1. Purpose
This policy sets out how the Practice orders, receives, stores, transports, administers and disposes of vaccines while maintaining cold-chain assurance.
It also covers fridge failure, temperature excursions, wrong vaccine administration, omissions and Yellow Card reporting.
2. Sources to verify before adoption
- GOV.UK, Green Book chapter 3, Storage, distribution and disposal of vaccines: https://www.gov.uk/government/publications/storage-distribution-and-disposal-of-vaccines-the-green-book-chapter-3
- Human Medicines Regulations 2012: https://www.legislation.gov.uk/uksi/2012/1916/contents
- GOV.UK, report a problem with a medicine or medical device: https://www.gov.uk/report-problem-medicine-medical-device
- GOV.UK, Yellow Card scheme: guidance for healthcare professionals: https://www.gov.uk/government/publications/yellow-card-scheme-guidance-for-healthcare-professionals
- CQC GP mythbuster 17, Vaccine storage and fridges in GP practices: https://www.cqc.org.uk/guidance-providers/gps/gp-mythbusters/gp-mythbuster-17-vaccine-storage-fridges-gp-practices
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12: https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 17: https://www.legislation.gov.uk/uksi/2014/2936/regulation/17
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 20: https://www.legislation.gov.uk/uksi/2014/2936/regulation/20
3. Scope
This policy applies to:
- vaccines ordered by the Practice
- vaccine receipt, storage and disposal
- vaccine-fridge monitoring
- vaccine transport where the Practice carries or sends vaccines
- vaccination clinics
- cold-chain breaches
- wrong vaccine administration
- vaccine omission tracking
- adverse-event reporting
- staff who handle, prescribe, administer or record vaccines
It applies to NHS vaccination programmes and private vaccination services where the Practice provides them.
4. Cold-chain process
The Practice follows a documented cold-chain process for every vaccine.
4.1 Ordering and receipt
Staff order vaccines through the approved route.
On receipt, staff record:
- date and time received
- vaccine name
- batch number
- expiry date
- quantity
- condition on arrival
- temperature concern where known
- staff member receiving
- storage location
Staff place vaccines in the approved fridge promptly and escalate any concern about delivery condition.
4.2 Fridge storage
Vaccines are stored only in approved vaccine fridges.
The Practice keeps each fridge:
- clean
- secure
- labelled
- within the locally verified temperature range
- organised by vaccine type and expiry date
- connected to the required monitoring equipment
- free from food, specimens and non-vaccine items
Staff check current UKHSA Green Book chapter 3 and CQC source material for exact storage requirements before adoption.
4.3 Temperature monitoring
The Practice records vaccine-fridge temperatures according to the local procedure.
The temperature record includes:
- date
- time
- current temperature
- minimum and maximum temperature where equipment provides it
- staff initials
- reset action where required by local procedure
- escalation where the reading is outside the accepted range
Staff do not adjust or ignore readings without recording the reason and action taken.
4.4 Transport
Where the Practice transports vaccines, the Cold Chain Lead sets a written transport process.
The process records:
- container used
- vaccine name and batch
- time out of fridge
- temperature monitoring method
- destination
- staff member responsible
- receipt confirmation
- action if temperature cannot be confirmed
The Practice verifies transport process against current Green Book chapter 3 source material before adoption.
5. Cold-chain failure and quarantine
The Practice treats fridge failure, transport excursion and unexplained temperature reading as a cold-chain incident.
Staff:
- keep affected vaccines separate and clearly marked
- do not use affected vaccines until authorised
- record the temperature, time and vaccines affected
- inform the Cold Chain Lead and Registered Manager
- seek advice from the current vaccine advice route, supplier or commissioning route
- document the advice received
- decide whether vaccines can be used, must remain quarantined or must be disposed of
- record disposal where required
- record the incident and action taken
The Practice verifies batch quarantine wording and decision routes against current UKHSA Green Book chapter 3 and local commissioning guidance before adoption.
6. Vaccine incidents and Yellow Card reporting
The Practice records vaccine incidents as incidents.
This includes:
- wrong vaccine administered
- wrong dose
- wrong interval
- vaccine given despite contraindication
- vaccine omitted where local process expected administration
- vaccine administered after cold-chain breach without authorisation
- adverse event after vaccination
Where an adverse event or medicine-safety concern may need Yellow Card reporting, staff check the current GOV.UK Yellow Card route and record the decision.
Where wrong vaccine or significant omission creates patient-safety risk, staff:
- make the patient safe
- seek clinical advice
- contact the patient or representative where appropriate
- consider duty of candour
- record the event in the incident register
- review whether other patients or batches are affected
- assign corrective action
7. Responsibilities
- Registered Manager: owns this policy, ensures vaccine governance and signs off annual review.
- Cold Chain Lead: owns day-to-day fridge monitoring, stock control, cold-chain incident response and weekly log review.
- Lead GP or GP Partner: reviews clinical vaccination incidents, contraindication concerns and doctor-only decisions.
- Nursing lead: supports vaccination clinic procedure, staff competency and administration records.
- All staff handling vaccines: follow the cold-chain process, record checks and escalate concerns immediately.
8. Recording requirements
The Practice keeps the following records:
- vaccine order and receipt record
- vaccine stock record
- vaccine-fridge temperature log
- fridge service and maintenance record
- cold-chain incident record
- batch quarantine decision
- disposal record
- vaccination administration record
- vaccine omission record
- Yellow Card reporting decision
- staff competency record
- weekly validation log review
Records are kept in the Practice governance records or clinical system according to the local procedure.
9. Audit cadence
The Practice uses the following Verivius default audit rhythm unless current source material requires more frequent review:
- Daily: staff complete vaccine-fridge temperature checks according to the local procedure.
- Weekly: the Cold Chain Lead reviews cold-chain logs, stock records, failed readings and corrective actions.
- On incident: the Cold Chain Lead reviews affected vaccine batches, patient risk and learning.
- Quarterly: the Practice reviews vaccination incidents, omissions, adverse events and staff competency.
- Annually: the Registered Manager audits the cold-chain process against Green Book, CQC and HMR source material.
Audit findings are recorded as improvement actions with an owner and review date.
10. Version control and review date
The Practice keeps a controlled copy of this policy. The footer or document-control table records:
- policy owner
- version number
- date approved
- next review date
- changes made since the last version
- source material checked during the review
11. Related records
- Vaccine-fridge temperature log
- Vaccine stock register
- Cold-chain incident register
- Vaccination administration record
- Yellow Card reporting decision
- Incident register
- Duty of candour policy
- Staff training matrix
- Equipment maintenance record
- Improvement action register
Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.