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Manajemen Risiko

dan
Penjagaan Kualitas Fasyankes

Amal Sjaaf
Dep. Administrasi dan Kebijakan Kesehatan
Fakultas Kesehatan Masayarakat – Universitas Indonesia
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 :
• Systems awareness,
• Leadership,
• Ownership.
• Teamwork, and
• Communication
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 :
- tranparansi,
- 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 :
- kepemimpinan klinik,
- audit klinis,
- data klinis,
- risiko klinis berbasis bukti,
- peningkatan kinerja,
- pengelolaan keluhan,
- mekanisme monitor hasil pelayanan,
- pengembangan profesional, dan
- akreditasi rumah sakit
Key elements of the NHS Quality Strategy

1. Standards :
• National Institute for Clinical Excellence
• National Service Frameworks
2. Local Duty of Quality :
• Clinical Governance
• Control Assurance
3. Assuring Quality of Individual Practice :
• NHS performances procedures
• Annual Appraisal
• Revalidation
4. Scrutiny :
• Commission for Health Improvement
• Educational Inspection visits
Key elements of the NHS Quality Strategy
5. Learning mechanisms :
• Adverse incident reporting
• Learning Networks
• Continuing Professional Education
6. Patient Empowerment :
• Better information
• New patient Advocacy Services
• Right of redress
• Patient’s view sought
• Patient involve throughout the NHS
7 Underpinning strategy :
• Information and Information Technology
• Research and Development
• Education and Training
Education
& Training
Risk
manage- Clinical
ment audit
Clinical
Governance
Clinical
Account-
Effective-
ability
ness
R&D
Aspect of the health care risk manager’s role and
responsibilities
Loss prevention and reduction :
• Identify patterns of behavior that gave rise to claims and
changes to make in practice that could allow the practitioner
to avoid costly lawsuits.
Claims management :
• managing actual or potential claims, from reporting and
investigation to resolution.
• management and defense of malpractice claims includes
protecting the assets of the organization as well as supporting
and defending providers.
• resolution of claims by hiring of outside counsel.
Transferring of risk/risk financing :
• assess the organization’s total potential risk, determine the
organization’s risk appetite (or ability to fund and finance
some of their own risk), and
• select partners to assist them in structuring a program that
would combine self-insurance, co-insurance, and excess
insurance.
Regulatory and accreditation compliance:
• promoting compliance with requirements to report specific
incidents to state and federal agencies
• promoting compliance with regulations and with accreditation
standards
Risk management operations :
• develop risk management policy statement and plan
• coordinating and administering risk management and patient
safety committees
Bioethics :
• Reviewing policies and procedures related to end-of-life
issues for conformance with ethical principles and adherence
to applicable regulation as well as relating to human subjects
research for adherence to applicable regulation and
organizational policy
Managing Interrelated Risks in the Healthcare Setting
Domains of risk in health care
• Strategic
• Operational
• Financial
• Human capital
• Legal and regulatory
• Technology
The American Society of Healthcare Risk Managers
(ASHRM)
Components of Quality in Health Care
Components of Quality in Health Care

EFFICACY
The ability of the science and technology of health care to
bring about improvements in health when used under the
most favorable circumstances.
EFFECTIVENESS
The degree to which attainable improvements in health are,
in fact, attained.
EFFICIENCY
The ability to lower the cost of care without diminishing
attainable improvements in health.
OPTIMALITY
The balancing of improvements in health against the costs of
such improvements.
Components of Quality in Health Care
ACCEPTABILITY
Conformity to the wishes, desires, and expectations of
patients and their families.
LEGITIMACY
Conformity to social preferences as expressed in ethical
principles, values, norms, mores, laws, and regulations.
EQUITY
Conformity to a principle that determines what is just and fair
in the distribution of health care and its benefits among
members of the population
Approaches to assessing the quality of care.

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 :
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
Physiological-biochemical :
• Abnormalities
• Functions
– Loss of function
– Functional reserve —includes performance in test situations under
various degrees of stress
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
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
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
Risk management : (The Joint Commission or JCAHO)
• clinical and administrative activities undertaken to identify,
evaluate, and reduce the risk of injury to patients, staff, and
visitors, and the risk of loss to the organization itself
• health care risk management is committed to reducing loss
associated with patient safety–related events in health care
settings.
Four tiers for improving patient safety :
• leadership and knowledge in the causes of medical error
• identifying and learning from errors
• setting performance standards and expectations for safety;
and
• implementing safety systems in healthcare organizations.
Determining What to Monitor
Instances or situations where the quality of care falls below the level
expected or desired through:
Troubleshooting
• action taken by clinicians or administrators when a problem is
presented to them by some untoward event
Planned reconnaissance
• action taken to reveal problems or opportunities for improvement:
- by group discussion and study,
- by routine surveillance
Routine surveillance
• a category that includes two subdivisions:
- opinion surveys
- performance monitoring
Tracer methods
• with an assumption that the quality of a bundle of related clinical
activities can be represented by one activity in the bundle or, at most,
by a very small number
Determining What to Monitor
Sources of information
• Medical records :
– Incompleteness,
– doubtful veracity,
– difficulty of interpretation, j
– justifying responses,
– verification of recorded information,
– supplementing the record,
– modifying the assessment procedure,
– improving the record,
– made-to-order recording
• Surveys :
– Surveys of Patients and Family Members
– Surveys of Practitioners
– Surveys of Populations
• Financial Records
• Statistical Records
• Direct observations
• Test situation
When and how to monitor
Prospective Monitoring :
Prospective or anticipatory monitoring is the attempt to pass
judgment on a proposed clinical event or intervention before the
event occurs or the intervention is implemented.
Concurrent monitoring :
occurs during the course of care, either periodically as a routine,
or when something happens that triggers a review of the way a
case is being handled.
Retrospective monitoring :
method most frequently used, conducted by reviewing a sample
of medical records and —based on the record as well as on
additional information, if needed —making a judgment on the
quality of care.
How to monitor
Controls over the Process of Care :
• Certification and recertification of admissions and stays
• Second surgical opinion programs
Reminders: Computerized and Other :
• Failures or errors in clinical care result not only from ignorance or
dereliction, but also from inattention and forgetfulness due to the
pressure of medical work and its constantly
Status-Progress Monitoring :
• adjust the care and assess its consequences, by paying close attention to
how each patient under care progresses, or otherwise responds, by
getting better or worse
• Classifying patients by stage or severity of illness  case-mix adjustment,
Aberrance monitoring :
• designate a continuous or periodic attention paid to unwanted adverse
events whose occurrence leads one to suspect that health care has not
met standards of accessibility or of quality, or both :
- Anecdotal" or "clinical" aberrance monitoring
- Statistical" or "epidemiological" aberrance monitoring
How to monitor
Goal-Attainment Monitoring :
• fixes attention on the more important objectives of care and, by revealing
whether or not these objectives have been met, signals either success or
failure
Cohort-Trajectory Monitoring :
• envisages a group of patients who have a given diagnosis or condition who
are followed as they progress through a health-care system
Challenge Monitoring :
• actions taken to present a health-care system with a predefined stimulus
in order to reveal how the system reacts to the challenge of that stimulus
• an established procedure in testing the quality of diagnostic services
Case Studies :
• consists of a patient-by-patient assessment of the quality of care, based
on information in the medical record and supplemented, if needed, by
interviews with caregivers and patients
• Primary and secondary case studies
Health care risk management

• Concern with a tremendous variety of issues and situations


that hold the potential for liability or casualty losses for the
organization.
• A comprehensive risk management program must address
the full scope of the following categories of risk:
- Patient care–related
- Medical staff–related
- Employee-related
- Property-related
- Financial
- Other
• Risk management --> clinical and administrative activities
undertaken to identify, evaluate, and reduce the risk of
injury to patients, staff, and visitors, and the risk of loss to
the organization itself.” (Joint Commission)
• Most common adverse events that patients experience
while receiving health care services include : (AHRQ)
– medication and transfusion errors,
– infections,
– complications of surgery (including wrong-site surgery),
– suicide,
– restraint-related injuries, falls, burns, pressure ulcers,
– misidentification, delays, and
– wrong diagnosis or treatment.
The Patient Safety and Quality
Improvement Act
• Created with three distinct goals:
– to encourage the development of Patient Safety
Organizations (PSOs) that work with healthcare
providers to identify, analyze, and reduce the risks
and hazards associated with patient care,
– to foster a culture of safety by establishing federal
confidentiality and privilege protections for
reported patient safety information, and
– to identify and publicize solutions for the risks and
hazards associated with patient care.
CMS policy eliminating reimbursement to hospitals for 10
events (Appendix 7–B) on the National Quality Forum’s (NQF)
“never-events” list:
1. Surgery on the wrong body
2. Objects left in the body during surgery
3. Mismatched blood transfusion
4. Cause serious injury or death
5. Air embolism
6. Injuries from patient falls
7. Pressure ulcers
8. Urinary-tract infections
9. Vascular-catheter-associated infections
10. Mediastinitis, an infection following heart surgery (Zhang,
2007)
• Medical errors are caused by the following : (AHRQ)
- Communication problems
- Inadequate information flow
- Human-related problems
- Patient-related issues
- Organizational transfer of knowledge
- Staffing patterns and workflow
- Technical failures
- Inadequate policies and procedures
• Joint Commission --> National Patient Safety Goals for
Hospital Accreditation Program (Effective January 1, 2014)
Patient safety work product
• Defined as any data, reports, records, memoranda, analyses
(such as root-cause analyses), or written or oral statements :
– assembled or developed by a provider for the purpose of
reporting to a patient safety organization and are reported
to a patient safety organization,
– developed by a patient safety organization for the conduct
of patient safety activities and that could result in
improved patient safety, healthcare quality, or healthcare
outcomes; or that identify or constitute the deliberations
or analysis of, or identify the fact of reporting pursuant to,
a patient safety evaluation system
– does not include medical records or billing and discharge
information, or information that is collected, maintained,
or developed separately from a patient safety evaluation
system
Steps in Risk Management Decision Making
Steps in Risk Management Decision Making
Structural Elements Risk Management Program
• Authority :
– to enact the changes in clinical practice, policies and
procedures, and employee and medical staff behavior
• Visibility :
– consciousness-raising, education, and communication,
awareness of risk management practices and techniques
• Communication :
– ‘advise’ risk management implications frequently
overlooked by employee and medical staff
• Coordination :
– establish reporting and communication relationships with
key individuals within the organization
• Accountability :
– annual performance appraisals assessing achievement of
specific, measurable risk management goals
UU no 44 thn 2009 ttg Rumah Sakit
Pasal 3
Pengaturan penyelenggaraan Rumah Sakit bertujuan :
• memberikan perlindungan terhadap keselamatan pasien,
masyarakat, lingkungan rumah sakit dan sumber daya manusia di
rumah sakit;
• meningkatkan mutu dan mempertahankan standar pelayanan
rumah sakit; dan

Penjelasan :
• Yang dimaksud dengan keselamatan pasien (patient safety” adalah
proses dalam suatu rumah sakit yang memberikan pelayanan
pasien yang lebih aman. Termasuk di dalamnya asesmen risiko,
identifikasi, dan manajemen risiko terhadap pasien, pelaporan dan
analisis insiden, kemampuan untuk belajar dan menindaklanjuti
insiden, dan menerapkan solusi untuk mengurangi serta
meminimalisir timbulnya risiko.
UU no 44 thn 2009 ttg Rumah Sakit
Pasal 36
• Setiap Rumah Sakit harus menyelenggarakan tata kelola
Rumah Sakit dan tata kelola klinis yang baik.

Penjelasasn
• Tata kelola rumah sakit yang baik adalah penerapan fungsi-
fungsi manajemen rumah sakit yang berdasarkan prinsip-
prinsip tranparansi, akuntabilitas, independensi dan
responsibilitas, kesetaraan dan kewajaran.
• Tata kelola klinis yang baik adalah penerapan fungsi
manajemen klinis yang meliputi kepemimpinan klinik, audit
klinis, data klinis, risiko klinis berbasis bukti, peningkatan
kinerja, pengelolaan keluhan, mekanisme monitor hasil
pelayanan, pengembangan profesional, dan akreditasi rumah
sakit.
UU no 44 thn 2009 ttg Rumah Sakit
Bagian Kelima - Keselamatan
Pasien Pasal 43
• Rumah Sakit wajib menerapkan standar keselamatan pasien.
• Standar keselamatan pasien sebagaimana dimaksud pada ayat (1)
dilaksanakan melalui pelaporan insiden, menganalisa, dan menetapkan
pemecahan masalah dalam rangka menurunkan angka kejadian yang tidak
diharapkan.
• Rumah Sakit melaporkan kegiatan sebagaimana dimaksud pada ayat (2)
kepada komite yang membidangi keselamatan pasien yang ditetapkan
oleh Menteri.
• Pelaporan insiden keselamatan pasien sebagaimana dimaksud pada ayat
(2) dibuat secara anonim dan ditujukan untuk mengkoreksi sistem dalam
rangka meningkatkan keselamatan pasien.
• Ketentuan lebih lanjut mengenai standar keselamatan pasien
sebagaimana dimaksud pada ayat (1) dan ayat (2) diatur dengan Peraturan
Menteri.
UU no 44 thn 2009 ttg Rumah Sakit
Penjelasan Pasien Pasal 43
• Yang dimaksud dengan keselamatan pasien (patient safety) adalah
proses dalam suatu Rumah Sakit yang memberikan pelayanan
pasien yang lebih aman. Termasuk di dalamnya asesmen risiko,
identifikasi, dan manajemen risiko terhadap pasien, pelaporan dan
analisis insiden, kemampuan untuk belajar dan menindaklanjuti
insiden, dan menerapkan solusi untuk mengurangi serta
meminimalisir timbulnya risiko.
• Yang dimaksud dengan insiden keselamatan pasien adalah
kesalahan medis (medical error), kejadian yang tidak diharapkan
(adverse event), dan nyaris terjadi (near miss).
PerMenKes No 1691 ttg Keselamatan Pasien RS

PENYELENGGARAAN KESELAMATAN PASIEN RUMAH SAKIT


Pasal 9
• Dalam rangka menerapkan Standar Keselamatan Pasien, Rumah Sakit
melaksanakan Tujuh Langkah Menuju Keselamatan Pasien Rumah Sakit.
• Tujuh Langkah Menuju Keselamatan Pasien Rumah Sakit sebagaimana
dimaksud pada ayat (1) terdiri dari:
a. membangun kesadaran akan nilai keselamatan pasien;
b. memimpin dan mendukung staf;
c. mengintegrasikan aktivitas pengelolaan risiko;
d. mengembangkan sistem pelaporan;
e. melibatkan dan berkomunikasi dengan pasien;
f. belajar dan berbagi pengalaman tentang keselamatan pasien; dan
g. mencegah cedera melalui implementasi sistem keselamatan pasien.
Risk Management Benchmarking

• Process of collecting and analyzing data to identify trends in performance


and, when compared with other collectors of the same data, identifying
best performers and determining if interventions that were introduced to
address identified problems yielded the desired results.
• Risk management benchmarking :
– Internal : collect only data elements from within their own
organization, analyze to identify best performers at the unit or
department levels, see trends within the organization
indicative of either improvement or deterioration of the risk
environment
– external : look outside the healthcare industry to identify other service
providers who have excelled at the same or similar function,
clear definition of all the data elements that are to be
collected due to sensitive nature of the information to be
shared.
Strengths and values of healthcare risk manager
Risk Assessment :
• Assess particular environments and situations that pose a threat of risk to patients,
healthcare providers, or the organization
• Understand the root-cause-analysis process in order to identify the true systemic
components contributing to risk
• Use data to estimate the economic value to the risks assessed, and to minimize
existing risks
Risk Finance
• Evaluate a variety of commercial insurance products to determine which is most
appropriate for the risks assessed
• Analyze the capability of the organization to assume some of the financial risk and
transfer the rest in a manner that allows for the most sound financial portfolio for
the organization
Risk Control
• Design unique and creative approaches to minimizing the risks that are identified
• Relate to multiple persons through education to ensure that all who con- tribute to
the organization understand key risk management and patient safety concepts
• Understand the legal process and to assist in achieving the most favorable
resolution of a claim or incident
Risk management in healthcare environment

• Develop a systematic process for proactively identifying the nature and


severity of risks created or acquired through the expansion into diverse
healthcare services that manage a patient population well beyond the
inpatient experience
• Determine the risk tolerance of the organization, and design the most
advantageous risk-transfer and risk-sharing program to minimize
dependence of fragile insurance and financial markets
• Develop a strategy for managing and controlling the systemic clinical,
administrative, and contractual liabilities arising out of delivering care in
the changing healthcare environment
• Develop and provide innovative strategies and tools that will contribute to
improvement of patient care and service
• Develop a system for collecting risk management information in a manner
that will be beneficial for benchmarking and strategic planning
Risk Identification
• Identify all risks confronting the organization regardless of organizational
setting.
• identify and analyze other areas of risk beyond what is referred to as
operational or clinical risk.
• Identify and analyze the relationship among risks.
– Understand organizational dynamics and their effect on culture and
the environment
– Corroborate the organization’s mission, vision, and strategy
– Understand the organization’s structure and identify lines of business,
units, divisions, and programs
– Educate senior leadership in understanding the risk exposure of the
organization
– Garner support necessary to develop and implement future solutions.
– Build credibility and promote collaboration for risk management
activities.
Early Warning of Risks

• Review existing early warning systems and implement new systems as


necessary  adverse events—preventable and unpreventable, incidents,
occurrences, potentially compensable events, and claims
• Early warning systems for the identification of risk can be formal or
informal reporting and notification mechanisms which are are used
internally by the organization and externally for reporting to outside
parties
• Formal risk identification systems  follow policies and procedures to
comply with requirements by insurance carriers as a requisite for
coverage, alternative risk financing arrangements such as programs of self-
insurance (captives, risk retention groups, trusts, and so on), compliance
with state statutes and other regulatory requirements, and to meet
standards
• Incident report  as any happening that is not consistent with the routine
care of a particular patient or an event that is not consistent with the
normal operations of a particular organization
Early Warning of Risks

• Examples of incidents might include a union strike, criminal acts such as


homicide or burglary, wrong-site or wrong-patient surgery, medication
errors, or a physical disaster such as a hurricane, a bioterrorism threat, or
the onset of mold contamination
• Occurrence reporting gives clear guidelines and specific examples of
reportable incidents, such as the following:
– Missed diagnoses or misdiagnoses that result in patient injury, such as
failure to diagnose acute myocardial infarction, fractures, serious head
trauma, or appendicitis
– Surgically related occurrences, such as the wrong patient being
operated on, the wrong site operated on, the wrong procedure being
performed, an incorrect instrument or sponge count, or an unplanned
return to the operating room
– Treatment- or procedure-related occurrences, such as reactions to
contrast material used in a diagnostic procedure, undesirable
exposure to X-rays, or burns resulting from improper use of hot packs
Early Warning of Risks

– Blood-related occurrences, such as the wrong type of blood given to


the patient, transmission of disease via infected blood, or improper
use of blood or blood products
– Intravenous-related occurrences, such as the wrong solution being
administered, infiltration of solution, or an incorrect infusion rate
– Medication-related occurrences
– Lack of adequate follow-up, such as failure to notify a patient of
abnormal laboratory findings
– Falls
Aspek Pasien dalam Manajemen Risiko di Rumah Sakit

Types of Documents of Interest to Health Care Risk Managers


• Medical records • Autopsy reports
• Fetal monitoring strips • Consent forms
• Electrocardiogram reports • Record of patient’s valuables
• Radiology films (X-ray, CT, MRI) • Discharge reports and forms
• Patient logs (surgery, labor and (with patient’s signed under-
delivery, emergency standing of any discharge
department)
instructions provided; AMA
• Incident and occurrence reports forms)
• Patient transfer forms • Checklists (regarding falls,
• Consultation reports restraints, activity, dietary,
• Care plan preoperative, sponge and needle
• Medication administration counts)
record • Non–stress test
• Lab reports results/cardiotocography
Types of Documents of Interest to Health Care Risk Managers

• OSHA records backup tapes


• Licenses, certificates, and • Insurance policies
permits • Contracts and agreements
• Accreditation and other • Medical staff bylaws
inspection reports
• Credentialing files
• Employee health records
• Billing records • Claims files and legal records
• Corporate and organizational • Advance directives
policies and procedures • Equipment maintenance records
• Minutes of board and • Patient education materials
committee meetings • Staff training manuals and
• Personnel files (including records
documentation of competencies
and job descriptions)
• Electronic correspondence and
Types of Documents of Interest to Health Care Risk Managers

• OSHA records backup tapes


• Licenses, certificates, and • Insurance policies
permits • Contracts and agreements
• Accreditation and other • Medical staff bylaws
inspection reports
• Credentialing files
• Employee health records
• Billing records • Claims files and legal records
• Corporate and organizational • Advance directives
policies and procedures • Equipment maintenance records
• Minutes of board and • Patient education materials
committee meetings • Staff training manuals and
• Personnel files (including records
documentation of competencies
and job descriptions)
• Electronic correspondence and

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