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

Section 6 Storage Troubleshooting

Contents

6.1 Steps in Handling Inappropriate Vaccine Storage Conditions (Light and Temperature)
6.2 Dealing with Malfunctioning Vaccine Storage Units
6.3 Refrigerator and Freezer Door Problems
6.4 Thermometer Problems
6.5 Power Outages
6.6 References

6.1 Steps in Handling Inappropriate Vaccine Storage Conditions (Light and Temperature)

If you become aware of inappropriate vaccine storage conditions, the following steps should be taken immediately:

1) Notify the designated vaccine coordinator.

2) Record the following information:

• Date and time of incident
  
  
• The issue (e.g. inappropriate temperature and/or exposure to light)
  
  
• Length of time the vaccine may have been exposed to inappropriate conditions
  
  
• The room temperature where the vaccine storage unit is located
  
  • A standard household thermometer may be used.
  • Do not use the thermometer from the vaccine storage unit.
  • Do not rely on the temperature displayed by the room thermostat.
    
    
• Current temperature inside the vaccine storage unit (and freezer)
  
  
• Minimum and maximum temperature readings inside the vaccine storage unit (and freezer)
  
  
• Presence of water bottles in the refrigerator
  
  
• Presence of frozen packs in the freezer
  
  
• Action that has been taken to protect the vaccines
  
  
• Action that has been taken to correct the issue

Use the Suspected Cold Chain Failure Exposure and Wastage Report in the Resources Section.

3) Document the inventory of the vaccines affected by this event. Include vaccine name, lot number, expiry date, and quantity. Use the Suspected Cold Chain Failure Exposure and Wastage Report in the Resources Section to help you organize your response. Consult your local public health office or immunization program* for any special instructions or forms.

4) Isolate and quarantine the affected vaccines and mark them as "DO NOT USE."

5) Store the affected vaccines under appropriate conditions until the integrity of the vaccine is determined. If your vaccine storage unit is not maintaining the appropriate storage conditions, activate the Urgent Vaccine Storage and Handling Protocols. (See Section 2—Vaccine Storage and Handling Protocols for more details and use the Urgent Vaccine Storage and Handling Protocols Checklist in the Resources Section.)

Do not assume that vaccine inappropriately exposed to light or to excessive temperatures cannot be salvaged. Contact your local public health office or immunization program* for further guidance.

6.2 Dealing with Malfunctioning Vaccine Storage Units

General Instructions

The most important step to take if the vaccine storage unit is not working properly is to protect the vaccine supply. Do not allow the vaccine to remain in a non-functioning unit for an extended period of time while you attempt to correct the problem. If you are not sure that the problem can be corrected in time to maintain an appropriate temperature, activate the Urgent Vaccine Storage and Handling Protocols. (See Urgent Vaccine Storage and Handling Protocols in Section 2—Vaccine Storage and Handling Protocols and the Urgent Vaccine Storage and Handling Protocols Checklist in the Resources Section for more details.)

The most important step to take if the vaccine storage unit is not working properly is to protect the vaccine supply.

Vaccine Storage Unit Problems

Vaccine storage unit is too warm

• Check for the following (see Section 3—Vaccine Storage Equipment for more details):
  
  • Unit is plugged in, turned on, and the control knob has been set properly.
  • The door is closing properly.
  • The thermometer is properly located.
  • The freezer compartment is free of thick frost (< 1 cm).
  • There is good air circulation inside and outside the unit.
  • Exposed coils and the motor are free from dust.
  • The room temperature is appropriate.
    
    
• Call a refrigeration technician to assess equipment if necessary.

Vaccine storage unit is too cold

• Check for the following (see Section 3—Vaccine Storage Equipment for more details):
  
  • The control knob is properly set.
  • The thermometer is properly located.
  • The freezer compartment is free of thick frost (< 1 cm).
  • There is good air circulation inside and outside the unit.
  • The room temperature is appropriate.
    
    
• Call a refrigeration technician to assess equipment if necessary.

Vaccine storage unit is too noisy

• If the unit is making an unusual noise, contact a refrigeration technician to assess the equipment.

Vaccine storage unit has stopped

• Check for the following:
  
  • The electrical cord is undamaged.
  • The unit is plugged in and turned on.
  • The wall outlet is operative. (Appropriate personnel should check fuses and circuit breakers.)
    
    
• Call a refrigeration technician to assess the equipment if necessary.

Document all the checks you made and the actions taken in the vaccine storage unit logbook. (See Routine Equipment Maintenance Logbooks in Section 3—Vaccine Storage Equipment for more details.)

Use the Algorithm to Assess Problems in Temperature Readings Outside the Recommended Range in the Resources Section. There are two algorithms that summarize actions to take if the refrigerator temperature reading is less than +2°C or greater than +8°C.

6.3 Refrigerator and Freezer Door Problems

Checking the Door Seal

To check that the vaccine storage unit door is sealing properly:

1. Place a thin paper strip against the cabinet front.
2. Close the door.
3. Pull the paper strip. If it moves easily or falls away by itself, the door and the rubber-like seal need to be adjusted.
4. Check all the way around the door. Pay particular attention to the corners.

Adjusting the Door Seal

If you have checked the door seal and determined that the refrigerator door is not closing properly, call a technician.

6.4 Thermometer Problems

Checking Thermometer Placement

If the thermometer indicates a temperature outside the recommended range, check that the thermometer is appropriately situated in the center of the storage unit compartment, adjacent to the vaccine. If the thermometer is placed near the coils, walls, floor, door, or fan, it may indicate colder or warmer temperatures than a thermometer appropriately placed in the center of the compartment where the vaccines should be kept.

Checking if the Thermometer Works

A slight variation in temperature is often seen from one thermometer reading to another, even when the vaccine storage unit thermostat is set at a particular temperature. If the thermometer reading does not fluctuate at all over several readings, temporarily remove the thermometer from the storage unit and place it outside the unit at room temperature. Check whether the temperature reading rises. If no change in the temperature reading occurs, check the batteries. Batteries should be changed at least once a year. If there continues to be a problem with the thermometer, call the manufacturer. The thermometer may be faulty and need to be replaced. (See Section 3—Vaccine Storage Equipment for more details.)

Thermometers should be checked annually to ensure:

• Temperature measurement is accurate
• Batteries are functioning
• Cables or probes are not damaged
• Adequate supplies of graph paper and ink pens for chart recorders

Checking if the Thermometer Is Accurate

If the thermometer appears to be working but there is concern regarding the accuracy of the reading, the slush test should be used to test the accuracy of the thermometer. (See Section 3—Vaccine Storage Equipment for more details.)

6.5 Power Outages

Advance Preparations

When there is reasonable cause to believe that a power outage may occur, emergency procedures should be implemented in advance of the event. (See Urgent Vaccine Storage and Handling Protocols in Section 2—Vaccine Storage and Handling Protocols and the Urgent Vaccine Storage and Handling Protocols Checklist in the Resources Section for more details.)

When there is reasonable cause to believe that a power outage may occur, emergency procedures should be implemented in advance of the event.

Temperature Considerations

Most refrigerated vaccines will remain stable at elevated temperatures for limited periods of time. Knowledge of a vaccine's stability, especially the rate of decline in potency at a given temperature, can be helpful in determining impact on expiry date and use of product after a temperature excursion has occurred. The World Health Organization⁽¹⁾ provides general information on vaccine potency. Consult your local public health office or immunization program* for product specific up-to-date stability data.

Power Outage Procedures

The information below is provided as a guideline. Consult your local public health office or immunization program* for any special instructions or forms.

If there is an ongoing power outage, take the following steps:

1) Do not allow the vaccine to remain in a nonfunctioning unit for an extended period of time. If you are unsure that the problem can be corrected in time to maintain an appropriate temperature, activate the Urgent Vaccine Storage and Handling Protocols. (See Urgent Vaccine Storage and Handling Protocols in Section 2—Vaccine Storage and Handling Protocols and the Urgent Vaccine Storage and Handling Protocols Checklist in the Resources Section for more details.)

Note: Even purpose-built fridges, especially those with glass doors, may not be able to maintain temperatures for longer than 30 minutes (anecdotal experience). Knowing the technical details of the refrigerator will help in the assessment. (See Section 3—Vaccine Storage Equipment and Section 4—Vaccine Storage Practices for more details.)

2) If it is a scheduled, time-limited power outage and you are certain the power will be restored before the vaccine storage unit temperature rises above the recommended range, take the following steps:

• Do not open the refrigerator or freezer door until the power is restored. Staff should be aware of the specific defrost timeframe of their refrigerator and/or freezer.
• Continue to monitor the temperatures inside the vaccine storage unit if the thermometer allows temperature monitoring without opening the storage unit doors.
• Record the room temperature and the temperature(s) inside the unit(s) at the time the problem is discovered, as well as the minimum and maximum temperatures reached inside the unit(s) during the power outage.
• Record the room temperature and the temperatures inside the vaccine storage units as soon as possible after power has been restored. Note the length of time the power has been off and the maximum temperature observed.
• If the temperature inside the refrigerator has exceeded the recommended +8°C or if the temperature inside the freezer has risen above -15°C, record the duration of inappropriate temperature exposure and follow the procedures in “Steps in Handling Inappropriate Vaccine Storage Conditions (Light and Temperature)” earlier in this section.

6.6 References

1. World Health Organization. Thermostability of vaccines. Geneva, World Health Organization, 1998. (WHO/GPV/98.07)

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