Cold Chain

Recording vaccine fridge temperatures – brief summary

• All staff should be made aware of the cold chain policy and their responsibilities
• Vaccines should be stored at the manufacturer’s recommended temperature range (+2°C to +8°C)
• The temperature recording should be visible externally without having to open the fridge door
• Only fridges suitable for the specific storage of vaccines should be used. These should be cleaned, serviced and calibrated as per the manufactures guidance
• There should be adequate ventilation space around the refrigerator to allow free circulation of air to cool the compressor motor
• Where possible refrigerators should not be placed against an external wall or near a window as this may be subject to hot and cold temperatures with changes in weather
• To prevent an accidental interruption of the electricity supply fridges should either be directly plumbed into the system or a note placed on the plug socket to ensure it is not removed or switched off
• Only vaccines should be stored in the fridge
• Opening of the fridge door should be kept to a minimum to prevent variations in the internal temperature
• Vaccines should not be exposed to ultraviolet light and not frozen as this can affect vaccine potency
• The vaccines boxes should not touch the sides and back of the fridge walls as this can affect the vaccines
• Where possible vaccines should be stored in their original packaging and placed in the fridge on delivery
• Stock should be rotated on a regular basis checking for expiry dates and any damage to the packaging and this should be documented including:
  • Vaccine type and brand
  • Quantity
  • Batch number and expiry date
  • Date and time of receipt
  • Signature of person receiving goods
• All vaccines are Prescription Only Medicines (POMs) and must be stored under locked conditions. Either the refrigerator is lockable or the room is locked when not occupied by a member of staff
• Vaccines must never be left unattended once removed from the fridge
• The fridge should be no more than 50% full
• Vaccines should be stored on the shelves but not in the compartments on the door or on the floor of the main unit
• Maximum and minimum fridge temperatures should be recorded at least daily and preferably twice a day, this can be dependent on how often the fridge is accessed.
• The following date should be documented referring to the 4Rs:

1. Read
2. Record
3. Reset
4. React

• Any potential breaches in the cold chain should be escalated immediately Vaccine Incidence guidance (publishing.service.gov.uk)

Please access the following links for more detailed information

• CQC GP Mtyhbuster 17: Vaccine storage and fridges in GP practices | Care Quality Commission (cqc.org.uk) Items stored in a refrigerator should be kept within the range of 2°C to 8°C.
• Green_Book_Chapter_3_v3_0W.pdf (publishing.service.gov.uk) pgs. 28-29 vaccine storage and temperature recordings
• Using fridges appropriately to store COVID-19 vaccines – SPS - Specialist Pharmacy Service – The first stop for professional medicines advice

You are advised to contact the quality team at your ICS for more support and guidance.

Transporting Vaccines

CQC say "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 practice will ensure learning from cold chain incidents"

The NHS Specialist Pharmacy Service (SPS) has a policy specific for Primary care  that also covers transporting vaccines. It is recommended that you look at the policy in full, however the section on transport tells us: -

 10. Transporting vaccines

• Domestic cool boxes must not be used to store, distribute or transport vaccines.
• Validated cool boxes and cool packs from a recognised medical supply company should be used in conjunction with validated maximum–minimum thermometers. A data logger is required if vaccine is to be transported and then subsequently returned to the base refrigerator.
• Cool packs should be stored in accordance with the manufacturer’s instructions, usually at +2˚C to +8˚C (not a freezer compartment) to ensure they maintain the cold chain at the right temperature.
• In general, ice packs and frozen cool packs should not be used as there is a danger of these freezing some vaccine doses during transit. The exception to this is when the cool box manufacturer’s instructions specifically state that ice packs should be used.
• Individual manufacturer’s instructions must be strictly adhered to.
• A validated cool box provides ongoing assurance that the vaccines will be maintained within the cold chain temperature range during transport.
• With time and use, cool boxes may no longer be able to maintain this temperature range for extended periods, so monitoring is always required.
• The cool box manufacturer should also provide sufficient evidence for assurance that a stable temperature within the range of the cold chain can be maintained for several hours.
• Vaccines must be kept in the original packaging, wrapped in bubble wrap (or similar insulation material) and placed into a cool box with cool packs as per the manufacturer’s instructions. This will prevent direct contact between the vaccine and the cool packs and will protect the vaccine from any damage.
• When transporting vaccines, named individuals are responsible for ensuring that only the amounts of vaccines necessary for each session are removed from the vaccine refrigerator. These should be placed quickly into the validated cool boxes and opening must be kept to a minimum.
• An example vaccine in cool box temperature monitoring sheet is available in Appendix 2

 10.1 Returned vaccines that have been transported

Vaccination sessions away from the base clinic should be planned in such a way that the correct amount of vaccine is transported, thereby minimising any need to return vaccine.  In general, unused vaccines may be returned to the base clinic vaccine refrigerator, providing there is evidence from the data logger that the cold chain has been maintained. Returned vaccines should be marked, segregated and used at the earliest opportunity.  This general information is not applicable to all situations and vaccine specific information should be followed where this is available, for example vaccines that are particularly temperature sensitive or require complex handling.

If the cold chain cannot be guaranteed, then advice must be sought from the manufacturer or local Medicines Information Department/ICS Pharmacy team (insert local contact details XXX) and if necessary, the vaccines should be destroyed.

Data loggers

Many practices have been using data logger’s for several years as it provides an accurate ongoing temperature recording which can provide additional information should there be a breach in the cold chain. They can also be useful if you are the person overseeing temperature recordings and based in an alternative location. There are a range of data loggers available and the prices can vary, you are advised to refer to the manufactures guidance on frequency of calibration.

It is recommend that practices continue to record fridge temperatures manually at least daily even if using a data logger.

Ambient room temperature for storage of medicines

Safe Ranges for ambient medication, will be dependent on the medicines and can range between 15°C to 25°C for most medicines, although some medicines can be stored at up to 30°C. Some CCGs recommend that if the ambient temperature remains at 25 degrees for a number of consecutive days this should be investigated and recorded as a SE e.g. Dorset ICS. You are recommended to speak to the medicines management team at your ICS for clarification and guidance.