Prevent and control infection in a healthcare service

Regulation 12 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires a registered provider to assess the risk of, and prevent, detect and control the spread of, infections, including those that are health care associated. The Health and Social Care Act 2008 code of practice on the prevention and control of infections, known as the Hygiene Code, is the statutory guidance on how to do it. The Care Quality Commission (CQC) must take the Code into account when it makes registration decisions, and you must have regard to it when deciding how to comply.

You do not have to follow the Code, but you must be able to show the Care Quality Commission that another approach is equally effective or better. It applies in proportion to risk: a care home where people live in a domestic setting does not need the facilities of an acute hospital.

Meet the ten criteria

The Code sets out ten criteria. Not all of them apply to every regulated activity, so use a risk assessment to decide which do. You need to show that you have:

• systems to manage and monitor the prevention and control of infection, based on risk assessments that consider how susceptible your service users are
• a clean and appropriate environment in the premises you manage
• appropriate antimicrobial use and stewardship
• suitable, accurate and timely information on infections for service users, visitors and anyone providing further care
• a policy to identify promptly anyone who has or is at risk of an infection, so they get the right treatment and the risk to others is reduced
• systems to make sure all care workers, including contractors and volunteers, know and discharge their responsibilities
• adequate isolation facilities, or the ability to secure them
• adequate access to laboratory support where it is needed
• policies designed for each person's care and for your organisation that help to prevent and control infection
• a system to manage staff health and wellbeing and your obligation to manage infection

Appoint an IPC lead

Outside NHS bodies, an infection prevention and control (IPC) lead must be accountable directly to the registered provider. The lead is responsible for your IPC programme, cleanliness, the built environment where it applies, and antimicrobial stewardship. The lead oversees your policies, can set and challenge cleanliness standards, and produces an annual statement on compliance with IPC practice that you make available on request.

Record a comprehensive assessment of infection risks and the steps you take to reduce them. Give every worker IPC information, training and supervision that suits their role, put IPC in job descriptions and induction, and keep a record of the training. Where it is appropriate, designate a decontamination lead and set up a water safety group and plan and a ventilation group.

Write the policies the Code lists

The Code lists the policies a provider should have, and you decide which apply after a risk assessment. They include:

• standard and transmission-based precautions, including hand hygiene, bare below the elbow rules and personal protective equipment
• aseptic technique, isolation, and closing rooms, wards or premises to new admissions
• outbreaks of communicable infection
• safe handling and disposal of sharps, and preventing and managing exposure to blood-borne viruses
• decontaminating reusable medical devices, and handling single-use devices only once
• antimicrobial prescribing and stewardship
• handling and disposing of waste, and packaging laboratory specimens
• uniforms and dress code, and immunisation

Each policy should name its owner and author, show a review date, and be audited on a rolling programme. NHS organisations are expected to adopt the National Infection Prevention and Control Manual as their mandatory policy. Other providers may adopt it or equivalent guidance.

Segregate and dispose of clinical waste

Classify your healthcare waste and separate it where it is produced. Infectious waste with no chemical or medicine contamination goes in orange bags, offensive hygiene waste in yellow bags with a black stripe, and infectious waste that is also chemically contaminated in yellow bags. Anatomical, chemical and medicinal waste, including cytotoxic waste, goes for incineration. The Environment Agency expects healthcare practices to follow Health Technical Memorandum 07-01, Safe management of healthcare waste, which explains how to segregate each type.

Keep the environment clean

Name one person to oversee cleaning, environmental services and the decontamination of devices and equipment. Set out the cleanliness standard for each part of your premises, with a schedule of who cleans what and how often, available on request, and a way for staff to ask for extra cleaning. Provide suitable hand-washing facilities and products, and make sure equipment used at the point of care, such as hoists, beds and commodes, is cleaned and decontaminated. Keep premises in good repair, and provide linen and laundry arrangements that suit the care you give.

Decontaminate reusable medical devices following the manufacturer's instructions and national or local best practice, in facilities designed for the purpose. Devices used in invasive procedures must be traceable through each use and decontamination cycle, to the service users they were used on.

Respond to outbreaks

Your outbreak policy should cover the first risk assessment, communication, management and organisation, investigation and control, including vaccination where it is appropriate. Tell your local UK Health Security Agency health protection team about outbreaks as soon as possible. Set clear criteria for closing and reopening rooms, wards or premises, and decontaminate the environment before you reopen.

If you provide inpatient healthcare, you must be able to provide or secure adequate isolation facilities. Care settings without dedicated isolation rooms are expected to apply isolation precautions when someone is suspected or known to have an infection that can spread.

Use antimicrobials responsibly

Where appropriate, designate a lead for antimicrobial stewardship. Write a local policy and infection management guidelines drawing on NICE guidance, the British National Formulary and UK Health Security Agency guidance. Prescribers should record the person's allergy status, the reason for the antimicrobial, the dose, route and duration. Monitor and audit adherence to prescribing guidance and the post-prescribing review at 48 to 72 hours, and give everyone who prescribes, dispenses or administers antimicrobials induction and training in their prudent use.

Protect your staff

All staff need access to occupational health services or advice. Make vaccines available free of charge to employees where national guidance or a risk assessment shows a risk of exposure to biological agents, check whether each employee is already immunised, and keep confidential records of vaccinations offered, given and refused. Immunise against hepatitis B where the Green Book advises. Train staff on occupational exposure, such as sharps injuries and respiratory protective equipment, including fit testing.

Know how it is enforced

The Care Quality Commission assesses infection prevention and control against regulation 12, safe care and treatment, and regulation 15, premises and equipment. The records above are your evidence: the risk assessment, policies with review dates, audit results, training records and the IPC lead's annual statement.

It is an offence for a registered person to fail to comply with regulation 12 where the failure results in avoidable harm to a service user or exposes them to a significant risk of it. On summary conviction the fine is unlimited. It is a defence to prove that you took all reasonable steps and exercised all due diligence to prevent the breach. The Care Quality Commission also has enforcement powers it can use if you do not comply.