1. Vaccine Storage & Handling Part II: Vaccine Monitoring, Transport, & Disaster Preparedness

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

3. Today’s Presenter: Graham Barden, III, MD, FAAP Completed Undergraduate Degree at Duke University, Medical Degree at Duke University Medical School, & Pediatric Residency at Vanderbilt University Member, Committee on Practice and Ambulatory Medicine (COPAM) since 2011; Member, Section on Administration and Practice Management (SOAPM) since 1998; Active Member, North Carolina Chapter Coastal Children’s Clinic in New Bern, North Carolina

4. Before Giving a Vaccine… You should know that: A) The Expiration Date has not been reached B) The Cold Chain has not been broken

5. Why is vaccine monitoring important? Appropriate monitoring can prove that a vaccine has been stored according to the manufacturer’s specifications and therefore is 1) Safe to give to a patient ~ And ~ 2) Is fully potent when given

6. Temperature Excursions Temperature excursions are events where a buffered thermometer in with vaccine measures a temperature outside of +2-8 C for refrigerated vaccines, or outside of -50 C to -15 C for frozen vaccine. It is important to know the maximum temperature deviation as well as its duration.

7. Thermometer Types 1)Old Fashioned mercury-in-glass with or without a temp buffer - Mercury has been replaced with other fluids -Although accurate, they generally do not work well for vaccines since max/min is not continually monitored -Cannot be read remotely -Easily broken 2) Electronic Thermometers - measures temperature by measuring the resistance of a wire probe to an electrical current

8. Electronic Thermometers - Can easily record the Maximum and Minimum temperatures reached during a set period -Can display values on the outside of a refrigerator with the probe reading wirelessly or by a thin wire into the refrigerator/freezer -Can record sequential temperature data for extended periods (data loggers) -Can be designed to measure “air” temp or a “buffered” temperature. -Rarely lose calibration

9. What do I need for proper vaccine thermal monitoring? Electronic Certified Thermometers capable of displaying max/min data Continuous data logger (optional) Glycol or other temperature buffer Manual data log Alarm dialer for automatic notification of staff of excursions or power outages (optional)

10. What features should you look for in a thermometer/data logger? Outside-mounted, digital display Shows minimum, maximum, and current temperatures Accurate to +/- 0.5°C Ample storage (at least 4,000 readings or more) & thus allow for several weeks or months of recording Easy archiving & displaying of data Valid certificate of traceability and calibration testing

11. What features should you look for in a thermometer/data logger (cont.)? Hi/Lo audible alarm for out-of-range temperatures Low battery indicator Data recording loops – records over oldest data – when memory is full* Detachable temperature buffered probe, which allows the cord to pass through the port on biologic-grade refrigerators instead of the door User programmable logging interval of 10 minutes or less

12. Recording of Data Even with a data logger it is required that you continue to manually check the temperature twice daily, and record it by hand in a log. Remember to download and review data weekly and always clear/reset the data logger to preserve adequate memory. Data should be stored for 3 years. Documentation of known excursions or thermometer malfunctions should be recorded along with the raw data and should include corrective actions taken to address the excursions. Software will likely be needed in order to view the stored data.

13. Phone-enabled thermometers Max/min thermometers keep patients safe by telling you the vaccine has experienced an excursion and “probably” should not be used; Data Loggers can tell you the duration of excursion and saves vaccine that might still be good despite the excursion; Phone-enabled thermometers can call you for help or be queried for current temp – thus they are able to PREVENT damage to vaccine stock, not just quantify the damage

14. “Air” vs. “Buffered” thermometers “Air” data logger thermometers are able to record rapid air temp changes and thus are useful for characterizing a new refrigerator or transport method. “Buffered” data loggers/thermometers should be used to capture what a vaccine actually experiences. These are the readings that matter when deciding if a vaccine is damaged or not.

15. What is a Certificate of Traceability and Calibration Testing? CDC Thermometer Requirements include: “Thermometer calibration must be tested annually or according to the manufacturer’s recommendation by a laboratory with accreditation from an International Laboratory Accreditation Cooperation (ILAC) Mutual Recognition Arrangement (MRA) signatory body.”

16. Options When Certificate Expires CDC recommends one of the following: 1) Have the accuracy of your thermometer tested by an accredited laboratory (RECERTIFY) 2) Purchase NEW thermometer with a Certificate of Traceability and Calibration Testing (generally the cheapest option) 3) Contact your immunization program for resources on checking the accuracy of your thermometer…

17. Having your thermometer calibrated Sending your thermometer to a lab for re- certification will require: Removing the probe and display unit from all storage units. Installing a backup certified unit that is also in date. Re-connecting your newly certified thermometer

18. Purchase a new certified thermometer Significant expense replacing all thermometers, but LESS than recertifying if the minimalist thermometer is purchased. Will have to order one every 11 months.

19. Ice melting point test This option must be approved by your VFC Coordinator. It allows you to test your thermometers without disrupting your vaccine monitoring system. Essentially measures the temperature of a slurry of ice water & compares that value to 0.0 C

20. Alarm Dialers Alerts/Alarm phone-dialer (alerts through landline, text, e-mail and/or mobile phone). A phone-dialer is able to alert you to a temperature excursion during the event so the situation can be corrected in time to prevent the loss of vaccine. No single notification method works best in all situations – sometimes you may need a combination of methods.

21. Alarm Dialers (cont.) Understand the likely outages (local and regional power failure, local and regional internet service, local and regional phone/cellular/VOIP) that you may experience and understand the notification system can fail under such conditions. Your office should have a plan in place for vaccine storage and transport during emergencies.

22. Transporting Vaccine While it is best to never transport vaccine, on occasion moving vaccine is necessary. I will discuss how to do so safely….

23. Vaccine Transport When can you transport vaccine? During an emergency or power outage expected to last over 4 hours – if there is a safe place with proper storage units to receive the vaccine. When your vaccine storage equipment is not functioning. When you need to redistribute vaccine among different clinics. This should not happen often. All attempts should be made to order correctly for each clinic. When is vaccine transport prohibited? Never transport multi-dose vials of vaccine that have been opened. That is against FDA regulations. All opened vials must be used in the facility that opened them.

24. General rules for transporting vaccines Transport refrigerated-vaccine in a separate container than frozen vaccine (those containing Varivax). Always hand-carry by a trusted & trained employee. Do not delegate to a commercial service. –Do not place in the trunk of the vehicle – carry in the passenger cabin. –Use an attached probe or wireless unit to constantly monitor temperature. –Promptly unpack and place into appropriate storage units upon arrival. Never use dry ice, not even for frozen vaccine.

25. General rules for transporting vaccines Whatever method you use, do dummy tests with an air data logger or max/min thermometer BEFORE you transport real vaccine! Always prove to yourself that your method works as expected!

26. Devices for Transporting Vaccine Active Cooling: 12v Refrigerators and freezers that can draw current from your car during the actual transport Passive Cooling: Uses chilled coolant (frozen half-liter bottles) and thick walled coolers to avoid warming.

27. Devices for Transporting Vaccine (Cont’d) Active Cooling: 1) Potentially dangerous to refrigerated vaccine by over- cooling (freezing) 2) Possibly only method for transporting frozen Varivax containing vaccines 3) Must be tested with data logger prior use

28. Devices for Transporting Vaccine (Cont’d) Passive Cooling: 1) Practical for short transports and those lasting 24 hours or more 2) Very predictable results with fewer variables 3) Has to be pre-planned so coolant is chilled prior need 4) New phase-change gel packs at +5C and -20C (rather than 0C like ice) may improve techniques greatly

29. Cooling Materials For refrigerated vaccine in a cooler: Appropriately conditioned, frozen gel packs or conditioned frozen water bottles (CFWBs) –CFWBs are clear plastic drinking water bottles (available by the case at grocery stores) that have been hard frozen and then “conditioned.” –Conditioning means warming them until a small amount of liquid water is visible on the inside of the bottle indicating the solid ice has begun to melt. For frozen vaccine in a cooler: Very difficult to do without using Dry Ice (CDC feels dry ice may over freeze vaccine by being less than -50C) Can be done using special phase-change material where the phase change occurs colder than -15C. Water bottles or gel packs that are not “conditioned” may be colder than 0 degrees C and can freeze vaccine. Freezing refrigerated-vaccine can render them impotent. Take precautions to never freeze these vaccines!

30. Procedure for packing refrigerated vaccine If available, place vaccine and diluents in a portable, tested, monitored, powered refrigerator. If a portable refrigerator is not available, layer the following into a Pre-Chilled passive cooler: –a row of CFWBs on the bottom, cardboard (this will protect the vaccine paper boxes from condensation), –the refrigerated vaccine & corresponding diluent, –more cardboard, –another layer of CFWBs on top. If the cooler is not big enough for two layers of bottles, at least put one layer on top of the vaccines (with a layer of cardboard in between). Place a calibrated chilled thermometer (preferably a buffered thermometer viewable from outside) in as close to the vaccines as possible.

31. Procedure for packing frozen vaccine It is imperative that varicella-containing vaccine be transported frozen. Although it may arrive from the manufacturer warmer than -15 ° C, once you receive it, it must be stored between -50 ° C and -15 ° C. This is a difficult vaccine to transport safely. If it must be transported, aim for a travel time of < 1 hour, and: –Store a small soft cooler(s) in your office freezer with frozen gel packs to pre-chill the soft cooler. –Place the Varicella-containing vaccine in the soft cooler(s) along with a small data logger if possible and then place that container(s) in a larger polystyrene or similar thick-walled cooler with a large number of hard frozen gel bricks below and above. –Pack a freezer thermometer in the larger cooler so that the transport temperature can be verified on arrival. –Document times and temperatures during transport. Call the manufacturer (Merck) at 1-800-637-2590 or your VFC coordinator as soon as possible whenever Varicella-containing vaccine has been warmer than -15°C. Merck or your VFC coordinator can advise you whether the vaccine can still be used.

32. Other transport tips Transport diluents with corresponding vaccines, never freeze diluents. Always continue to monitor temperature of vaccines when transporting, and when stored at a temporary location. Only remove vaccine that will be administered immediately from its temporary storage location. Keep temporary storage containers closed as much as possible.

33. Planning for Disaster The following events may jeopardize your practice’s ability to maintain vaccine at the appropriate temperature: Storage unit malfunction Power outages Natural disasters Other emergencies

34. Steps to take before the emergency Designate primary and alternate vaccine coordinators with emergency contact information. In addition to routine vaccine storage activities, coordinators should: Monitor the operation of the vaccine storage equipment and systems; Track inclement weather conditions; Set up and maintain a monitoring/notification system during times of inclement weather or other conditions that might cause a power outage (a continuous- monitoring temperature alarm/notification system should be considered, especially for facilities with large inventories, see AAP Data Loggers and Vaccine Monitoring;AAPData Loggers and Vaccine Monitoring

35. Steps to take before the emergency (cont.) Post emergency contact information on circuit breaker(s) or electrical panel; Ensure the appropriate handling of vaccine during a disaster or power outage; Ensure 24-hour access to the building and vaccine storage unit(s). Ensure backup energy source (generator). Ensure that sufficient fuel is on hand to continuously run the generator for at least 72 hours.

36. Steps to take before the emergency (cont.) Have your written emergency vaccine storage and handling plan posted where staff can easily find it, preferably near the vaccine storage units. Ensure access to up-to-date phone numbers for vaccine distributers, vaccine manufacturers, and VFC Coordinators. Ensure all staff read and understand the emergency vaccine storage and handling plan. List the name and contact information of a local refrigeration repair shop that could potentially fix a failed unit.

37. Developing your emergency plan Designate an alternate site with 24-hour access where vaccines and diluents can be safely stored. Develop written protocols and list of vehicles and drivers for transporting vaccines to and from the alternate vaccine storage facility. Obtain and store an adequate number of appropriate packing containers and materials (e.g., polystyrene coolers, frozen water bottles, bubble wrap) in the facility where the vaccines will be packed for safe transport. –Communicate to staff where everything is kept. –Include written directions for packing vaccines and diluents for transport. –A max/min thermometer or data logger should be placed in each packing container.

38. Sample activities to include in your emergency plan Building security/after hours access procedure Floor diagram, Alarms (including instructions for use) Door location Flashlights locations Spare batteries location Light switches location Keys location Locks location Circuit breakers location Packing materials location Incorporate written procedures for managing potentially compromised vaccines. Include contact information for vaccine manufacturers and/or the VFC Coordinators. Include written instructions for entering your facility and vaccine storage spaces in an emergency if the building is closed. These instructions should include:

39. During a power outage Do not open freezers and refrigerators, except to transport vaccine to an alternative storage location, if alternative storage with reliable power is available. Refrigerators will generally be warmer than 8 °C within 4 hours of a power outage. If it is likely for the power to be off for more than 4 hours, plan on moving the vaccine to a safer location. Always carefully follow proper transport protocols. Monitor temperatures during transport using wireless or wired remote probes.

40. During a power outage (cont.) Do not discard vaccine that has been warm. Most vaccines are heat tolerant. Immediately segregate all compromised vaccine in a container or (trash) bag and place refrigerated-vaccine between 2°C and 8°C and frozen vaccine at ≤ -15°C. Mark “DO NOT USE” on the sealed bag. Call vaccine distributers and VFC Coordinators to cancel any upcoming vaccine deliveries.

41. Once power is restored Record the temperature in the vaccine storage unit as soon as possible, after the power has been restored. Continue to monitor and record. It can take a domestic refrigerator 4-8 hours to cool below 8°C Record the duration of any temperate excursions observed. Separate any vaccine product exposed to temperature excursions from vaccine that was not exposed, but store the compromised vaccine in the proper temperature range until final dispensation. Mark “DO NOT USE”.

42. Once power is restored (cont.) Do not administer or discard any vaccine that has been exposed to temperature excursions until speaking with the proper authorities. –Call your VFC Coordinator to report the event and ask for advice on handling the compromised vaccine. You should also report any privately purchased compromised vaccine directly to the appropriate manufacturers. It is possible that your VFC Program and the manufacturer may have differing guidance, and you may have to clarify with both parties which is the most appropriate. –If instructed that private vaccine should not be administered, discuss returning the vaccine for a credit with the vaccine manufacturer. –Document the event, the calls, and the corrective action taken in your vaccine log book. Notify vaccine distributers or VFC Coordinator to resume vaccine deliveries.

43. Possible Alternative to Transporting Although not yet recommended by the CDC, it is possible to “Shelter In Place” and not actually leave the building for a power outage expected to last longer than 4 hours. Transporting vaccine has its own risks. Sometimes staying on-site with passive cooling is the safest option.

44. Shelter In Place You will need: 1)A supply of frozen half-liter water bottles (~20+ = $4) 2)A supply of either thick-walled Styrofoam coolers or igloo “camping/fishing” coolers 3)Or a solid door refrigerator (not glass – glass-door’d refrigerators leak cold too easily)

45. Shelter In Place (cont’d) The procedure: 1) Condition the frozen water bottles by placing each in water for approximately one minute until liquid water is visible. 2) Place 4 or more CFWB’s on top of the vaccine in the coolers and close lid. 3) Or place 20 or more on the top shelf of a solid door refrigerator with the vaccine moved to lower shelves

46. Shelter In Place (cont’d) If time is available, it is best to pre-chill the coolers with the hard frozen water bottles for 15-30 minutes before adding vaccine. If free water is visible in the bottles after chilling the coolers, conditioning the frozen water bottles further is not necessary. Remember, always test techniques before using them!

47. AAP Resources AAP Immunization Web Site: http://www2.aap.org/immunization/inde x.html http://www2.aap.org/immunization/inde x.html AAP has information sheets to help locate biologic-grade refrigerators: http://www2.aap.org/immunization/pedi atricians/pdf/VaccineStorageRF.pdf http://www2.aap.org/immunization/pedi atricians/pdf/VaccineStorageRF.pdf AAP Vaccine Storage and Handling PediaLink course: http://bit.ly/vaccinestorage http://bit.ly/vaccinestorage

48. Questions???

49. 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.orgjlopez@aap.org