1. Vaccine Storage & Handling Part I: Selecting & Purchasing Equipment

2. Today’s Agenda
Introduction
Presentation
AAP Resources
Questions (please submit online)
Adjourn

3. Today’s Presenter: Graham Barden, III, MD, FAAP
Member, Committee on Practice and Ambulatory Medicine (COPAM); Member, Section on Administration and Practice Management (SOAPM)
Biosketch & Picture

4. Why is Vaccine Storage Important?
“A common mistake that people make when trying to design something completely foolproof is to underestimate the ingenuity of complete fools."
From Douglas Adams in “Mostly Harmless”

5. Why is Vaccine Storage Important?
When vaccines are exposed to inappropriate temperatures, their potency and efficacy can be diminished or destroyed, increasing the risk that vaccinated children will not get optimal protection against disease.
Poor vaccine storage is very prevalent, even among pediatricians
A report by the Office of the Inspector General (OIG) published in June 2012 found that 76% of sampled VFC providers had vaccines that were exposed to temperatures outside of recommended ranges.

6. Why is Vaccine Storage Important?
Pediatricians provide most vaccines to children in the United States (90%)
Vaccines are one of the most successful intervention available in modern medicine, but in order to work, vaccines must be properly stored.
If discovered that vaccines were stored improperly, your practice may need to notify patients to be revaccinated.

7. How Do You Keep Vaccines Safe?
Which in Pediatrics, is the same thing as saying… How Do You Keep Your Patients SAFE?
By storing them in an appropriate environment at all times -
i.e., you need reliable storage units and certified thermometers to make sure the units ARE reliable!

8. How Do You Keep Vaccines Safe?
Store them at 2-8° C
Limit temperatures excursions!
Freezing, even briefly, can destroy some vaccines without leaving evidence!
Heat may shorten life span, and if exposure is long enough, destroy vaccines
By storing them in an appropriate environment at all times -
i.e., you need reliable storage units and certified thermometers to make sure the units ARE reliable!

9. How Do You Keep Vaccines Safe?
Reduce Risk that Vaccines will be Exposed to Temperature Excursions by having:
Excellent Refrigeration Units
Excellent Staff
Excellent Thermometers
Rapid Notification of Problems

10. CDC Recommendations
The CDC makes Vaccine Storage and Handling Recommendations and Requirements
State immunization programs must enforce the CDC’s requirements and often choose to adopt the recommendations as well
Currently these guidelines are available in the CDC Vaccine Storage and Handling Toolkit at:

11. CDC Recommendations
In 2012 CDC developed the following new recommendations regarding vaccines storage:
Use of stand-alone refrigerator and stand-alone freezer units suitable for vaccine storage rather than combination (refrigerator + freezer) or other units not designed for storing fragile biologics, such as vaccines, and…
Discontinuing use of dorm-style or bar-style refrigerator/freezers for ANY vaccine storage, even temporary storage, and…….

12. CDC Recommendations They ALLOW combination domestic units if:
1) Only the refrigerator section is used
2) Top shelf is not for vaccine storage (frequently ignored advice)
- drawers, doors and along the sides and back should also not be used for vaccine storage
This still may not create the ideal conditions for vaccine storage and are discouraged for use by CDC and AAP experts.

13. What is Wrong With Combo Units?
They are cooled with freezing air from the freezer
They have glass shelves that trap cold air and reduce air circulation
Much of the space is not usable for vaccine storage
There is no port for a thermometer wire to pass through

14. Demonstration Of Top Shelf Freeze

15. Middle Shelf Glycol Buffered Probe

16. Top Shelf Glycol Buffered Probe

17. Why replace your domestic combination unit?
To protect vaccine potency
To protect investment in vaccines (often $15,-$40,000 per provider)
To decrease risk of freezing (and thus destroying) refrigerated vaccine.
Storage space is likely inadequate & stand-alone units can hold much more vaccine than combination refrigerators.
Biologic-grade refrigerators have internal circulation fans, and wire shelves which greatly reduce the variation in temperature and allows for storage throughout the unit.

18. A biologic-grade refrigerator is ideal
Also known as medical-grade, or pharmacological-grade
These are designed for vaccine storage. They are designed to maintain a very precise and narrow temperature range (within 1-2 C) throughout
Circulating fans and wire shelves allow temperature to remain even and maximize useable space
Controlled by electronic / microprocessor thermostat, not mechanical dial

19. A biologic-grade refrigerator is ideal

20. Biological-Grade Electronic digital thermostats
Visible Digital Temperature Displays
Adjustable Wire Shelves
Interior Circulating Fans
Ports for Temperature Probes
Door Ajar Alarms
Options for “glass” or “solid”doors
Wide range of sizes
Optional locks for security

21. Biological-Grade
These may not be available immediately, plan 2-4+ weeks to receive this equipment
Measure carefully to ensure the unit will fit in your space
Especially pay attention to doorway measurements
Strongly recommend paying extra to have the unit delivered into your office, rather than just to the parking lot.

22. Alternatives for vaccine storage
Stand-alone (Freezer-less) Domestic Refrigerators
Twin Cooling Dual Domestic Refrigerators

23. Stand-alone (Freezer-less) Refrigerators
Minimal shelving in the doors, no ice maker, wire shelves and generally a cold plate on the back wall to cool the refrigerator.
Least costly alternatives to combination units at $600 to $900 depending on size.
Analog thermostat that requires adjustments and careful monitoring.

24. Twin Cooling Dual Refrigerators
Only domestic units with a totally separate cooling mechanism for the refrigerator and freezer sections
Refrigerator-only coils reduce the risk of freezing for the refrigerated vaccine (Models without ice makers are preferred.)
Electronic thermostat for increased accuracy of temperatures and less drift over time
Generally available on the same day at local retailers, but at a comparable cost to biologic-grade refrigerators
Space usage is not ideal. Glass shelves block air circulation and are designed with lots of unusable door storage
Has not been tested by NIST

25. Freezers CDC recommends a stand-alone freezer
The freezer section of a combination unit is disallowed by CDC guidance.

26. Freezers
Freezer management can be less precise in temperature regulation since they just have to be “colder than -15°C” (5°F)
Although it is nice to have digital thermostats on freezers, it is not as important as in refrigerators. However, the small freezers are cheap enough that two can be purchased to help with manual defrosting – the “cold spare” can safely hold the vaccine as the main freezer is defrosted.

27. Defrosting Freezers
The CDC currently recommends an “auto-defrost” freezer.
That feature is difficult to find in freezer-only units and generally quite expensive.
Freezers with manual defrost analog controls are acceptable and the small 1.1 to 1.5 cu. ft. models are inexpensive (between $200 and $300).
Purchase 2 and use one to store vaccines while you manually defrost the other
Maintenance of frozen temperature is especially problematic with defrost cycles. These cycles require warming of the freezer above the recommended temperature range of -15C to -58C

28. Storage Space in the Office
Before purchasing new vaccine storage units, assess the clinical space available and work-flow characteristics of your practice.
You may select one of two broad styles of vaccine storage:
bulk storage with smaller point of service (POS) refrigerators in the clinical area, and
centralized storage with one or more units.

29. Bulk storage with smaller point of service (POS) refrigerators
Bulk storage refers to having a large one- or two-door refrigerator placed either in or out of the clinical area.
The point of service (POS) refrigerators can be small and located at a nurses’ work station where vaccine will be prepared.

30. Bulk storage Advantages Disadvantages
Clinical staff have easy access to vaccines during their busy day
With a POS and bulk storage, the cumulative effect of the temperature variation is potentially less.
Potentially greater cost* of the smaller POS refrigerators (approximately $900) plus the bulk storage unit
More units that need temperature monitoring
The vaccine in the POS may be exposed to temperature variation from frequent door openings, but the small biologic-grade refrigerators are designed for this purpose and recover their temperature quickly.
The bulk storage unit where the vaccine spends most of its time has relatively few door openings on a daily basis.
*Since the bulk storage is rarely entered, you can use solid doors that are cheaper than the glass doors and retain cold longer in power outages.

31. Centralized Storage
Centralized storage refers to having one or more main refrigerators that store all of your practice’s vaccine.
Each dose is retrieved from that unit.
If space allows, you may have one large double-door refrigerator or two smaller units
One for VFC vaccine
One for private stock vaccine
Remember, VFC and private vaccine, even if stored in the same unit, should be kept separate and labeled 

32. Centralized Storage Advantages Disadvantages
Potentially less cost and fewer monitored units
Increased walking distance to a central unit
Potential for a traffic jam when more than one clinician needs vaccines
Frequent opening and closing of the door
The cost may not be much less since most opt for the more expensive glass door refrigerator when used in this way. The glass door helps the staff to pick the correct vaccination more quickly.
Frequent opening and closing of the door increases the potential for temperature variations and forces the unit to work harder to maintain temperature.

33. Under the Counter Units
If you use an under the counter unit, determine where it discards waste heat and make sure there is adequate ventilation
If to the rear, you need to be sure there is adequate ventilation behind the unit.
If to the front, there is usually a noticeable grill on the lower front of the unit.
Some of the smaller POS and freezers have their heat exchange coils in the outer side walls of the refrigerator. That keeps them from getting dusty or damaged, but you will need proper lateral and top clearance for heat to leave.

34. Choosing a Refrigerator
You will need to determine:
Size:
The easiest way to pick a refrigerator size is to consider what you currently have and assess your inventory and practice population needs.
Estimate how much room you currently have and how much you would rather have.
Study the published dimensions and compare to actual measurements of what you have
Plan for delivery – “Inside Delivery” a must!
Time for set up and temperature stabilization
What size of refrigerator should your practice pick?
In order to find the right size, measure what you are currently using and estimate what you’d like to have. Remember the rated size does not indicate the useful storage area. A 49 cu. ft., two-door refrigerator may have only 25cu. ft. of usable space! Visiting practices of a similar size may also help you decide the amount of room you need. For some, a 23 cu. ft. rate refrigerator with 5 shelves would likely be sufficient for a practice with two pediatricians that also uses a small (2.5 cu. ft.) POS refrigerator.
Additional considerations for size It is hard to have too much room! Extra vaccine storage allows you to take advantage of promotions in private vaccine purchasing as well as stocking up before a new higher price goes into effect. It is better to err on the side of having too much vaccine storage space than too little. Note the time of year that you will have the most vaccine stock when ordering. This may be during flu season or during back-to-school-physical crunch time.
Plan for the delivery of the refrigerator If you are ordering a double door refrigerator, be very careful to measure the height of all doorways. The double door units are too large to be tilted to go through a standard doorway. While large castor wheels can be removed, an inch or more is still needed for a specialized dolly to grip the edges. Some carriers offer “inside delivery” or “white glove” delivery for an extra charge. Strongly consider this service – it is worth the money not to have a large refrigerator left in your parking lot!
Plan for set-up time
Before you can safely use a new unit for vaccine storage, you must allow time for the unit’s temperature to reach and stabilize at the correct vaccine storage temperature. Depending on the unit, this could take up to a week. A reasonable expectation is 2 to 3 days. After connecting the unit to power, immediately place a data logger in the middle of the unit and monitor temperatures several times per day until the correct temperature is reached and stabilizes for several hours.
Quick Tip: You can also help to stabilize the temperature of a storage unit more consistently and protect against temperature variations from busy clinic days with frequent door openings/closing by using water bottles in refrigerators and ice packs in freezers as thermal ballast.

35. Purchasing Aids
AAP has information sheets to help locate biologic-grade refrigerators

36. Questions???

37. Thank You for Joining Us!
Next SOAPM-PPMA Webinar: Vaccine & Storage Handling Part II Mid-July 2014

38. Thank You for Joining Us!
If you have any questions or ideas for future webinar topics: Jose Lopez, Manager, Practice Management 847/ or