Vaccine Storage & Handling Part I: Selecting & Purchasing Equipment

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

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

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”

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.

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.

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!

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!

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

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: http://www.cdc.gov/vaccines/recs/storage/toolkit/storage-handling-toolkit.pdf

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…….

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.

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

Demonstration Of Top Shelf Freeze

Middle Shelf Glycol Buffered Probe

Top Shelf Glycol Buffered Probe

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.

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

A biologic-grade refrigerator is ideal

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

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.

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

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.

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

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

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.

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

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.

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.

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.

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 

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.

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.

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.

Purchasing Aids AAP has information sheets to help locate biologic-grade refrigerators http://www2.aap.org/immunization/pediatricians/pdf/VaccineStorageRF.pdf

Questions???

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

Thank You for Joining Us! If you have any questions or ideas for future webinar topics: Jose Lopez, Manager, Practice Management 847/434-4089 or jlopez@aap.org