTaP,Tdap Td, DT
Hib
HepA
HepB
HPV
IPV
TIV,LAIV
MMR*
MCV4; MPSV
PPSV; PCV13
Rotavirus
MMR*
MMRV
VAR
ZOS

17. Place vaccines in the most temperature-stable area of refrigerator.
The temperature in the vegetable bins, on the floor, next to the walls, in the door, and near the cold air outlet from the freezer (if applicable) may differ significantly from the temperature in the body of the refrigerator. Always store vaccines in their original packaging in the body of the refrigerator away from these locations. Place vaccine packages in such a way that air can circulate around the compartment. Stabilize temperature with containers of water to fill up the dead space.
Consider removing the vegetable bins from the refrigerator. This provides extra space for storing containers of water and also removes the temptation to use the bins for storage of food, beverages, or vaccines.
No vaccine stored in door.
Notice labeling!

18. In a combo unit, useful space is more limited.
In a combo unit, the usable space is limited. Note how vaccines must be kept away from the cold air vent from the freezer.

19. Place vaccines in the most temperature-stable area of freezer.
Freezer: Store vaccines in the middle of the unit. Place vaccine packages in such a way that air can circulate around the compartment. Stabilize temperature with frozen packs or ice trays stored along the walls, back, and inside the racks of the door. Always store vaccines in their original packaging.

20. Do not store ANYTHING ELSE in the refrigerator
If you MUST store another biologic product in the refrigerator, place it BELOW the vaccines on a different shelf. This prevents contamination of the vaccines should the product spill, and reduces the likelihood of medication errors. NOT recommended by CDC.
Frequent opening of the refrigerator door to retrieve food items can adversely affect the internal temperature of the unit and damage vaccines. Storing other medications can lead to mix-ups, overpacking, contamination, and more frequent opening of the unit.

21. Use ONLY a calibrated thermometer with a Certificate of Traceability and Calibration
For measuring vaccine storage unit temperatures, CDC recommends using only calibrated thermometers with a Certificate of Traceability and Calibration. The traceability declaration is to confirm that the measurement standards and instruments used during calibration of the product are from an ISO (International Organization of Standardization) accredited testing laboratory, to NIST (National Institute of Technology), or to another internationally recognized standards agency.
Do NOT use uncertified liquid or dial-type household thermometers. These are not accurate enough to protect your expensive vaccine.
Continuous recording provides the most information—with the other 2 types, you could have an out-of-range temperature fluctuation that isn’t caught—Albert will talk about this.
The thermometer should be placed in the center of the compartment away from the coils, walls, floor, and cold air vent to obtain a true reading.
Check with the manufacturer to determine if and when recalibration is necessary. Purchasing a replacement thermometer may be less expensive than recalibration.

22. Monitor and record refrigerator & freezer temperatures
At least twice daily
First thing in the morning
and
At clinic closing time
Temperatures fluctuate throughout the day, so should be checked at the beginning and end of the day to determine if the refrigerator and freezer units are getting too cold or too warm. Ideally, you should have continuous thermometers that measure and record temperatures all day and all night—Albert will discuss.
You can always monitor the temperatures more frequently, especially if you think a problem might be developing.
Recently published study of 54 refrigerators in a county health department in Texas using digital data loggers for monitoring the temp (every minute), found that 24% had protracted periods of temperatures below freezing. This finding suggests that improper storage of vaccine may have contributed to an increase in pertussis rates in the area.

23. Maintaining acceptable temperatures
Refrigerator compartment should maintain temperatures between 35° and 46°F (2° and 8°C). Best to set the temperature mid-range at 40°F (5°C) for the best safety margin.
Freezer compartment should maintain a temperature of 5°F (-15°C) or colder.
Only the primary or backup vaccine S&H manager should adjust the thermostat of a vaccine storage unit.
Monitor the temperature in a new or repaired unit for week before using it for vaccine storage.

24. Take IMMEDIATE action for out-of-range temperatures
Make it easy to do right—notice how you are more likely to notice the out-of-range temperature because it is recorded in the red area.
Don’t want to be like the practice that wrote that their temperatures had been out of range for an “extended” period of time with the result being they had many 2-year-olds who received 4 doses of DTaP, ALL of which were stored improperly.

25. Maintain temperature logs for at least 3 years
It’s important that you keep your temperature logs for at least three years (longer if your health department or institution requires it). As the refrigerator ages, you can track recurring problems. If out-of-range temperatures have been documented, you can determine how long this has been happening and take appropriate action.
If a continuous recording/graphic thermometer is used, the graphs should be kept with the logs for 3 years.
It’s a good way to lobby for a new refrigerator!

26. Take Preventive Measures
Use a plug guard or safety-lock plug
Post a warning sign at the plug and on the refrigerator and freezer
Label fuses and circuit breakers
Install temperature alarms for each unit
Make it easy to do the right thing and hard to do wrong!

27. Vaccine Handling Develop inventory management protocols/stock records
Rotate stock to use up older vaccine first (place in front). Remove any expired vaccine.
Store vaccines and diluents in a way that will best avoid mix-ups
Keep vaccines in their boxes until ready to use
Open only one vial at a time
Label vaccines once drawn into a syringe
Use reconstituted vaccine within the time limit
Don’t prefill syringes (except in limited situations)
I won’t be going into any more detail on a couple of these points—keeping vaccines in their box (some are light-sensitive and it also avoids mix-ups) and opening one vial at a time are pretty self-explanatory.
HPV, MMR, MMRV, varicella, rotavirus, and zoster vaccines are sensitive to light.

28. Inventory Management Protocols
Proper inventory management means knowing:
Quantities of vaccines & diluents received
Which vaccines & diluents are currently in stock
Which vaccines & diluent vials should be used first
Which vaccine & diluent vials have expired
What quantities of vaccines & diluents have been administered, wasted, or spoiled
How many vials are in excess supply and might be returned for credit
Which vaccines & diluents need to be ordered
We received many letters about situation where patients have been given an expired vaccine—no one is happy!

29. Guiding principles for ordering vaccine
Order and stock enough vaccine to meet the needs of your patients. This is typically enough to last 60 days with a re-ordering threshold of 30 days.
Do not over-order vaccines. This can lead to unused vaccine expiring. You also risk losing a large quantity of vaccine (and money) in the event of a S&H accident.
Try to order vaccines in one large order rather than multiple small orders. This minimizes the number of vaccine shipments your practice must handle and keep track of within the cold chain.
The updated VFC Operations Guide states:  “Order vaccine in accordance with actual vaccine need.”

30. Use older vaccine first and check the expiration date
Almost all multi-dose vials of vaccine contain a preservative and can be used until the expiration date on the vial unless it has been contaminated. Vaccine may be used through the last day of the month indicated on the expiration date.

31. Store vaccines and diluents to avoid mix-ups
Store vaccine products that have similar packaging or names in different locations to avoid confusion and medication errors
Store adult and pediatric versions of the same vaccine on different shelves
Make clear which diluents go with which vaccines
Keep VFC and privately purchased vaccine separated and labeled
Store vaccine boxes in bins or baskets and LABEL!
A study using the largest medication error reporting database in the U.S. found that administration of the wrong vaccine was commonly reported.
Such errors usually involved vaccines whose generic or trade names looked or sounded alike (Tdap/DTaP, Adacel and Daptacel), or which have similar packaging.
We receive many s about Tdap and Dtap mix-ups and many also about dosage errors (adult hep B or A given to child or vice versa). Varicella-containing vaccines (Varivax, Zostavax, and MMRV) are also confused—keep in mind that Zostavax vaccine contains about 14 times as much varicella vaccine virus as Varivax.
Also mix-ups with the wrong diluent being used: “Someone in our office inadvertently spilled a couple of boxes of vaccine in our fridge and when they put the various things back in their boxes, put a HIB reconstitution solution into the sterile diluent box. Because of this, someone gave a varicella vaccine reconstituted with the HIB solution.”

32. A helpful resource from California—making it easier to do right.

33. Once a vaccine is drawn into a syringe, the content should be indicated on the syringe. There are a variety of methods for identifying or labeling syringes (e.g. keep syringes with the appropriate vaccine vials, place the syringes in a labeled partitioned tray, or use color coded labels or preprinted labels).
Had one about a practice where 2 adolescent sisters were supposed to get a dose of varicella and one of meningococcal each—instead one sister got 2 varicella and one sister got 2 mening.

34. Prefilling syringes? This practice is strongly discouraged by CDC
May result in vaccine administration errors
You may consider in situations of heavy use of a single vaccine (e.g., annual influenza clinic)
The pre-drawn syringes should be stored at temperatures appropriate for the vaccine they hold
Do not draw more than 1 vial or 10 doses (whichever is greater) into syringes
Syringes other than those filled by manufacturer should be discarded at end of clinic day. Also, manufactured pre-filled syringes that have had the caps removed and a needle attached to the syringe should be discarded at the end of the day.
More details about this in CDC’s toolkit.
Only a single type of vaccine (e.g., influenza) is administered at the setting
Vaccine is not drawn up in advance of its arrival at the mass-vaccination clinic site
Clinic staff monitor patient flow carefully and avoid drawing up unnecessary doses or delaying administration of pre-drawn doses.

35. Storage and handling resources from IAC
Checklist for Safe Vaccine Handling and Storage
Don’t Be Guilty of These Errors in Vaccine Storage and Handling
Vaccine Handling Tips
Maintaining the Cold Chain During Transport
Emergency Response Worksheet

36. Storage and handling resources from IAC
Temperature Log for Vaccines (Fahrenheit)
Temperature Log for Vaccines (Celsius)
“Do Not Unplug” sign (color)
“Do not stop power to circuit breaker” sign
Vaccines with Diluents: How to Use Them
Piece on diluents includes detailed information on how to reconstitute and how long such vaccines can be used after reconstitution.

37. Storage and handling resources from CDC
This 20-page guide provides shipping requirements; condition upon arrival; storage requirements; shelf life; instructions for reconstitution and use; shelf life after reconstititution, thawing and opening; and any special instructions for all recommended vaccines. Go to:
Also can check the package inserts

38. Storage and handling resources from CDC
CDC’s Vaccine Storage and Handling Toolkit is being revised and will be available again soon. Subscribe to IAC Express ( to be informed when this resource is back online.

39. Storage and handling resources from EZIZ
EZ-IZ is a project of the California VFC program. The EZ-IZ website offers helpful resources on vaccine S&H, including information on how to select good storage units, best setups for freezer and refrigerator storage, and more. The site also offers free online training about various topics.
For storage and handling resources, go to:
To access all of EZ-IZ’s resources, go to:
They also have resources on administration and more.

40. Need more help?
Call your state immunization manager (contact information can be found at
Contact the vaccine manufacturer
CDC’s experts:
IAC:
coalition
immunization action
immunize.org

41. Teresa A. Anderson, DDS, MPH tanderson@immunize.org
Deborah L. Wexler, MD
Immunization Action Coalition
1573 Selby Avenue, STE 234
Saint Paul, MN 55104
coalition
immunization action
immunize.org