Maintaining the Cold Chain: Dealing with vaccine storage incidents

Maintaining the Cold Chain: Dealing with vaccine storage incidents

What Healthcare Professionals Need to Know

Vaccines are highly sensitive biological products. Their potency and safety depend on strict adherence to storage conditions, especially temperature control throughout the cold chain.

Correct vaccine storage and handling has been an important factor in preventing and eradicating many common vaccine preventable diseases. Yet each year, storage and handling errors result in cold chain breaches causing significant financial loss of wasted vaccines and the need to revaccinate patients.

The ‘cold chain’ is a term used to describe the specific temperature conditions in which vaccines should be kept during storage and distribution to protect against loss of potency.  Failure to store and handle vaccines correctly can reduce vaccine potency, resulting in inadequate immune responses and poor protection against disease.

When cold chain breaches occur it’s crucial to act promptly and systematically to protect public health and uphold clinical standards. Service users can lose confidence in vaccines and immunisation service providers if they have to be revaccinated after receiving vaccines that may have been compromised.

This blog provides a clear action plan for healthcare professionals, drawing on guidance from:

• Vaccine Incident Guidance: Responding to Vaccine Errors
• Storage, Distribution and Disposal of Vaccines – Green Book, Chapter 3
• Vaccines Stored Outside the Recommended Temperature Range – Leaflet

At least two designated members of staff who have received appropriate training should be responsible for ordering, receipt and care of vaccines. However, all members of the team should understand importance of good vaccine management.

All providers should have a policy which includes how to handle vaccines to maintain the cold chain from the point of delivery to administration. It should include transport of vaccines outside the practice, actions to take in the event of a breach in the cold chain and details of how the workplace will ensure learning from cold chain incidents.

What is a Cold Chain Breach?

The Green book Chapter 3 advises that vaccines should be stored according to the manufacturers summary of product characteristics (SPC) – this is usually at +2°C to +8°C. Vaccines should also be protected from light as prolonged exposure to light can cause loss of potency.

Exposing vaccines to any temperature outside the manufacturer’s recommended range is considered a breach of the cold chain and may invalidate the product license.

A cold chain breach occurs when vaccines are exposed to temperatures outside the recommended +2°C to +8°C range.

This can happen due to:

• Fridge failure or power outage
• Incorrect storage or transport procedures
• Human error (e.g., leaving the fridge door open)

Even short exposures to improper temperatures can compromise vaccine effectiveness.

Step-by-Step: What to Do if a Cold Chain Breach Occurs

The Vaccine incident guidance document has been developed to provide consistent guidelines for both providers and commissioners of immunisation services. This document draws on existing guidance on vaccine storage and handling and reflects best practice procedures that should already be in place. Each breach of the cold chain should be immediately acted upon and specialist advice should be sought in order to ascertain what action, if any, is required.

Actions to take in the event of a vaccine storage incident (cold chain breach)

1. Embargo the fridge and/or affected vaccines

• Isolate potentially compromised vaccines
• Clearly label them as “Do Not Use” and store at the correct temperature
• Fridge should remain switched on
• All staff should be informed that vaccines are not used until further notice

2. Confirm and define the incident

• Complete cold chain incident checklist
• Make an inventory of all exposed vaccines

3. Report the incident to your local Screening and Immunisation Team

4. Investigate the incident

• Request a refrigerator engineer to inspect fridge/thermometers
• Confirm current temperature using data logger for 48-72 hrs
• Check fridge service history
• Check temperature records and clarify cold chain breach

5. Carry out informed risk assessment

• Using available stability data, identify if vaccine potency is affected by cold chain breach
• Consider seeking further advice from SIT, HPT or UKHSA national immunisation team

6. Outcome of risk assessment

Vaccines ‘satisfactory for use’

• Label as involved in incident and use first

Vaccines compromised

• Dispose as per local wastage policy
• Complete stock incident and report on Immform

Compromised vaccines given to patients

• A formation of incident control team should be considered .
• Refer to – Section 8: UKHSA Vaccine Incident guidance
• Every stage of the incident should be fully documented

7. Documentation, reporting and evaluation

• Every stage of the incident should be fully documented

• Healthcare professionals should report the incident via their local governance systems so future lessons can be learnt and the risk of further incidents minimised

By following the vaccine incident guidance and acting swiftly and systematically, healthcare professionals can safeguard both patient safety and the integrity of immunisation services.

Preventing future vaccine storage incidents.

To minimise risk:

• Use calibrated digital maximum-minimum thermometers
• Monitor temperatures at least twice daily (during working week)
• Ensure all staff are trained in cold chain procedures
• Implement backup power solutions and contingency plans
• Regularly review and maintain vaccine fridges

Remember the 4 R’s

READ, RECORD, RESET AND REACT.

• READ                  Daily fridge temperature recordings (max, minimum and current)
• RECORD           Record temperatures on a standard form and sign
• RESET                 Reset thermometer after each reading
• REACT                Act if the temperature falls outside the +2°C to +8°C range          

REMEMBER:

It is the responsibility of the immuniser to ensure that the vaccines they use have been stored in conditions in accordance with the product license.  Where storage conditions have been breached, it is the responsibility of the immuniser to ensure that appropriate actions have been taken in accordance with the relevant best practice guidance UKHSA Vaccine incident guidance

Off label vaccines

An ‘off label’ vaccine is

‘A vaccine that for whatever reason has breached its license but experts have advised that there are clear benefits of using the vaccine in this way and it is still considered as  safe and effective’ UKHSA 2022

Care Quality Commission

During a CQC inspection, inspectors will expect to see evidence of maintenance of the cold chain. Providers will be asked to show how they follow the UKHSA recommendations. This includes receipt of vaccines into the practice until administration to the patient. Inspectors may also ask to see evidence of the log of fridge temperatures, maintenance checks and a policy for what to do if a temperature breach occurs. Inspectors may also check the fridge to see if the vaccines are being stored appropriately.

Further learning and resources

Online resources

The Green Book. Chapter 3: Storage, distribution and disposal of vaccines.

Gov.uk guidance. Protocol for ordering, storage and handling vaccines

GP myth buster 17: Vaccine storage and fridges in GP practices

Online learning module: Vaccine storage

Healthcare professionals are recommended to complete  vaccine storage training within the Immunisation modules on the NHS eLearning for healthcare online programme (elfh) . This session provides information to immunisers on the correct procedures to follow for the storage of vaccines. The assessment will test practitioners’ knowledge and understanding of the vaccine storage session.

Healthcare professionals can also visit:

The Specialist Pharmacy service website Managing Temperature excursions.