Sample policy · GP

Vaccination and cold chain policy (gp)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The primary subject-matter sources for vaccine storage and cold chain are the UKHSA Green Book (chapter 3) and the Human Medicines Regulations 2012; Regulation 12 is the engaged CQC regulation. · primary source

1. What the regulation says

Care and treatment must be provided in a safe way for service users. (Reg 12(1) (the headline duty))

assessing the risks to the health and safety of service users of receiving the care or treatment, (Reg 12(2)(a) (risk assessment))

doing all that is reasonably practicable to mitigate any such risks, (Reg 12(2)(b) (risk mitigation))

where equipment or medicines are supplied by the service provider, ensuring that there are sufficient quantities of these to ensure the safety of service users and to meet their needs, (Reg 12(2)(f) (sufficient equipment + medicines supply))

the proper and safe management of medicines, (Reg 12(2)(g) (medicines management))

The full text of the regulation is at https://www.legislation.gov.uk/uksi/2014/2936/regulation/12. Where this policy and the regulation diverge, the regulation wins.

2. Plain-English summary

Care and treatment must be provided in a safe way. The regulation lists the areas a provider must address, including risk assessment, risk mitigation, staff competence, safe premises, safe equipment, sufficient equipment and medicines, medicines safety, infection prevention and shared-care planning. Regulation 12 is central to CQC's safety expectations.

3. 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.

4. Sources to verify before adoption

5. Scope

This policy applies to:

It applies to NHS vaccination programmes and private vaccination services where the Practice provides them.

6. Lawful authority to administer vaccines

The Practice must ensure that every vaccine is supplied and administered under a lawful authority.

Before a vaccine is given, staff must confirm which authority applies:

A vaccine must not be administered unless the staff member is authorised under the relevant mechanism, trained, competent, and working within the limits of their role.

Where a PGD is used, the Practice must keep the current authorised PGD, the start and expiry dates, inclusion and exclusion criteria, dose, route, contraindications, referral requirements, record-keeping requirements, and the list of staff authorised to use it. Staff must not use an expired PGD, use a PGD outside its stated scope, or delegate PGD supply or administration to a person who is not authorised under it.

Where a PSD or individual prescription is used, the record must identify the named patient, prescriber, vaccine, dose, route and date. Staff must not treat a general clinic instruction as a PSD unless it clearly relates to a named patient and vaccine.

The vaccination administration record must show the authority used, for example prescription, PSD, PGD name/version, or national protocol reference.

If the authority is unclear, expired, outside scope, or not recorded, the vaccine must not be administered until the issue is resolved by the prescriber, vaccination lead or Registered Manager.

7. Cold-chain process

The Practice follows a documented cold-chain process for every vaccine.

7.1 Ordering and receipt

Staff order vaccines through the approved route.

On receipt, staff record:

Staff place vaccines in the approved fridge promptly and escalate any concern about delivery condition.

7.2 Fridge storage

Vaccines are stored only in approved vaccine fridges.

The Practice keeps each fridge:

Staff check current UKHSA Green Book chapter 3 and CQC source material for exact storage requirements before adoption.

7.3 Temperature monitoring

The Practice records vaccine-fridge temperatures according to the local procedure.

The temperature record includes:

Staff do not adjust or ignore readings without recording the reason and action taken.

7.4 Transport

Where the Practice transports vaccines, the Cold Chain Lead sets a written transport process.

The process records:

The Practice verifies transport process against current Green Book chapter 3 source material before adoption.

8. Cold-chain failure and quarantine

The Practice treats fridge failure, transport excursion and unexplained temperature reading as a cold-chain incident.

Staff:

The Practice verifies batch quarantine wording and decision routes against current UKHSA Green Book chapter 3 and local commissioning guidance before adoption.

9. Vaccine incidents and Yellow Card reporting

The Practice records vaccine incidents as incidents.

This includes:

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:

10. Responsibilities

11. Recording requirements

The Practice keeps the following records:

Records are kept in the Practice governance records or clinical system according to the local procedure.

12. Audit cadence

The Practice uses the following Verivius default audit rhythm unless current source material requires more frequent review:

Audit findings are recorded as improvement actions with an owner and review date.

13. Version control and review date

The Practice keeps a controlled copy of this policy. The footer or document-control table records:

14. Related records

Review cadence: annual or on regulatory change, whichever sooner. Owner: Registered Manager.

15. Sources and further reading

This template is based on CQC's guidance for providers and managers, the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, and other topic-specific legislation and guidance listed below. It is a starting point for adaptation, not a substitute for legal, clinical, HR, safeguarding or specialist professional advice.

16. When to seek further advice

Seek specialist advice where the issue involves serious harm, safeguarding, deprivation of liberty, restraint, children, professional misconduct, controlled drugs, radiation, termination of pregnancy, infection outbreak, water safety, employment dismissal, DBS barring referral, or regulatory enforcement.

17. Document control

Version Date Author Changes
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: anchored to Regulation 12, added verbatim regulation text, plain-English summary, standard sources, advice and document-control blocks. All original operational sections preserved and renumbered.

This sample policy template was issued by Verivius. It is a template, not a substitute for legal advice or the tenant's own policy-development process. Where this template and live law or regulator guidance diverge, the live source wins.

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Last reviewed 10 June 2026