Infection prevention and control (Scotland): Healthcare Improvement Scotland rules
What an independent hospital, clinic or medical agency in Scotland must do about infection prevention and control under regulation 3 of the Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011, the standards and manual Healthcare Improvement Scotland expects you to follow, the registration fee and enforcement, and the equivalent rule for care services.
If you provide an independent healthcare service in Scotland, you must run it so that infection is prevented and controlled. Regulation 3(d)(i) of the Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011 (SSI 2011/182) requires a provider to have appropriate systems, processes and procedures for all aspects of care and treatment, including in particular the prevention and control of infection. The same paragraph covers decontamination of equipment, management of clinical and other waste, management of medication, and use of Class 3B or Class 4 laser and intense light source equipment.
The duty sits on the provider, the person registered to provide the service. Healthcare Improvement Scotland (HIS) registers and inspects independent healthcare services. Section 10F of the National Health Service (Scotland) Act 1978 lists them as independent hospitals, private psychiatric hospitals, independent clinics, independent medical agencies and independent ambulance services. NHS services are not registered by HIS. NHS boards follow the national manual directly.
- Statutory source
- Regulation 3(d)(i) of the Healthcare Improvement Scotland (Requirements as to Independent Health Care Services) Regulations 2011 (SSI 2011/182), made under the National Health Service (Scotland) Act 1978
- Regulator
- Healthcare Improvement Scotland (HIS)
- Who must comply
- The registered provider of an independent hospital, clinic or medical agency in Scotland (regulation 2 requires the service to be provided in a manner that promotes quality and safety)
- Related duties in the same Regulations
- Fit premises (regulation 10), suitably trained staff (regulation 12), and a system to manage risk with a review of the quality of treatment (regulation 13)
- Standards HIS points applicants to
- HIS Infection Prevention and Control Standards (published 16 May 2022, nine standards), the National Infection Prevention and Control Manual, and Scottish Health Technical Memorandum 64 on clinical hand wash basins
- Registration fee (2026/27)
- Application fee of £5,708 for an independent hospital, or £3,996 for an independent clinic or independent medical agency (HIS fees information 2026/27, published January 2026). The figures are set each year within the maximum fees in the Healthcare Improvement Scotland (Fees) Regulations 2024 (SSI 2024/130), so check HIS's current fees page before you apply
- Annual continuation fee (2026/27)
- For example £286 per surgical or inpatient place for an independent hospital, £1,907 for an independent clinic or medical agency doing non-surgical work with staff, and £3,928 for an independent clinic carrying out surgical procedures
- Processing time
- HIS says processing takes a minimum of six months from receipt of a full and complete application, including the paid registration fee
- Operating before registration
- Offence on summary conviction, with a fine not exceeding level 5 on the standard scale, imprisonment of up to three months, or both (section 10Z9 of the 1978 Act)
- Enforcement
- Inspection (section 10J), improvement notice (section 10R), cancellation of registration (section 10S) and emergency cancellation through the sheriff (section 10T)
What you must do
- Register before you open. Apply to HIS through its online form. Your application must say what arrangements you have for infection prevention and control, and HIS expects you to have an infection prevention and control policy in place that draws on regulation 3(d)(i), the HIS Infection Prevention and Control Standards and the National Infection Prevention and Control Manual. You also supply your accounts, business plan, insurance certificates, recruitment policy and premises plans. Do not provide the service while HIS is processing the application. It is an offence to provide an independent healthcare service that is not registered.
- Write and operate your infection prevention and control system. The regulation asks for "systems, processes and procedures", so document them and show they are followed: standard infection control precautions, transmission-based precautions, cleaning, decontamination of reusable equipment, management of clinical waste and management of outbreaks.
- Use the national manual. The National Infection Prevention and Control Manual (NIPCM) covers standard infection control precautions, transmission-based precautions, healthcare incident and outbreak management, and the built environment and decontamination. It is mandatory for NHSScotland and is treated as best practice in all other health and care settings, and HIS's application guidance lists it among the guidance you should apply.
- Meet the nine standards. The HIS Infection Prevention and Control Standards cover leadership, staff training, communication, monitoring, antimicrobial stewardship, policies, equipment cleaning, a built environment that supports safe care, and acquiring equipment. They apply to health and adult social care settings, including independent healthcare.
- Train your staff and keep your premises fit. Staff must receive education and training appropriate to their work (regulation 12), premises must be suitable, in good repair and have adequate equipment and ventilation (regulation 10), and you must run a system to manage risk and review quality (regulation 13).
- Plan for a change of provider. If the person providing the service changes, the new provider must register and pay a new registration fee.
Enforcement
Failing to meet regulation 3 is not itself a criminal offence: regulation 16 makes only the fitness rules for providers, managers and employees (regulations 5(1), 6(1) and 8(1)) offences. HIS enforces regulation 3 through inspection and registration powers. It can give an improvement notice requiring significant improvement by a set date and, if the service is still not carried on in accordance with the requirements of the Regulations, propose to cancel registration. In an emergency it can ask the sheriff to cancel registration where there is a serious risk to life, health or wellbeing.
Care services
Care homes and other care services registered with the Care Inspectorate have a parallel duty in regulation 4(1)(d) of the Social Care and Social Work Improvement Scotland (Requirements for Care Services) Regulations 2011 (SSI 2011/210): where necessary, a provider must have appropriate procedures for the prevention and control of infection. A Care Home Infection Prevention and Control Manual, aligned with the NIPCM, supports care homes.