Cold Chain Receiving and Storage

DISPENSARY
Standard Operating Procedure

RECEIVING AND STORING COLD CHAIN ITEMS
Purpose
To ensure the integrity of cold chain item supply (eg, vaccines) into the dispensary.
 Scope
This SOP covers the process to be followed for receiving and storing cold chain items,
and should be used in conjunction with the SOP on receiving and checking dispensary
stock
 This SOP does not cover the measuring and recording of fridge temperature – refer to
SOP: Fridge temperature monitoring
Receiving cold chain items

 Where a discrepancy arises, documentation needs to be appropriately amended before
signing
 Items which were not ordered should not be accepted and should be returned to the
delivery driver
Storing cold chain items

 Pharmaceutical-grade fridges must be used for the storage of all cold chain items; under
no circumstances should food/drink/non-medicinal items be stored in the same fridge
 Fridges should be placed in a way that enables the door to automatically close if left
open
 The on/off switch, along with the plug, for the fridge must be clearly marked to prevent
against the fridge being accidently switched off
 Vaccines must be stored in the original packaging
 Allow sufficient space between the cold chain items within the fridge to allow air to
circulate – ideally fridges should be fan operated to force the air to circulate
 Different types of fridge lines should be stored in a designated sections of the fridge for
ease of recognition
 Fridge stock checks should be carried out at least weekly
 Items with shorter expiry dates should be placed in front of other items and should be
used to dispense first if appropriate
 Mark clearly any vaccine returned to the fridge with the date and time of its return and
place it at the front of the fridge – this should only be done with vaccines that have
remained in the cold chain
 All medicines, including cold chain items must be stored securely where they would not
be accessible to unauthorised personnel
 Every month vaccine stock should be audited and recorded
 Fridges must not be situated near radiators/heat sources/direct sunlight and the
surrounding area should be adequately ventilated
 Do not place cold chain items directly against the cooling plate or the sides/back of the
fridge to avoid freezing of the items
Monitoring of cold chain storage

 The dispensary should have robust arrangements in place in the event of a fridge
breaking down, or a power failure – refer to practice continuity guidance
DISPENSARY
 Digital thermometers are preferred for monitoring fridge temperature as they are more
reliable
 Fridges that display the temperature externally should also contain a digital thermometer
inside to mitigate the risk of failure of the in-built thermometer or fridge failure
 Records of fridge servicing and cleaning should be maintained – refer to fridge
manufacturer guidance
 Maintenance of the cold chain forms part of all immunisation training updates
 A routine vaccine management review is performed quarterly.
Fridge failure, loss of power or temperature fluctuations

 Arrangements must be in place for a back-up fridge to be available in the event of fridge
failure
 All details of the incident should be reported:
o As per the dispensary reporting procedure; refer to relevant SOP on dealing with
incidents
o To the dispensary manager/responsible GP
 Records of fridge servicing and cleaning should be maintained – refer to fridge
manufacturer guidance
Cold chain audit

The cold chain audit aims to ensure cold chain items are stored and managed properly –
cold chain storage procedures should be audited periodically, for example, once every 12
months or more frequently if multiple disruptions occur.
Refer to Appendix 1 for cold chain fridge audit.
Useful references
Chapter 3 of the Green Book ‘Storage, distribution and disposal of vaccines [online] at:
www.gov.uk/government/collections/immunisation-against-infectious-disease-
the-green-book
National Patient Safety Agency advice on vaccine cold storage [online] at:
www.nrls.npsa.nhs.uk/resources/type/alerts/?entryid45=66111
Public Health England protocol: ordering, storing and handling vaccines [online] at:
https://www.gov.uk/government/publications/protocol-for-ordering-storing-and-handling-
vaccines
PHE guidance: Vaccine incidents. Responding to errors [online] at:

https://www.gov.uk/government/publications/vaccine-incident-guidance-responding-to-
vaccine-errors
DISPENSARY
Receiving cold chain items
In addition to normal delivery Check delivered items

protocols, ensure suppliers can against the delivery note
assure the integrity of the cold
chain during transport
Transfer items to the

fridge promptly, ensuring
shorter shelf life products
are at the front
Within
Item can be
Refer to SOP: Ensure fridge range
Fridge dispensed/administered
temperature is within
temperature 2 °C and 8°C as appropriate
checks
Outside
range
Administering/supplying Quarantine any affected

items stored outside of the cold chain items, and
temperature range place into a back-up
specified in their SPC will be fridge if available
unlicensed
Make a list of the cold

chain items affected and Unusable
contact manufacturers Dspose of item
for information regarding appropriately
stability
Usable
Refer to SOP:
Remove from quarantine Disposal (general
and return item for medications)
administration/dispensing
Report incident
Appendix 1: Cold chain fridge audit

DISPENSARY
Date of audit:
Yes No
Name of staff member completing audit: (tick (tick Notes
) )
1) Cold chain items are placed into a pharmaceutical-
grade fridge promptly after arrival in the dispensary
2) Delivery notes for cold chain items obtained are kept for
a minimum of one year
3) Steps have been taken to reduce the risk of interruption
to the power supply, for example, the fridge should have
a switchless socket or there should be clear notices on
the plug and socket warning people not to switch it off
4) A maximum-minimum thermometer is inside the fridge
and is operating correctly
5) Maximum-minimum temperatures are recorded daily
6) Recorded temperatures are within the range of 2 °C and

8°C
7) No other items apart from cold chain items are stored in
the fridge
8) Cold chain items are not placed directly against the
fridge side or back walls or near the cooling plate
9) There is sufficient space around the cold chain items for
air to circulate
10) Access to the fridge is restricted or the fridge is locked
11) Expiry dates of the cold chain items and stock levels are
checked at least weekly and recorded in the stock
inventory
12) There are records for fridge cleaning and servicing, in
line with supplier guidance
13) There is a system in place for the disposal of
expired/damaged cold chain items
14) There are records that a routine vaccine management
review is performed quarterly.
Action(s) to be taken following audit Date to be Completed

completed by
by (name)
1.
2.
3.
4.
5.
DISPENSARY
Date of Preparation: Date next review

due
Prepared by:
Signature: Date review takes

place and
signature of
reviewer
Version number:
I have read and understood this standard operating procedure.
Name Position held Signature Date

DISPENSARY

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DISPENSARY

Standard Operating Procedure

Receiving cold chain items

Storing cold chain items

Monitoring of cold chain storage

Fridge failure, loss of power or temperature fluctuations

Cold chain audit

PHE guidance: Vaccine incidents. Responding to errors [online] at:

Receiving cold chain items

In addition to normal delivery Check delivered items

Transfer items to the

Administering/supplying Quarantine any affected

Make a list of the cold

Appendix 1: Cold chain fridge audit

6) Recorded temperatures are within the range of 2 °C and

Action(s) to be taken following audit Date to be Completed

Date of Preparation: Date next review

Signature: Date review takes

I have read and understood this standard operating procedure.

Name Position held Signature Date

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