This article relates to the CQC key question: Is your practice safe?
Public Health England (PHE) has published guidance regarding ordering, storing and handling vaccines.
This applies to all staff involved in immunisation to ensure vaccines are stored and managed properly so immunisations are carried out safely and efficiently.
Vaccines may lose their effectiveness if they become too hot or too cold at any time. Vaccines naturally biodegrade over time and storage outside of the recommended temperature range – including during transport – may speed up loss of potency, which cannot be reversed. This may mean the vaccine fails to create the desired immune response and consequently provides poor protection. Vaccines cost the NHS around £200m a year; inappropriate storage and transport also causes wastage and unnecessary costs.
Management of vaccines
When ordering and taking delivery of vaccines staff should ensure that:
- orders are placed every 2-4 weeks, according to need
- vaccine is promptly stored in a fridge after delivery, maintaining the ‘cold chain’ at all stages
- stock is properly rotated – the shortest expiry date used first
- orders are placed in sufficient time to ensure there is an adequate supply for clinics.
Named, trained, people need to be responsible for ordering, receipt and care of vaccines (preferably one from the nursing team and one from management). All members of the primary care team should be aware of the importance of good vaccine management.
The vaccine fridge
Specialised refrigerators are available for the storage of pharmaceutical products and must be used for vaccines and diluents. Ordinary domestic refrigerators must not be used.
- Specialised vaccine fridges cost £600 – £1,200
- A validated medicines fridge must be used for the storage of vaccines and other medicines.
- It must only be used to store pharmaceutical products, ie food and clinical specimens must not be stored alongside vaccines.
- The temperature must be maintained between +2 deg C and +8 deg C.
- Minimum, maximum and actual temperatures of the medicines fridge must be recorded daily when the practice is open.
- The person recording should document on a standard form the minimum and maximum temperature, and the time, and then reset the thermometer and sign the form.
- Records should be kept for a year.
- A second independent thermometer is ideal but if that is not available the thermometer used should be calibrated monthly to confirm accuracy. A second thermometer provides a method of cross-checking the accuracy of the temperature.
- Care should be taken that the thermometer probe cable does not interfere with the door seal, causing the temperature to fall outside the permitted range.
- The practice needs to reduce the probability of accidental interruption of electricity supply, such as installing a switchless socket or clearly labelling the vaccine refrigerator plug with a cautionary notice, eg 'Do not unplug/switch off'.
- The medicines fridge must be secure and accessible only to authorised practice staff. In practice, the fridge should be locked or kept in a locked room
- The fridge should be in a well-ventilated position and away from heat sources.
- It should be large enough to allow sufficient space around the vaccine packages for air to circulate.
- Vaccines must be kept in their original packaging.
- The fridge must be maintained in a clean condition with no build-up of ice.
- There should be a maintenance contract that allows for at least yearly servicing, calibration of the temperature gauge and Portable Appliance Testing.
The ‘cold chain’
This term is used to describe the cold temperature conditions in which certain products need to be kept during storage and distribution:
- all those administering vaccines should have had training on the importance of maintaining the cold chain
- validated cool boxes from a recognised medical supplier should be used to transport vaccines
- all those involved in administering vaccines as well as the practice manager should understand what to do in the event of a failure in the cold chain.
Observe the four Rs: Read; Record; Reset; React
Make sure that the person making the recording:
- does it every day during the working week and signs the sheet
- records it in a standard fashion and on a standard form
- acts if the temperature falls outside +2 deg C and +8 deg C
- resets the thermometer after each reading.
Follow this schedule:
Every week: fridge contents should be checked at least once.
Every month: vaccine stock should be audited and recorded.
Every three months: audit records of stock and temperature management can be shared with your local screening and immunisation teams.
PHE has also produced guidance on what to do if the cold chain is compromised or believed to be compromised.
The important principle is that the vaccines must remain in cold storage under quarantine and the local screening and immunisation team at NHSE contacted for advice. Vaccines should not be used or discarded until further advice has been sought.
- Professor Nigel Sparrow is senior national GP advisor and responsible officer at the CQC
More CQC resources
- View the full CQC Essentials series on Medeconomics
- CQC's recommended reading to help practices meet regulations and prepare for an inspection
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