DON T PUT YOUR VACCINES IN

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1 DON T PUT YOUR VACCINES IN Proper Vaccine Storage & Handling Techniques Lena Boulanger, Vaccine Accountability Coordinator Lori Johnson, Vaccine Quality Specialist Sheryl Proulx, Asst. Vaccine Accountability Coordinator NH Immunization Program March 21, 2018 Proper Vaccine Management is key to the successful efforts against vaccine-preventable disease. Vaccines exposed to temperatures outside the recommended ranges can have reduced potency and protection. Storage and handling errors can cost thousands of dollars in wasted vaccine and revaccination. Errors can also result in the loss of patient confidence when repeat doses are required. It is better to not vaccinate than to administer a dose of vaccine that has been mishandled. Vaccine management, including proper storage and handling procedures, is the basis on which good immunization practices are built. 1

2 VACCINE CDC COST/ DOSE PRIVATE SECTOR COST /DOSE PENTACEL $56.73 $92.58 GARDASIL $ $ MENACTRA $89.16 $ VARICELLA $92.72 $ MMR $20.59 $

3 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport

4 What is A. Mother Nature s fury? B. Children moving during administration or parent changing mind? C. Not observing or tracking expiration dates allowing vaccine to expire? D. Not packaged properly during shipping? IF A COMBINATION MUST BE USED Recommended-use the refrigerator section only and acquire stand alone freezer for frozen vaccine. NHIP/VFC Requirement-Combinations must have dual controls for proper adjusting of temperatures.. No Dorm Style 4

5 Dorm or bar-style units pose a significant risk of freezing vaccine even when used for temporary storage. Dorm /Bar style is described as a small combination refrigerator/freezer unit that has one exterior door and an evaporator plate (cooling coil) which is usually located inside the refrigerator. Your Current unit is 10 years or older Your vaccine usage is increasing-needing more room for proper air circulation The seals on your current unit are loose or leaking air and door does not close tightly Maintenance calls on current unit are increasing due to unexplained out of range temps You observe ice or water in your unit Your recorded temperatures have become unstable 5

6 Refrigerator and Freezer capacity guidelines Refrigerator Freezer 6

7 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport What is A. A retro colored refrigerator? B. A dorm style refrigerator? C. A combination refrigerator/freezer unit? D. A tabletop refrigerator? 7

8 Wire shelving best for air circulation Vaccine in open/ventilated baskets Separate State supplied vaccine from private Baskets clearly labeled Keep vaccines in original boxes Earliest expiration to the front of the shelf Do not store in drawers, on floor or door of unit Water bottles throughout the unit and on doors if equipped Glycol bottle in center of unit Fasten door closed with velcro or clasp No food/drink PRIVATE SUPPLIED VACCINE STOCK STATE SUPPLIED CHILDREN S VACCINE STOCK 8

9 A.Solid storage bins do not provide good air flow B. Vaccines touching unit walls C. Vaccines stored on unit door D. Unit is too full 9

10 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport What are A. Cold gel-packs? B. Cans of soda? C. Water bottles? D. Coolant fans? 10

11 Correct vaccine storage temperatures ensure that the vaccines are effective when they are administered to patients, and help prevent unnecessary wastage of these expensive products. REFRIGERATOR 2.0⁰c 8.0⁰c FREEZER 15⁰c - 50⁰c Ensures that all excursions are captured improving confidence in vaccine supply efficacy Quickly analyze results Historical data storage Alarms/alerts = quick response time to scenario Wireless models allow off-site monitoring 11

12 Detachable Bio safe glycol-probeor similar buffered solution, that remains in the refrigerator or freezer. This should be placed in the center of the unit. Continuous Monitoring. The ability to record and save temperature information 24 hours a day. Measures at least one reading every 15 minutes. A digital display on the outside of the unit. An outside reading allows the temperature to be monitored without opening the unit door keeping the temperature inside colder longer. The ability to display the minimum and maximum temperatures between readings. A Hi/Lo alarm, audible or visual, for out- of- range temperatures The ability to download and transmittemperature information by or fax. Low battery indicatorto give advance warning to ensure that vaccine monitoring is not interrupted or complete. A current certificate of calibrationthat is traceable to the National Institute of the Standards and Technology (NIST). Accuracy of +/-1ºF (0.5ºC) This information should be contained in the Certificate of Traceability and Testing (also known as the Report of Calibration). 12

13 VFC/NHIP healthcare practices are required to use a certified and calibrated continuous monitoring (24/7) device or system to monitor temperatures in storage units where federally funded vaccines are stored. Each practice must also have one available to serve as a backup should the main monitoring device fail or need recalibrating (if device allows). 13

14 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport

15 What are A. Chart recorders? B. Food grade temperature monitoring devices? C. Min/Max temperature monitoring devices? D. Continuous temperature monitoring devices? TEMPERATURES TWICE A DAY (AM & PM) MINIMUM & MAXIMUM (EVERY AM) at a minimum 15

16 TEMPERATURES and A.M. MIN/MAX TEMPS ON PAPER LOG VFC/NHIP Providers submit to NHIP at the end of every month for review Anytime you have an out of range temperature that may effect your vaccine! The proper, safe temperatures for vaccine: Refrigerator 2.0⁰ and 8.0⁰ celsius Freezer -15⁰and -50⁰ celsius 16

17 All vaccines should be stored at their proper temperatures according to manufacturers package insert. Determine issue - door ajar (close door), power failure (move to back up facility), unit failure (alternate storage/back up facility) Quarantine separate, label etc. Do Not Use Download temperature report and review data (highest or lowest out of range temp, number of minutes/hours out of range) Call manufacturers to confirm viability (stability data) NHIP/VFC Providers call the Immunization Program 17

18 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport

19 What is A. 2⁰f and 8⁰f? B. Above freezing? C. 2⁰c and 8⁰c? D. -2⁰c and -8⁰c? Who? What? Where? When? Why? Don t leave other staff wondering what to do if there is an emergency! Required for VFC/NHIP healthcare providers 19

20 Develop and maintain a written plan for daily routinevaccine management and standard operating procedures (SOPS). Do you know where your plan is? 20

21 For the protection and safety of your vaccines and to minimize potential loss in the event of storage unit failure/malfunction, power outages, natural disasters, or other emergencies that might compromise vaccines, a written Emergency Action Plan for an alternative storage of vaccine should be readily available to ALL STAFF at the facility. If your facility has a backup generator, it should be tested quarterly and serviced annually. VFC/NHIP healthcare providers with generators must still have a written plan for mechanical failure, out of fuel, storage unit failure etc 21

22 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport What are A. The plans for the weekend? B. The actions taken at the end of the day? C. Written plans created for the safe management of vaccine? D. Two types of data loggers? 22

23 Emergency transport only Power Outages -Unit Failure -Soon to Expire BE SURE: Vaccines attended to at all times during transport. Not placed in the vehicle trunk Delivered directly to the facility Promptly unpacked and placed in appropriate storage units on arrival Appropriate storage conditions must be maintained at every link of the chain. 23

24 Hard-sided cooler or styrofoam vaccine shipping containers Frozen water bottles (conditioned before use) Insulating material-2 of each layer Bubble wrap/packing foam/styrofoam for layering above & below vaccines Corrugated cardboard-layer between the above material and the conditioned water bottles Temperature monitor- digital data logger 24

25 Conditioning Frozen Water Bottles (process time is dependent on water bath temperature ) Frozen water bottles in sink with several inches of cool/lukewarm water or under running tap water until layer of water forms near the surface of the bottle. STRAIGHT UP Properly conditioned when ice block inside spins FROZEN when rotated in hand. (If ice sticks, put bottle back BOTTLES FOR TRANSPORT OF in water for another minute). FROZEN VACCINES Line bottom and top of cooler with a single layer of conditioned bottles. Do NOT reuse coolant packs from original vaccine shipping container. 25

26 Vaccine Management Proper Storage Units Storage Unit Set-up Temperature Monitoring Routine & Emergency Management Vaccine Transport What is A. The cold train? B. The cold chain? C. The vaccine management plan? D. The data logger? 26

27 May reduce potency, resulting in inadequate immune responses in patients and poor protection against disease May cause patients to lose confidence in vaccines and their providers when re-vaccination is necessary May result in significant financial loss if the vaccine(s) cannot be used 27

28 What is A. Increased risk that recipients will not be protected against vaccine preventable diseases? B. Patients losing confidence in their provider if needing to be re-vaccinated? C. Significant financial loss? D. All of the above? Please leave your polling device on your chair before exiting 28