Managing temperature excursions for COVID-19 vaccines

Ian Allen, Pharmacy Quality Assurance Regional Specialist (NW), North West Pharmaceutical Quality AssurancePublished Last updated See all updates

Correct cold chain management will prevent temperature excursions. Where they do occur, set actions should be undertaken to gather information and seek advice.

1) Take immediate remedial actions

Secure and quarantine affected stock

  • Return to refrigerated storage any vaccine vials that have been exposed to temperatures outside of +2°C to +8°C
  • Quarantine the affected stock within the fridge by attaching a “DO NOT USE” label

Rectify any obvious immediate cause

  • Check obvious causes e.g. the fridge door having been left open or a power switch having been turned off
  • Confirm the fridge is within range or has returned to +2°C to +8°C and, once documented, reset the min/max fridge reading
  • Where no obvious rectifiable cause can be identified, take the fridge out of use until an investigation into the cause of the excursion has been concluded. The fridge should be returned to use only once it has been confirmed to be functioning correctly.

2) Gather information

Establish the basics

Record as much as you are able to about the incident, for example:

  • What happened overall
  • How warm the vaccine became
  • How cold the vaccine became
  • The time period for the excursion
  • Whether the vaccine froze

Determine and record the detail

To help understand the conditions the vaccine has been exposed to you should:

  • Determine the length of time vaccine has been outside of the recommended storage conditions
  • Determine the maximum / minimum temperature reached
  • Examine the records of current and past data from the fridge

Where a min/max temperature recorder is in use

The last time the cold chain will be guaranteed is the point at which the min/max was last read and found to be within 2 to 8°C.

Min/max records provide limited information to support decision making as they only capture the extremes of temperature the fridge has reached since the last time the min/max recording was reset.

Where a continuous data logger is in use

Download and examine the data.

Continuous data loggers are able to provide a detailed picture of temperatures within the refrigerator and, in the event on a temperature excursion, aid decision making in comparison to the use of min/max recordings alone.

Use forms to help gather information

SPS has produced a Temperature Excursion Reporting Checklist to aid information gathering in the event of a temperature excursion. This is attached below.

3) Seek advice

Contact your Regional Vaccination Operations Centre

Private: Contact emails for Regional Vaccination Operation Centres

In the event of vaccine temperature excursions, Regional Vaccination Operation Centres may need to be contacted for advice

4) Prevent reoccurrence

Actions to prevent reoccurrence should include:

Train staff

Ensure staff are trained and competent for the fridge (s) being used.

Ensure the fridge is functioning correctly

To prevent reoccurrence of the temperature excursion, an investigation should be undertaken to identify its cause. Effective actions should be taken to address any causes identified. Areas for consideration within your investigation should include:

  • Equipment – Is there a fault with the fridge or a thermometer? A refrigerator engineer may be required to review and correct technical faults with the equipment.
  • Procedures – Are procedures for use of the fridge and management of the cold chain robust and clearly documented. Procedures may require updating if weaknesses identified have led to the excursion.
  • Training – Are staff effectively trained against the procedures? Retraining of staff and assessment of their understanding in the use of the fridge and management of the cold chain may be required.

The correct set up and monitoring of your fridge is essential to both prevent excursions, and minimise their impact should they occur.

Follow our advice

Follow our good practice advice on fridge use will help you prevent recurrence of excursions.

5) Record the outcome

All excursion incidences should be fully documented locally; as a minimum, record:

  • The time and extent of the temperature excursion
  • Details of the vaccines and batch numbers affected by the temperature
  • Details of any advice taken and whom this was sought from
  • Actions taken to prevent a future reoccurrence of the excursion

Change history

  1. SPS Temperature Excursion Reporting Checklist added
  1. Published