Healthcare Governance

Healthcare Governance
© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

Learning objectives:
1. To know the meaning of the term of “Clinical Governance”
2. To be able to apply the clinical governance framework in the healthcare firms
3. To know the clinical governance components

Lecture Contents:
1. Clinical Governance Definition
2. Clinical Governance Objectives
3. Clinical Governance Principles
4. Clinical Governance Components

Governance Domains
Corporate
Governance
Disclosure & Clinical

Transparency Governance
Governance
Hospital Audit & Risk

Sustainability & Management
Responsibility

Clinical Governance
Clinical Governance is defined as “A framework through which
organizations are accountable for continually improving the quality
of their services and safeguarding high standards of care by creating
an environment in which excellence in clinical care will flourish.”

Clinical Governance…. Is it important?

99.9 % Perfection ….. Is it enough?
250 beds hospital:
Each year:
- 12 inpatients would die due to errors
- 9,742 wrong medications would be delivered
- 4,932 incorrect lab tests would be reported
- 502 incorrect radiographs would be completed
(Children’s Mercy Hospital, 2008)

Numbers Talk!!!

Clinical Governance Objectives
1. Recognition of unsafe practice
2. Promoting culture of safety
3. Identification of education & training needs
4. Supporting the evidence-based practice medicine
5. Providing clinical care information for related stakeholders
6. Ensuring lessons are learned from errors, complaints, and claims
Create consistency
within the work Patient Safety
processes

Recognition of Unsafe Practice
It means that the hospital quality system has the ability to discover
the quality problems
Examples of hospital tools for recognition of unsafe practice:

✔ Incident reporting
✔ Risk assessment activities
✔ On-site audit, rounds, tracers, and inspection
✔ Data collection & analysis
✔ Medical records audit

Incident Reporting System
Characteristics of Effective Incident Reporting System:
❑ Confidentiality
❑ Protection of reporters from blaming
❑ Empowering ALL staff to report
❑ Availability of feedback from reports
❑ Regular summaries and analysis reports
❑ Real improvement plans based on the reporting
❑ Accessible, ease to fill the form (self-explanatory) and friendly interface

Incident Reporting System
Notes
✔ The voluntary reporting systems are incapable of providing accurate rates of errors
✔ The system changes are the real measures of success NOT the numbers of incident
reports
✔ The system ability to act on the incident reports promptly & effectively is more likely
to be more effective than one with far more reports and less actions

Medical Records Audit Using Triggers Tools
Trigger Tools in general are:
- Retrospectively used for detection of adverse events
- Utilized for medical records
- The triggers are clues for potential adverse events
- Less value when & where poor documentation occurs
The most common, famous & reliable tool is IHI Global Trigger
Tool

IHI Global Trigger
▪ First developed in 1999 for medication errors only
Tool
▪ Upgraded in 2003 to include all other medical & clinical errors
and adopt the NCC MERP’s medication errors categories for all
other errors
▪ The second edition was released in 2009
▪ The tool consists of 6 modules containing 51 triggers
General Care Medications Surgical Intensive Care Perinatal

Module Module Module Module Module
Emergency
Department Module
IHI Global Trigger
Examples
Tool of triggers:
Transfusion of Blood or Use of Blood Products
Decrease in Hemoglobin or Hematocrit of 25% or Greater
Readmission within 30 Days
Vitamin K Administration
Naloxone (Narcan) Administration
Change in Procedure
Admission to Intensive Care Post-Operatively
Readmission to the Intensive Care Unit
Revisit to the ED within 48 Hours

IHI Global Trigger
1. Organize the teamHow to use the tool?
Tool
2. Get your sample
3. Review to look for the presence of triggers
4. Focus review (if trigger is found)
5. Determination of an adverse event
6. Assign the category of harm
7. Data collection
8. Data Display
Occurrence Reporting
▪ The occurrence reporting is another type of patient safety reporting systems that
depends on reporting the occurrence of certain indicators such as the morbidity
triggers
▪ It’s a system combining between the voluntary action of incident reporting and the
depending on objective indicators as in the case of IHI Global Trigger Tool

Culture of Safety
Informed Culture
No fear of blames atmosphere
Learning Culture
Flexible Culture
Just Culture
System Factors
❑ Values-supportive model of shared accountability

Human Factors
❑ Non-punitive response to reporting of safety issues

and events
❑ Does not punish staff members involved in errors or

adverse events related to system failures
❑ Zero tolerance for carelessness, negligence or reckless

behavior

Culture of Safety
Staff Psychological Safety

1. Stress Recognition How to avoid work-related stress?
- Good work organization
- Good work conditions
2. Support second victims - The work demands are matching with staff knowledge
- Support from supervisors and colleagues
Second victims are those clinical staff involved in medical errors

What is Patient Safety?
“The absence of preventable
harm to patients and prevention
of unnecessary harm by
healthcare professionals” Harm: Impairment of the physical,
emotional or psychological function or
(WHO, 2019) Preventable = Avoidable structure of the body and/or pain may
result therefrom.
Preventable ≠ inevitable

Related GAHAR Standards
OGM.16 Leaders create a culture of safety and quality within the facility
Evidence of Compliance:
1. Leaders participate in safety rounds.
2. Leaders support quality and patient safety initiatives, monitoring, and
improvement activities.
3. Leaders creates a just culture to encourage reporting errors and near misses.

OGM.17 The hospital ensures positive workplace culture.
1. The hospital has an approved policy for positive workplace culture, The policy
addresses at least a) to e) in the intent.
2. The workplace is clean, safe, and security measures are implemented.
3. Measures of workplace violence, discrimination, and harassment are
implemented.
4. There are communication channels between staff and hospital leaders
5. Staff feedback and staff satisfaction are measured.

Clinical Governance Principles
Accountability
Patient-center
Ethics
ed Care
Clinical
Governance
Culture of
Responsibility
Safety
Transparency

❑ Accountability: Clinical teams are responsible & liable for their actions to
patients, hospital, and community
❑ Responsibility: Clinical teams are given privileges to take the responsibility
for clinical care & services
❑ Transparency: Clinical teams are responsible to make a balance between
patients’ confidential information and disclosure of required information for
continuity of care and for formal investigations

Ethical Framework
❑ Ethical dilemmas are most common in hospitals challenging providing safe care &
services for patients
❑ Mostly, this is due to financial constraints, advanced technology, increasing
expectations, and availability of wide variety of clinical interventions
❑ Hospital Leadership is responsible to develop & create an Ethical Framework
❑ This framework should be applied on both business & clinical activities

Ethical Framework
Ethical Framework should address at least the followings:
1. Marketing & advertising ethics
2. Patient right of information and consents
3. Business ethics
4. Disclosure of ownership when referrals or recommendations take place
5. Nondiscrimination
6. Clear policies of admission & discharge criteria
7. Billing accuracy
8. Care dilemmas

OGM.18 The hospital ensures ethical management.
1. The hospital has an approved policy for ethical management that addresses at
least a) to F) in the intent.
2. Staff members are aware of the policy
3. Ethical issues are discussed and managed according to the approved code of
ethics.
4. Solved ethical issues are used for education and staff professional development

OGM.14 The hospital manages the patient billing system.
1. The hospital has an approved policy for billing patients accurately.
2. There is an approved price list.
3. Patients are informed of any potential cost pertinent to the planned care.
4. The hospital uses accurate and approved codes for diagnoses, interventions, and
diagnostics.
5. In the case of a third-party payer (or health insurance), the timeliness of approval
processes is monitored.
6. Billing staff is oriented on various health insurance processes.
Patient-centered Care
“it means that the patients (or relatives) and community at large
are involved in all aspects of healthcare delivery, and tailored
services are provided to each patient according to patient’s
clinical condition”

Patient-centered Care
To achieve patient-centered Care:
1. Communication of accurate timely information for patient/relatives
2. Patient & family education
3. Giving the patients opportunity to ask questions
4. Taking consents before invasive procedures & high risk services
5. Respect the patient right to refuse treatment or procedure
6. Respect patient cultures & values
7. Involve stakeholders in clinical services planning and execution
8. Comprehensive patient assessment & integrated care plans
9. Emotional support & physical comfort

Lecture Contents:
1. Clinical Governance Definition
2. Clinical Governance Objectives
3. Clinical Governance Principles
4. Clinical Governance Components

Clinical Governance Components

Medical Staff Structure
❑ The hospital should have a medical staff structure that is developed according to the hospital’s
mission, scope of services and recommendations of professional practices to meet patient
needs.
❑ Medical staff structure is approved by the governing body
❑ Medical staff structure clearly defines lines of authority and lines of responsibilities during
working hours and after hours
❑ The objective of the medical staff structure is to provide oversight on quality of care, treatment,
and services.
❑ The director of the medical staff structure agrees with the governing body about the
communication channels between medical departments & the governing body (or the board of
directors)

WFM.10 An organized medical staff structure is developed to provide oversight on
quality of care, treatment, and services.
1. The hospital has a medical staff structure that is developed according to the
hospital’s mission, scope of services and recommendations of professional
practices to meet patient needs.
2. Medical staff structure is approved by the governing body
3. Medical staff structure clearly defines lines of responsibilities during working
hours and after hours

Medical Staff Bylaws
❑ The medical staff bylaws are document approved by the hospital governing body.
❑ Bylaws address the followings:
1. Medical staff structure
2. The process of appointment & privileging
3. Medical staff duties & responsibilities
4. Process & criteria for suspension
5. The mechanism of fair hearing & appeal process
6. Peer review process

WFM.11 Medical staff bylaws are developed.
1. The governing body approves medical staff bylaws.
2. Medical staff bylaws are consistent with laws, regulations, and professional
practices recommendations
3. The documents include elements in the intent from a) through j)

Staff Credentialing & Professional Development
❑ Credentials are documents that are issued by a recognized entity to indicate
completion of requirements or the meeting of eligibility requirements
❑ Examples of credentials:
- Graduation certificate
- Postgraduation certificate
- Residency evidence
- MOH license
- Professional membership
- Workshops & training sessions

❑ Credentialing is the process of obtaining, verifying, and assessing the qualifications
of a health care practitioner to provide patient care services in or for a health care
organization.
❑ Credentialing is done through:
1. Gathering the required credentials
2. Assessing & evaluating the gathered credentials
3. Primary source verification

Reappointing
Performance
Evaluation
Privileging /
Job
Appointing Descriptions
Credentialing
&
Application Verification
for
recruitment

❑ Privileging is The process whereby a specific scope and content of patient care
services are authorized for a health care practitioner by a health care organization,
based on evaluation of the individual’s credentials and performance
❑ Types of privileges:
1. First privilege
2. Renewal privilege
3. Temporary privilege
4. Emergency privilege

❑ The job description is a broad, general, and written
statement of a specific job, based on the findings of a
job analysis.
❑ It generally includes duties, purpose, responsibilities,
scope, and working conditions a job
❑ Specific job responsibilities should be mentioned in the
job description
Example: Emergency nurse’s job description shows
requirement for triage process
Professional Clinical Staff Performance Evaluation
❑ Ongoing & dynamic process

❑ Done through ongoing data collection for the purpose of assessing a practitioner’s clinical competence
and professional behavior
❑ Data are collected on both levels:
- Hospital-wide level
- Departmental specific level
❑ Evaluation results are utilized in education & training planning, reprivileging, & reappointing

WFM.12 Appointment of medical staff members is performed according to applicable
laws and regulations and approved medical staff bylaws.
1. There is a uniform process for the initial appointment of medical staff members.
2. Medical staff appointments are made according to the hospital medical staff
bylaws
3. Medical staff appointments are consistent with the hospital mission and services.
4. Medical staff appointments are according to laws and regulations.

WFM.13 Medical staff members have current and specific delineated clinical
privileges approved by the medical staff committee.
1. The hospital has an approved policy that addresses at least all elements from a)
through f) in the intent
2. Medical staff members are aware of the process of clinical privileges delineation
and what to do when they need to work outside their approved clinical privileges
3. Clinical privileges are delineated to medical staff members based on defined
criteria

WFM.13 Medical staff members have current and specific delineated clinical
privileges approved by the medical staff committee.
4. Clinical privileges are accessible to and used by staff involved in booking of surgery
and invasive procedures
5. Physicians' and dentists' files contain personalized recorded clinical privileges,
including renewal when applicable.
6. Physicians and dentists comply with their clinical privileges.

WFM.14 Performance of each medical staff member is reviewed and recorded at
least annually.
1. Performance evaluation records include at least all elements from a) through e) in
the intent
2. Medical staff members are aware of performance evaluation criteria
3. Evidence of medical staff members’ performance is assessed based on defined
criteria, including patient’s medical records completion and medication use.
4. Performance evaluation results are used to improve individual medical
performance
Research & Development
The hospital fosters research for:
✔ Continuous generation of reliable, robust research-based
data.
✔ Documentation and revision of results.
✔ Creating bodies of evidence to improve results

Research & Development
While doing this, the hospital is committed to:
Hospital
Laws & Ethical Capabilities
Program Selection regulations Considerations (resources)
Admission to
Patients involved Information specialized Protection
in the program Consent
units
Patient
Confidentiality
Oversight the
Committee IRB
program

ADD.06 The hospital establishes an ethical framework for research activities.
1. The hospital ensures that the research ethics committee has a multidisciplinary
membership, and that it includes individuals with backgrounds relevant to the areas of
research.
2. The hospital supports the committee with resources, including staffing, facilities, and
financial resources.
3. The committee members are trained and competent to perform their job.
4. The committee sets minimum requirements for approval of research protocols.
5. The committee approves all research protocols that involve human subjects as required
by law and regulation.
ADD.07 Patient rights are protected during research activities.
1. The hospital has an approved program that includes all the points in the intent
from a) through d).
2. Researchers are aware of the policy requirements.
3. Signed patient consent for participation in research is placed in the research file
and in the patient's medical record.
4. When patient safety issues are identified during research, patients are informed
and actions are taken to ensure patient safety.

Clinical Audit
❑ Clinical Audit is a continuous evaluation and improvement of clinical practices by
reviewing the provided care against set criteria
❑ Clinical Audit areas could be:
Adverse events & unsafe practice
Compliance with hospital policies, guidelines, and protocols
Effective communication between healthcare givers
Appropriate utilization of hospital resources
❑ Clinical Audit tools such as:
✔ Medical records audit
✔ Case review
✔ Peer review
✔ Patient interview or survey © 2022 Productivity and Quality Institute, Alexandria, All rights reserved
WFM.15 An ongoing peer review process is developed. .
1. The hospital has an approved policy that addresses all elements from a) through c)
in the intent
2. Medical staff members are aware of the peer review processes
3. Peer review processes are implemented
4. Results/reports of peer review are used for reappointment and re-privileging of
relevant regulatory bodies

Clinical Effectiveness
Clinical team
knowledge &
experience
Meeting patient’s Clinical effective

expectations outcome
Evidence-based
medicine practice
Clinical Effectiveness
Hospitals tools that will assist to achieve this outcome are:
1. Clinical standards :clinical guidelines, pathways and local practice protocols.
2. Clinical indicators: measures or benchmarks that enable the hospital to
compare it with similar hospitals.
3. Clinical audits: can be used to evaluate and improve the effectiveness of the
clinical practice.

Clinical Risk Management
Harm:
Physical, emotional & psychological injury or damage
Hazard:
The source of harm
Risk:
The likelihood of the hazard to cause harm

Risk Management objectives:
1. Identify hazards & risks
2. Prioritize risks
3. Develop the related plans, programs and actions to mitigate the
risk

Risk Management Activities
Proactive Reactive Ongoing
Ex. Root Cause Analysis (RCA)

Ex. Risk Register
Ex. Failure Mode & Effect Analysis (FMEA)

Risk Management Cycle
Risk
Identification
Risk
Risk Analysis
Monitoring
Risk Risk
Mitigation Evaluation
Risk
Identification 1. Identify the hazard
Risk
Risk Analysis
2. Identify the (potential) harm
Monitoring
3. Identify the (potential) error

Risk
Mitigation
Risk
Evaluation
4. Identify the (potential) process variation
5. Risk description
6. Additional information: location, coding, …..

Risk
Identification
1. Risk Category
Risk
Monitoring
Risk Analysis
2. Who would be affected?
3. How would it affect?
Risk Risk
Strategic Operational Financial Compliance Reputational
Patients Staff organization

Risk
Identification
Risk is the likelihood of hazard to cause a harm
Risk Likelihood = Probability = Frequency
Risk Analysis
Monitoring
▪ Rare – Unlikely – Likely – Frequent
▪ Low – Moderate – High
Risk Risk - Give objective definitions for likelihood options

Mitigation Evaluation - Give a “score” for each option
Impact = Severity = Consequences

Minor – Moderate – Major - Severe
- Give objective definitions for severity options

- Give a “score” for each option
Risk Score = Likelihood Score X Severity Score

Example:

Risk Matrix

Risk 1. Determine the mitigation strategy
Identification
2. Review the current controls
Risk
Monitoring
Risk Analysis 3. Ensure preventive actions are in place (if applicable)
4. Develop corrective actions
Risk Risk
Acceptance Avoidance Transfer Reduction

Risk
Identification 1. Develop risk-related indicators
Risk 2. Develop monitoring checklists

Risk Analysis
Monitoring
3. Prepare related reports
Risk Risk
4. Continue the cycle

Clinical Risk Management
Hospital should address risks
affecting patients, staff, and
organization, and achieve balance
between mitigation strategies in
order to create safe environment
and safe practices in the hospital

Information Management
Clinical Governance is concerned with two information systems:
1. Medical Records
2. Screening & Incident Reporting

Are Medical Records Important?
❑ Communication between healthcare givers
❑ Continuity of care
❑ Financial purposes
❑ Medico legal aspects
❑ Statistics function

Medical Records Audit:
What to be audited? How? Who Frequency

- Inpatients & outpatients
- Open & closed The review
- Completeness - Representative sample of: At least
is done by
- Legibility • all services
those who quarterly
• all units
- Timeliness • Staff make
- Random stratified sample entries in
- Use of - The results are the medical
abbreviations incorporated with the
records
quality improvement
- Accuracy program
- The results are reported to
the management © 2022 Productivity and Quality Institute, Alexandria, All rights reserved
Advanced Technology
Computerized Provider Order Entry (CPOE)

▪ Entry the medication orders and physicians’ order through computer applications
▪ Dropdown lists of medications, lab investigations, radiology services
Benefits:
- Reduction of medication errors due to illegibility
- Reduction of the risk of transcribing
- Capability to embed alarming system (high alert medications,
critical values)
- Integrated each patients’ data and summarized screens
- Integration with other healthcare systems
- efficient communication between different disciplines to
reduce turn-around-times and increase efficiency
- Ensures more confidentiality
- Enhances the billing function

Advanced Technology
Clinical Decision Support System (CDSS)

✔ The system objective is to enhance the clinical decision
✔ It’s composed of huge database of:
- Clinical guidelines
- Protocols
- Specific order sets
- Physicians’ orders & progress notes
- Clinical summaries
Benefits:
- Investigations reports - Recommendations of diagnoses
✔ Advanced versions are supported with the AI - Recommendations of treatment plans & medications
- Prediction of investigation results
- Alerts for existing or predicted risks
- Could be integrated with CPOE

Risks associated with healthtech
- Unfriendly user software

- Training & orientation is mandatory
- Hardware and/or software malfunction
- Software malfunction
- IT system downtime
- Failed integration
- Power supply cut
- Resistance to change
- Unauthorized access to confidential information
Risk Mitigation Strategies
❑ Tested prior to implementation (pilot testing)
❑ Evaluated after implementation
❑ Develop a response action plan to planned & unplanned downtime of data systems
❑ Data back-up process
❑ Ensure confidentiality and No unauthorized access to patients’ information

Patient & Public Involvement
▪ Hospital should be keen to meet the needs of the population it serves
▪ Communication channels should be established with public (as surveys, social media)
▪ Patients should be involved in clinical decisions
▪ Patients & community should be involved in services planning & execution


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© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

2. To be able to apply the clinical governance framework in the healthcare firms

3. To know the clinical governance components

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

2. Clinical Governance Objectives

3. Clinical Governance Principles

4. Clinical Governance Components

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

Disclosure & Clinical

Hospital Audit & Risk

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

Examples of hospital tools for recognition of unsafe practice:

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

- Utilized for medical records

- The triggers are clues for potential adverse events

- Less value when & where poor documentation occurs

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

General Care Medications Surgical Intensive Care Perinatal

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

depends on reporting the occurrence of certain indicators such as the morbidity

depending on objective indicators as in the case of IHI Global Trigger Tool

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

❑ Values-supportive model of shared accountability

❑ Non-punitive response to reporting of safety issues

❑ Does not punish staff members involved in errors or

❑ Zero tolerance for carelessness, negligence or reckless

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

Staff Psychological Safety

Second victims are those clinical staff involved in medical errors

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

1. Clinical Governance Definition

2. Clinical Governance Objectives

3. Clinical Governance Principles

4. Clinical Governance Components

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved

© 2022 Productivity and Quality Institute, Alexandria, All rights reserved