Plain-English explanations of the technical terms and legislation used in this document.
- Anaphylaxis
- A severe, life-threatening allergic reaction needing immediate emergency treatment.
- Calibration
- Checking and adjusting a thermometer or other instrument against a known standard so its readings can be trusted.
- Care Quality Commission (CQC)
- The independent regulator of health and social care services in England.
- Cold chain
- Keeping vaccines and certain medicines within a safe temperature range, here 2 to 8 degrees Celsius, from delivery through to use.
- Cold-chain indicator
- A small device or label included with a delivery that changes to show whether the vaccines have been exposed to an unsafe temperature in transit.
- Contemporaneous
- Written down at the time the event happened, rather than from memory later.
- Contingency plan
- A prepared set of actions to follow if something goes wrong, such as the refrigerator failing or losing power.
- Data logger
- An electronic device that continuously records a refrigerator's temperature and can sound an alarm or report when the temperature goes out of range.
- Green Book (Immunisation against infectious disease)
- The UK Health Security Agency's official guidance on vaccines and how to store, handle and give them.
- Health and Social Care Act 2008 (Regulated Activities) Regulations 2014
- The regulations setting out the fundamental standards that registered health and care providers must meet, enforced by the Care Quality Commission.
- Health Protection Team (HPT)
- A local team, linked to the UK Health Security Agency, that gives advice on controlling infection and on incidents such as vaccine temperature excursions.
- Human Medicines Regulations 2012
- The main UK law governing how medicines, including vaccines, are authorised, supplied, stored and handled.
- Max/min thermometer
- A thermometer that shows the current temperature plus the highest and lowest temperatures reached since it was last reset.
- Medicines and Healthcare products Regulatory Agency (MHRA)
- The body that regulates medicines and medical devices in the United Kingdom and sets expectations for storing them safely.
- Pharmaceutical refrigerator
- A refrigerator built specially to hold medicines and vaccines at a steady, even temperature, unlike an ordinary domestic fridge.
- Potency
- How strong and effective a vaccine is; potency is lost if the vaccine is stored at the wrong temperature.
- Quarantine
- Setting aside and clearly labelling stock so it is not used until a decision has been made about whether it is safe.
- Registered Manager
- The person registered with the regulator as responsible for the day-to-day running of a service.
- Regulated activity
- A type of care or treatment the law requires a provider to register with the regulator to deliver.
- Regulation 12 (Safe care and treatment)
- The part of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 that requires care and treatment, including medicines storage, to be provided safely.
- Screening and Immunisation Team (SIT)
- A local team responsible for overseeing vaccination and screening programmes and advising practices on vaccine supply and incidents.
- Standard Operating Procedure (SOP)
- A written, step-by-step instruction setting out how a particular task must be carried out consistently and safely.
- Stock rotation (first expired, first out)
- Arranging and using stock so that items with the earliest expiry date are used before newer ones, to reduce waste.
- Temperature excursion
- Any recorded temperature outside the safe 2 to 8 degrees Celsius range, or any period when the temperature is unknown, for example after a power loss.
- UK Health Security Agency (UKHSA)
- The national public health agency for the United Kingdom, which publishes the Green Book and advises on protecting people from infectious disease.
- Vaccine lead
- The named member of staff with day-to-day responsibility for ordering, storing and monitoring vaccines and acting on any cold-chain problem.
- Validated transport container
- A cool box or carrier proven to keep vaccines within the safe temperature range while they are moved.