Understanding Temperature Excursions and Pack-outs Kansas Immunization Program Dena Rueb & Jayme Lewis Our Mission: To protect and improve the health and environment of all Kansans.
OBJECTIVES: 1. Define Temperature Excursions and Pack outs. 2. Demonstrate how to manage and report a temperature excursion. 3. Demonstrate a proper pack out.
Pack out What is a Pack out? A pack out is the process of properly placing the vaccine in coolers for transport.
If short term power loss (less then 2 hrs) don t move, keep door shut. Go to the place you are moving your vaccine to prior to an emergency so you know storage units are acceptable. Don t forget you still have to take twice daily temps.
Materials needed for pack out: 1. Cooler 2. Conditioned water bottles 3. Card board 4. Data logger (or digital thermometer) 5. Bubble wrap 6. Inventory Sheet (transfer form, piece of paper)
Points to help with Pack-out 1. Pack out materials ready. 2. Everyone has knowledge of where materials stored. 3. Pack out sheet and Routine Storage and Handling plan with cooler. 4. Data logger always goes with the vaccine, wherever the vaccine goes. 5. Conditioned water bottles is a must.
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What is wrong with this picture?
Reference You can find the Pack-out instructions at: https://www.cdc.gov/vaccines/recs/storage/downloads/emergency transport.pdf
Key Points for successful Pack-outs: 1. Never place refrigerated vaccine directly on ice. 2. Always place data logger (or digital thermometer if you do not have Data logger) with the vaccine. 3. Remember if you keep your vaccine labeled (VFC,CHIP or Private) from the time you receive them it will be easier if you have to move them. 4. Frozen doesn t like hot, cold doesn t like frozen.
Temperature Excursion Reporting Objectives: 1. Define Temperature Excursion. 2. Demonstrate how to manage and report a Temperature Excursion.
What is a Temperature Excursion? A (TE) Temperature Excursion occurs when vaccine is exposed to temperatures outside of its specified temperature range for any length of time. TE requires an immediate investigation on behalf of the Provider in order to determine if the exposed vaccine is still viable. There are 2 potential areas of temperature sensitivity: temperatures above the specified range and temperatures below the specified range. When a TE occurs the affected vaccine must be quarantined immediately and dispensing of the impacted vaccine must cease!
Why does Storage & Handling matter? A TE can have a significant impact on quality, efficacy and safety of vaccines. More importantly, a TE can have a significant impact on the safety of the vaccine patient if not detected and investigated. Improper temperatures can damage or destroy vaccine potency, thus resulting in minimal or no immune response in the recipient. Vaccine that has been stored at improper temperatures should not be administered! If such vaccine has already been administered, all doses must be repeated.
Quiz 1: TE What is the acceptable period of time for an inactivated liquid vaccine containing adjuvant (example: DTaP) to be below freezing (<32 F, <0 C) temperatures? a) None b) < 1 hour c) Up to 24 hours d) Usable if frozen once, but not multiple freeze/thaw cycles e) Visually examine: if it passes the shake test (no particulates), it is usable
Quiz 1: TE (Answer) What is the acceptable period of time for an inactivated liquid vaccine containing adjuvant (example: DTaP) to be below freezing (<32 F, <0 C) temperatures? A) NONE! b) < 1 hour c) Up to 24 hours d) Usable if frozen once, but not multiple freeze/thaw cycles e) Visually examine: if it passes the shake test (no particulates), it is usable
Quiz 2: TE One unopened and one partially used vial of polio vaccine was left out on the counter overnight. What is the BEST answer? a) Discard them b) Put them back in the storage unit and use within the week c) Put them back in the storage unit labeled do not use and call the manufacturer/health department for advice d) No special action necessary, put back in fridge
Quiz 2: TE (Answer) One unopened and one partially used vial of polio vaccine was left out on the counter overnight. What is the BEST answer? a) Discard them b) Put them back in the storage unit and use within the week c) Put them back in the storage unit labeled do not use and call the manufacturer/health department for advice d) No special action necessary, put back in fridge
Provider Temperature Excursion Worksheet Contact Vaccine Manufacturers, report excursion and request they fax or email their recommendations. (Document: Case #, Date, Time & Customer Service Rep) Manufacturer Vaccines Vaccines GlaxoSmith Kline (GSK) 877 356 8368 vaccine.servicecenter@gsk.com Infanrix Pediarix Kinrix Hiberix Engerix B Havrix Rotarix Flulaval Fluarix Boostrix Bexsero Menhibrix Menveo Cervarix Twinrix Case#: Date: Time: Spoke with: Case Information Comments PROVIDER NAME: BUSY BETTY S IMMUNIZATION CLINIC PIN: 9999 DATE: 6/6/17 Page 1 Kansas Immunization Program, 1000 SW Jackson, Suite 210, Topeka, KS 66612 5/19/2017
Provider Temperature Excursion Worksheet ProQuad Case #: Date: Merck @ Co, Inc. Gardasil PedvaxHIB Rotateq Time: 877 829 6372 RecombivaxHB Varivax Spoke with: Vaqta MMR II PPSV23 Zostavax Pfizer/Wyeth Prevnar 13 Trumemba 800 438 1985 Sanofi Pasteur Daptacel IPOL Case #: Date: Pentacel Menactra Time: 800 822 2463 Quadracel Adacel Spoke with: DT Td ActHIB Fluzone MedImmune LAIV Flu Mist 877 633 4411 Seqirus Afluria Fluvirin 888 435 8633 Fluad 855 358 8966 Flucelvax Protein Sciences Flublok 800 488 7099 Direct entry KSWebIZ users, print your current vaccine inventory on KSWebIZ Aggregate users, print your current vaccine inventory on KSWebIZ, edit vaccines no longer in stock Reported by : Jayme Lewis, RN Date: June 6, 2017
Clinic Name: Busy Betty s Immunization Clinic Pin: 9999 Date: 6/6/17 Prepared by: Jayme Lewis, RN Email: Jayme.lewis@ks.gov Phone: 785 213 6337 TEMPERATURE INFORMATION Date discovered: 6/5/17 Time Discovered: 8:05 AM Temperature: Data Logger: Yes No Did data logger display an X alarm or out of range temperature Yes No Back up thermometer used: Yes No Brand: Thermco Estimated time between when event was discovered and last documented temperature reading: Min/Max since last documented temperature: Min: Max: STORAGE UNIT Type of vaccine storage unit: Refrigerator/Freezer Pharmaceutical/Household Stand Alone/Combo Brand: MIGALI Describe previous problems with storage unit: None, fridge is less than 1 year old. Was temperature adjusted prior to this excursion: Yes No Water Bottles: Present /Added/NA Describe previous temperature adjustments made to the storage unit: No recent temperature adjustments made to MIGALI fridge. ACTIONS TAKEN Describe actions taken (was vaccine transported, to where? Who is monitoring temperatures, how are the temps being monitored, data logger, back up thermometer, other. (Please explain & attach additional documentation.) REPORTING Excursion reported to KIP: Yes No SUMMARY
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