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))
ensuring that persons providing care or treatment to service users have the qualifications, competence, skills and experience to do so safely, (Reg 12(2)(c) (staff competence))
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. The professional standards for running a Yellow Fever Vaccination Centre and issuing the ICVP sit in NaTHNaC's centre requirements, the UKHSA Green Book yellow fever chapter, and the International Health Regulations (2005), named in full below. Where this policy and the regulation or the live professional guidance diverge, the live source 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 yellow fever vaccination this means the vaccine is given only by a designated, trained practitioner in a registered centre, only after a documented risk assessment that checks contraindications, and the official certificate is completed accurately and only for a vaccine actually given.
3. Purpose
Yellow fever vaccine is a live vaccine that can only be given by a centre registered to do so, and it comes with an official International Certificate of Vaccination or Prophylaxis (ICVP) that some countries require for entry. It also carries rare but serious risks, so it must not be given to a traveller for whom it is unsafe. This policy sets out how the Service runs as a registered Yellow Fever Vaccination Centre: who may give the vaccine, how the traveller is assessed, how the certificate is issued, and what happens when the vaccine is not safe to give.
The Service must verify this policy against current NaTHNaC Yellow Fever Vaccination Centre requirements and the Green Book yellow fever chapter before adoption.
4. Scope
This policy applies to:
- the giving of yellow fever vaccine and the issuing of the certificate
- the Service's registration as a Yellow Fever Vaccination Centre and the practitioners designated within it
- travellers assessed for yellow fever vaccination, including those for whom it is contraindicated
5. Registration and who may give the vaccine
- the Service holds current registration as a Yellow Fever Vaccination Centre and keeps that registration up to date
- yellow fever vaccine is given only by a practitioner designated and trained within the registered centre
- the official stamp used on the certificate is controlled, kept secure, and used only by the centre
6. Assessing the traveller before yellow fever vaccine
Because yellow fever vaccine is a live vaccine with rare serious adverse events, the Service carries out a careful risk assessment before giving it and checks for contraindications and precautions, which include (the Service confirms the current list against the Green Book):
- immunosuppression, whether from a condition or from treatment
- age (extra caution at the extremes of age)
- pregnancy and breastfeeding
- a history of thymus disorder or thymectomy
- severe allergy to a vaccine component, including egg
Where the vaccine is not clearly safe, the Service weighs the risk of the vaccine against the traveller's real risk of yellow fever on their trip, and does not give it simply because a certificate is wanted.
7. The certificate (ICVP)
- where the vaccine is given, the certificate is completed accurately and stamped, and the traveller is told when it becomes valid for travel
- the Service explains the current validity of the certificate and keeps a record of every certificate issued
- the Service issues, replaces or amends ICVP documentation only where this is permitted by current NaTHNaC and International Health Regulations requirements and supported by reliable records
8. When yellow fever vaccine is contraindicated
Where the vaccine is unsafe for the traveller but a destination requires proof of vaccination, the Service:
- explains the position honestly, including that an exemption may or may not be accepted at the border
- considers issuing a medical letter of exemption where that is appropriate, following the current guidance on what such a letter should say
- advises strongly on bite avoidance and other protection, because an exemption removes the certificate, not the disease risk
9. Adverse events
The Service is alert to the rare serious reactions to yellow fever vaccine, manages any acute reaction (see the anaphylaxis policy), advises the traveller on the symptoms to watch for and how to get urgent help, and reports serious adverse events as the guidance requires.
10. Recording
The Service records each yellow fever assessment, the decision to give or withhold the vaccine and why, the vaccine batch, the certificate issued, and any exemption letter given.
Operational controls to adapt
Roles and responsibilities
- Registered Manager: owns Yellow Fever Vaccination Centre governance, makes sure registration, designated practitioners, stamp control, vaccine storage and audit are current.
- YFVC lead: maintains NaTHNaC centre requirements, practitioner designation, training records, ICVP stock, official stamp security and escalation routes.
- Designated practitioner: completes the travel and yellow fever risk assessment, checks contraindications and precautions, vaccinates only when appropriate, and completes the ICVP accurately.
- Administration staff: support appointment booking, certificate storage and traveller information without issuing clinical advice beyond approved scripts.
- Governance lead: reviews adverse events, certificate errors, contraindication decisions, exemption letters, complaints and improvement actions.
Yellow fever and ICVP procedure
- Confirm centre status before offering vaccination. Check YFVC registration, designated practitioner status, training currency, official stamp availability and vaccine stock.
- Complete the travel risk assessment. Record destinations, transit, country certificate requirements, exposure risk, trip timing and current NaTHNaC or TravelHealthPro guidance used.
- Check contraindications and precautions. Use the current yellow fever checklist and record immune status, age factors, pregnancy or breastfeeding, thymus history, allergy and relevant medicines.
- Balance disease risk and vaccine risk. Do not vaccinate just to produce a certificate. Record the clinical rationale where the risk-benefit decision is not straightforward.
- Give informed advice and consent. Explain serious but rare vaccine risks, expected side effects, certificate validity, bite avoidance and what symptoms need urgent help.
- Complete the ICVP accurately. Issue, stamp and sign the certificate only for a vaccine actually given and only in line with current NaTHNaC and International Health Regulations requirements.
- Manage contraindications safely. Where vaccination is unsafe, consider an exemption letter only where appropriate, explain that border acceptance is not guaranteed, and give bite-avoidance advice.
- Escalate and learn. Serious adverse events, certificate errors, stamp loss, training lapse, contraindication uncertainty or vaccine storage concerns are opened on the relevant register.
Records and register links
The YFVC record should include:
- YFVC registration status, practitioner designation, training date, stamp custody and ICVP stock control
- destination, itinerary, certificate requirement, disease-risk assessment and guidance source date
- contraindication and precaution checklist, risk-benefit rationale, consent and advice given
- vaccine name, dose, route, batch, expiry, site, date and practitioner
- ICVP details, serial or stock control reference where used, stamp use and certificate validity advice
- exemption letter rationale, wording source and advice that border acceptance is not guaranteed
- adverse event, Yellow Card report, cold-chain issue, complaint, incident, risk or improvement-action reference
Certificate errors, missing contraindication checks, stamp-control failures, non-designated administration and adverse events are reviewed through governance, not handled only by individual correction.
11. Training
Designated practitioners complete the required yellow fever training and keep it current, and the Service keeps its registration and its practitioners' training in date. The Service records who is designated and the next refresher date.
12. Audit cadence
The Service checks, on a stated cadence, that:
- registration is current and the vaccine is given only by designated, trained practitioners
- a documented risk assessment with the contraindications checked precedes every dose
- certificates are issued accurately, recorded, and only for vaccines actually given
- contraindicated travellers are managed safely, with exemption letters where appropriate
- the controlled stamp is secure
The Registered Manager and the clinical lead review the results and record 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.
- NaTHNaC, Yellow Fever Vaccination Centre registration, standards and resources: https://nathnac.net/
- Immunisation against infectious disease (the Green Book), the yellow fever chapter: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
- International Health Regulations (2005) and the validity of the ICVP: https://www.who.int/health-topics/international-health-regulations
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014, Regulation 12 (safe care and treatment): https://www.legislation.gov.uk/uksi/2014/2936/regulation/12
- UKHSA Green Book and vaccine storage / cold-chain guidance
- CQC Regulation 12: Safe care and treatment
- Resuscitation Council UK (anaphylaxis management); see also the Service's emergency medicines and equipment policy
Related reading
- Related policy: Pre-travel risk assessment and consultation policy
- Related policy: Vaccine storage and cold chain policy
- Related policy: Anaphylaxis management policy
- Related policy: Patient Group Directions and prescribing policy
- Related policy: Consent policy
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.
15. Document control
| Version | Date | Author | Changes |
|---|---|---|---|
| v1.1 | 2026-07-14 | Verivius (sample) | Added YFVC role ownership, yellow fever procedure, ICVP records, register links and related reading. |
| v1 | 2026-06-10 | Verivius (sample) | Conformed to the Verivius policy standard: added statutory anchor (Reg 12), verbatim regulation quotes, plain-English summary, standard sources and document-control blocks. Original 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.