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. 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 this means being ready to recognise and treat anaphylaxis: the right in-date adrenaline and kit, trained staff, and a clear plan to act fast.
3. Purpose
Any service that gives vaccines or injections must be ready to recognise and treat anaphylaxis, a rare but life-threatening allergic reaction that can happen within minutes. A travel clinic gives many injections, so it must have the right equipment, trained staff and a clear plan. This policy sets out how the Service prevents, recognises and treats anaphylaxis and learns from any event.
The Service must verify this policy against current Resuscitation Council UK anaphylaxis guidance and the Green Book chapter on adverse reactions before adoption.
4. Scope
This policy applies to:
- every vaccine or injection the Service gives
- the recognition and treatment of anaphylaxis on the premises
- the clinicians who inject and any staff who would assist in an emergency
5. Reducing the risk
- before any vaccine the Service checks for known allergies and previous reactions to a vaccine or its components
- where a traveller has a history that raises the risk, the Service takes advice and acts on it before giving the vaccine
- travellers are advised to wait on the premises for a short period after vaccination so that an early reaction can be seen and treated, and the Service states that period
6. Recognising anaphylaxis
Staff are trained to tell anaphylaxis apart from a simple faint. Anaphylaxis is a sudden reaction with airway, breathing or circulation problems, often with skin changes. A faint usually settles quickly when the person lies down. When in doubt, the Service treats it as anaphylaxis, because delay is the main cause of harm.
7. Immediate treatment
The Service follows the current Resuscitation Council UK anaphylaxis algorithm. In outline:
- call for help and call 999 for an ambulance early
- give intramuscular adrenaline at the correct dose for the person's age and weight, into the outer mid-thigh, and repeat after five minutes if there is no improvement
- position the person appropriately for their symptoms (lying with legs raised for circulation problems; sitting up if breathing is the main problem; recovery position if unconscious and breathing)
- give oxygen and other treatment, and monitor, as the algorithm and the team's training allow
- stay with the person until the ambulance arrives and hand over clearly
The Service confirms the exact doses and steps against the current Resuscitation Council UK guidance.
8. Equipment and medicines
- an anaphylaxis kit with in-date adrenaline at the right strengths, plus the other items the algorithm needs, is immediately available wherever injections are given
- the kit and its contents are checked regularly and after any use, restocked, and kept in date, with the checks recorded
- resuscitation equipment appropriate to the Service is available and maintained
9. After an event
- the person is referred to hospital for observation, because a reaction can return after it first settles
- the event is recorded in full, logged as a patient-safety incident, and reviewed
- the reaction is reported through the MHRA Yellow Card scheme
- the traveller is given clear advice for the future, including which vaccine or component to avoid
Operational controls to adapt
Roles and responsibilities
- Registered Manager: owns emergency readiness, makes sure anaphylaxis kit, training and drills are current, and reviews incidents, complaints and audit findings.
- Clinical or resuscitation lead: keeps the anaphylaxis algorithm, emergency medicines list, dose aids and drill plan current against live Resuscitation Council UK guidance.
- Vaccinating clinician: checks allergy and reaction history, recognises suspected anaphylaxis, starts treatment within competence, calls 999 early and records the event.
- Support staff: know how to summon help, bring the kit, clear the area, support basic life support within competence, and record times during the emergency.
- Governance lead: checks debriefs, Yellow Card reports, duty-of-candour decisions, statutory-notification decisions and improvement actions are completed.
Anaphylaxis response procedure
- Check readiness before clinics start. Confirm adrenaline, syringes, needles, oxygen where held, AED, dose aids, emergency contacts and the current algorithm are available wherever injections are given.
- Screen before vaccination. Check allergy history, previous vaccine reactions, relevant vaccine components and whether specialist advice is needed before proceeding.
- Observe and listen after vaccination. Tell the traveller what symptoms to report, keep them where staff can see or hear them for the stated observation period, and act on concerns promptly.
- Treat suspected anaphylaxis as an emergency. Use an ABCDE approach, call 999 early, position the person safely and give intramuscular adrenaline according to the current algorithm.
- Record times as the event unfolds. Capture symptom onset, observations, adrenaline time and dose, repeat dose decision, 999 call time, ambulance arrival and handover.
- Do not close the case at recovery on site. The person is transferred or referred for medical assessment and observation as the live guidance requires.
- Recover the system after the event. Restock the kit, quarantine any medicine or vaccine involved where needed, complete the clinical record, Yellow Card report, incident record and debrief.
- Review learning. Repeated kit gaps, delayed response, unclear role allocation or documentation gaps are opened on the risk or improvement-actions register.
Records and register links
The anaphylaxis readiness and event record should include:
- emergency equipment and medicine check date, checker, batch, expiry, missing items and corrective action
- staff anaphylaxis, life-support and drill records, including refresher dates
- allergy and previous-reaction questions asked before vaccination
- event timeline, symptoms, ABCDE findings, observations, treatment, adrenaline dose, route, batch where relevant and response
- 999 call time, ambulance handover, transfer or referral advice and follow-up outcome where known
- Yellow Card report, duty-of-candour decision, statutory-notification decision, debrief and improvement action
- linked incident, risk, medicines, training, complaint or improvement-action reference
Missing or expired adrenaline, delayed treatment, unclear records, overdue training and repeated drill failures are logged as incidents or risks, not left as informal reminders.
10. Training and drills
- everyone who gives injections, and the staff who would assist, are trained in anaphylaxis recognition and treatment and in resuscitation to the level the Service requires, and refreshed on a stated cadence
- the Service runs occasional drills so the team can act quickly and knows where the kit is
- the Service records who is trained and the next refresher date
11. Audit cadence
The Service checks, on a stated cadence, that:
- the anaphylaxis kit and adrenaline are present, in date and checked, wherever injections are given
- staff who inject are trained in anaphylaxis and resuscitation and are in date
- any anaphylaxis event was treated per the algorithm, recorded, referred, reported and reviewed
- allergy histories are checked before vaccination and post-vaccination waiting is offered
The Registered Manager and the clinical lead review the results and record the improvement actions that follow.
12. 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.
- Resuscitation Council UK, emergency treatment of anaphylaxis guidance: https://www.resus.org.uk/
- Immunisation against infectious disease (the Green Book), the chapter on adverse reactions: https://www.gov.uk/government/collections/immunisation-against-infectious-disease-the-green-book
- MHRA Yellow Card scheme for adverse drug and vaccine reactions: https://yellowcard.mhra.gov.uk/
- CQC Regulation 12: Safe care and treatment
- Emergency medicines and equipment checking policy (in this pack)
- 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
Related reading
- Related policy: Emergency medicines and equipment checking policy
- Related policy: Medical emergencies and deteriorating patient policy
- Related policy: Vaccine storage and cold chain policy
- Related policy: Incident reporting, investigation and learning policy
- Related policy: Duty of candour policy
13. 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.
14. Document control
| Version | Date | Author | Changes |
|---|---|---|---|
| v1.1 | 2026-07-14 | Verivius (sample) | Added role ownership, anaphylaxis response procedure, readiness records, register links and related reading. |
| v1 | 2026-06-10 | Verivius (sample) | Conformed the existing draft to the Verivius policy standard: added statutory anchor, verbatim Regulation 12 quotes, plain-English summary, sources and further reading, and document control. All original sections and source URLs 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.