National Vaccine Storage and Handling Guidelines for Immunization Providers (2007)

Section 2 Vaccine Storage and Handling Protocols

Contents

2.1 General Recommendations
2.2 Routine Vaccine Storage and Handling Protocols
2.3 Training Personnel
2.4 Urgent Vaccine Storage and Handling Protocols
2.5 Emergency Actions
2.6 Mass Immunization Plans (Including Pandemic)
2.7 References

2.1 General Recommendations

• All health care providers who administer vaccines should evaluate their cold chain procedures to ensure that vaccine storage and handling guidelines are being followed.
  
  
• Each immunization clinic should develop detailed written protocols for:
  
  • Routine Vaccine Storage and Handling for day to day operations and
  • Urgent Vaccine Storage and Handling in the event of refrigerator or freezer malfunctions, power failures, natural disasters, or other emergencies that might compromise vaccine storage conditions.
    
    
• All staff members who administer or handle vaccines in any way should be familiar with both protocols.
  
  
• The protocols should be updated and placed in an area accessible by all staff that handle vaccines or provide immunizations, preferably near the vaccine storage units.

All immunization clinics should develop detailed written protocols for Routine Vaccine Storage and Handling and for Urgent Vaccine Storage and Handling.

2.2 Routine Vaccine Storage and Handling Protocols

Routine protocols should include all aspects of day to day vaccine management, from ordering vaccines and controlling inventory to handling vaccines and monitoring storage conditions.

Designated Vaccine Coordinators

Each site should designate one staff member to be the primary vaccine coordinator and another staff member as a backup in case the primary coordinator is unavailable. The designated person will be responsible for ensuring that all vaccines are handled correctly, that procedures are documented, and that all personnel receive appropriate cold chain training.

Designated vaccine coordinators should be fully trained in routine and urgent vaccine storage and handling protocols.

The routine protocols should include:

• Up-to-date contact information for:
  
  • Designated vaccine coordinators who are responsible for routine vaccine storage and handling
  • Provincial, territorial, or local public health office or immunization program*
  • Refrigerator and freezer maintenance and repair company(s)
  • Vaccine storage unit alarm company (if applicable)
  • Sources of packing materials and calibrated thermometers
    
    
• Descriptions of the roles and responsibilities of the designated vaccine coordinators and other staff members
  
  
• Summaries of the storage requirements for each vaccine and diluent in your inventory
  
  
• Protocols for:
  
  • Vaccine storage unit temperature monitoring
  • Vaccine storage equipment maintenance
  • Placement of vaccine within storage units
  • Responding to vaccine storage and handling problems
  • Vaccine inventory management
  • Packaging, transporting and receiving vaccine shipments
  • Disposal of vaccines and diluents as directed by jurisdictional policy or guidelines
    
    
• Samples of the forms used in your immunization program

Use the Routine Vaccine Storage and Handling Protocols Checklist and the Contact List for Routine Vaccine Storage and Handling in the Resources Section to help you organize your plan.

Each site should designate one staff member to be the primary vaccine coordinator and another staff member as a backup in case the primary coordinator is unavailable.

Other Staff

All staff members (including support staff, program manager(s), immunization coordinator(s), public health nurses, physicians, physician office staff, administration staff, janitors, security staff, etc.) should be familiar with the site's policies and procedures for vaccine storage and handling. This especially includes staff members, such as receptionists and mail handlers, who accept vaccine shipments. All policies and procedures should be available in writing and kept near the vaccine storage units for easy reference.

All staff members should be familiar with their site's policies and procedures for vaccine storage and handling

2.3 Training Personnel

All new staff that handle or administer vaccines should be trained in proper vaccine storage and handling practices. All other new staff should be trained to have an understanding of the importance of cold chain maintenance and basic practices so they are aware of their responsibilities to the cold chain. A refresher training session should be held annually for all staff. Staff who monitor and record vaccine storage unit temperatures should immediately report inappropriate storage conditions (including exposure to inappropriate temperature or light exposures) to the designated vaccine coordinator.

2.4 Urgent Vaccine Storage and Handling Protocols

Various situations may compromise vaccine storage conditions, for example, equipment failures, power outages, or natural disasters. Ensure that all staff (current and new) has appropriate training so that they understand the urgent vaccine storage and handling protocols and their responsibility in maintaining the cold chain. Also ensure that janitorial staff and security staff are aware of the plan and know the procedures to notify designated personnel about any problems with vaccine storage equipment. Review and update the contact lists in the plan as staffing changes occur. Review and update the entire protocol annually.

When immunization providers have reasonable cause to believe that weather conditions, natural disasters, or other emergencies might affect vaccine storage conditions, urgent procedures should be implemented in advance of the event.

The following personnel, equipment, information, and protocols should be in place:

• Emergency staff contact list, in order of contact preference.
  
  
• Designated vaccine coordinators, who should
  
  • Monitor the operation of the vaccine storage equipment and systems.
  • Track inclement weather conditions.
  • Set up and maintain a monitoring and notification system in anticipation of times of inclement weather or other conditions that might cause a power outage (a continuous-monitoring temperature alarm and notification system should be considered, especially for sites with large inventories).
  • Ensure the appropriate handling of the vaccine during a disaster or power outage.
  • Ensure designated staff who will attend to after hours emergencies has 24-hour access to the building and vaccine storage unit(s).
  • Ensure that sufficient fuel and/or battery power is on hand to continuously run a backup generator for at least 72 hours if the facility has one.

When immunization providers have reasonable cause to believe that weather conditions, natural disasters, or other emergencies might affect vaccine storage conditions, urgent procedures should be implemented in advance of the event.

• Vaccine storage unit specifications and records
  
  • For each vaccine storage unit in your facility, identify the type of unit (e.g. refrigerator, freezer, combination refrigerator and freezer), the brand name, the model number, the serial number, and its location.
    
    
• Alternate vaccine storage facility or facilities
  
  • Establish working agreements with at least one alternate storage facility with a backup generator where vaccine can be appropriately and securely stored and monitored for the interim (e.g. provider offices, hospital or community pharmacies, provincial or territorial depots, local pharmaceutical warehouses or distributors that could offer or meet both refrigeration and freezer requirements).
  • Make advance arrangements with the facility to store your vaccine when weather predictions call for inclement conditions, when your vaccine storage equipment cannot be repaired, or when the power cannot be restored before the vaccine storage unit temperature rises above the recommended range.

Establish at least one alternate storage facility where vaccine can be appropriately stored and monitored. Ideally, this facility would have a backup generator.

• Written protocols, vehicles, and drivers for transporting vaccine to and from the alternate vaccine storage facility
  
  • Develop written protocols for transporting vaccine to and from the alternate vaccine storage facility.
  • If the vaccine can be moved to the alternate facility before the vaccine storage temperature goes outside the recommended range, it may be transported in appropriately insulated and packaged containers or coolers within ordinary vehicles inside the passenger compartment.
  • Make advance arrangements for a primary and backup vehicle and a driver, and record the contact information.
  • If the location is far away or if you have a large quantity of vaccine, consider renting a refrigerated truck to transport the vaccine. In this case, joining with other sites to reduce costs may be advantageous.
  • Make advance arrangements with a local refrigeration company and an alternate and record the contact information.
  • Establish how to load the vehicle.
  • Have pre-selected routes to take (and alternate routes if necessary).
  • Determine the estimated time en route.
    
    
• Written instructions for entering your facility and vaccine storage spaces in an emergency if the building is closed or if it is after hours
  
  • These instructions should include the building security and after-hours access procedure, a floor diagram, and the locations of the following:
    • Doors
    • Flashlights
    • Spare batteries
    • Light switches
    • Keys
    • Locks
    • Alarms (including instructions for use)
    • Circuit breakers
    • Packing materials
      
      
• Appropriate packing materials to safely transport or temporarily store vaccine may include:
  
  • Insulated containers
  • Refrigerated packs
  • Frozen packs (may be gel or ice)
  • Dry ice if product must be frozen
  • Insulating barrier materials or materials used as barriers between the vaccine and refrigerated/frozen packs and as filler

(See Section 9—Vaccine Shipments for more details.)

In situations where an alternate vaccine storage facility with a backup generator cannot be identified within a reasonable distance, maintain the appropriate packing materials to temporarily and safely store vaccine at your facility. Record the contact information for sources of these materials.

• Written protocol for vaccine packing
  
  • Every facility has access to different types of shipping materials and coolers, so each facility should develop its own standard operating procedures (SOP) for packing vaccine based on their experience using the materials and/or guidance provided by their local jurisdictional immunization program*. These instructions should be readily available for staff unfamiliar with vaccine packing procedures.
    
    
• Key steps that should be reflected in all SOPs include:
  
  • Open the refrigerator and/or freezer doors only when absolutely necessary and only after you have made all preparations for packing and moving the vaccine to the alternate storage facility.
  • Use properly insulated containers to transport the vaccine. These containers should be qualified (previously tested resulting in a high degree of assurance that a specific process will meet its pre-determined acceptance criteria⁽¹⁾ by the facility using them) to ensure that they are capable of maintaining the vaccine at the correct temperatures. Shipping containers the vaccines arrive in from the manufacturer may be used if they meet your criteria. Alternatively, you may use qualified hard-sided, plastic, insulated containers or styrofoam coolers with at least 2-inch thick walls. Thin-walled recreational-use styrofoam coolers, such as those purchased to hold beverages, are not acceptable.
    
    
• Refrigerated vaccines
  
  • Document the vaccine storage unit temperature at the time the vaccine is removed for transport.
  • Pack the refrigerated vaccines first, using enough refrigerated and/or frozen packs to maintain the cold chain. The number and placement of refrigerated or frozen packs inside the container will depend on container size, outside temperature, and jurisdictional variations. (See Section 9—Vaccine Shipments for more details.) Soft-sided ice packs can be placed into plastic bags if puncture or leakage is a concern.
  • Vaccines should be packed in layers using the following materials: refrigerated or frozen packs, insulating barrier (e.g. bubble wrap, crumpled brown packing paper, styrofoam peanuts), vaccine, a temperature monitor, and filler materials (may be the same as those used as insulating barriers) to prevent shifting of the contents during transport. (See Section 9—Vaccine Shipments for more details.)
  • Vaccines should never be directly placed next to the ice pack or refrigerated pack. Be sure to place an insulating barrier (e.g. bubble wrap, crumpled brown packing paper, styrofoam peanuts) between the refrigerated or frozen packs and the vaccines to prevent accidental freezing.
  • Use properly placed temperature monitors to assess whether the cold chain has been broken. The temperature monitor should be placed next to the vaccine and should not come in contact with the refrigerated or frozen packs.
  • Record vaccine type(s), brand names, lot numbers, expiry date, quantity, time, and originating facility on a packing slip included inside the container.
  • Attach labels to the outside of the container to clearly identify the contents as valuable and fragile vaccines. Labels should include special instructions to refrigerate immediately upon arrival.
    
    
• Frozen vaccines
  
  • Document the vaccine storage unit temperature at the time the vaccine is removed for transport.
  • Pack the frozen vaccines last, using a separate insulated container.
  • Pack with dry ice immediately before they are to be transported. At least 6 pounds of dry ice should be used in the container to maintain vaccines in their frozen state.
  • Record vaccine type(s), brand names, lot numbers, expiry date, quantity, time, and originating facility on a packing slip included inside the container.
  • Attach labels to outside of the container to clearly identify the contents as valuable and fragile vaccines. Labels should include clear instructions to “keep frozen.”
    
    
• Written protocol for appropriately storing vaccine at the alternate vaccine storage facility
  
  • Refrigerator stable vaccines should be stored in the refrigerator at +2°C to +8°C. Vaccines which are frozen should be stored at -15°C or colder.
  • There should be adequate cold air circulation around the vaccines.
  • Each alternate vaccine storage unit should have a functioning calibrated temperature monitor in each compartment.
  • Temperatures inside the storage units and the room temperature should be monitored and recorded at least twice a day at the start and close of business for as long as vaccine is stored in this location.

Temperatures inside the storage units and the room temperature should be monitored and recorded at least twice a day at the start and close of business for as long as vaccine is stored in this location.

Use the Urgent Vaccine Storage and Handling Protocols Checklist and the Contact List for Urgent Vaccine Storage and Handling in the Resources Section.

2.5 Emergency Actions

The following emergency procedures should be implemented in advance of the event whenever possible.

• Suspend immunization activities. This will allow sufficient time for packing and transporting vaccine.
• Notify staff at the alternate vaccine storage facility. Before moving your vaccine, call the alternate storage facility to make them aware of the situation and to ensure that their backup generator is working.
• Conduct an inventory of the vaccines and record the actions taken. Use the Vaccine Tally Sheet in the Resources Section.
• Follow established vaccine transport procedures for moving vaccine.
• If a cold chain failure occurs or is suspected use the Suspected Cold Chain Failure Exposure and Wastage Report in the Resources section.

Whenever there is a question about integrity of the vaccine,contact your local public health office or immunization program* for advice.

2.6 Mass Immunization Plans (Including Pandemic)

It is important for all jurisdictions to have a mass immunization plan in the event that an outbreak or a pandemic occurs. These should be developed based on jurisdictional needs. It is beyond the scope of this document to outline further information. Also please see your local pandemic plan and/or the appropriate provincial or territorial pandemic plan for further information.

2.7 References

1. Bishara RH. Qualification versus validation and good cold chain management practices. Pharmaceutical Manufacturing and Packing Sourcer 2005: 102, 104, 106.

* Including local, regional, provincial, territorial, or federal health departments, or other jurisdictional immunization programs.