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.

What good looks like here

Written from an ex-CQC inspector's chair, but the point is safe, well-led care your team can stand behind. Each row shows what strong evidence looks like, what thin evidence looks like, and where the expectation comes from.

A vaccine is one of the very few treatments given to people who are entirely well, most often healthy children, pregnant women and older patients passing through a high-volume seasonal clinic. When the cold chain fails, nothing visible happens at the point of care: the dose looks normal, the person feels no different, and a child recorded as protected against measles may simply not be. The only thing that will ever say otherwise is the temperature record and the batch trail sitting behind it, which is why the fridge log, the batch quarantine decision and the recorded authority on each administration record are clinical records rather than paperwork. Where that trail is intact, a practice can name exactly who received suspect stock and offer a repeat dose with a straight explanation. Where it is not, the choice is between recalling far more people than needed and saying nothing at all, and neither is a good conversation to have with a parent months later.

  1. The cold chain held, and the record can show it. Daily fridge temperatures are recorded with minimum and maximum where the equipment provides them and with staff initials, and readings outside the accepted range are escalated, not adjusted or ignored without a recorded reason. A dose drawn from a fridge that drifted looks and feels identical to one stored properly, so the temperature record is the only thing that will ever tell a patient whether the vaccine they were given protected them.

    Strong evidence: The vaccine-fridge temperature log (date, time, current temperature, minimum and maximum, initials, reset action and escalation) and the weekly validation log review (sections 7.3, 11 and 12).

    Weak evidence: The log looks complete because one person filled in the whole week in the same pen, with an identical tidy reading every day, no minimum and maximum entered even though the data logger records them, and blanks across weekends and bank holidays. Where a reading did fall outside range there is a tick and an initial but nothing recording which batches were in that fridge or what happened to them, so the log evidences attendance rather than temperature.

    What the regulator expects to see. Not a law in itself, but CQC judges you against it, so an inspector will look for it and expect a reason where you depart from it.

  2. Every vaccine is given under a valid lawful authority, not a general clinic instruction. Each dose traces to an individual prescription, a Patient Specific Direction for a named patient, a current in-scope Patient Group Direction signed by the administering staff member, or an adopted national protocol, and the administration record names the authority used, with no expired or out-of-scope Patient Group Direction in use. It is what lets a colleague picking the record up months later say on whose authority the dose was given.

    Strong evidence: The vaccination administration record showing the authority used (prescription, Patient Specific Direction, Patient Group Direction name and version, or national protocol) and the current authorised Patient Group Direction with its start and expiry dates and authorised-staff list (sections 6 and 11).

    Weak evidence: The administration record says the vaccine was given, with a signature and a batch number, and nothing at all naming the authority it was given under. The practice can produce a Patient Group Direction, but it expired last season, or the current version has no signature sheet for the nurse who ran Saturday's clinic, or a printed patient list with an email from a GP saying these are all for flu is being treated as though it were a Patient Specific Direction for each named person.

    A legal duty. This comes from legislation that applies to your service, so meeting it is not optional. The exact provision is cited beneath the badge.

    Human Medicines Regulations 2012, reg 214(2) (no parenteral administration of a prescription only medicine except by, or in accordance with the directions of, an appropriate practitioner), with regs 229-233 and Sch 16 (Patient Group Directions: required particulars, expiry date, authorised class of health professional) and reg 247A (national protocols)

  3. A fridge failure or excursion leads to quarantine, not continued use. Affected stock is kept separate and clearly marked, is not used until authorised, advice is sought and documented, and the use, quarantine or disposal decision is recorded, rather than suspect vaccines staying in circulation. An intact batch trail is what lets a practice name the few people who received suspect stock and offer them a repeat dose with a straight explanation, instead of recalling far more people than needed or saying nothing at all.

    Strong evidence: The cold-chain incident record and batch quarantine decision, with the disposal record where required (sections 8 and 11).

    Weak evidence: The excursion appears in the temperature log and the trail stops there: no list of which batches were in the fridge at the time, no quarantine label or physical separation, and no record of who was asked whether the affected stock was still usable or what they said. Staff recall being told it was probably fine, the stock went back into general use, and nobody can now say how long it sat outside range or whether any given dose came from the affected batch.

    The instructions from the maker of a product, device, or medicine. Following them is how the item is used safely, and for medical devices it is effectively expected.

  4. Vaccine errors are logged as incidents and widened out, not treated as one-off slips. Wrong vaccine, wrong dose, wrong interval, contraindication and omission events are recorded, a Yellow Card report to the MHRA is considered for adverse events or medicine-safety concerns, whether other patients or batches were affected is reviewed, and the duty of candour is considered where harm or possible harm occurred. Those last two are separate duties and neither discharges the other: the Yellow Card report goes to the MHRA and concerns the medicine, while the duty of candour is owed to the person affected and is not a notification.

    Strong evidence: The incident register entry, the Yellow Card reporting decision and the review of other affected patients and batches (sections 9 and 11).

    Weak evidence: A wrong interval, a wrong dose or a missed vaccine is quietly corrected in the patient record and never reaches the incident register, so it is never counted and never trended. Where an entry does exist it closes with staff reminded, with nothing showing whether other patients shared the same batch or the same booking error, no recorded decision either way on Yellow Card reporting to the MHRA, and no record that the duty of candour threshold was considered or where it landed.

    Our recommended baseline. Not a legal or regulatory requirement, but a sensible standard we suggest where the rules leave the detail to you. Adapt it to your service.

  5. Stock is rotated and staff are signed off as competent, not assumed to be. Fridge stock is organised by expiry date with nothing out of date in use, and there is a competency record for the staff who run vaccination clinics. In the middle of a busy season this is what stops an expired pack being discovered at the point of drawing up, and what tells whoever is staffing the clinic which colleagues are signed off for which vaccines and which age groups.

    Strong evidence: The vaccine stock record and the staff competency record (sections 7.2 and 11).

    Weak evidence: Out-of-date boxes are still on the shelf to be used up and short-dated packs sit behind long-dated ones, so expiry gets discovered at the point of drawing up rather than at the point of stocking. Competence rests on an e-learning certificate, with no record that anyone assessed this member of staff against the national minimum standards for immunisation training, so at the height of the season nobody can say which staff are signed off for which vaccines and which age groups.

    The recognised standard from a professional or clinical body, such as NICE or a royal college. Not a legal duty, but the accepted mark of safe practice, and a departure needs a documented reason.

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Last verified 20 July 2026

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Last reviewed 10 June 2026