Healthcare premises and equipment requirements

If you operate a healthcare premises in England, you must meet CQC Regulation 15 requirements for premises and equipment. This applies to all CQC-registered providers including GP surgeries, dental practices, clinics, hospitals, and care homes.

Some other requirements on healthcare premises are enforced by other regulators, such as HSE, the fire and rescue service and the Environment Agency, alongside CQC.

CQC Regulation 15: Premises and equipment

Regulation 15 of the Health and Social Care Act 2008 (Regulated Activities) Regulations 2014 requires that premises and equipment used by a registered provider must be:

• suitable for their intended purpose, with a design, layout and size that support safe delivery of your regulated activities
• clean and properly maintained, with cleaning schedules, maintenance logs and evidence of regular upkeep
• decorated and furnished to give your service users a dignified environment
• big enough for staff to work safely and for patients to receive care in privacy

Equipment must be:

• Properly maintained and calibrated according to manufacturer instructions
• Suitable for its intended use and available when needed
• Used by trained and competent staff
• Subject to planned preventive maintenance (PPM) schedules

CQC assesses premises and equipment compliance under the Safe and Well-led key questions during inspections. Non-compliance can result in requirement notices or conditions on your registration.

Radiation protection

If you use ionising radiation equipment such as dental X-ray machines, diagnostic imaging, CT scanners, or fluoroscopy, the Ionising Radiations Regulations 2017 (IRR17) and the Ionising Radiation (Medical Exposure) Regulations 2017 (IR(ME)R) apply to your premises.

In addition to appointing an RPA, you must:

• appoint a Radiation Protection Supervisor (RPS), a named member of staff who oversees radiation safety day to day in each area where radiation is used
• write Local Rules for each piece of radiation equipment and display them where staff can refer to them
• mark out controlled and supervised areas around radiation equipment, with signs and restricted access
• give staff working in controlled areas personal dosimeters, and have the RPA review the results
• keep records of quality assurance testing, acceptance testing of new equipment and routine performance checks

HSE enforces IRR17 and may inspect your radiation arrangements. CQC also assesses radiation safety as part of the Safe key question for services providing diagnostic and screening procedures.

Healthcare ventilation requirements

NHS Health Technical Memorandum HTM 03-01 provides specialist ventilation guidance for healthcare premises. While HTMs are written primarily for NHS facilities, CQC expects independent healthcare providers to follow equivalent standards where applicable.

Key ventilation requirements by setting:

• Operating theatres need at least 25 air changes per hour with positive pressure relative to surrounding areas, ultra-clean ventilation (UCV) for orthopaedic implant surgery
• Isolation rooms need negative pressure ventilation for containment of airborne infections, with air exhausted externally rather than recirculated
• Dental surgeries need ventilation suited to aerosol-generating procedures (AGPs). Guidance updated after the COVID-19 pandemic recommends at least 10 air changes per hour or equivalent
• General clinical areas need adequate natural or mechanical ventilation to maintain indoor air quality and reduce infection transmission

Ventilation systems must be regularly tested and maintained, with documented records of commissioning, validation, and ongoing verification testing.

Medical gas systems

If your premises have piped medical gas systems (oxygen, nitrous oxide, medical air), NHS Health Technical Memorandum HTM 02-01 applies. Key requirements:

• The medical gas pipeline system (MGPS) must be installed by competent contractors and commissioned in accordance with HTM 02-01
• Terminal units must be tested after any maintenance, with identity and quality checks on the gas delivered
• You need written procedures for gas supply failure, including backup cylinder supplies.
• You need an Authorised Person (Medical Gas), a named individual responsible for managing the MGPS safely.

Decontamination of reusable medical devices

If you reprocess (clean, disinfect, or sterilise) reusable medical instruments, you must follow NHS Health Technical Memoranda:

• HTM 01-01 covers management and decontamination of surgical instruments (used in hospitals and sterile services departments)
• HTM 01-05 covers decontamination in primary care and community dental practice (applies to most GP surgeries and dental practices)

Key requirements:

• If you decontaminate on site, your local decontamination unit (LDU) must meet specified standards for washer-disinfectors and sterilisers
• Larger providers may use central sterile services departments (CSSDs) with full traceability systems
• You need traceability from patient to instrument to decontamination cycle, enabling recall if a failure is identified
• Dental practices must follow HTM 01-05, including use of ultrasonic cleaners or washer-disinfectors, validated sterilisation cycles, and pouched storage

CQC inspectors routinely check decontamination arrangements during inspections of dental practices and surgical services.

Hazardous waste from healthcare premises

Healthcare premises generate clinical waste (sharps, infectious waste, cytotoxic waste) that must be managed under hazardous waste regulations. In England, the requirement to register premises with the Environment Agency was abolished on 1 April 2016 — you no longer need to register, but consignment notes and the duty of care still apply.

Accessibility

Under the Equality Act 2010, healthcare providers have a duty to make reasonable adjustments so that disabled patients can access your services. This applies to all healthcare premises regardless of size.

Reasonable adjustments for premises typically include:

• physical access, such as a step-free entrance, accessible consulting rooms, accessible toilet facilities, adequate corridor widths for wheelchair users
• help for sensory impairments, such as hearing loop systems, large-print materials, appropriate lighting, and visual contrast in signage
• communication aids, such as information in accessible formats and interpreters including British Sign Language (BSL) interpreters

NHS and adult social care providers in England must also comply with the Accessible Information Standard, which requires you to identify, record, flag, share and meet the communication needs of patients with disabilities or sensory loss.

Failure to make reasonable adjustments is unlawful discrimination. The Equality and Human Rights Commission (EHRC) can take enforcement action, and patients can bring claims to court.

Fire safety in healthcare premises

Healthcare premises where patients stay overnight (hospitals, care homes, hospices) are classified as sleeping risk premises because occupants may not be able to self-evacuate. This creates additional fire safety requirements beyond those for standard workplaces.

Key requirements for healthcare fire safety:

• Instead of evacuating the entire building, you use progressive horizontal evacuation: patients are moved to an adjacent fire compartment on the same level. This requires proper compartmentation of the building into fire-resistant zones.
• You need Personal Emergency Evacuation Plans (PEEPs) for patients with mobility issues, cognitive impairment, or other conditions affecting their ability to evacuate. PEEPs should be reviewed whenever a patient's condition changes.
• Your fire risk assessment must account for the specific risks of healthcare settings including medical gases, oxygen therapy, electrical medical equipment, and flammable substances.
• All staff must receive fire safety training appropriate to their role, including practice evacuations. Staff in sleeping-risk areas need training on progressive horizontal evacuation procedures.

Both HSE and your local fire and rescue service may inspect healthcare premises. CQC also assesses fire safety as part of the Safe key question.