1. Proper vaccine storage in ltc
LTC Advisory Meeting
May 7, 2019
Gregory Gahm, MD

2. Resources for presentation
CDC Vaccine Storage and Handling Document / Toolkit
Provides information, recommendations, and resources to assist in proper storage and handling of vaccine supplies
Brings together best practices from the Advisory Committee on Immunization Practices (ACIP) General Best Practice Guidelines for Immunization, product information from vaccine manufacturers, and results of scientific studies

3. Problems with improper storage
Vaccines exposed to storage temperatures outside the recommended ranges may have reduced potency, creating limited protection and resulting in the revaccination of patients and enormous expenses for wasted vaccine
Must be maintained at a proper, cold temperature from manufacture through delivery / administration to the patient
Frozen / thawed vaccines typically have NO potency

4. Staff and training Should include:
Facilities should have clear, detailed policies about storage and handling
Should include:
Guidance for emergencies such as equipment or power failures
Contact information for vaccine manufacturer or distributor
Contact information for equipment service providers
Identify which staff are responsible for vaccine management
Steps to take if / when equipment fails or the power goes out
Keep easily understood guidelines in an obvious place near vaccine
Document which staff have been trained / when

5. Staff and training
Designate primary and secondary vaccine coordinators to oversee:
Ordering
Receipt / Handling of deliveries
Setting up temperature monitoring devices and tracking
Regular (weekly) review of temperature logs
Rotating stock to use oldest vaccine first
Removing expired or damaged vaccine (eg, frozen, overheated)
Staff training

6. Storage and Temperature Monitoring
Purpose-built or pharmaceutical grade units are more expensive, but have chip-based temperature controls and fans that better insure uniform temperatures throughout the unit
Amazon: 4.3 Cu Ft: $709; 10 Cu Ft: $ $1700
Glycol Thermometer with Alarm: $40
Household-grade units are acceptable, but the freezer compartments are not recommended for storing frozen vaccines and areas of the rest of the unit may be unevenly cooled
Separate freezers should be used if you have frozen vaccine
Do not store vaccine near the freezer portion of dorm refrigerators or in vegetable / fruit drawers or in door shelves of larger refrigerators (decreased air flow)

7. Storage and Temperature Monitoring
Before using a new unit, check temperature logs twice daily for 2-7 days to assure compliance (preferably with a digital thermometer)
Refrigerators should maintain temperatures from 36o – 46o F
Freezers should maintain temperatures from –58o to 5o F
Each vaccine storage unit must have a Temperature Monitoring Device
CDC recommends a “digital data logger (DDL)” [Amazon: $150]
Includes data on when it is operating outside the recommended temperature range (“excursions”)
Should have an alarm for out-of-range temps and a low-battery indicator
Require current / valid Certificates of Calibration Testing
See Guidelines for DDL Certification details

8. Temperature Monitoring Devices (TMDs)
TMDs NOT recommended by the CDC:
Alcohol or mercury thermometers
Bimetal stem
Those used for food
Infrared

9. Protecting the power supply
Plug in only 1 storage unit per electrical outlet
Use a safety-lock plug or outlet cover to prevent the unit from accidentally being unplugged
Post ”DO NOT UPLUG” Warning Signs
Label fuses and circuit breakers with alerts not to shut off
Don’t use outlets operated by wall switches
Don’t use in a multioutlet power strip

10. Organizing and storing vaccine
Store in original packaging (avoid excess light)
Check / record minimum and maximum temps each day
Note actions taken if a temperature excursion occurred
Avoid storing anything but vaccine, diluent and water bottles in these storage units
Leave space between vaccines to allow for air circulation

11. Organizing and storing vaccine
Store water bottles above, below and in the door of large refrigeration units to help maintain stable temperatures (unless contraindicated by the unit’s manufacturer)

12. temperature excursions
Immediately involve the facility’s vaccine coordinator
Place exposed vaccines in a separate container marked
“DO NOT USE”, but do not discard
Document:
Date, time and room temperature during event
How long the vaccine may have been affected
General description of event
Problems with storage unit

13. temperature excursions
Adjust temp to appropriate range
Make sure TMD is placed in center of vaccines
Contact manufacturer or distributor with information to determine if vaccine can be used
Document information received and who provided it

14. Routine maintenance Check seals and door hinges
Clean coils and defrost freezer units regularly
Keep unit interior clean to prevent microorganism growth
Adjust temps seasonally depending on room temp

15. Vaccine management
Schedule deliveries so they aren’t accidentally left sitting out
Unpack units immediately before storing, ie, don’t store in the shipping box with cool packs that can affect vaccine temps once placed in a refrigeration unit
Look for damage to shipment
Make sure you don’t receive expired vaccine
Track all doses used
Immediately remove expired dosages to avoid using them

16. Vaccine preparation
Only prepare vaccine when it is ready for immediate use
Double-check expiration dates and type of vaccine
For vaccines that are lyophilized (freeze-dried) and need to be mixed with a liquid (diluent), always recheck the package insert to confirm volume of diluent to use
If a reconstituted vaccine is not used within 30 minutes, check manufacturer’s guidelines to determine how long it may be stored at what temperature before it must be discarded

17. Vaccine transport
Do not transport vaccines from one facility to another without appropriate coolant use that maintains a constant temperature in the appropriate range

18. Emergency Vaccine storage
Know in advance where to move vaccine if the power or refrigeration unit fails and post this information where it can easily be found in an emergency
Document the time to transport and follow transport guidelines
During a power outage to a facility, make sure the vaccine storage areas are covered by the emergency generator and that there is someone who knows to check them quickly if the generator fails

19. Closing comments
The CDC Guideline contains several pages of checklists and documents that may be useful at the end of the document
It also contains some sample warning labels that can be used
When vaccinating, take only a few vaccines at a time from the refrigerator and use them quickly. Do not leave vaccines out for more than a few minutes (5-10?) before using to avoid having them warm to room temperature and lose potency