Infection prevention and control (Wales): Healthcare Inspectorate Wales rules
What an independent hospital, clinic or medical agency in Wales must do about infection prevention and control under regulations 9, 15 and 31 of the Independent Health Care (Wales) Regulations 2011, including the written infection control policy, protection against healthcare associated infection, 24-hour outbreak notification, registration fees and penalties, and the equivalent rule for care services.
If you run an independent hospital, independent clinic or independent medical agency in Wales, the Independent Health Care (Wales) Regulations 2011 (WSI 2011/734) set out what you must do to stop infection spreading. The Regulations apply in Wales only and are made under the Care Standards Act 2000. Healthcare Inspectorate Wales (HIW) registers and inspects these services for the Welsh Ministers. HIW also registers private dental practices, but those fall under the Private Dentistry (Wales) Regulations 2017 instead.
Three provisions carry the infection control duties: regulation 9 (a written infection control policy), regulation 15 (safe equipment and protection against healthcare associated infection) and regulation 31 (notifying outbreaks). They bind the registered person.
- Statutory source
- Regulations 9(1)(n), 15(3), 15(7) and (8), and 31(1)(c) of the Independent Health Care (Wales) Regulations 2011 (WSI 2011/734), made under the Care Standards Act 2000
- Regulator
- Healthcare Inspectorate Wales (HIW), on behalf of the Welsh Ministers
- Written policy
- A written infection control policy covering hand hygiene, safe handling and disposal of clinical waste, housekeeping and cleaning regimes, and relevant training and advice (regulation 9(1)(n))
- Policy review
- At intervals of not more than three years, keeping copies of every policy for at least three years (regulation 9(5) and (6))
- Outbreak notification
- Tell HIW within 24 hours of an outbreak of infectious disease that a medical practitioner employed in the establishment considers sufficiently serious, and confirm any oral notice in writing within 72 hours (regulation 31)
- Standards HIW applies
- The National Minimum Standards for Independent Health Care Services in Wales
- Provider application fee
- £500 for an independent clinic or medical agency; £0 to £2,500 for an independent hospital depending on its category (for example £0 for a hospice, £500 for a non-surgical laser or intense light hospital, £2,500 for an acute hospital); £100 for a manager (£0 for a hospice) (regulation 3 of the Independent Health Care (Fees) (Wales) Regulations 2011)
- Annual fee
- £500 flat rate for an independent clinic or medical agency; most hospitals pay a base fee plus a charge per approved place (regulation 6 of the 2011 Fees Regulations)
- Breaching regulations 9, 15 or 31
- Offence under regulation 52, liable on summary conviction to a fine not exceeding level 4 on the standard scale (section 25 of the Care Standards Act 2000)
- Operating without registration
- Offence under section 11 of the Care Standards Act 2000, punishable by a fine (the Act says level 5, but section 85 of the Legal Aid, Sentencing and Punishment of Offenders Act 2012 made that unlimited for offences committed on or after 12 March 2015), with up to six months' imprisonment, or both, if the registration was previously cancelled or this is a repeat offence
What you must do
- Register with HIW before you open. Apply through HIW with a statement of purpose, patients' guide, references, enhanced DBS certificates for the registered manager and responsible individual, financial references, and an index of your policies and procedures. HIW must be satisfied that you will comply with the Regulations and the National Minimum Standards for Independent Health Care Services in Wales.
- Write an infection control policy. Regulation 9(1)(n) requires written policies on the arrangements relating to infection control, including hand hygiene, safe handling and disposal of clinical waste, housekeeping and cleaning regimes, and relevant training and advice. Base them on the size of the service and the number and needs of patients, implement them, make copies available to HIW for inspection, review them at least every three years and keep every version for at least three years.
- Protect patients and others from healthcare associated infection. So far as is reasonably practicable, you must protect patients, and others who may be at risk while working in or for the service, from identifiable risks of acquiring a healthcare associated infection (regulation 15(7)). The means are: effective systems to assess the risk of, and to prevent, detect and control the spread of, infection; appropriate treatment for those affected; and appropriate standards of cleanliness and hygiene in the premises, in equipment and reusable medical devices, and in materials at risk of contamination (regulation 15(8)).
- Decontaminate reusable devices. Where you use reusable medical devices, put procedures in place for cleaning, disinfection, inspection, packaging, sterilisation, transportation and storage, so that devices are handled safely and decontaminated effectively before re-use (regulation 15(3) and (4)).
- Report outbreaks. If a medical practitioner employed in the establishment considers that an outbreak of infectious disease is serious enough to be notified, tell HIW within 24 hours and confirm in writing within 72 hours if you notified orally (regulation 31).
- Use the national manual. Wales hosts the National Infection Prevention and Control Manual, developed by NHS Scotland, for use by healthcare organisations in Wales. It covers standard infection control precautions, transmission-based precautions, incident and outbreak management, and the built environment and decontamination. It replaced Public Health Wales's earlier model policies.
Enforcement and penalties
A contravention of regulations 6 to 17, 19 to 35 and others listed in regulation 52 is an offence, so failing to carry out the infection control duties in regulations 9, 15 and 31 is a criminal offence as well as a ground for HIW enforcement action. On summary conviction the penalty is a fine not exceeding level 4 on the standard scale (section 25 of the Care Standards Act 2000). Carrying on or managing an independent healthcare establishment without being registered is a separate offence under section 11 of the Act.
Care services
Care homes and other regulated care services in Wales have their own rule. Regulation 56 of the Regulated Services (Service Providers and Responsible Individuals) (Wales) Regulations 2017 requires the service provider to have arrangements for satisfactory standards of hygiene and appropriate disposal of general and clinical waste, and to have policies and procedures for the control of infection and to minimise its spread, and to provide the service in accordance with them. Care Inspectorate Wales (CIW) regulates those services.