Regulation of Private healthcare facilities in hong kong Office for Regulation of Private Healthcare Facilities Department of Health The Government of the Hong Kong Special Administration Region

Organisation chart of Department of Health Director of Health Consultant in-charge, Dental Service Controller, Regulatory Affairs Office for Regulation of Private Healthcare Facilities Other regulatory affairs, including: - Drug Office - Radiation Health Unit - Medical Device Control Office - Boards and Councils - Chinese Medicine Division Controller, Centre for Health Protection Deputy Director of Health

Dual-track healthcare system in Hong Kong Inpatient service (number of bed days) Private ~10% Public ~90% Public ~30% Private ~70% Outpatient service(number of attendances)

Current Regulation of Private Healthcare Facilities Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) Medical Clinics Ordinance (Cap. 343) Private Hospitals and Maternity Homes (N=12) Nursing Homes (N=66) Non-profit-sharing medical clinics (N=87)

Regulation of private hospitals and nursing homes Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap. 165) Enacted in 1936 Does not include any hospital maintained by the Government, any military hospital or any public hospital within the Hospital Authority Ordinance Registration requirements： Accommodation Staffing Equipment

Code of Practice Sets out the regulatory standards General Corporate governance (e.g. organization, human resource, information management) Clinical governance (e.g. quality management, risk management, complaints, clinical research) General management (e.g. facility management, healthcare engineering, infection control) Clinical services (e.g. patients’ right, care of patient, telemedicine, specific service requirements) Supporting services Price transparency De-registration Compliance to CoP is one of the conditions of registration

Registration Inspection Sentinel Event Complaint handling New application Annual registration new applications / change in hospital services Inspection Unannounced At least twice a year Theme of ad-hoc inspection based on the risk identified Sentinel Event 11 reportable events Conduct root cause analysis Annual Patient Safety Digest to share lesson learnt Complaint handling Monitor the compliance of licensing requirements

Reportable events Sentinel event Serious untoward event Surgery / interventional procedure involving the wrong patient or body part Retained instruments or other material after surgery / interventional procedure ABO incompatibility blood transfusion Medication error resulting in major permanent loss of function or death Intravascular gas embolism resulting in death or neurological damage Death of an in-patient from suicide (including home leave) Maternal death or serious morbidity associated with labour or delivery Infant discharged to wrong family or infant abduction Other adverse events resulting in permanent loss of function or death (excluding complications) Serious untoward event Medication error which could have led to death or permanent harm or carries a significant public health risk Patient misidentification which could have led to death or permanent harm

Regulation of Medical Clinics Medical Clinics Ordinance (Cap. 343) Enacted in 1963 Regulate non-profit sharing clinics Does not include the following clinics: Premises maintained by the Government, Hospital Authority, universities Private consulting rooms used by registered medical practitioners, not bearing the word ‘clinic’ or ‘polyclinic’ Premises used by dentists, Chinese medical practitioners, pharmacists, physiotherapist, optometrist, etc Registration requirements： Accommodation Staffing Equipment Non-profit sharing

Code of Practice Sets out the regulatory standards Human Resources Management Accommodation and Equipment Rights of Patients Medical Records Drug Dispensing Fire Safety & Occupational Health Infection Control Reporting to the Department of Health Compliance to CoP is one of the conditions of registration

Private Healthcare Facilities Ordinance (Cap 633) Passed in November 2018 Provides for a new regulatory regime for private healthcare facilities (PHFs), for premises where registered medical practitioners and/or dentist practise Key licensing requirements: Appointment of Chief Medical Executive Complying with the requirements of the Ordinance, Conditions of Licence and Code of Practice issued by the Director of Health Putting in place a Complaints Management System Price Transparency measures

Regulation under the new Private Healthcare Facilities Ordinance Hospitals Day Procedure Centres (DPCs) Clinics Exempted Clinics (small practice clinics, i.e. those involving only solo or small group practice) Risk Level

Scheduled Medical Procedures Scheduled medical procedures that can be performed in day procedure centres but not in clinics Include the following eight classes of specialized services – Endoscopic procedure Chemotherapy Haemodialysis Interventional radiology and lithotripsy Radiotherapy Surgical procedure Anaesthetic procedure (such as general anaesthesia and deep sedation) Dental procedure

Group of ≥ 4 clinics operated Requirements on CME   Hospital DPC Clinic Group of ≥ 4 clinics operated by the same licensee General Must possess the necessary qualifications and experience Must be physically and mentally fit to administer a PHF  Must be of integrity and good character Qualification Registered medical practitioner Medical practice: Registered medical practitioner Dental practice: Registered dentist Combined medical and dental practices: Registered medical practitioner (with a registered dentist appointed to assist CME) Experience (Registered in HK) ≥ 15 years ≥ 6 years ≥ 4 years ≥ 8 years

Validity of licences Hospital Clinic Day Procedure Centre Small Practice Clinic Renewal of exemption not required Clinic Up to 5 years Day Procedure Centre Up to 3 years Hospital Up to 2 years

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