Healthcare premises and equipment requirements

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 - the design, layout, and size must support safe delivery of the regulated activities you provide
• Clean and properly maintained - documented cleaning schedules, maintenance logs, and evidence of regular upkeep
• Appropriately decorated and furnished - creating a dignified environment suitable for your service users
• Sufficient in space - adequate space 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.

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 - minimum 25 air changes per hour with positive pressure relative to surrounding areas, ultra-clean ventilation (UCV) for orthopaedic implant surgery
• Isolation rooms - negative pressure ventilation for containment of airborne infections, with air exhausted externally rather than recirculated
• Dental surgeries - appropriate ventilation for aerosol-generating procedures (AGPs), with guidance updated following the COVID-19 pandemic to recommend at least 10 air changes per hour or equivalent
• General clinical areas - 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:

• Specialist installation - MGPS must be installed by competent contractors and commissioned in accordance with HTM 02-01
• Regular testing - terminal units must be tested after any maintenance, with identity and quality checks on the gas delivered
• Emergency procedures - documented procedures for gas supply failure, including backup cylinder supplies
• Authorised Person (Medical Gas) - a named individual responsible for safe management of the MGPS

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

Key requirements:

• Local decontamination units (LDUs) - if you decontaminate on-site, your LDU must meet specified standards for washer-disinfectors and sterilisers
• Centralised sterile services - larger providers may use CSSDs with full traceability systems
• Instrument tracking - traceability from patient to instrument to decontamination cycle, enabling recall if a failure is identified
• Dental instruments - 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. In Wales, if your premises produce more than 500kg of hazardous waste in any 12-month period, you must register with Natural Resources Wales (registration is free).

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 - step-free entrance, accessible consulting rooms, accessible toilet facilities, adequate corridor widths for wheelchair users
• Sensory impairments - hearing loop systems, large-print materials, appropriate lighting, and visual contrast in signage
• Communication aids - provision of information in accessible formats, access to interpreters including British Sign Language (BSL) interpreters
• Accessible Information Standard - NHS and adult social care providers in England must 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:

• Progressive horizontal evacuation - instead of evacuating the entire building, patients are moved to an adjacent fire compartment on the same level. This requires proper compartmentation of the building into fire-resistant zones.
• Personal Emergency Evacuation Plans (PEEPs) - individualised plans 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.
• Fire risk assessment - must account for the specific risks of healthcare settings including medical gases, oxygen therapy, electrical medical equipment, and flammable substances.
• Staff training - 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.

What to do next

Once your premises meet these requirements:

• Schedule regular audits of your premises against CQC Regulation 15 standards
• Keep all maintenance, calibration, and testing records in an accessible format for inspections
• Review your radiation protection arrangements annually with your RPA (if applicable)
• Update fire risk assessments whenever you make changes to the building, its use, or the patient population
• Review accessibility regularly and document any reasonable adjustment requests and your response