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Secretariat,

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Secretariat,

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  1. Working Group on Defining High-Risk Medical Procedures/Practices Performed in Ambulatory SettingConsultation on the Draft Recommendations Secretariat, Working Group on Defining High-Risk Medical Procedures/Practices Performed in Ambulatory Setting 5 December 2013

  2. Background • The Working Group is one of the working groups set up under the Steering Committee on Review of Regulation of Private Healthcare Facilities Steering Committee on Review of the Regulation of Private Healthcare Facilities Working Group on Differentiation between Medical Procedures and Beauty Services Working Group on Regulation of Premises processing Health Products for Advanced Therapies Working Group on Defining High-Risk Medical Procedures Performed at Ambulatory Setting Working Group on Regulation of Private Hospitals

  3. Composition of the Working Group • Chairman: Professor Raymond Liang • Members: • Steering Committee members – representatives from MCHK, HKMA, HKDA, FHB, HA, DH and other professional bodies • Co-opted members – representatives from HKAM and Colleges, Federation of Medical Societies, patient group

  4. Objectives of the Working Group • To define the range of high-risk procedures/practices that should be performed in regulated ambulatory facilities only • To recommend appropriate regulatory approaches to the Steering Committee

  5. Work Approach • Review of overseas regulatory framework and local situation • Set up Expert Groups • Surgical procedures • Endoscopic procedures • Dental and maxillofacial procedures • Chemotherapy, diagnostic/interventional radiological procedures • Haemodialysis, peritoneal dialysis, cardiac catheterisation, lithotripsy

  6. Current Regulatory Framework

  7. Recommendations • Scope of high-risk procedures • Regulatory approach for ambulatory facilities where high-risk procedures are performed • Regulatory standard for such facilities

  8. Scope of High-Risk Procedures • Three principle factors of classifying high-risk procedures - • Risk of procedure • Risk of anaesthesia involved • Patient’s condition • “High-risk” can be defined by ANY of the three factors

  9. Scope of High-Risk Procedures Highest risk Procedures to be performed in hospital-setting only Procedures to be performed in regulated facilities only • High-risk vs Non-high-risk • Risk of anaesthesia • Risk of procedure • Patient’s condition Procedures may be performed in any facilities Lowest risk

  10. Scope of High-Risk Procedures

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  22. Scope of High-Risk Procedures

  23. Scope of High-Risk Procedures

  24. Scope of High-Risk Procedures

  25. High-Risk Procedures at Ambulatory Setting • High-risk procedures could be performed at regulated ambulatory facilities only if: • the patient is discharged on the same calendar day of admission; AND • the expected total duration of the procedure and the recovery does not exceed 12 hours; AND • the patient is classified not higher than Class 3-unstable based on ASA Physical Status classification system

  26. Scope of High-Risk Procedures Highest risk Hospital vs Ambulatory Operation + recovery not more than 12 hours Same day discharge Patient’s condition classified not higher than ASA physical status class 3-unstable Procedures to be performed in hospital-setting only Procedures to be performed in regulated facilities only • High-risk vs Non-high-risk • Risk of anaesthesia • Risk of procedure • Patient’s condition Procedures may be performed in any facilities Lowest risk

  27. Hospital-Only High-Risk Procedures • Chemotherapy that is not administered by parenteral or oral route; (e.g. intrathecal, intravesical) • Radiological-guided core biopsy of deep-seated organ • Cardiac catheterisation • Continuous venous-venous haemofiltration • Organ transplant [except corneal transplant] and complicated transplant procedures • Some members proposed to include bronchoscopy

  28. Regulatory Approach • Ambulatory facilities for high-risk procedures: • Statutory registration in the long run • Administrative listing as interim measure • Administrative listing also proposed for facilities for peritoneal dialysis and endoscopic procedures outside the scope of high-risk procedures

  29. Regulatory Standards

  30. Regulatory Standards • The regulatory standards in general should not be more stringent than those for private hospitals • HKAM to be invited to set and update the procedure-specific regulatory standards

  31. Way Forward • The Working Group will present its final recommendations to the Steering Committee in Q1 2014 • Other preparatory works • Survey to estimate the number and type of facilities under the proposed scope of high-risk procedure • Public consultation on legislative proposal

  32. Advice Sought • HKAM and member Colleges to advise on the draft recommendations • HKAM to set up mechanisms to - • maintain and update the list of high-risk procedures • set procedure-specific regulatory standards and advise the regulatory authority accordingly

  33. - End -