Understanding Temperature Excursions and Pack-outs

Our Mission: To protect and improve the health and environment of all Kansans.

Kansas Immunization Program

Dena Rueb & Jayme Lewis

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. Cooler2. Conditioned water bottles3. Card board4. Data logger (or digital thermometer)5. Bubble wrap6. 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.

What is wrong with this picture?

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 abovethe 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 belowfreezing (<32°F, <0°C) temperatures?

a) Noneb) < 1 hourc) Up to 24 hoursd) Usable if frozen once, but not multiple freeze/thaw cyclese) 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 hourc) Up to 24 hoursd) Usable if frozen once, but not multiple freeze/thaw cyclese) 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 themb) Put them back in the storage unit and use within the weekc) Put them back in the storage unit labeled “do not use” and call the manufacturer/health department for adviced) 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

Contact Vaccine Manufacturers, report excursion and request they fax or email their recommendations. (Document:  Case #, Date, Time & Customer Service Rep)     Manufacturer 

   Vaccines 

   Vaccines 

Case Information 

 Comments 

GlaxoSmithKline (GSK)   877‐356‐8368 vaccine.service‐ center@gsk.com 

□Infanrix □Pediarix □Kinrix □Hiberix □Engerix‐B □Havrix □Rotarix □Flulaval □Fluarix 

□Boostrix □Bexsero □Menhibrix□Menveo   □Cervarix □Twinrix 

Case#:   Date:                      Time:                            Spoke with: 

 

 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

Provider Temperature Excursion Worksheet

Merck @ Co, Inc.  □Gardasil    □ProQuad  Case #:Date:

 

  □PedvaxHIB  □Rotateq  Time:       877‐829‐6372  □RecombivaxHB □Varivax  Spoke with:     □Vaqta 

  □MMR II     

  □PPSV23   □ZostavaxPfizer/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    □FlucelvaxProtein 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 stockReported by :  Jayme Lewis, RN  Date:   June 6, 2017

 

Clinic Name: Prepared by: 

Busy Betty’s Immunization Clinic Pin: 9999 Date: 6/6/17Jayme Lewis, RN 

Email:  Jayme.lewis@ks.gov  Phone: 785‐213‐6337TEMPERATURE INFORMATION Date discovered:  6/5/17  Time Discovered:  8:05 AMTemperature: Data Logger: 

 Yes   No  Did data logger display an X alarm or out of range temperature Yes No

Back‐up thermometer used:  Yes NoBrand:  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  NoSUMMARY 

Questions

Our Mission: To protect and improve the health and environment of all Kansans.

Our Mission: To protect and improve the health and environment of all Kansans.

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