1. Purpose
Vaccines are biological products that lose their effect if they get too warm or too cold. A vaccine that has been outside the right temperature range may not protect the traveller, even though it looks the same. This policy sets out how the Service keeps its vaccines at the right temperature from delivery to use, watches for problems, and acts when the cold chain is broken.
The Service must verify this policy against the current Green Book chapter on storage, distribution and disposal of vaccines and UKHSA cold-chain guidance before adoption.
2. Sources to verify before adoption
- Immunisation against infectious disease (the Green Book), the chapter on storage, distribution and disposal of vaccines: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
- UKHSA vaccine cold-chain guidance and the protocol for ordering, storing and handling vaccines: https://www.gov.uk/government/organisations/uk-health-security-agency
- The Summary of Product Characteristics for each vaccine (its storage conditions)
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
3. Scope
This policy applies to:
- every vaccine the Service holds and gives
- the fridge or fridges used to store them, and the monitoring of those fridges
- the staff who order, receive, store, monitor and use vaccines
4. The vaccine fridge
- vaccines are stored in a dedicated vaccine fridge, not a domestic fridge and never with food or specimens
- the fridge holds vaccines at the temperature the manufacturers require, which is normally between 2 and 8 degrees Celsius
- vaccines are arranged so air can circulate, away from the walls and not in the door, and the fridge is not overfilled
- the fridge is serviced and, where possible, has an alarm; it is connected to a supply that will not be switched off in error
5. Temperature monitoring
- the fridge temperature, including the maximum and minimum since the last reading, is read and recorded at the start of every working day the fridge is in use, and the thermometer is reset
- readings are kept as a record that can be reviewed
- a reading outside the safe range triggers the cold-chain breach procedure straight away; vaccines are not assumed to be fine
6. Stock management
- stock is rotated so the vaccines with the earliest expiry are used first
- expiry dates are checked on receipt and before use, and out-of-date vaccine is removed and disposed of safely
- the Service holds a level of stock it can use within shelf life, and keeps a record of what it holds
7. Receiving deliveries
When vaccines arrive, they are checked and put into the fridge promptly. The Service confirms they were transported in the cold chain, records receipt, and does not leave vaccines out at room temperature while other work is done.
8. Cold-chain breach
If the temperature has been outside the safe range, or the fridge has failed or been switched off:
- the affected vaccines are marked, kept separate and not used
- the Service finds out how long, and how far, the temperature was out of range
- the Service seeks advice (from the manufacturer or UKHSA) on whether the vaccines can still be used, and follows that advice
- the event, the affected stock and the decision are recorded, and any traveller given a vaccine later found to be affected is identified and managed
9. Disposal
Vaccines that are out of date, damaged or no longer safe to use are disposed of as the Service's waste arrangements and the guidance require, and the disposal is recorded.
10. Training
Staff who order, receive, store, monitor or use vaccines are trained in the cold chain and the breach procedure, and refreshed on a stated cadence. A named person is responsible for the cold chain, with a named deputy. The Service records who is competent and the next refresher date.
11. Audit cadence
The Service checks, on a stated cadence, that:
- fridge temperatures, including maximum and minimum, are read and recorded every working day
- stock is in date and rotated, with a sensible holding level
- cold-chain breaches are recorded and acted on, with the right advice sought
- a named person and deputy are responsible and trained
The Registered Manager reviews the results and records the improvement actions that follow.