Clinical Governance

Handbook


HKU Health System (HKUHS) is the umbrella executive arm overseeing the LKS Faculty of Medicine’s clinical enterprises. The objectives of the HKUHS include:

To ensure robust clinical governance, set uniform standards and exercise effective oversight of the clinical settings we serve to ensure the quality of our clinical service and to protect HKUHS’s reputation.

Purpose
The purpose of this “HKU Health System Clinical Governance Handbook” is to set out uniform guidance and accountability requirements to ensure robust clinical governance that embeds quality and safety in our everyday practice and to facilitate effective oversight of ‘Special Service’ Units within the HKU Health System.

“Clinical governance is a system through which organisations are accountable for continuously improving the quality of their services and safeguarding high standards of care.” Put simply, clinical governance is a generic term for everything that helps to maintain and improve high standards of patient care. It covers a whole range of quality and patient safety improvement activities, and provides a framework to draw these activities and tools together in a co-ordinated way.

In developing this handbook, reference was taken from prevailing local and overseas regulatory and professional standards and guidelines where applicable, with a view to setting out the appropriate clinical governance standards for the safe provision of services in our Special Service Units. These references included the Department of health’s Draft Standard for medical Clinics under the Private Healthcare Facilities Ordinance.

Applicability of this Handbook
This handbook is applicable to all Special Service Units within the LKS Faculty of Medicine that provide direct clinical services to patients. For the purpose of this handbook, clinical services means a diagnosis, treatment (other than first aid treatment) or care for the patient given by a registered Medical Practitioner or a registered Chinese Medicine Practitioner, but excludes the Faculty’s Clinical Trials Centre (CTC) which has its own governance arrangements.

Professor Joseph Lui
Clinical Director, HKU Health System
July 2019

1. Governance Management

1.1

Practitioner-in-charge

1.1.1

Each of the Faculty’s Special Service Units must, at all times, have a Practitioner-in-charge (PIC) of the unit.

1.1.2

The PIC should be a registered Medical Practitioner, Chinese Medicine Practitioner or Clinical psychologist, as appropriate, appointed by the head of the respective school, department or centre.

1.1.3

The head should also appoint a registered practitioner to deputise for the PIC in the latter’s absence from duties.

1.1.4

The PIC is accountable for:

  • Providing leadership to develop a culture of safety and quality improvement
  • Day-to-day administration and medical management of the units clinical services
  • Adoption and implementation of relevant policies and procedures for the units healthcare services
  • Ensuring the unit’s compliance with relevant legal and regulatory requirements
  • Ensuring that all healthcare professionals working in the clinic have the requisite qualifications, valid registration and practising certificates, and relevant training

1.1.5

The PIC should also ensure that the policies and procedures are consistent with the Code of Professional Conduct for the Guidance of Registered Medical Practitioners issued by the Medical Council of Hong Kong and/or the Code of Conduct for the Guidance of Chinese Medicine Practitioners, as applicable.

 

1.2

Statutory requirements under the Private Healthcare Facilities Ordinance

1.2.1

Under the Private Healthcare Facilities Ordinance (PHFO) (Cap 633), gazetted on 30 November 2018, HKU healthcare facilities that meet the following conditions are excluded from that regulatory regime:

  1. Facility operating as a Clinic, Day Procedure Centre or Clinical Trial Centre (as defined in the Ordinance);
  2. Primary used for teaching or research related to medicine or dentistry; and
  3. Managed or controlled by HKU.

1.2.2

Private Healthcare Facilities that do not meet these conditions must comply with this regulatory regime, including obtaining a licence and meeting “Codes of Practice” for Medical Clinics / Day Procedure Centres, established by the Department of Health under the PHFO.

1.2.3

The PIC must immediately inform the Clinical Director (HKU Health System) if their unit does not continue to meet these conditions for exclusion.

 

1.3

Launching new or changing Special Service Units

1.3.1

All schools, departments and centres intending to provide new clinical services at an existing unit, or to set up a new unit to provide clinical services to patients, whether or not such clinical services are incidental to a teaching and/or research activity, and irrespective of the funding sources, must notify the Clinical Director (HKU Health System), before proceeding to assure proper clinical governance is in place.

1.3.2

HKU Health System will assess compliance with the relevant PHFO exclusion criteria and, if confirmed, will notify the Department of Health and the Food and Health Bureau of this and the relevant the details. A unit which does meet the PHFO exclusion criteria will be required to obtain a licence to operate the facility under that Ordinance.

 

1.4

Compliance with other legal and regulatory requirements

1.4.1

The PIC should ensure the unit complies with all relevant legal and regulatory requirements. A list of ordinances that may be relevant to the unit is included at Appendix 1 for reference.

1.4.2

The PIC should ensure that all necessary licences for the unit’s operation are obtained, that any relevant licencing conditions continue to be met and a system is established to ensure licence renewal at required times.

1.4.3

Any instances of non-compliance identified should be reported using the incident reporting mechanism (para 9.2 refers). Receipt of any warning, non-compliance notice or the like from a relevant regulatory body should immediately be reported to the Clinical Director (HKU Health System).

 

1.5

Compliance assurance and accountability reporting

1.5.1

The PIC shall report to the Clinical Director (HKU Health System) on matters related to the clinical governance of the facility.

1.5.2

The PIC should ensure that a self-assessment of the unit’s compliance with the clinical governance guidance set down in this handbook using the “Clinical Governance Self-assessment Checklist at Appendix 9 is completed at least annually.

1.5.3

The PIC shall make a six monthly clinical governance report to the Clinical Director (HKU Health System) that includes the following (report template at Appendix 2 refers):

  1. Summary of clinical service statistics and KPI / quality indicators *;
  2. Summary of feedback / complaints / appreciations received;
  3. Summary of reported incident/adverse events; and
  4. Certification that the unit is in compliance with relevant legal and regulatory requirements.

* Each unit to develop and report at least one KPI / quality indicator.

1.5.4

At the direction of the Clinical Director (HKU Health System), HKUHS may carry out an assessment of a unit’s level of performance in clinical governance and to identify possible areas for improvement.

2. Staff Training and Credentialing

2.1

Taking into account the number and needs of patients and types of services provided, the PIC should ensure that there are, at all service times, a sufficient number and skill mix of staff commensurate with organisational need and the provision of safe, high quality care.

2.2

All staff involved in clinical care should have the necessary licences, registration, qualifications, skills and experience to fill their defined roles and be appropriately trained in the use of relevant medical equipment and, as appropriate for the types of services provided, in assisting in medical procedures.

2.3

The PIC should implement a process to ensure necessary licences and registration of staff are current (e.g. annual practising certificate).

2.4

The PIC should ensure that the staff involved in clinical care are practising within their professional scope of practice and competence and in accordance with the code of practice of relevant professions.

2.5

All new staff to the unit should receive job orientation, including details of operational manuals and clinical guidelines, and how they can be easily accessed.

2.6

The PIC should undertake periodic succession planning for key posts within the unit.


3. Physical Conditions

3.1

Clinic management

3.1.1

The physical design, size, layout and condition of the unit are appropriate for the safe and effective delivery of services and the needs of its patients.

3.1.2

All buildings, furniture, furnishings, fittings and equipment of the unit are maintained in good operational order.

3.1.3

The unit is kept clean and hygienic. Ventilation, lighting and signage are adequate and appropriate.

3.1.4

The PIC should ensure that the facility and its use are in compliance with relevant ordinances and regulations of the Laws of Hong Kong.

3.1.5

In the planning and design of the facility, risk reduction and general safety should be considered in tandem with healthcare delivery in order to ensure the unit meets its legal obligations and its duty of care. Fire safety should also be addressed, in the placement of emergency exit.

3.1.6

The PIC should consult the HKU Estates Office in respect of the physical design, size, layout and condition, as well as the construction and use of the unit, as and when required.

 

3.2

Equipment and stores

3.2.1

The PIC should ensure that the unit has the required and readily accessible medical equipment, instruments, appliances and materials that are necessary for the type and level of patient care it provides

3.2.2

The quantities stored should be appropriate for the safe and effective provision of its services.

3.2.3

The PIC should ensure that the unit’s equipment is:

  1. Used as intended for their purposes;
  2. In good working order; and
  3. Properly maintained.

3.2.4

Records of maintenance and servicing of medical equipment should be kept.

3.2.5

Staff involved in clinical care are appropriately trained in the safe and proper use of medical equipment utilised in the unit.

3.2.6

Medical devices labelled by the manufacturer as ‘single-use’may not normally be re-used in any way.

3.2.7

Where high-risk procedures are conducted, back-up power supply should be available for safe completion of such procedures.

4. Service Delivery and Care Process

4.1

Patient’s rights

4.1.1

Patients have the right to:

  1. Receive medical advice and treatment which fully meets the currently accepted standards of care and quality;
  2. Know the name and post of staff providing services;
  3. Information about what health care services are available, and what charges are involved;
  4. Be informed of the investigation, procedure and treatment planned for them, and give informed consent to any investigation, procedure and treatment;
  5. Accept or refuse any medication, investigation or treatment, and be informed of the likely consequences of doing so;
  6. Choose whether or not to take part in medical research / teaching programmes;
  7. Have their privacy, dignity and religious and cultural beliefs respected;
  8. Have information relating to their medical condition kept confidential;
  9. Access their own health records; and
  10. Make a complaint through channels provided for this purpose, and to have any complaint dealt with promptly and fairly.

4.1.2

The PIC should embed the rights of its patients into the unit’s culture and everyday practices.

 

4.2

Patient’s identification

4.2.1

Staff should check the details of a patient’s identification at each and every appropriate stage of a health care delivery process to ensure the right patient receives the right care. The patient should be involved in the identification process so far as possible.

4.2.2

The PIC should establish written policies and procedures for patient identification and appropriate verification processes to ensure that the correct patient receives the correct information, investigation, procedure and treatment.

4.2.3

As a minimum, to ensure all patients are positively identified,at least two of the following approved personal identifiers should be used each time identification occurs:

  • Patient’s name (Chinese or English)
  • HK Identity card (HKIC) number / passport number (PP)
  • Date of birth (written as DD/MM/YYYY)

 

4.3

Evidenced based practice

4.3.1

The PIC should ensure that systems are in place to support the delivery of evidence-based clinical care within the designated clinical scope and capability of the unit.

 

4.4

Laboratory Specimens

4.4.1

The PIC should ensure there are mechanisms in place for the proper handling, including correct patient identification, of laboratory specimens, where relevant to their service.

 

4.5

Healthcare records

4.5.1

The PIC should put written policy in place for the creation, management, handling, storage and destruction of healthcare records, both written and electronic, as relevant.

4.5.2

The unit should set a standard recording practice, so that relevant data are consistently collected, is accurate, legible and up-to-date, and should facilitate future retrieval of the information to support the delivery of quality patient care.

4.5.3

Healthcare records should include at least the following:

  • Sufficient information to identify the patient;
  • Residential address;
  • Contact telephone number;
  • Drug allergy history;
  • Relevant consultation notes;
  • Investigation(s), treatment; and
  • Where appropriate, sick leave and referral records.

4.5.4

The PIC should establish policies, procedures and physical security arrangements to ensure that healthcare records are kept confidential, secure and are protected from unauthorized access, alteration or loss.

4.5.5

Healthcare records should be retained for a specified minimum period.

 

4.6

Medication management

4.6.1

The PIC should ensure that the handling and supply of medicines at the unit are in accordance with the requirements of the relevant legislation and prevailing guidelines issued by relevant regulatory authorities, including the DDO.

4.6.2

The unit should keep an up-to-date drug formulary. All medicines supplied should be registered pharmaceutical products in Hong Kong

4.6.3

All medicines must be clearly labelled and stored appropriately. A system must be in place to check the expiry dates of medicines. Expired medicines should not be used for dispensing or administration and should be disposed of properly.

4.6.4

Medicines are dispensed under the supervision of a registered medical practitioner or pharmacist. Staff responsible for dispensing and administering medicines should receive appropriate training. There should be a system is in place to monitor the accuracy of dispensing and administration of medicines, as appropriate to the types of services provided.

 

4.7

Handling feedback and complaints

4.7.1

The PIC should implement a mechanism for handling feedback and complaints made by patients, or persons representing the patient, that is in accordance with the HKUHS Standard Operating Policy on Feedback / Complaint Handling (Appendix 10 refers).

4.7.2

The PIC should ensure that patients and/or carers of patients are provided with information about the procedure for making feedback/complaints and the process for managing and responding. This should at least include the display within the unit of the HKU Health System Feedback/Complaints Poster (Appendix 3 refers), following its adaptation for the unit’s circumstances.

4.7.3

The complaint handling system and information should form a component of the unit’s risk management system.

 

4.8

Patient satisfaction

4.8.1

The PIC should establish a programme to regularly (at least annually) obtain feedback from patients /carers in order to gain a better understanding of their priorities and concerns.

4.8.2

An example of a Patient Satisfaction Survey, which can be adapted for your unit, is shown at Appendix 4.

5. Patient's consent for medical treatment, research and teaching

5.1

Consent to research and teaching

5.1.1

As the primary purpose of the facility is for teaching and/or research, consent must be obtained from a patient for their involvement in teaching and research.

5.1.2

Contrary to consent to medical treatment, a patient who voluntarily submits to treatment provided by your unit does not necessarily indicate their willingness to participate in the relevant research and teaching activities.

5.1.3

Express written consent must be obtained from all patients, as relevant to your unit, for their involvement in teaching and research, and to use their clinical data for the purposes of teaching, research and/or publication.

 

5.2

Consent to transfer patient’s data outside HKU

5.2.1

If patient data (including clinical data) collected by your unit will be shared with/transferred to an entity outside HKU (e.g. the Hospital Authority, Department of Health, other academic institutions) for teaching, research or otherwise, express written consent to share identified health information must be obtained from the patient.

 

5.3

Consent to medical treatment

5.3.1

The PIC should establish policy and procedures which ensure the patient and/or carer are informed of the consent process, and they understand and provide consent for their health care, including for financial consent, before commencing.

5.3.2

The patient and/or carer should be informed of risks and complications inherent in the procedure or treatment. This is part of the duty of care owed to the patient by the health professional who provides treatment.

5.3.3

While consent for minor and non-invasive treatments can be implied by a patient’s conduct in consulting a doctor, express and specific written consent is required for major treatments, invasive procedures, and any treatment which may have significant risks.

5.3.4

For written consent, a reasonably clear and succinct record of the explanation (including risks and complications) given to the patient and/or carer should be made in the consent form. The patient, the doctor and the witness (if any) should sign the consent form at the same time.

5.4

Appendix 5 shows the elements considered essential for inclusion in a patient consent form/s. Contact the HKU Health System to seek further assistance on reviewing your existing consent forms or developing new consent forms, as required.

6. Protection of Patient's Data

6.1

Handling of Patient’s Information

6.1.1

All patient information, in any form, must be treated in the strictest confidence and be protected by all practicable steps.

6.1.2

Staff handling personal data should be aware of the provisions of the Personal Data (Privacy) Ordinance (Cap. 486) and have due regard to their responsibilities under that ordinance.

6.1.3

In order to comply with the notification requirement under Data Protection Principle 1(3) of the Personal Data (Privacy) Ordinance (Cap. 486 of Laws of Hong Kong), the unit shall inform the patients, amongst other things, the purpose for which the personal data (including clinical data) is to be used and the classes of person to whom the data may be transferred. The notification requirement shall be complied with before collection of any personal data, and can be achieved by providing the patient with a Personal Information Collection Statement.

6.1.4

To meet this notification requirement, the PIC should ensure that the HKUHS Personal Information Collection Statement (Appendix 6 refers), adapted to meet the unit’s needs, is visibly displayed in the facility.

6.1.5

While the Personal Data (Privacy) Ordinance does not require such notification to be given in writing, it is a good practice for the unit to also provide a copy of the PICS to the patient in the interest of transparency and to avoid possible misunderstanding.

 

6.2

Access to Patient Information

6.2.1

As a general rule, only the unit staff involved in the healthcare process of the patient are allowed access to the patient’s information on a need basis.

6.2.2

Staff must not allow other patients or unauthorised persons to have access to Patient’s healthcare records under any circumstances.

 

6.3

Use of Patient Information

6.3.1

Patient information should only be used by the relevant staff for purposes of treatment, teaching or research, unless with the prior consent of the patient concerned.

6.3.2

Personal Data, in any form, should not be disclosed in teaching/research materials without a patient’s explicit consent.

6.3.3

Should there be need to use a patient’s photo showing their face and/or personal identifiers in teaching/research materials, staff should blur out or mask certain areas of the photo to the extent that the patient’s identity could not be ascertained, unless an explicit consent has been provided by the patient for that purpose.

 

6.4

Sharing / disclosure of patient’s information with third parties

6.4.1

The PIC shall ensure that valid consent (preferably in written form) had been obtained from patients before sharing and/or disclosing any patient’s information (including healthcare records) to other departments/units within HKU or to a third party, even if the purpose of such sharing and/or disclosure is for continuity of care of the patient concerned.

 

6.5

Loss of Patient Personal Data or Patient Records

6.5.1

In the unfortunate event that any Personal Data of patients, in any form, or any Patient Record, is lost, the unit must report the loss using the incident reporting mechanism (para 9.2 refers) and to the Faculty’s Personal Data Co-ordinator.

7. Research

7.1.1

If clinical research is conducted involving patients, the PIC should ensure that research ethics have been reviewed and the conduct of research is in accordance with standards that may be prescribed by relevant regulatory authorities.

7.1.2

Any unit intending to advertise their clinical services, for research purposes or otherwise, must ensure strict compliance with the Undesirable Medical Advertisements Ordinance (Cap 231) (UMAO). If uncertain, advice from the HKU Health System should be sought.

8. Infection Control

8.1

IC measures

8.1.1

The PIC should appoint, or act as, the Infection Control Officer (ICO) for the unit. The ICO shall have appropriate training in infection control practices.

8.1.2

Using a risk-based approach, the unit’s ICO ensures that all staff of the unit observe infection control and preventive measures, including but not limited to standard precautions of infections. Reference shall be made to relevant guidelines issued by international or local health authorities (e.g. the Centre for Health Protection of the Department of Health).

8.1.3

Ensure appropriate and adequate stocks of personal protective equipment are available for use by staff.

8.1.4

The PIC should report unusual clustering of communicable diseases to the Department of Health, in addition to the statutorily reportable infectious diseases stipulated in the Prevention and Control of Disease Ordinance (Cap 599).

 

8.2

Cleaning, disinfection and sterilization

8.2.1

Reusable equipment and supplies used in invasive procedure are properly reprocessed by appropriate disinfection and sterilisation methods. Sterile equipment and supplies should be stored in a clean and dry area. There should be a system for regular checking of expiry of sterile supplies.

8.2.2

All sterilising equipment, if utilized in the unit, are regularly inspected and maintained with proper documentation. Relevant staff are appropriately trained in the use of this sterilising equipment.

 

8.3

Waste disposal

8.3.1

Clinical and chemical wastes are handled properly and safely according to written policies and procedures promulgated by the Environmental Protection Department pursuant to the Waste Disposal Ordinance (Cap. 354) and its related regulations, including but not limited to Waste Disposal (Chemical Waste) (General) Regulation and Waste Disposal (Clinical Waste) (General) Regulation.

8.3.2

For Waste Disposal (Chemical Waste), refer to: A Guide to Chemical Waste Control Scheme.

8.3.3

For Waste Disposal (Clinical Waste), refer to: Code of Practice for the Management of Clinical Waste (Small clinical Waste producers); and Segregation, Packaging and Labelling of Clinical Waste for Small Producers.

8.3.4

Radioactive waste are handled properly and safely according to the provisions of the Radiation Ordinance (Cap. 303) and the Radioactive Substances Licence issued by the Radiation Board in respect of the handling of the waste.

9. Risk Management, continuous improvement and contingency

9.1

Risk management

9.1.1

Risk is inherent in health care. Minimising risk to patients is an important component of medical practice. The PIC should ensure that there is a written risk management policy and safety inspection procedures for the identification and assessment of risks and hazards in the facility and its services.

9.1.2

Contingency planning should focus upon the analysis of risk, and then address those threats most likely to significantly interrupt the provision of services.

9.1.3

Risks/hazards identified and subsequent mitigation actions taken should be recorded in the unit’s Risk Register (Appendix 7 provides a sample Risk Register format).

9.1.4

Risk management should be integrated with quality improvement and planning.

9.1.5

A risk management approach is to be used when considering and developing new and modified services, including refurbishment of the physical facility. Risk reduction and general safety should be considered together with requirements for healthcare delivery.

 

9.2

Incident reporting

9.2.1

Incident reporting should form a key component of the unit’s risk management system.

9.2.2

The PIC should implement policies and procedures for incident reporting and handling in compliance with (or may adopt) the HKUHS Standard Operating Policy on Clinical Incident Reporting (Appendix 11 refers).

9.2.3

The PIC should encouraged staff to report clinical and non-clinical incidents and near misses.

9.2.4

If an incident is deemed significant from preliminary investigation, the PIC should IMMEDITATELY report the case to HKU Health System. If the incident is of public health significance (e.g. Sentinel event or Serious Untoward Event [SUE]), HKU Health system to report case to the Department of Health within 24 hours.

9.2.5

Reported incidents and near misses should be investigated and timely remedial action taken as required to ensure improvements.

9.2.6

A six monthly report analysing all reported incident/events along with the learning during the six month period will be made to the unit’s management committee/board, with copy to the Clinical Director, HKU Health System.

 

9.3

Continuous Quality Improvement (CQI)

9.3.1

The PIC provides leadership to develop a culture of safety and quality improvement within the unit.

9.3.2

The following evaluation mechanisms are used to assess and help identify opportunities for improvement in the quality of care and services provided:

  • Quality & Key Performance Indicators (KPIs) (Target: establish at least 1 indicator)
  • Clinical Audit (Target: at least 1 per year)
  • Complaint Handling (para 4.7 refers)
  • Patient Satisfaction Survey (para 4.8 refers)

9.4

Emergency response

9.4.1

The PIC should ensure that there is a written emergency response protocol outlining the procedures to be followed in the event of an emergency affecting the provision of services at the Facility.

9.4.2

Taking into account the types of services provided, the PIC should ensure that there are written protocols for management in medical emergencies / rendering medical assistance, including for:

  • Resuscitating a patient suffering cardiac or respiratory arrest; and
  • Emergency transfer, when necessary, to an acute care hospital.
  • A sample Emergency Medical Assistance Protocol is shown at Appendix 8 that maybe adopted or adapted to suit.

9.4.3

The PIC should ensure that there is adequate resuscitation equipment (e.g. AED) and supplies that are easily accessible and checked at regular intervals.

9.4.4

The PIC should ensure that sufficient staff are trained in first aid, basic life support and advanced life support, as appropriate to their role.

9.4.5

The unit should carry out resuscitation drills periodically and these should be documented.

 

9.5

Fire safety and evacuation

9.5.1

The PIC should ensure that there are adequate precautions against the risk of fire.

9.5.2

The PIC should ensure that there is an internal fire and emergency response plan incorporating evacuation procedures and evacuation routes are clearly displayed.

9.5.3

Fire evacuation exercise is conducted at regular intervals and is documented.

10. Fees and Charges

10.1

Settings Fees and charges

10.1.1

Fees and charges for clinical services should be reviewed periodically and appropriate approval obtained for planned changes.

10.1.2

In setting fees and charges, the following should be considered:

  1. Must comply with the principle of no cross subsidisation.
  2. All costs, including university overheads.
  3. Not to compete unfairly with the market.

10.2

Price transparency

10.2.1

There should be price transparency. Patients should be informed of the charges of service whenever practicable before clinical service is provided.

10.2.2

An up-to-date fee schedule covering major chargeable items, written in both Chinese and English, must be readily available for reference of patients at the reception office / cashier and, where possible, on the internet for public information.

10.2.3

If it is not possible to provide a fixed fee for a particular chargeable item, the fee could be presented in the form of a price range or a remark be inserted to indicate that price information will be available upon request.

11. Appendices
  • Appendix 1 - Relevant Hong Kong Ordinances

The above list is for general reference only and is not meant to be exhaustive.