Standard operating procedure

Immunisation Administration Procedure

How [Organisation Name] confirms eligibility, gains consent, prepares, administers and records vaccines safely and legally, with anaphylaxis cover always in place

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What's inside

This standard operating procedure is fully drafted and structured, ready to brand and complete for your service. It covers:

  • 1. Purpose
  • 2. Scope
  • 3. Definitions and abbreviations
  • 4. Responsibilities
  • 5. Equipment and materials
  • 6. Procedure
  • 7. Records
  • 8. Related documents
  • 9. Review and version control
  • 10. Disclaimer

Legislation & standards it maps to

  • UK Health Security Agency, Immunisation against infectious disease (the Green Book) - current online edition, including the disease-specific and vaccine-specific chapters
  • The Human Medicines Regulations 2012 (SI 2012/1916, as amended) - including the provisions for Patient Group Directions and the supply and administration of prescription-only medicines
  • Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 - Regulation 11 (Need for consent) and Regulation 12 (Safe care and treatment)
  • Resuscitation Council UK, guidance on the emergency treatment of anaphylactic reactions and on resuscitation standards for primary care
  • National Institute for Health and Care Excellence, Drug allergy: diagnosis and management (NICE guideline CG183, 2014)
  • Data Protection Act 2018 and the UK General Data Protection Regulation

Who it applies to

All GP partners, salaried and locum GPs, practice nurses, advanced nurse practitioners, healthcare assistants and pharmacists who are trained, competent and authorised to administer immunisations at [Organisation Name], together with reception, administrative and recall staff who support the immunisation service

Glossary

Plain-English explanations of the technical terms and legislation used in this document.

Adverse reaction
Any unexpected or unwanted reaction linked to a vaccine or medicine that harms, or could harm, a patient.
Anaphylaxis
A severe, life-threatening allergic reaction needing immediate emergency treatment, usually an injection of adrenaline into a muscle.
Aseptic non-touch technique
A careful method of preparing and giving an injection that avoids touching the parts that must stay sterile, so infection is not introduced.
Care Quality Commission (CQC)
The independent regulator of health and social care services in England.
Chaperone
A trained person present during an intimate examination to support and protect the patient and the clinician.
Child Health Information Service
A regional record-keeping service that holds and shares children's immunisation and health information.
Cold chain
Keeping vaccines within a safe temperature range, usually 2 to 8 degrees Celsius, from delivery through to use.
Contraindication
A specific reason why a particular vaccine or treatment should not be given to a particular person.
Decontamination
The combined process of cleaning, disinfecting and, where needed, sterilising equipment so it is safe to reuse.
Diluent
A sterile liquid used to mix with a powdered vaccine to make it ready to inject.
Five rights
A safety check made before giving a vaccine: the right patient, right vaccine, right dose, right route and right time.
Gillick competence
The test of whether a child under 16 has enough understanding and maturity to consent to their own treatment.
Green Book
The UK Health Security Agency's online reference, Immunisation against infectious disease, which is the national guide on vaccines and how to give them.
Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
The regulations setting out the fundamental standards that registered care providers must meet, including consent and safe care and treatment.
Healthcare assistant
A trained support worker who carries out clinical tasks they are competent and authorised to do, under the supervision of registered professionals.
Human Medicines Regulations 2012
The main UK law controlling how medicines, including vaccines, are supplied and administered.
Immunosuppression
A weakened immune system, caused by illness or treatment, which can affect whether or when a vaccine should be given.
Informed consent
Agreement to treatment given freely after the risks, benefits and alternatives have been clearly explained.
Intramuscular
Given by injection directly into a muscle.
Intranasal
Given as a spray into the nose.
Medicines and Healthcare products Regulatory Agency (MHRA)
The UK body that regulates medicines, vaccines and medical devices and monitors their safety.
National Institute for Health and Care Excellence (NICE)
The national body that produces evidence-based guidance on treatments and care for health and social care services.
National protocol
A national instruction that lets trained, competent staff give a named vaccine for a specific immunisation programme without an individual prescription or a Patient Group Direction.
Near miss
An event that could have caused harm but did not, by chance or because it was caught in time.
Parental responsibility
The legal rights and duties a person has for a child, including the right to consent to that child's treatment.
Patient Group Direction (PGD)
A written instruction letting named, trained staff supply or give a medicine to a defined group of patients without an individual prescription.
Patient Specific Direction (PSD)
A written instruction from a prescriber for a medicine to be supplied or given to one named patient.
Personal protective equipment (PPE)
Items such as gloves, aprons and masks worn to protect against harm or infection.
Prescription-only medicine (POM)
A medicine that may lawfully be supplied only on the instruction of an appropriate prescriber.
Reconstitution
Mixing a powdered vaccine with its liquid diluent to make it ready to inject.
Records Management Code of Practice
National guidance on how long health and care records should be kept and how they should be managed and disposed of.
Registered Manager
The person registered with the regulator as responsible for the day-to-day running of a service.
Resuscitation Council UK
The national organisation that sets the standards and guidance for treating cardiac arrest and emergencies such as anaphylaxis.
Sharps
Needles, blades and other items that can cut or puncture the skin.
Single assessment framework
The structure the Care Quality Commission uses to judge a service, built around quality statements and five key questions (safe, effective, caring, responsive, well-led).
Standard Operating Procedure (SOP)
A written, step-by-step instruction describing how a particular task must be carried out consistently and safely.
Summary of Product Characteristics (SmPC)
The manufacturer's official document giving the approved details on how a vaccine or medicine should be stored, prepared and used.
UK General Data Protection Regulation (UK GDPR)
The UK's main data-protection law governing how personal information is collected and used.
UK Health Security Agency (UKHSA)
The national public-health body responsible for protecting people from infectious diseases and other health threats, and for vaccine guidance.
Yellow Card Scheme
The UK system, run by the Medicines and Healthcare products Regulatory Agency, for reporting suspected side effects of medicines and vaccines.

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