Lab-Call / Pediatric Arts Confidential
Policy Title:
Approved by:
Effective date:
Policy #:
Last revision date:
Pediatric Arts Clinic Vaccine Recovery Plan
Vaccine Recovery Plan
Overview
This Plan provides guidance in the event of a refrigeration disruption due to power outage and other events
that could compromise Vaccine Efficacy:
General Information: General principles and actions for each emergency
Standard Rules: For any emergency
Contact List: A list of Key Contacts in an Emergency
Power Failure Actions: For both internal and external power failure
OOR (Out of Range) Temperature Actions: For any OOR temperature condition
Primary Site Information: Only if you wish it to be documented here
Compromised Vaccine Inventory: A list of any currently compromised Vaccine
Transport Vaccine Inventory: A list of Vaccines to be transported to the emergency facility and temperature logs
Policy: Staff and physicians must follow the guidelines for vaccine recovery. The following
procedures have been developed to protect vaccine supply during storms, floods, power
Outage (both clinic and area wide) and equipment / policy failure. Being prepared can prevent
the loss of expensive and at times, difficult to obtain, vaccines.
Purpose: To prevent the compromise/loss of vaccine.
General Information:
Lab-Call provides real-time access to temperatures during an excursion as well as hourly logs of temperatures.
There are additional resources available on your Lab-Call web page. To access the web page, follow the
following instructions:
Log into your Lab-Call web page: lab-call.exosite.com/login
Email :
[email protected]
Password: Vaccine5
The name and phone number of the Lab-Call Units attached to your freezer and refrigerator are:
PedArts01
612-581-2966
A copy of this policy must be attached to the refrigerator / freezer as well as being located with the packing materials. In
addition, Lab-Call will send a link to your VRP via text and email during an incident.
Lab-Call / Pediatric Arts Confidential
Standard Rules for any Vaccine Emergency
Standard Temperature Ranges:
1. Proper Refrigerator Range = 35°‐ 46° F (2°‐ 8° C)
2. Proper Freezer Range = 5° F (‐15° C) or colder
What constitutes a “compromised vaccine”?
Refrigerated vaccines that have been frozen are seriously compromised and you need to contact the vaccine manufacturers
immediately.
Refrigerated vaccines stored at any temperature above 50°F or below 33°F for an extended period of time could seriously
compromise their efficacy. If this occurs then you need to contact the vaccine manufacturers directly to obtain their
recommendations. Temperatures between 47°F and 50°F are not as serious but you should need to correct the problem as
soon as possible.
Frozen vaccines whose temperatures have elevated above 25°F for more than 60 minutes or have thawed have been
compromised and you need to contact the vaccine manufacturers immediately.
Frozen vaccines that are elevated between 5°F and 25°F over two hours may be compromised and you should contact the
vaccine manufacturers immediately.
If the vaccines are in danger of / or have been compromised they will need to be moved.
• Contact Dr. Raghib
• Package the refrigerated and frozen vaccines per the plan and move them to: 325 Edgewater Drive, West
Fargo, ND 58078
• Packaging and transport supplies are located in: PAC Storage closet
• Packaging and transport instructions are located in: PAC Storage Closet
Inventory of Frozen and Refrigerated Vaccines must be taken using the attached "Inventory" spreadsheet
Any Vaccines that are compromised must be logged on the attached "Compromised Vaccines" spreadsheet
Frozen vaccines must be separated from refrigerated vaccines and labeled as such
Compromised Vaccines must be separated (via "Zip-Lock" bags) from non compromised vaccines and labeled as such
Public vaccines must be separated from private vaccines and labeled as such
make sure that the transport coolers are labeled clearly and appropriately
Verify that the emergency site refrigerator / freezer is operating at the correct temperatures
Alternate Locations:
Essentia HealthCare Pediatrics
1702 South University Avenue
Fargo, ND 58103
Dr. David Clutter
701 304 8000
Pediatric Arts Clinic - Home
5280 S0th Avenue South
Fargo, ND 58104
Dr. Ender Raghib
701 388 2065
Urgent Medicine Associates
2829 University Avenue South
Fargo, ND 58103
Dr. Kurt Kooyer
701 730 1677
Lab-Call / Pediatric Arts Confidential
Vaccine Coordinators
Name
Bridget Krause
Colleen Marquart
Cell Phone
email
701 541 4436
701 571 1943
Emergency Notification
Name
Office Main Phone
Ender Raghib
Bridget Krause
Colleen Marquart
Kurt Kooyer
Phil Sondreal
Emergency Resources
Police
Fire
Power
Phone Service
Temperature Monitoring
Security Monitoring
Building
Refrigeration
North Dakota State
Immunization Resources
Cell Phone
email
701 388 2065
[email protected]
[email protected]
[email protected]
[email protected]
[email protected]
701 541 4436
701 571 1943
701-730-1677
701-239-9821
Company
Contact
Fargo PD
Fargo FD
Excel
702
Communications
Lab-Call
Mark Gobel
Phone
Goldmark
Appliance
Bothers
701 239 5840
Patrick Vesey
701 235 4493
701 241 1540
800 895 1999
218 284 5702
612 384 5560
701 238 5333
701 328 4556
www.ndhealth.gov
Lab-Call / Pediatric Arts Confidential
Building or Area Power Failure-What to Do
Log into the Lab-Call Cloud from your account at lab-call.com
Username: [email protected]
Password: Vaccine5
From here you can get real-time temperature and power data as well as an event log
Call the power company and the police department to understand if the outage is area wide
• If the outage will last more than four hours, plan to go into the clinic within the next four hours
• If the outage will last less than four hours, wait until power is restored
Call the building management if the outage appears to be building related.
• If the building management will respond within two hours, wait until they are on site.
• If the building management will not respond within two hours or they cannot resolve the power issue,
plan to go into the clinic within two hours to execute the VRP
If Lab-Call is sending you alerts that the temperatures in the refrigerator / freezer are out of range, follow the
following guidelines:
• If the Freezer Temperature is above 25 degrees F and rising or 4 hours have elapsed, and the repair is
not imminent, the vaccines need to be moved ASAP!
• If the refrigerator is 55 degrees or greater or four hours have elapsed, the vaccines should be moved
ASAP!
Out of Range Temperature Actions
Please follow the GENERAL rules below to follow with respect deciding whether or not there is a need to
implement the Vaccine Recovery Plan in the event of a temperature excursion.
Acknowledge the Lab-Call Alert via Cell phone or email response ("ACK")
Log into the Lab-Call Cloud from your account at lab-call.com
From here you can get real-time temperature and power data as well as an event log
1) Watch for 30 minutes. Remember that Lab-Call sends the first alert to you AFTER 30 minutes.
This means that as you start to watch you will already be at minute 30.
2) If the temperature is stable, not significantly out of range and moving back into the proper range
within an hour so of the initial out of range condition, watch until it moves back into range.
Lab-Call will record the time out of range and the temperatures throughout the event.
3) If the temperature continues to increase beyond 20 degrees F for the freezer and
55 F for the refrigerator; implement the VRP ASAP.
4) If the refrigerator temperature is at 33 degrees F or below; implement the Vaccine Recovery Plan
ASAP. You can still watch at 33.8 F but be careful.
5) If the freezer temperature is at 28 degrees F or above or 25 degrees and rising; implement the Vaccine
Recovery Plan ASAP.
6) While Lab-Call has patent pending software to reduce false alarms, extended, abnormal defrost cycles
will trigger false alarms.
Lab-Call / Pediatric Arts Confidential
A WORD ABOUT DEFROST CYCLES
In an ideal world, all clinics would have pharmacy grade refrigerators and freezers.
However, most clinics have Single compressor refrigerators (Refrigerator and Freezer in the same unit).
These units will typically perform a defrost cycle on a daily basis.
This cycle typically varies from 5 minutes to 30 minutes but should be less than 25 minutes if all is healthy.
This is well within the manufacturing tolerances of all common the Vaccines.
There is specific information on your Lab-Call web page ("General Outage Instructions and Temperature Patterns")
that details abnormal patterns and possible remedial actions to be taken.
If you have a question, please call Lab-Call support at 651 552 0478
There are seven main causes of “temperature excursions” besides power failure:
1. Compressor Failure: This has a temperature pattern very similar to power failure.
2. Door left ajar: Very common and easy to deal with once you are in the clinic.
3. The thermostat settings have been changed.
4. The probes have been moved in front of the defrost blower in the freezer.
5. Inadequate temperature mediation (water) around the vaccines in the refrigerator.
6. Defrost Timer - Defrost limiter failure: This can require sudden action on your part as freezer temperatures
can jump to 50 degrees F quickly.
7. The refrigerator / freezer are BROKEN!
Lab-Call / Pediatric Arts Confidential
Transportation to the Alternate Site
Lab-Call / Pediatric Arts Confidential
General instructions for packing vaccine
1. Use hard-sided or Styrofoam coolers with at least two-inch thick walls; don’t use thin-walled Styrofoam coolers,
soft-sided coolers, or lunch bags found at grocery stores or gas stations.
2. Depending on the type of vaccine, place cold/frozen packs on the bottom of the cooler and at the sides to surround
the vaccine.
• Don’t transport refrigerated vaccines in the same cooler with frozen vaccines.
• Don’t place vaccines directly on or next to cold/frozen packs.
3. Place a minimum of two inches of insulating barrier over the cold/frozen packs.
This will help keep the vaccine from touching the packs and prevent accidental freezing and shifting during transport.
Some examples of insulating barrier include:
• Bubble wrap
• Brown packing paper
• Newspaper
4. Place vaccines (in their original packaging) in a plastic bag on top of the insulating barrier.
5. When transport will take more than one hour, place a calibrated thermometer on top of the vaccine, preferably
one with an internal probe and external read.
6. Add another two-inch layer of insulating barrier.
7. Add another layer of cold/frozen packs.
8. Secure lid; tape if necessary.
Packing Supplies Summary
ˆˆ Calibrated thermometer or Lab-Call
ˆˆ Cooler
ˆˆ Cold or frozen packs
ˆˆ Plastic bags
ˆˆ Packing tape
ˆˆ Insulating barrier:
Bubble wrap
Brown packing paper
Newspaper
Packing refrigerated vaccines
Refrigerated vaccines include DTaP, DT, Td, Tdap, hepatitis A and B, Hib, HPV, influenza (TIV, LAIV), IPV,
meningococcal, pneumococcal, rotavirus, and combinations of these vaccines. MMR can also be packed as a
refrigerated vaccine.
•
•
•
•
Keep cold at 35° to 46°F (2° to 8°C), but do not freeze.
Use cold or frozen packs depending on the outdoor temperature:
Frozen packs for temperatures of 75°F or more
Cold packs for temperatures of 74°F or cooler
Refrigerated Vaccines Packing Diagram
Lab-Call / Pediatric Arts Confidential
Packing frozen vaccines
Frozen vaccines include MMRV, varicella, and zoster. Even if you pack and transport them with frozen packs, the
viability of these vaccines may not be preserved At best, their shelf life will be reduced. These vaccines are extremely
fragile and should only be packed and transported when:
• You need to give one or two prescheduled doses at an off-site location.
• There is an emergency such as a weather-related disaster.
• There may be a long-term power outage (four hours or more).
Keeping vaccine frozen between -58°F and +5°F (-50°C and -15°C):
• Use frozen packs to pack and transport frozen vaccine because it can maintain the temperature between 58°F and +5°F.
• Do not freeze diluents; the vials may break.
• Do not use dry ice.
• Pack frozen vaccines immediately before transporting them.
Using frozen packs:
• Use a minimum of 6 frozen packs to surround the vaccine on all sides.
• Place vaccines (in their original packaging) in a plastic bag directly on frozen packs; you don't need an
insulating barrier.
• Place a calibrated thermometer between the vaccine and frozen packs, preferably between the vaccine boxes.
• Tape the cooler shut until you are ready to unpack the vaccine.
• Check the temperature of the cooler immediately upon arrival:
• If the temperature is between -58°F and +5°F (-50°C and -15°C), the vaccine is still considered frozen and can
be placed in the freezer.
• If the temperature is 5°F to 32°F (-15°C to 0°C), the vaccine is still considered frozen and can be placed in the
freezer. However, because the temperature exceeded 5°F (-15°C) the expiration date may need to be
adjusted. Contact the manufacturer (ask for the medical consultant or quality assurance staff) for guidance on
adjusting the vaccine expiration date. Be ready to provide temperature details, transport time, lot numbers,
and current expiration dates.
• If the temperature is 33°F to 46°F (1°C to 8°C), the vaccine is no longer frozen and should be placed in the
refrigerator and used within 72 hours BUT you must get instructions from the vaccine manufacturer.
• If the temperature is 47°F (9°C) or above, place it in the refrigerator marked “DO NOT USE,” and call the your
vaccine vendors or the State Immunization program for guidance right away (651-201-5522, 1-800-657-3970).
• Document your actions
Clinic Name
COMPROMISED VACCINES STORED IN REFRIGERATOR OR FREEZER
VACCINE
MANUFACTURER
LOT #
EXP.
DATE
# OF
DOSES
# OF
AFFECTED
VILES
ACTION TAKEN
VACCINES STORED IN FREEZER
VACCINE
MANUFACTURER
LOT #
EXP.
DATE
# OF
DOSES
# OF
AFFECTED
VILES
ACTION TAKEN
VACCINE TRANSPORT EMERGENCY INVENTORY
COMPLETED BY:
______________________
DATE: ___________
PRIVATE VACCINE
DOSES ON
HAND
COMMENTS
STATE VACCINE
EXAMPLE
HEP A - VAQTA
HEP A - VAQTA
HIB - ACTHIB
HIB - ACTHIB
GARDASIL - HPV
GARDASIL - HPV
PREVNAR - 13
PREVNAR - 13
ROTATEQ - ROTAVIRUS
ROTATEQ - ROTAVIRUS
PENTACEL - DTaP-IPV-Hib
PENTACEL - DTaP-IPV-Hib
DAPTACEL - DTaP
DAPTACEL - DTaP
MMR
MMR
IPV - IPOL
IPV - IPOL
ADACEL - TdaP
ADACEL - TdaP
VARIVAX - Chicken Pox
VARIVAX - Chicken Pox
DECAVAC - DT ADULT
DECAVAC - DT ADULT
PNEUMOVAX (Pneumonia)
PNEUMOVAX (Pneumonia)
MENACTRA - MCV4
MENACTRA - MCV4
HEP B - RECOMBIVAX
HEP B - RECOMBIVAX
FLU <3 PF
FLU <3 PF
FLU >3 PF
FLU >3 PF
FLU <3 (FLUZONE)
FLU <3 (FLUZONE)
FLU >3 PF
FLU >3 PF
FLUMIST
FLUMIST
Adult Hep A
Adult Hep B
VARIVAX - Chicken Pox
DOSES ON
HAND
COMMENTS
VACCINE TRANSPORT EMERGENCY INVENTORY
COMPLETED BY:
______________________
DATE: ___________
PRIVATE VACCINE
EXAMPLE
DOSES ON
HAND
COMMENTS
STATE VACCINE
DOSES ON
HAND
COMMENTS