Sample policy · Travel clinics

Vaccine storage and cold chain policy (travel clinics)

Statutory anchor: Regulation 12 (safe care and treatment), Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 (SI 2014/2936). The clinical standard for vaccine storage and the cold chain is set by the UKHSA Green Book chapter on storage, distribution and disposal of vaccines, which is the primary source for the operational detail. · primary source

1. What the regulation says

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

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

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

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))

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

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. For a travel clinic, keeping vaccines within their required temperature range from delivery to use is part of the proper and safe management of medicines and of mitigating risks to the people who receive them.

3. Purpose

Vaccines are biological products that lose their effect if they get too warm or too cold. A vaccine that has been outside the right temperature range may not protect the traveller, even though it looks the same. This policy sets out how the Service keeps its vaccines at the right temperature from delivery to use, watches for problems, and acts when the cold chain is broken.

The Service must verify this policy against the current Green Book chapter on storage, distribution and disposal of vaccines and UKHSA cold-chain guidance before adoption.

4. Scope

This policy applies to:

5. The vaccine fridge

6. Temperature monitoring

7. Stock management

8. Receiving deliveries

When vaccines arrive, they are checked and put into the fridge promptly. The Service confirms they were transported in the cold chain, records receipt, and does not leave vaccines out at room temperature while other work is done.

9. Cold-chain breach

If the temperature has been outside the safe range, or the fridge has failed or been switched off:

10. Disposal

Vaccines that are out of date, damaged or no longer safe to use are disposed of as the Service's waste arrangements and the guidance require, and the disposal is recorded.

Operational controls to adapt

Roles and responsibilities

Cold-chain procedure

  1. Check the fridge each working day it is in use. Record current, minimum and maximum temperatures, reset the thermometer and act on any reading outside the safe range.
  2. Control fridge access and layout. Keep vaccines in a dedicated vaccine fridge, allow air circulation, avoid the door and walls, and prevent accidental switch-off.
  3. Receive deliveries safely. Check delivery time, packaging, temperature evidence where supplied, vaccine identity, quantity, batch, expiry and any damage before stock is accepted.
  4. Rotate and reconcile stock. Use earliest-expiry stock first, check expiry before use, keep stock to a sensible level and investigate discrepancies.
  5. Quarantine suspected breaches. Label affected vaccines, separate them, stop use, estimate the time and temperature excursion and keep the fridge closed where appropriate.
  6. Seek advice before disposal or use. Follow manufacturer, UKHSA or other relevant specialist advice and record the decision.
  7. Trace affected travellers if needed. Identify anyone who received affected vaccine, assess risk, inform them where appropriate and record the recall or reassurance plan.
  8. Prevent recurrence. Log the breach, review equipment, training, power supply and process failures, and open improvement actions.

Records and register links

The cold-chain record should include:

A cold-chain breach is recorded even when the vaccines are later confirmed safe to use, because the service still needs evidence that the risk was assessed.

11. Training

Staff who order, receive, store, monitor or use vaccines are trained in the cold chain and the breach procedure, and refreshed on a stated cadence. A named person is responsible for the cold chain, with a named deputy. The Service records who is competent and the next refresher date.

12. Audit cadence

The Service checks, on a stated cadence, that:

The Registered Manager reviews the results and records the improvement actions that follow.

13. 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.

Related reading

14. 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. In particular, seek advice from the vaccine manufacturer or UKHSA on the usability of any vaccine that has been outside its required temperature range.

15. Document control

Version Date Author Changes
v1.1 2026-07-14 Verivius (sample) Added role ownership, cold-chain procedure, breach records, register links and related reading.
v1 2026-06-10 Verivius (sample) Conformed to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 quotes, plain-English summary, standard sources and document-control blocks. Original purpose, scope, fridge, monitoring, stock, deliveries, breach, disposal, training and audit sections preserved.

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 that has been too warm or too cold looks exactly like one that has been stored properly, and the traveller feels nothing different when it is given. The harm is silent and deferred: it surfaces weeks later, in another country, when someone who believed they were protected against rabies, yellow fever, typhoid or hepatitis meets the thing they were vaccinated against, with UK healthcare a long flight away. That is why the daily maximum and minimum reading, the batch number recorded against each dose given and a traceable breach decision matter more in a travel clinic than the paperwork around most other fridges: together they are the only route back to the specific people who need to be told and offered a repeat dose. Travellers also tend to fly within days of their appointment, so a breach found on a Monday morning leaves a very short window in which a recall can still reach someone before they leave the country. The point of the record is the traveller's real protection abroad. A service that can follow its own cold chain is one that knows which of its vaccines worked, and can say so to the person who trusted it.

  1. Someone reads the fridge every working day it is in use, capturing the maximum and minimum since the last reading and resetting the thermometer, not just taking an occasional current-temperature glance, so a vaccine that drifted out of range overnight is caught before it reaches a traveller.

    Strong evidence: Cold-chain record fields: daily current, minimum and maximum temperature, checker, reset confirmation and corrective action (section 6 and the Records and register links list); audit cadence line that fridge temperatures including maximum and minimum are read and recorded every working day.

    Weak evidence: A log with one figure a day, or a column of ticks against "temp OK", with no minimum and maximum recorded and no confirmation that the thermometer was reset, so nobody can tell what happened overnight or at the weekend. Rows are blank on days the clinic was open and the fridge was running, or a fortnight is signed off in one sitting in the same pen, and every reading is an implausibly identical 4.0.

    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.

  2. An out-of-range reading triggers the cold-chain breach procedure and quarantine, not a note that the vaccines were probably fine; affected stock is marked, kept separate and not used while the excursion is assessed.

    Strong evidence: Section 6 (a reading outside the safe range triggers the breach procedure straight away, vaccines are not assumed to be fine) and the breach record: start and end estimate, temperature range, affected stock, quarantine action, advice sought and final decision.

    Weak evidence: An out-of-range reading circled in the log with a note like "door left ajar, stock fine" and nothing further: no breach record opened, no quarantine label on the affected boxes, no estimate of how long or how far the temperature was out, and the same vials used in clinic that afternoon. Affected stock sits back on the normal shelf alongside in-range stock, so the next person at the fridge cannot tell which vaccines are in question.

    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.

  3. Where a breach occurs, advice on usability is sought from the manufacturer or the UK Health Security Agency (UKHSA) and followed, rather than decided in-house; the record names the advice source and the final decision.

    Strong evidence: Cold-chain procedure step 6 (seek advice before disposal or use, follow manufacturer, UKHSA or other specialist advice and record the decision) and the breach record fields advice sought and final decision.

    Weak evidence: The "advice sought" field is blank, or reads "team agreed it was fine" or "the nurse was happy to use it", with no named contact, no date and no summary of what was said. A call to the manufacturer or the UK Health Security Agency (UKHSA) is mentioned in passing but the answer is not recorded, or advice was obtained and then quietly set aside because the stock was expensive or the clinic list was full.

    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.

  4. A cold-chain breach is logged even where the vaccines were later confirmed usable, so there is evidence the risk was assessed; what matters is that a decision trail exists, not whether stock was wasted.

    Strong evidence: The policy note that a cold-chain breach is recorded even when the vaccines are later confirmed safe to use because the service still needs evidence the risk was assessed, read with the breach record fields.

    Weak evidence: The breach file only holds excursions that ended in stock being destroyed, so a year shows two breaches while the temperature log shows a dozen out-of-range mornings. Where vaccines were later confirmed usable the entry stops at "stock confirmed safe", or was never opened at all, leaving no record of the temperature range, the duration, who assessed it or on what basis.

    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. Where affected vaccine has already been given, the service identifies those travellers, assesses risk and records a recall or reassurance plan, because the breach does not end at the fridge door.

    Strong evidence: Section 9 trace step and cold-chain procedure step 7, plus the record field for affected traveller review, recall or revaccination decision where relevant.

    Weak evidence: The breach is closed at the fridge door: the affected batch is quarantined but nobody checks which of those batch numbers were already administered. Batch numbers are captured on the delivery record but not against the dose in each traveller's vaccination record, so the affected travellers cannot be identified. There is no recorded decision on whether to recall, revaccinate or reassure, and no note of who was contacted or what they were told.

    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.

  6. A named person and a named deputy are responsible for the cold chain and their training is in date, so daily monitoring does not lapse when one person is away.

    Strong evidence: Section 11 (a named person responsible with a named deputy, records of who is competent and the next refresher date) and the audit cadence line that a named person and deputy are responsible and trained.

    Weak evidence: The policy names a role rather than a person, or names one person with no deputy, and the temperature log has a two-week gap that lines up exactly with that person's annual leave. Training evidence is an induction signature from years ago with no refresher date, no record of who else is assessed as competent to read and reset the thermometer, and nothing to show anyone has been taken through what to do when a reading is out of range.

    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.

Related

Last verified 20 July 2026

Spotted something to improve?

These are sample templates, not the last word. If you would change a wording, or want to help us confirm a detail, tell us and we will look at it.

Related Verivius content

Want help adapting this to your service?

A Verivius consultant can read your adapted policy against the live regulation and your service shape. The work fits inside a Mock Inspection engagement or a shorter consulting brief. A 20-minute conversation is the fastest way to find out whether the fit is right.

Get started free

Free to start, no card. A 14-day trial when you subscribe.

Last reviewed 10 June 2026