Tata Kelola Klinis

Rumah Sakit
 UU 29 thn 2004 ttg Praktik Kedokteran

Pasal 44
• Dokter atau dokter gigi dalam menyelenggarakan praktik
kedokteran wajib mengikuti standar pelayanan kedokteran atau
kedokteran gigi.
• Standar pelayanan dibedakan menurut jenis dan strata sarana
pelayanan kesehatan.
• Standar pelayanan untuk dokter atau dokter gigi sebagaimana
dimaksud pada ayat (1) dan ayat (2) diatur dengan Peraturan
Menteri.
Pasal 49
• Setiap dokter atau dokter gigi dalam melaksanakan praktik
kedokteran atau kedokteran gigi wajib menyelenggarakan kendali
mutu dan kendali biaya.
 Kepmenkes No 631 thn 2005 ttg Pedoman Peraturan
Internal Staf Medis (Medical Staff Bylaws) Di Rumah Sakit
• Setiap rumah sakit wajib menyusun Peraturan Internal Staf Medis
(Medical Staff Bylaws) di Rumah Sakit untuk meningkatkan mutu
profesi medis dan mutu pelayanan medis.
• Rumah sakit dalam menyusun Peraturan Internal Rumah Sakit
(Medical Staff Bylaws) mengacu pada Pedoman sebagaimana
dimaksud dalam Lampiran I tentang Tata Cara Penyusunan
Peraturan Internal Staf Medis (Medical Staff Bylaws ) dan Lampiran
II tentang Pengorganisasian Staf Medis dan Komite Medis.
• Pedoman Internal Staf Medis (Medical Staff Bylaws ) Di Rumah Sakit
sebagaimana dimaksud dalam Diktum Ketiga merupakan acuan
setiap rumah sakit dalam menyusun Pedoman Peraturan Internal
Staf Medis (Medical Staff Bylaws) yang disesuaikan dengan situasi,
kondisi dan kebutuhan masing -masing rumah sakit.
UU 40 thn 2004 ttg Sistem Jaminan Sosial Nasional
UU 44 thn 2009 ttg Rumah Sakit
• Setiap Rumah Sakit harus menyelenggarakan tata kelola Rumah
Sakit dan tata kelola klinis yang baik.
• Organisasi Rumah Sakit disusun dengan tujuan untuk mencapai visi
dan misi Rumah Sakit dengan menjalankan tata kelola perusahaan
yang baik (Good Corporate Governance) dan tata kelola klinis yang
baik (Good Clinical Governance).
• Tata kelola rumah sakit yang baik adalah penerapan fungsi-fungsi
manajemen rumah sakit yang berdasarkan prinsip-prinsip :
- transparansi,
- akuntabilitas,
- independensi dan responsibilitas,
- kesetaraan dan kewajaran.
UU 44 thn 2009 ttg Rumah Sakit
• Tata kelola klinis yang baik adalah penerapan fungsi manajemen
klinis yang meliputi :
1. kepemimpinan klinik
2. audit klinis
3. data klinis
4. risiko klinis berbasis bukti
5. peningkatan kinerja
6. pengelolaan keluhan
7. mekanisme monitor hasil pelayanan
8. pengembangan profesional, dan
9. akreditasi rumah sakit
 Permenkes No 755 tahun 2011 ttg Penyelenggaraan
Komite Medik Di Rumah Sakit

• Komite medik adalah perangkat rumah sakit untuk menerapkan

tata kelola klinis (clinical governance) agar staf medis dirumah
sakit terjaga profesionalismenya melalui mekanisme kredensial,
penjagaan mutu profesi medis, dan pemeliharaan etika dan
disiplin profesi medis.
• Staf medis adalah dokter, dokter gigi, dokter spesialis, dan dokter
gigi spesialis di rumah sakit
• Peraturan internal staf medis (medical staff bylaws) adalah
aturan yang mengatur tata kelola klinis (clinical governance)
untuk menjaga profesionalisme staf medis di rumah sakit.
Clinical Governance (CG)

• Clinical governance was the centrepiece of an NHS white paper

introduced soon after the Labour government came into office in
the late 1990s.
• Under the market driven system for the NHS, the quality of
professional care had become subservient to price and quantity
in a competitive ethos.
• The series of high profile failures in standards of NHS care
caused deep public and professional concern and threatened to
undermine confidence in the NHS
• The white paper provides the framework to support local NHS
organisations as they implement the statutory duty of quality,
which was placed on them through the 1990 NHS act.
Clinical Governance (CG)
• The England’s Department of Health defined CG as :
‘a framework through which NHS organizations are accountable
for continuously improving the quality of their services and
safeguarding high standards of care by creating an environment
in which excellence in clinical care will flourish’.
• Health professions and disciplines have provided different
definitions for CG and its core elements but acknowledged the
‘temple-like’ model of CG that comprises seven pillars and five
substantial foundations seems to be the fundamental CG
paradigm
• World Health Organization Regional Committee for the Eastern
Mediterranean strongly advocated that member states use
frameworks such as CG to assess and enhance the quality of
their hospital services
Clinical Governance (CG)
The seven pillars of Clinical Governance :
1. Clinical effectiveness,
2. Clinical audit,
3. Risk management,
4. Patient and public involvement,
5. Staff and staff management,
6. Education and training, and
7. Use of information
These pillars have been shown to be founded on five essential
cornerstones :
1. Systems awareness,
2. Leadership,
3. Ownership.
4. Teamwork, and
5. Communication
The elements of clinical governance
Components of the clinical governance framework
Components of Quality in Health Care
Components of Quality: Definitions
Dimensions of quality
 Approaches to assessing the quality of care (Donabedian)

Structure :
• Material resources, such as facilities and equipment
• Human resources, such as the number, variety, and qualifications
of professional and support personnel
• Organizational characteristics, such as the organization of the
medical and nursing staffs, the presence of teaching and research
functions, kinds of supervision and performance review, methods
of paying for care, and so on.

Process :
• activities that constitute health care —including diagnosis,
treatment, rehabilitation, prevention, and patient education—
usually carried out by professional personnel, but also including
other contributions to care, particularly by patients and their
families. .
 Approaches to assessing the quality of care.
Outcome :
1. Clinical
• Reported symptoms that have clinical significance
• Diagnostic categorization as an indication of morbidity
• Disease staging relevant to functional encroachment and prognosis
• Diagnostic performance —the frequency of false positives and false
negatives as indicators of diagnostic or case finding performance
2. Physiological-biochemical :
• Abnormalities
• Functions
– Loss of function
– Functional reserve —includes performance in test situations under
various degrees of stress
3. Physical
• Loss or impairment of structural form or integrity—includes
abnormalities, defects, and disfigurement
 Approaches to assessing the quality of care.
• Functional performance of physical activities and tasks
- Under the circumstances of daily living
- Under test conditions that involve various degrees of stress
4. Psychological, Mental
• Feelings—includes discomfort, pain, fear, anxiety (or their opposites,
including satisfaction)
• Beliefs that are relevant to health and health care
• Knowledge that is relevant to healthful living, health care, and
coping with illness
• Impairments of discrete psychological or mental functions
- Under the circumstances of daily living
- Under test conditions that involve various degrees of stress
5. Social And Psychological
• Behaviors relevant to coping with current illness or affecting future
health, including adherence to health-care regimens, and changes in
health-related habits
 Approaches to assessing the quality of care.
• Role performance
- Marital
- Familial
- Occupational
- Other interpersonal
• Performance under test conditions involving varying degrees of stress
INTEGRATIVE OUTCOMES
• Mortality
• Longevity
• Longevity, with adjustments made to take account of impairments of
physical, psychological or psychosocial function: "full-function
equivalents”
• Monetary value of the above

EVALUATIVE OUTCOMES
• Client opinions about, and satisfaction with, various aspects of care,
including accessibility, continuity, thoroughness, humaneness,
informativeness, effectiveness, and cost
 Norm, criteria, standards (Donabedian)
• Norm :
- a general rule of goodness, a standard based on such practice.
- a description of current practice or current outcomes
• Criterion :
- attribute of structure, process, or outcome that is used to draw an
inference about quality.
- criterion of structure could be the staffing of the intensive care unit.
- criterion of process could be whether or not blood transfusion has been
used during surgery.
- criterion of outcome could be case fatality.
• Standards :
- a specified quantitative measure of magnitude or frequency that
specifies what is good or less so.
- standards of structure could be not less than than one registered nurse
per two occupied beds in the intensive care unit.
- standards of process could be not less than 5% and not more than 20%
in surgeries of specified kind in a specified category of patients.
- standards of outcome could be no more than 0.1% for a specified
procedure (or a set of procedures) in a specified category of patients.
 Attributes of Criteria and Standards (Donabedian)

Derivation :
• Normative derivation :
- criteria and standards are based on what is known or agreed
to be good or acceptable and what is not so
- derived either from direct knowledge of the scientific
literature and its findings, or from the agreed-upon opinions
of experts and leaders, an opinion presumably based on
knowledge of the pertinent literature as well as on clinical
experience.
• Empirical derivation :
- criteria and standards are derived from "what there is”
existing practice or based on existing practice
- tend to be lower than those derived from normative sources.
- to correct for this disparity, could be set as the practice of
leading professionals or the practice in teaching institutions
Degree of Specification and Explicitness :
• Implicit criteria and standards :
- not specified, present in the minds of experts, asked to
judge, based on what they know or believe, whether the care
in each case has been good, fair, or poor.
• Explicit criteria and standards :
- specified in various degrees of detail, before the assessment
of quality is made
- considered to be fully specified there is almost no room left
for the opinions of reviewers
Validity :
• the accuracy represent the quality of care without
contamination by error or irrelevancy
• the single most important attribute of criteria-standards,
whether these are implicit or explicit
• derive from two sources:
- the science that generates them
- consensus among the experts who vouch for them.
Adaptability to case variation :
• adapt judgments to every clinical peculiarity of every
individual case
• with equal ease the presence or absence of indicated elements
of care, as well as the presence of those not needed or
contraindicated.
• adaptations could contribute to the validity of the resultant
judgment.
Recordability :
• how likely the items in question are to be noted in the medical
record, as well as omitted
• important since the medical record is the primary source of
information about the process of care and its immediate
outcomes.
• the attribute of recordability can also be generalized to include
the ease with which information can be obtained, from any
source, when needed for quality assessment
Stringency :
• level of performance required by the criteria-standards of the
quality of care which should be of the highest
• the resources and skills available in any given situation. If
resources are limited, a lower level of performance may be
acceptable, provided the adopted level envisages the best use of
what is available
• level of stringency should not be so high that almost everyone is
found to have failed nor should it be set so low that everyone
passes.
Screening efficiency :
• the success with which the criteria-standards can separate cases
of acceptable quality from those that are not acceptable
• have a set of criteria-standards that identifies almost every case
of unacceptable quality without including among the
"unacceptable" any cases of acceptable quality
• this requirement is a special case of the more general
epidemiological concepts of sensitivity
 Internally Motivated Monitoring Activities
• Purpose of all monitoring activities  to identify instances or situations
where the quality of care falls below the level expected or desired.
• Focus not on ”problems" but on so-called "opportunities for
improvement."
• Two kind of problem identification :
- Troubleshooting is the action taken by clinicians or administrators
when a problem is presented to them by some untoward event
- Planned reconnaissance as action taken to reveal problems or
opportunities for improvement. In this case, we take the initiative to
find the problems or opportunities.
• The kinds of action can be classified as problem identification :
- by group discussion and study, and
- by routine surveillance.
 Quality in the NHS (National Health Service)
• Effectiveness of the treatment and care provided to patients Measured by
both clinical outcomes and patient‐related outcomes. There is much
evidence of wide variation in the clinical effectiveness of care delivered
across the country;
• The safety of treatment and care provided to patients
Safety is of paramount importance to patients and is the bottom line when it
comes to what NHS services must be delivering. It has risen up the agenda
over the last ten years following the publication of An Organisation with a
Memory and Safety First: a report for patients, clinicians and healthcare
managers. High profile failures in more recent years, such as at Mid
Staffordshire and Basildon and Thurrock, have brought further, and
considerable, media attention to the agenda; and
• The experience patients have of the treatment and care they receive How
positive an experience people have on their journey through the NHS can
be even more important to the individual than how clinically effective care
has been.
 The board’s responsibilities for quality
- The board of a provider organisation is responsible for the quality of care
delivered across all services that the organisation provides.
• to ensure that the essential standards of quality and safety (as determined
by CQC’s registration requirements) are at a minimum being met by every
service that the organisation delivers
• to ensure that the organisation is striving for continuous quality
improvement and outcomes in every service; and
• to ensure that every member of staff that has contact with patients, or
whose actions directly impact on patient care, is motivated and enabled to
deliver effective, safe and person‐centred care
- The board to create a culture within the organisation that enables clinicians
and clinical teams to work at their best, and to have in place arrangements
for measuring and monitoring quality and for escalating issues
The Quality Governance Framework
Flow Diagram Activities
Determining What to Monitor
Dimensions of quality: 3 organizational dimensions
Worked example of Ishikawa’s fishbone to medication errors.
NICE indicator
• NICE indicators generally measure outcomes that reflect the quality of care or
processes linked by evidence to improved outcomes.
• Outcomes are ideally, but not always, related to NICE quality standards.
• Process indicators are evidence- based and underpinned by NICE quality
standards, NICE guidance or other sources of high-quality evidence.
Components of a NICE indicator
• a denominator, describing the target population included in an indicator
• a numerator, describing the number of people in the denominator who have the
specified intervention, treatment or outcome
• a description of the inclusions, exclusions and exceptions
• a short and long indicator title
• a detailed overview of the indicator, which includes:
- a description of the purpose of the indicator
- the reasoning for the indicator
- data source, reporting mechanisms and other technical details
- links to further information
• a cost-effectiveness and resource–impact analysis
Criteria to appraise the validity of indicators
Approaches to measuring and improving quality of care
Healthcare organisations and the achievement of quality care

Rob McSherry and Paddy Pearce., 2002

Key attribute associated with promotion of a quality organisation
Key components of the clinical governance framework
 Principles of the clinical governance framework

1. The health consumer being the primary focus of any model of health service provided
including focusing on improving health literacy wherever possible
2. Acceptance by the Board and Executive of the responsibility they have for clinical
governance and for creating and maintaining a structure and policies for managing
the quality of services
3. Clear definition of accountabilities for quality at all levels of the organisation
4. An emphasis on the evidence based models of care, with information and
communications technology being the enabler of delivery of the care models
5. An emphasis on the development of partnerships most especially with service
providers and their clinical personnel and between clinical and non clinical service
developers
6. The quality of health care being measured systematically with a focus on the use of
these data to minimise inappropriate variation, incidents and to continuously improve
services and to report to all who have responsibility for governance and management
7. Clinical risks being managed effectively, with an emphasis on preventing adverse
outcomes through proactive risk identification and management
8. Clinical governance being supported by high quality organisational systems that have
been evaluated by a recognised external accrediting body.
Clinical governance responsibilities
 Clinical Governance For Health Service Organisations Standard
(NSQHS Standards, 2nd ed.- Australian Commission on Safety and Quality in Health Care, 2017)

• Governance, leadership and culture – integrated corporate and clinical governance

systems are established, and used to improve the safety and quality of health care for
patients
• Patient safety and quality improvement systems – safety and quality systems are
integrated with governance processes to actively manage and improve the safety and
quality of health care for patients
• Clinical performance and effectiveness – the workforce has the right qualifications, skills
and supervision to provide safe, high-quality health care to patients
• Safe environment for the delivery of care – the environment promotes safe and high-
quality health care for patients
• Partnering with consumers – systems are designed and used to support patients,
carers, families and consumers to be partners in healthcare planning, design,
measurement and evaluation; elements of this component include
– clinical governance and quality improvement systems to support partnering with
consumers
– partnering with patients in their own care
– health literacy
– partnering with consumers in organisational
– design and governance.
 National Model Clinical Governance Framework
(NSQHS Standards, 2nd ed.- Australian Commission on Safety and Quality in Health Care, 2017)
The key components of the clinical governance framework
(Health Quality & Safety Commission, New Zealand, 2017)
Management structure associated with clinical governance
 Components of clinical governance base line assessment
(Rob McSherry and Paddy Pearce, 2014)

Risk management
Risk management strategy and policies associated with clinical and non-
clinical aspects of services
Compliance with Clinical Negligence Scheme for Trust (CNST) standards
System for reporting and detecting: equipment failure
Managing performance
System for reporting and detecting:
• Complaints
• Clinical incidents
• Untoward incidents
• Individual performance review
Quality improvement
Clinical audit
 Components of clinical governance base line assessment
(Rob McSherry and Paddy Pearce, 2014)

Compliance with NICE and National Service Frameworks (NSF’s)

guidelines/recommendations
Evidence based practice
Continuing professional development
Quality information
Clinical information system
Clinical outcomes data
Comparative data
Benchmarking
Accountability
Policies and procedures
Regular reporting to boards on efficiency and effectiveness of clinical
performance
Principles of Clinical Governance at Organizational Level
(Rob McSherry and Paddy Pearce, 2014)
System and process of Clinical Governance at Organizational Level
(Rob McSherry and Paddy Pearce, 2014)
Component of Clinical Governance at Individual Level
(Rob McSherry and Paddy Pearce, 2014)
 Kepemimpinan klinis
• Leadership is an influence relationship among leaders and followers
who intend real changes that reflect their mutual purposes
• Clinical leadership is used to encapsulate the concept of clinical
healthcare staff undertaking the roles of leadership: setting, inspiring
and promoting values and vision, and using their clinical experience
and skills to ensure the needs of the patient are the central focus in
the organisation’s aims and delivery
• Clinical leaders need to be both accountable and transparent in their
decision-making for sure, but they also need to be open to other
people’s points of view, to be visionary and capable of communicating
that vision and motivating others to achieve their best for the benefit
of patient care
(Tim Swanwick and Judy McKimm, 2011 )
 Tasks of clinical leadership
• Participating in setting the safety and quality agenda, and
taking responsibility for implementing that agenda
• Taking a substantial role in determining priorities for allocation
of resources to support best practice
• Acting as champions for improvement
• Attaching professional and organisational status to safety and
quality activities
• Taking the lead in prioritising, designing and implementing
improved processes of care
• Ensuring training and organisational support are available to
support involvement in clinical governance activities
(The Metropolitan Health and Aged Care Services Division Victorian Government
Department of Human Services, Melbourne Victoria, April 2005)
Clinical Leadership Competency Framework
(NHS Leadership Academy, 2011).
 The NHS Leadership Qualities Framework.
(NHS Institute for Innovation and Improvement, 2010).
 Demonstrating Personal Qualities
Effective leaders need to draw upon their values, strengths and abilities to
deliver high standards of care which requires leaders to demonstrate
competence in the areas of :
1. Developing Self Awareness
Clinicians show leadership through developing self awareness: being
aware of their own values, principles and assumptions and by being able
to learn from experiences.
Competent clinicians:
• Recognise and articulate their own values and principles,
understanding how these may differ from those of other individuals
and groups
• Identify their own strengths and limitations, the impact of their
behaviour on others, and the effect of stress on their own behaviour
• Identify their own emotions and prejudices and understand how these
can affect their judgment and behaviour
• Obtain, analyse and act on feedback from a variety of sources.
2. Managing Yourself
Clinicians show leadership through managing themselves: organising and
managing themselves while taking account of the needs and priorities of
others.
Competent clinicians:
• Manage the impact of their emotions on their behaviour with
consideration of the impact on others
• Are reliable in meeting their responsibilities and commitments to
consistently high standards
• Ensure that their plans and actions are flexible, and take account of
the needs and work patterns of others
• Plan their workload and activities to fulfill work requirements and
commitments, without compromising their own health.
3. Continuing Professional Development
Clinicians show leadership through continuing personal development:
learning through participating in continuing professional development and
from experience and feedback.
 Competent clinicians:
• Actively seek opportunities and challenges for personal learning and
development
• Acknowledge mistakes and treat them as learning opportunities
• Participate in continuing professional development activities
• Change their behaviour in the light of feedback and reflection.
4. Acting with Integrity
Clinicians show leadership through acting with integrity: behaving in an
open, honest and ethical manner.
Competent clinicians:
• Uphold personal and professional ethics and values, taking into account
the values of the organisation and respecting the culture, beliefs and
abilities of individuals
• Communicate effectively with individuals, appreciating their social,
cultural, religious and ethnic backgrounds and their age, gender and
abilities
• Value, respect and promote equality and diversity
• Take appropriate action if ethics and values are compromised.
 Clinical Data - Medical Record
• Important as a tool of effective communication.
• Facilitates continuous performance improvement
• Supports reimbursement of services provided
• Supplies clinical data for research and education.
• To document the course of a patient’s care and treatment.
• Various forms in different types of health care settings  acute care,
long-term care, ambulatory care
• The environment, regulatory and accreditation requirements may
specify the contents of the medical records as well as retention and
other requirements.
• Forms of medical records; paper, electronic, microfiche, and fax,
depending on the setting and culture of the organization
• Documentation is the essence of the medical record, and risk
management professionals have a vested interest in preserving the
record and in enhancing the quality of documentation.
Contents of Medical Record
 Clinical Audit
• Quality improvement process to improve patient care and outcomes through
measurement of the effectiveness of care against agreed and proven
standards for high quality, and taking action to bring practice in line with these
standards.
• Where indicated, changes are implemented at an individual, team, or service
level and further monitoring is used to confirm improvement in healthcare
delivery.
• The process which is now widely practised within trusts, should be at the core
of a system of local monitoring of performance. Must be fully supported by
trusts. They should ensure that health care professionals have access to the
necessary time, facilities, advice, and expertise in order to conduct audit
effectively.
• All trusts should have a central clinical audit office that coordinates audit
activity, provides advice and support for the audit process, and brings together
the results of audit for the trust as a whole.
• Clinical audit should be compulsory for all healthcare professionals providing
clinical care and the requirement to participate in it should be included as part
of the contract of employment.
The clinical audit cycle
The stages of clinical audit
STAGE 1 – PREPARING FOR AUDIT:
Choose a topic:
• Preferably one which is a high priority for the organisation
• May involve areas in which there is a high volume of work, high risks or
high costs of care, or an area identified as a priority by patients
• Relevant stakeholders should be given the opportunity to contribute to
the clinical audit
Identify available resources.:
• The organisation may have a local Audit Lead or office
• There will be existing guidelines defining desired standards for the
area chosen
• The procedures and practices implemented by staff in the prescription,
delivery and evaluation of care which may be specific to the clinical
process or service /administrative processes
• the effect of care received by service users as a result of healthcare
provision and the costs to the service of providing care i.e. the result of
clinical interventions.
STAGE 2 –SELECT THE CRITERIA:
• Define the standard - usually a target (percentage) this may be a
minimum standard or an optimal one, depending on the scenario.
• Define the criteria  explicit statements representing elements of care
which need to be achieved in order for that standard to be reached
STAGE 3 - MEASURING LEVEL OF PERFORMANCE:
Collect the data:
• Collection of relevant data about current practice in order to facilitate
comparison
• May be from computerised records, manual collection, or both
• May be retrospective or prospective
Analyse the data collected:
• Convert a collection of facts (data) into useful information in order to
identify the level of compliance with the agreed standard
• Compare actual performance with the set standard and Discuss how
well the standards were met
Drawing conclusions
• Identify the reasons why the standard was not met
Presentation of results
• Maximise the impact of the clinical audit on the audience in order to
generate discussion and to stimulate and support action planning
STAGE 4 – MAKING IMPROVEMENTS:
• Present the results and discuss them with the relevant teams in the
organisation
• The results should be used to develop an action plan, specifying what
needs to be done, how it will be done, who is going to do it and by when.
STAGE 5 – SUSTAINING IMPROVEMENT:
• This follows up the previous stages of the audit, to determine whether
the actions taken have been effective, or whether further improvements
are needed
• It involves repeating the audit (i.e. targets, results, discussion); hence the
terms “audit cycle”.
Scope of The Risk Management Program
• Patients care-related risks
– compliance with statutory regulations can help to minimise risks to
patients by ensuring that systems are regularly reviewed and
questioned by critical event audit and learning from complaints
– activity focuses on direct clinical patient care activities and the
consequences of inappropriate or incorrectly performed medical
treatments, other important patient-related issues also confront the
risk management professional
– information gathering, loss control efforts, medical professional
liability risk financing, and claims management activities, forms the
core of most health care risk management programs.
• Medical staff-related risks
- ensuring that clinicians are immunised against infectious diseases,
work in a safe environment and are helped to keep up to date are
important parts of quality assurance
 - concerns that stem from the unique relationship between a health
care organization and its medical staff merit the risk management
professional’s particular attention
- blurred distinctions between physicians as business partners with
health care entities and assume ownership interests in new
ventures, and as hospitals and other organizations purchase or
assume management of physician practices
• Employee-related risks
- maintaining a safe work environment for employees, reducing the
risk of occupational illness and injury, and providing for the
treatment and compensation of workers who suffer on-the-job
injuries and work-related illnesses.
- organisations need to reduce their own risks by ensuring high
quality employment practice, a safe environment, and well designed
policies on public involvement
- allegations of discrimination in recruitment, hiring, and promotion
based on age, race, sex, national origin, or disability; wrongful
termination; and other claims
• Property-related risks
- protect property assets of large hospital and clinic structures,
medical office buildings, and valuable medical and data processing
equipment from risk of loss due to fires, acts of God, floods, natural
disasters
- Protection should include a large volume of paper and electronic
records that are essential to the ongoing operations of the health
care institutions
• Financial risks
- directors and officers of health care organizations may face liability
imposed by suits from shareholders or others alleging inappropriate
conduct in the fulfillment of their duties
- contract with managed care organizations (MCOs) on an “at-risk”
basis (typically through capitated payment arrangements) need to
consider available options for limiting the financial risks inherent in
such agreements
• Other risks
- vulnerability to terrorist and bioterrorist attack
 Key Structural Elements Of The Risk Management Program
– Authority  maintain sufficient authority and respect to enact the
changes in clinical practice, policies and procedures, and employee
and medical staff behavior that are necessary to fulfill the purpose of
the risk management program.
– Visibility  risk management professional’s position should be
structured to enhance opportunities for interaction with others
through service on appropriate committees, participation in
educational activities such as employee orientation and staff in-
service offerings, and access to organization wide communication
mechanisms.
– Communication  risk management professional is in a position to
advise senior management on the risk management implications of
various new business arrangements, many of which can be
substantial but are frequently overlooked by executives not attuned
to risk management issues and specific insurance requirements
– Coordination  to adequately integrate and coordinate risk
management with other functions, the risk management professional
needs to establish formal and informal reporting and communication
relationships with key individuals within the organization; CEO, CFO,
performance improvement or quality management director, patient
safety director or officer, compliance officer, infection control
practitioner (ICP), safety officer, patient representative (or
ombudsman), The employee health nurse (or workers’ compensation
coordinator or personnel director), health information manager (or
medical records director), medical director (or chief medical officer),
patient accounts representative, Nursing and departmental
managers, education director (or in-service program coordinator),
and human resource director
– Accountability  risk management professionals need sufficient
authority to perform assigned functions, they should be held
accountable for that performance and should have a written job
description that outlines key risk management responsibilities
Risk Manager Position Description
Level One
The risk manager is responsible for the facility’s risk management
activities, which include, but may not be limited to, a general knowledge
of facility insurance programs, managing claims against the facility,
interfacing with defense legal counsel, administering the risk manage-
ment program on a day-to-day basis, managing and analyzing risk
management data, and conducting risk management educational
programs, complying with risk management related standards by
JCAHO and other accrediting and regulatory agencies with the objective
of enhancing patient safety, promoting patient safety, quality care, and
minimizing loss to protect the assets of the facility.
This individual participates in formulating policy and/or organizational
changes, but must seek advice and approval from higher authority. Risk
management may be one of several areas of responsibility for this
individual
Level Two
The risk manager is responsible for the facility’s risk management
activities, which include, but may not be limited to, coordinating
insurance coverage and risk financing, managing claims against the
facility, interfacing with defense legal counsel, administering the risk
management program on a day-to-day basis, managing and analyzing
risk management data, conducting risk management educational
programs, complying with risk management related standards by
JCAHO, all with the objective of maintaining patient safety, enhancing
quality care, and minimizing loss to protect the assets of the facility.
The level two risk manager performs these functions reporting to
management at the vice-president level.
This individual is responsible for reviewing and formulating policy or
organizational changes and making recommendations for final
approval by senior management.
Level Three
The risk manager is responsible for the facility’s risk management activities,
which include, but may not be limited to, procurement of insurance coverage
and risk financing, managing claims against the facility, interfacing with
defense legal counsel, administering an enterprise risk management
program on a day-to-day basis, managing and analyzing risk management
data, conducting risk management educational programs, complying with
risk management related standards by JCAHO other accrediting and
regulatory agencies with the objective of promoting patient safety, enhancing
quality care, and minimizing loss to protect the assets of the facility.
While the level 3 position may be responsible for the functions in level one
and two job descriptions, this position most often supervises and offers
overall program direction to staff performing the task in the first two job
description levels.
This position reviews, formulates, and implements policy and organizational
changes, performing within general programmatic authority delegated by the
CEO, chief financial officer, or governing body.
 Steps in risk management process
Steps 1 - Identify and Analyze Loss Exposures
Steps 2 - Consider alternative risk techniques
Steps 3 - Select the Best Risk Management Techniques

Steps 4 - Implement the Chosen Techniques

Steps 5 Monitor and Improve the Risk Management Program
Similarities between risk management and quality assurance

Differences between risk management and quality assurance

Clinical governance committee
Education and Training
• Clinical governance and continuous quality improvement (CQI) can be
successful only if healthcare organizations value their staff by having
education and training structures in place
• Lifelong learning and continuing professional development will be explored
as well as the need for cultural change within health and social care
organizations
– Learning
 Broad concept and comprises changes to knowledge, skills,
attitudes and behaviour
 Learning ought to be a feature of organizational culture in
healthcare organizations
 Formal learning takes place in the classroom and qualifications may
be awarded
 Informal learning occurs through observation within a social context
and healthcare practice environment
 Continuously update the evidence base of practice and provide safe
quality healthcare  Lifelong learning
 Pengembangan profesional
- Continuing professional development
 Fundamental to the development of all health and social care
practitioners, and is the mechanism through which high quality
patient and client care is identified, maintained and developed
 Process of lifelong learning for all individuals and teams which
meets the needs of patients and delivers the health outcomes and
healthcare priorities of the NHS and which enables professionals to
expand and fulfil their potential
 Should focus on the needs of patients and should help individuals
and teams deliver the health outcomes and healthcare priorities of
the NHS, as set out in national service frameworks and local health
improvement programmes
 Should be a partnership between the individual and the
organisation, its focus should be the delivery of high quality NHS
services as well as meeting individual career aspirations and
learning needs
 Setting, delivering, monitoring standards
(adapted with permission from A First Class Service - NHS Executive, 1998)
Continuous Professional Development Cycle (Adapted from Sale 2005:96)
Levels of education and training (Adapted from Wright and Hill 2003, Sale 2005)
Identifying learning development (Adapted from Swage 2004:181)
 Office of the Forum for Quality and Effectiveness in Health
Care (AHCPR)
• Practice guidelines are systematically developed statements to assist
practitioner and patient decisions about appropriate health care for
specific clinical circumstances.
• Medical review criteria are systematically developed statements that
can be used to assess the appropriateness of specific health care
decisions, services, and outcomes.
• Standards of quality are authoritative statements of (1) minimum
levels of acceptable performance or results, (2) excellent levels of
performance or results, or (3) the range of acceptable performance or
results.
• Performance measures (provisional) are methods or instruments to
estimate or monitor the extent to which the actions of a health care
practitioner or provider conform to practice guidelines, medical review
criteria, or standards of quality. `
 Attributes of Good Practice Guidelines (AHCPR)
• Validity
When followed, they lead to the health and cost outcomes projected
for them, other things being equal. A prospective assessment of
validity will consider the projected health outcomes and costs of
alternative courses of action, the relationship between the evidence
and recommendations, the substance and quality of the scientific and
clinical evidence cited, and the means used to evaluate the evidence.
• Reliability/ reproducibility
If —given the same evidence and methods for guidelines
development—another set of experts would produce essentially the
same statements and if—given the same clinical circumstances—the
guidelines are interpreted and applied consistently by practitioners or
other appropriate parties. A prospective assessment of reliability may
consider the results of independent external reviews and pretests of
the guidelines.
 Attributes of Good Practice Guidelines (AHCPR)
• Clinical applicability
Should be as inclusive of appropriately defined patient populations as
scientific and clinical evidence and expert judgment permit, and they
should explicitly state the populations to which statements apply.
• Clinical flexibility
Should identify the specifically known or generally expected
exceptions to their recommendations.
• Clarity
Should use unambiguous language, define terms precisely, and use
logical, easy-to-follow modes of presentation.
• Multidisciplinary process
Should be developed by a process that includes participation by
representatives of key affected groups. Participation may include
serving on panels that develop guidelines, providing evidence and
viewpoints to the panels, and reviewing draft guidelines.
 Attributes of Good Practice Guidelines (AHCPR)
• Scheduled review
Should include statements about when they should be reviewed to
determine whether revisions are warranted, given new clinical
evidence or changing professional consensus.
• Documentation
The procedures followed in developing guidelines, the participants
involved, the evidence used, the assumptions and rationales
accepted, and the analytic methods employed should be
meticulously documented and described.
 National Health and Medical Research Council
(NHMRC)
• Clinical practice guidelines are ‘systematically developed statements to
assist practitioner and patient decisions about appropriate health care
for specific clinical circumstances’ (Field & Lohr 1990).
• Clinical practice guidelines are often referred to as algorithms, clinical
pathways, protocols and practice policies, although these differ from
clinical practice guidelines in that they are often much more
prescriptive and not always based on evidence.
• Clinical practice guidelines are one component of good medical
decision-making, which takes into account patients’ preferences and
values, clinicians’ values and experience, and the available resources.
• The guidelines’ main purpose is to achieve better health outcomes by
improving the practice of health professionals and providing consumers
with better information about treatment options.
 Principles underlying the guideline development process
• Processes for guideline development and evaluation should be
outcome focused;
• Guidelines should be based on the best available evidence and
should include a statement about the strength of recommendations;
• Method used to synthesize the available evidence should be the
strongest applicable;
• Process of guideline development should be multidisciplinary and
should include consumers;
• Guidelines should be flexible and capable of adapting to varying local
conditions;
• Guidelines should be developed with resource constraints in mind;
• Guidelines should be developed, disseminated and implemented
taking into account their target audiences;
• Validity and usefulness of the guidelines should be evaluated; and
• Guidelines should be revised regularly.
 Clinical Practice Guideline Development (NHMRC)

• Determining the need for and scope of guidelines

• Convene a multidisciplinary panel to oversee the development of
the guidelines
• Define the purpose of and target audience for the guidelines
• Identify health outcomes
• Review the scientific evidence
• Formulate the guidelines
• Formulate a dissemination and implementation strategy
• Formulate an evaluation and revision strategy
• The guidelines themselves
 Pedoman Nasional Pelayanan Kedokteran (PNPK)

• Penyataan yang dibuat secara sistematis yang didasarkan pada

bukti ilmiah (scientific evidence), untuk membantu dokter dan
dokter gigi dalam membuat keputusan klinis tentang tata
laksana penyakit atau kondisi klinis tertentu.
• Berisi informasi tentang tata laksana pasien yang dianggap
paling efektif dan pada prinsipnya merupakan rekomendasi, dan
dibuat berdasarkan evidence mutakhir
• Dokter menggunakan informasi pada PNPK ini bersama dengan
pengetahuan dan pengalamannya untuk menentukan rencana
tata laksana yang paling sesuai terhadap pasien dengan
memperhitungkan keadaan lokal
• PNPK diperlukan bila suatu penyakit atau kondisi kesehatan
tertentu memiliki satu atau lebih karakteristik berikut:
- jumlah kasusnya banyak (high volume)
- mempunyai risiko tinggi (high risk)
- cenderung memerlukan biaya tinggi/banyak sumber daya
(high cost)
- terutama bila terdapat variasi yang luas (high variablitiy) di
antara para praktisi untuk penanganan kasus yang sama
• PNPK disusun oleh panel pakar yang bersifat multidisiplin dari
organisasi profesi, akademisi, pakar lain, di bawah koordinasi
Kementerian Kesehatan RI
• PNPK harus mempunyai karakteristik sebagai berikut:
– Sahih / valid
– Reproducible
 – Cost-effective
– Representatif, sering harus multidisiplin
– Dapat diterapkan dalam praktik
– Fleksibel
– Jelas
– Terjadwal untuk dilakukan revisi
– Dapat digunakan sebagai kriteria untuk audit klinis
• PNPK adalah rujukan utama pembuatan PPK (Panduan Praktik
Klinis) yang merupakan istilah administratif dibuat berdasarkan
pada evidence mutakhir, sehingga bersifat "ideal" dan tidak
selalu dapat diterapkan di semua fasyankes
• PPK dapat berupa atau disertai dengan salah satu atau lebih:
alur klinis (clinical pathway), protokol, prosedur, algoritme, dan
standing order
• Apabila PNPK belum/tidak ada maka PPK dibuat dengan
memperhatikan fasilitas setempat dan merujuk pada:
- Pustaka mutakhir berupa artikel asli
- Systematic review atau meta-analisis
- PNPK dari negara lain
- Buku ajar
- Panduan dari organisasi profesi,
- Petunjuk pelaksanaan program dari Kemenkes, dan
- Kesepakatan para staf medis
 Clinical Pathways (CP/CPW)
• Clinical pathways find their origin in Critical Path & Process Mapping
methodologies used in industry, particularly in the field of engineering from as
early as the 1950s.
• In the 1980’s, clinicians in the USA began to develop the pathway tool within
Managed Care;
• redefining the delivery of care and attempting to identify measurable
outcomes.
• focusing on the patient rather than the system, but needed to demonstrate
efficient processes in order to fulfill the requirements of the insurance
industry (National Library for Health 2007).
• The global concept of clinical pathways thus originated in the USA as a
framework for balancing costs and quality as a response to the escalating
costs of health care’
• In the United Kingdom however, clinical pathways are primarily seen as a way
of achieving a continuum of care across care settings. These different origins
of clinical pathways are partly responsible for the differences in definitions of
clinical pathways (De Bleser 2006).
Clinical Pathways (CP/CPW)
 CP operational definition

• Clinical pathway is a method for the patient-care management of a

well-defined group of patients during a well-defined period of time.
• Clinical pathway explicitly states the goals and key elements of care
based on EBM guidelines, best practice and patient expectations by
facilitating the communication, coordinating roles and sequencing
the activities of the multidisciplinary care team, patients and their
relatives; by documenting, monitoring and evaluating variances; and
by providing the necessary resources and outcomes.
• The aim of a clinical pathway is to improve the quality of care,
reduce risks, increase patient satisfaction and increase the
efficiency in the use of resources. (De Bleser, 2006)
 CP operational definition
• Document outlining a standardised, evidence-based multi disciplinary
management plan, which identifies the appropriate sequence of clinical
interventions, timeframes, milestones and expected outcomes for a
homogenous patient group’.(QIEP Pathways Board 2002)
• Clinical Pathways map out the sequence, timing and expected outcomes of
care for patients with a similar diagnosis or who are undergoing a similar
procedure.
• Clinical Pathways standardise care so that all patients are provided with the
same high quality care, that is timely and cost-effective and enable the
documentation of changes in care, as a result of the patient's health status
(Queensland Health, 2005)
• The aim of the Clinical Pathway is to: (Queensland Health, 2007)
• support the implementation of evidence based practice
• improve clinical processes by reducing risk
• reduce duplication through the use of a standardised tool
• reduce variation in health service delivery
 CPW operational definition

1. The intervention was a structured multidisciplinary plan of care;

2. The intervention was used to translate guidelines or evidence into local
structures;
3. The intervention detailed the steps in a course of treatment or care in a
plan, pathway, algorithm, guideline, protocol or other ‘inventory of
actions’
4. The intervention had time-frames or criteria-based progression; and
5. The intervention aimed to standardize care for a specific clinical problem,
procedure or episode of healthcare in a specific population

An intervention was considered to be a CPW if it met the first criterion

together with three of the other four criteria

(Kinsman et al, 2010; Lawal et al, 2016}

Clinical Pathway Development Process Flowchart
Process for developing integrated care pathways
 Accountability and performance

• Accreditation of healthcare
• Performance assessment framework
• Handling underperformance of clinicians
• Use of performance indicators in general practice
• Core values
• Good medical practice
• Competence
• Quality of care
• Revalidation
• Making decisions about priorities
• Minimising fraud in the NHS
 Accreditation of Health Care

• Means of reviewing the quality of the organisation of healthcare using

external surveyors and published standards
• Results of accreditation may be confidential to the participating
organisation or published to inform the public and purchasers about
the performance of local hospitals or health services, especially levels
of success and safety
• Directed at the organisation and management of hospitals rather than
the clinical competence of doctors and other health professionals
• The purpose of accreditation is to:
- improve quality – by stimulating changes in practice
- inform decision making – providing information about performance
as guidance
- make healthcare organisations accountable to statutory, other
agencies or the public
- regulate professional practice and behaviour to protect patients and
others.
 Key characteristics of accreditation

• Review of the performance or capacity to perform (e.g. with

respect to a hospital, practice or practitioner)
• External involvement of a statutory or professional body and/or
peers
• Standards to do with aspects of performance or capacity to be
assessed and the values or circumstance that are expected
• Measurement of performance or capacity to perform against
those standards
• Report of results – whether performance is at accepted level
with recommendations for action
 Licensure, Accreditation, and Certification Activities

• Characterize as mandatory and voluntary functions, although some, such

as deemed status relationships, play a dual role
• Mandatory functions include organizational licensure; individual health
care professional licensure; specific licensure for activities; approval to
participate in federal funding programs
• Regulatory programs such as workplace safety, equal rights, and the
Americans with Disabilities Act
• Mandatory surveying bodies are required for health care organizations to
operate and obtain a license as required in every state
• Voluntary surveying bodies  evaluate and improve their quality of care,
health care organizations voluntarily request that outside agencies
accredit them
• The Joint Commission on Accreditation for Healthcare Organizations
(JCAHO)  provides evaluation, accreditation, and consultation and
establishes standards for long-term care facilities, ambulatory health care
organizations, home care agencies, hospices, hospitals, health care
delivery networks, and organizations that offer major mental health
services
Benefits of Joint Commission accreditation for health care organization

• Improved patient care

• Demonstration of the organization’s commitment to safety and quality
• Consultative and educational experience
• Enhanced safety and quality improvement efforts
• Strengthened recruitment and retention efforts
• Substitution for federal certification surveys for Medicare and Medicaid
• Secured managed care contracts
• Facilitation of the organization’s business strategies
• Competitive advantage
• Enhanced image to the public, purchasers, and payers
• Fulfilling licensure requirements in many states
• Recognition by insurers and other third parties
• Strengthened community confidence
 Accreditation

Provisional Accreditation
Awarded when a health care organization :
- fails to address all requirements for improvement in an ESC within forty-
five days following survey,
- failed to achieve an appropriate level of sustained compliance as
determined by a “measure of success” (MOS) result, or
- fails to meet all requirements for the timely submission of data and
information to The Joint Commission within thirty-one days of the date
the information is due.
Conditional Accreditation
- fails to be in substantial compliance with the standards, usually
determined by the number of noncompliant standards that exceed
established thresholds at the time of survey.,
- must remedy identified problem areas through preparation and
submission of an ESC or MOS and a conditional follow-up survey,
- fails to meet all requirements for the timely submission of data and
information to The Joint Commission within sixty-one days of the due
date.
 Accreditation

Preliminary denial of accreditation

- results when there is justification to deny accreditation to the
organization as usually determined by the number of noncompliant
standards that exceed established thresholds at the time of survey
- decision is subject to appeal prior to the determination to deny
accreditation; the appeal process may also result in a decision other
than denial of accreditation
Denial of Accreditation
results when a health care organization does not permit the performance
of any survey by The Joint Commission or fails to do one or more of the
following:
- meet requirements for the timely submission of data and information to
The Joint Commission within ninety-one days of the due dates,
- resolve a conditional accreditation status prior to withdrawing from the
accreditation process, or
- submit payment for survey fees or annual fees.
 Accreditation

Preliminary accreditation
- results when the organization demonstrates compliance with selected
standards in the first of two surveys conducted under The Joint
Commission’s early survey policy option 1.
- the decision remains in effect until one of the other official
accreditation categories is assigned, based on a complete survey against
all applicable standards approximately six months later.
Accreditation Watch
- is a publicly disclosable attribute of an organization’s existing
accreditation status.
- when a sentinel event has occurred and a thorough and credible root
cause analysis of the sentinel event and an action plan have not been
completed in a specified time frame.
- when the organization has conducted an acceptable root cause analysis
and developed an acceptable action plan, the accreditation watch
designation is removed from the organization’s accreditation status.
 ISO 9001:2000
• To create a universal approach to evaluating, managing, and directing
quality based on global standards
• To encourage continuous performance improvement and documentation
of processes and procedures
• To help organizations achieve quality outcomes and results based on a
consistent, reliable, and cost-efficient model
• Health care industry  as both an alternative and an adjunct to existing
quality management systems
• Health care industry  for ISO-certified industry organizations to require
ISO certification from suppliers, including health care providers.
• Complying with ISO 9001:2000 standards does not indicate that every
product or service meets the customers’ requirements, only that the
quality system in use is capable of meeting them.
• Keys to a successful quality management system  consistently
measuring customer satisfaction and striving continually to improve
processes
 ISO 9001:2000

Considerations:
• To comply with customer requirements for ISO 9001:2000
• To compete in global and domestic markets
• To improve the existing quality management system
• To minimize repetitive auditing by accrediting organizations
• To improve subcontractor and vendor performance
Benefits :
• Enhanced understanding of quality management throughout the
organization
• A mechanism to improve documentation of process and procedure
• A tool to strengthen and improve supplier and customer confidence
• Cost savings and improved profitability
• Improved organizational awareness of quality
• Strengthened continuous performance improvement