4H-Program Manajemen Risiko 2015 - Final

PROGRAM MANAJEMEN RISIKO DAN KESELAMATAN PASIEN
RSUP Dr. Hasan Sadikin

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CHAPTER I
INTRODUCTION
A. Background
Program of Risk Management in RSUP Dr. Hasan Sadikin

Bandung is a dispensable part of Program of Enhancement in
Quality and Patient Safety (Program Peningkatan Mutu dan
Keselamatan Pasien [PMKP]). This program contain variety of action
plans arranged in detail and comphrehensive to enhance the quality
and patient safety. Program of risk management is arranged in order
to improve health service more effective, based on contex
operationally and strategically to organizational environment.
Program of Risk Management is designed to contribute the vision
and mission of RSUP Dr. Hasan Sadikin Bandung related to the
clinical risks and safety of patient, staff, visitor, businessman,
hospital environment.
Quality and patient safety actually has been existing in daily

work activities of the health professionals and other workers, that is,
at the time the doctor and nurse assess the patient requirement in
the efforts of reducing patient risks. However, Program of Risk
Management tries to help doctors and nurses and other staffs to
carry out the real improvement in helping patients and reducing
risks. For managers and other supporting staffs, they can apply
standards in their daily work leading to more efficient processes,
more rational utilization of resources, and reduced physical risks.
Thus, Program of Risk Management can stimulate development,
review, and revision of practical standards and protocols of
organization based on identified risks and choosing the strategies
for preventing and reducing adversity.
Program of Risk Management is a comprehensive
Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

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conceptual frame for guiding the initiative program and risk

management activities and patient safety. This Program of Risk
Management will describe the framework through systematic
approach in identifying, analyzing, and managing risks with various
risk management tools that are usable to contribute philosophy of
RSUP Dr. Hasan Sadikin Bandung and to be responsible for all
people in carrying out their activities in the Hospital. Program of
Risk Management will be perfomed via coordination of work unit,
installation, and department/SMF.
RSUP dr. Hasan Sadikin Bandung supports cultural

formation that emphasizes on practical application based on the
best evidence, learning from error analysis, and providing
constructive feed-back, rather than blaming or punishment. With
the culture, unsafe and endangerous condition can be identified
immediately and proactively, the error occurs both medical
incident and patient care are reported and analyzed, then openly
discussed, provided with acceptable recommendation for
improvement syatematically.
Every individuals must be responsible to comply to patient

safety and risk management. Therefore, when avaluation and
investigation can disclose the error or incident due to neglet or
violation against the policies intentionally, disciplinary action can be
done.

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B. Goals
In general the goals of Program of Risk Management of

RSUP Dr. Hasan Sadikin Bandung is to identify, analyze, reduce
risk and evaluate risks to the patient and staff safety. The special
aims are as follows:
1. Identifying various risks that are possible to develop in RSUP

Dr. Hasan Sadikin Bandung
2. Carrying out risk assessment includes defining the risk

priority.
3. Carrying out risk management
4. Carrying out investigation on the development of sentinel

event, Unexpected event, and injury events (KNC).
5. Arranging report on \risks in RSUP Dr. Hasan Sadikin

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CHAPTER II
MAIN ACTIVITIES AND DETAILED ACTIVITIES OF RISK

MANAGEMENT
A. Main activities
Main activities in Program of Risk Management of RSUP Dr.

Hasan Sadikin Bandung is arranged based on Standard of Risk
Management ISO 31000, consists of activities including:
1. Defines Context (coverage of risk management)
2. Risk Assessment
a) Risk identification
b) Risk analysis
c) Risk evaluation
3. Treating the Risk
4. Monitoring and Review
5. Arranging Report and socializing (Communication and

Consultation)

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Program of Risk Management and patient safety are

managed by risk manager and/or appointed staff, to report to the
management of the Hospital. Risk manager cooperates with the
administrative staff, medical service procurement, and other
profession ; and has authority cross-sectionally or cross-programly
to achieve the program goals. Risk manager (or staff appointed by
the leader) under authority of Committee of Qualitu and Patient
Safety. The Committee periodically holds meeting with
representative from work units, Department/SMF, and Installation.
Composition of the Committee of Quality and Patient Safety

is design to facilitate scientific transformation and practice of risk
management in various scientific disciplines and to optimize
variety of important findings from risk activities in providing
recommendation for reducing all unexpected events and to enhance
patient safety. The activities of the Committee of Quality and Patient
Safety is one part of integration with patient safety, evaluation
system, and quality improvement.
B. Detaild activities
Main activities of risk management is translated into the

following detailed activities:
1. Defining the coverage of risk management of RSUP Dr. Hasan

Sadikin Bandung ndung
Defining the coverage of risk management is carried out with

evaluation of various internal and external conditions of the
Hospital that can affect the implementation of the strategic
Hospital plan. At least the coverage of the Hospital risk

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management consists of:
1) Corporate risk: the event that can result in negative

impacts to the aims of RSHS.
2) Non-clinical (physical) risk: potential danger results from

environment
3) Clinical risk: potential danger results from clinical service
4) Financial risk: risk that affects negatively on the capability

of RSUP Dr. Hasan Sadikin in achieving the goals.
2. Risk assessment
Risk assessment consists of identification, analyisis, and

evaluation. All this activities are conducted with brainstorming
between the manager and the subordinates of eah unit using
some tools such as risk grading. The assessment results are
recorded in Risk registry (see the arraging methods in Appendix
1 and Appendix 2) which will be submitted to the the
Committee of Quality and Patient Safety.
1) Risk identification
Identification is important element in risk management

because risk cannot be handled effectively without previous
identification. Every work unit is asked to be able to identify
various types of risk existing in each unit based on various
information for identifying potential risk.
Some information sources that can be used including

patient complaint, survey results of satisfaction, discussion
with manager and other staffs and clients and report of
incident.
2) Risk analysis

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Risk analysi is subsequent step in risk management after

identification. Generally, risk that will give rise the greatest
detriment will be the interventional priority. Analysis is
conducted by risk grading, viz., level of risk by examining the
tendency to occur risk (frequency) and the impact when it
occurs.
3) Risk evaluation
Evaluating risk is conducted to assessment how far is the

Hospital able to receive the risk from various aspects of
assessment, both internal and external environment. Risk
criteria is used to measure and to rate risk, indicating which
risk can be accepted and which one must be managed.
3. Handling risk
Approach that can be used to manage and control risk is:
1) Avoiding risk : One of methods to control pure risk is to

avoid property, people, or activity from risk expose by
means:
a) Reject possess/receive/undertake an activities though

for time being.
b) Hand-over back the risk that has been accepted or

promptly stops the activity at once it is known
containing risk.
2) Controlling detriment by preventing and reducing against

the possibility of the event developing detriment by:
a) Minimizing the potential to occur detriments by

improving the process and system through RCA (root
case Analysis) and FMEA and HVA (sse How to
implement)
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b) Reducing the severity when the detriment really occurs

by: risk transfer via collaborating an insurance
company or risk acception/retention guarantor)
3) Accepting the risk and handled by the Hospital. This means

that the Hospital tolerates the occurrence of detriment to
prevent the compromised hospital operational activities by
budgeting for overcoming.

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C. Method to implement activities
Attached at Appendix

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D. Goals
Program of Risk Management of RSUP Dr. Hasan Sadikin has the

following goals:
1. Arrangement of Risk Registry of RSUP Dr. Hasan Sadikin.
2. Arrangement of RCA report of every sentinel case and

unexpected event occurs. Reporting includes RCA, action
plan, implementing and evaluation of followup results.
3. Arrangement of FMEA report for 1 (one) risky process. The

report includes analysis of failure model, effect which
develops, problem priority, root Case, action plan,
implementing and evaluation of followup results
4. Arrangement of HVA report, including analysis of hazard

potenrials, effect and impact to staffs and the Hospital
operations, capability of the Hospital to handle the events,
take priority rate for hazard to be guidelines in arranging
hospital disaster plan.
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E. Activity implementation schedule
Month
Activities
01 02 03 04 05 06 07 08 09 10 11 12
1. Arrangement of
risk management X
coverage of RSHS
2. Assessment of
Risk in every x x
work unit
a) risk
identificatio X
n
b) risk
X
analysis
c) risk
X
evaluation
3. Handling risk in
X X X X X X X X X X
every work unit
4. Arranging RCA*
5. Arranging
FMEA**
6. Monitoring and
X X X X X X X X X X X X
Evaluation
7. Arranging report
of risk
X X X X
management at
work unit level
8. Arranging report
of risk
management at X X
the Hospital
level
*every case of sentinel or unexpected event

** one FMEA per year
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F. Recording, reporting and evaluation of activities
1. Recording
All activities in Program of Risk Management of RSUP Dr.

Hasan Sadikin are recorded hierarchal from the work unit to
hospital level as follows:
1) Work unit will record various results of risk

assessment (identification, analysis, and evaluation)
in the form of risk registry then registry of five risk
with the highest score are submitted to the Committee
of Quality and Patient Safety to classify into the
Hospital registry of risk
2) Work unit will record the implementation process of

risk management using PDSA cycle. The recording
results will sent periodically to the Committee of
Quality and Patient Safety as a part of routine report
from work unit.
3) Work unit will also record RCA results with simple

investigation (for Unexpected event using blue and
green ribbon) to submit to the Committee of Quality
and Patient Safety as part of routine report. Results of
simple investigation will be recapped by the
Committee of Quality and Patient Safety as a part of
the Hospital report.
4) Work unit also will record FMEA results

subsequently to submit to the Committee of Quality
and Patient Safety as part of routine report. FMEA
results will be selected one to be the Hospital report.
5) The Committee of Quality will record the RCA process
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results compeltely for unexpected event with yellow

and red ribbon.
2. Reporting
Work unit will arrange report periodically every

three months to the Committee of Quality and Patient
Safety. The report contains at least the results of
assessment of risk that is newly identified; process and the
results of risk management including RCA and FMEA.
The Committee of Quality and Patient Safety

conducts report recapitulation from each existing unit as
the the Hospital report. The report at least consists of:
recap of risk assessment from all units in RSHS;
recapitulation of process and RCA results and report of
FMEA and HVA.
Report from the Committee of Quality and Patient

Safety is submitted to President Director of RSUP Dr.
Hasan Sadikin Bandung.
3. Evaluation
Evaluation is performed by the Committee of Quality

and Patient Safety periodically every six months in
according to the reporting schedule. Evaluation contains
program effectiveness of risk management in reducing
frequency and risk impact.
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Appendix 1
Arrangement of Risk Registry
1. The content are various forms of risk that develop in related
unit
2. Give the score of impact from each risk with 1-5 (score 1 is very
light impact, score 5 is very severe impact)
3. Give the score of frequency from each risk with 1-5 (score 1 is
very rare, score 5 is very frequent)
4. risk value is impact score is multiplied by frequency score (from
1 to maximum 25)
5. define the ribbon color (blue, green, yellow, or red) for each risk
as shown in the tableof risk grading matrix:
Table of Risk Registry

No Risk Impact Frequency Risk Ribbon Risk
Score Rank
1 2 3 4 5 1 2 3 4 5 1-25 R S T E
Table of Risk Registry
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Risk Grading Matrix

Frequency Impact
Nonsignif Mild Moderate Severe Catasthr
icant 2 3 4 opic
1 5
Very Moderate Moderate High Extreme Extreme
frequent
5
Frequent Moderate Moderate High Extreme Extreme
4
Possible Low Moderate High Extreme Extreme
3
Rare Low Low Moderate High Extreme
2
Very Rare Low Low Moderate High Extreme
1
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APPENDIX 2:
Simple investigation
Simple investigation is conducted by direct supervisor if the ribbon

/band grading for risk is blue or green.
The steps in conducting simple investigation is as follows:

1. Data collecting: observation, documentation, and interview
2. Define the incident causes using “5why” as follows:
a) immediate/direct cause: the cause that is related directly to
the incident/impact to patient.
b) The root cause: the cause that is as the background of direct.
(underlying cause)
3. Recommend and define PJ and date of implementation.
4. Action that will be done and define PJ and date of
implementation.
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Appendix 3
Comprehensive investigation/Root Cause Analysis
It is conducted by the Team of Patient Safety when the ribbon is
yellow or red. RCA is a structured method of evaluation for
identification of root cause of the unexpected event and adequate
action plan to prevent the similar events recurrently. Analytical
process method that can be used retrospectively to identify factors
causing unexpected events.
RCA process is a critical feature of management system of quality

and safety because it can answer questions on high risk matters,
such as:
- What actual occurrence is it?)

- What must be happened? (policy)
- Why does it happened and, thus,what action can we do for the
prevention?
- How can we know that our action can help increasing patient
safety? (measurement)
The steps of searching Root Cause Analysis :
1. identify the incident that will be investigated

2. define the team of investigators
3. collect data and information
1) Observation
2) Documentation
3) Interview
4. Map the chronology of the event
1) Narrative Chronology
2) Timeline
3) Tabular Timeline
4) Time Person Grid
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5. identify CMP (Care Management Problem) with Brainstorming,

or Brainwriting.
6. Analysis of information using:
1) 5 Why’s,
2) analysis of change
3) analysis of obstacle
4) FishBone analysis
7. Recommendation and Action Plan to improve
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APPENDIX 4
Failure Mode and Effect Analysis (FMEA)
In conducting FMEA there are 8 steps to do as follows:
1.
2. Select a high-risk process and assemble a team :
- Assessing (secondary) documents of the medication error

in health servicein RSHS.
- Defining high risk process.
3. Arrange process diagram:
- Make flow chart in detail by defining the start point and

the end point of the process , and analyze the flow chart.
- This step can be done through workshop with team of

FMEA or view the documented flow chart if it has been
made.
4. Brainstorm potential failure modes and determine their

effects :
- identifying the possibility of process failure and effect that

develops in patient.
- This step can be done through workshop with team of

FMEA
5. Determine the priority of failure modes:
- Define the level of severity effect on patient by workshop

method.
- This stipulation is based on the agreement of team of

FMEA in workshop on severity level.
- Each team must estimate:
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1. The size of failure modes possibility
2. Level of severity
3. Difficulty in failure detection.
- Subsequently calculate the Risk Priority Number (RPN)

with aim to determining the action priority.
6. Identify root causes of failure modes :
- Team of FMEA conducts workshop to identify problems

using fishbone aid.
- The identification is conducted based on the failure mode

with the highest RPN.
- The goal is to find the root cause and its relationship.
7. Redesign the process
- Redesign by brainstorming of opinions to determine and

decide new design.
- The outcome of the workshop is defining new design that is

served especially for trial and assessment of which it can
minimize risk incident of medication error.
8. Analysis and test the new process
- Performing testing the new design: initiated with

socialization the new design to the related staffs
- Performing implementation the new design and holding

training if necessary.
9. Implement and monitor the new process
 Evaluate the new design by \measuring the

effectiveness of re-deigning results with appropriate
parameter in the previous step of risk measurement
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 Subsequently, scoring is conducted to assess RPN

value whether there is a reduce in :
1. Severity
2. Occurance
3. Detectability
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APPENDIX 5
Hazard Vulnerability Analysis (HVA)
The steps of making HVA are as follows:
1. identify the hazard potential in community, that affects both

directly or indirectly to the Hospital.
2. Identification of hazard event
3. Estimate the probability
4. Determin the effect and impact to staff and operation oof the
Hospital
5. Estimate the capability of the Hospital in handling the event
6. Prioritize the hazard event be guidelines for arranging of
hospital disaster plan
7. Ensure that the hospital disaster plan is responsive to the
impact of hazard event to the staff and the operation
Potensial Hazards in community
1. Clinical laboratory, academic or research
2. Facility of agriculture
3. Industrial Plant or chemical/drug storehouse
4. Dam or irrigation
5. Factory or storehouse of Fuel
6. Infectious waste product treatment
7. Factory of firecracker
8. Nuclear Reactor
9. Military silo
10. Terrorist target
11. Etc.
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HVA TOOLS
1. Identify the hazard event
2. Estimate the probability
3. Defining the effect and impact on the Hospital staffs and

operation
4. Predict the capability of the Hospital to handle the events/
5. Prioritize hazard event to be guidelines in arrangement of

hospital disaster plan
6. Ensure the hospital disaster plan is able to response the

hazard event impact to the staffs and operation of the
Hospital.
Kategori Penilaian HVA
1. The category to determin the probability includes:
a. Known risk
b. Previous data
c. Statistic vendor/manufacturer
2. Category to determine response:
a. Timing to regulate response to event site
b. Coverage of response capability
c. Evaluation history of response successfulness
3. Category to determine impact:
a. On human : Potential for staff death or injury) and

Potential for patient death or injury
b. On property: cost for compensation, cost for

temporary (renting, purchasing). Cost for repair. Time
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to recover/sustain in business, to continue serving

normally.
c. In business: business obstacles (how long), staff

cannot report the work, customer cannot obtain
facilities, company violate the contract, penalty and
punishment charge, critical supply disturbance,
compromised product distribution, reputation, and
public image. Impact on finance/burden/.
4. Category to determine the readiness:
a. On-going Plan Status
b. Frequency of training
c. Training Status
d. Insurance
e. Availbility of alternative sources for critical

service/supply
5. Category to determine internal sources:
a. Type of existing stock/can it meet the requirement
b. Volume of existing stock/can it meet the requirement
c. Supply distribution
d. Staff availability
e. Coordination with related institution
f. Availability of extra system
g. Capability of internal ressources to sustain/survive

against disaster
6. Category to determine the external resources:
a. Type of agreement with public institution

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b. Coordination with local and national institution
c. Coordination with higher health care facilities
d. Coordination with higher special therapy facilities
e. Public resources
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PROGRAM MANAJEMEN RISIKO DAN KESELAMATAN PASIEN

RSUP Dr. Hasan Sadikin

Program of Risk Management in RSUP Dr. Hasan Sadikin

Quality and patient safety actually has been existing in daily

Program of Risk Management is a comprehensive

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

conceptual frame for guiding the initiative program and risk

RSUP dr. Hasan Sadikin Bandung supports cultural

Every individuals must be responsible to comply to patient

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

In general the goals of Program of Risk Management of

1. Identifying various risks that are possible to develop in RSUP

2. Carrying out risk assessment includes defining the risk

3. Carrying out risk management

4. Carrying out investigation on the development of sentinel

5. Arranging report on \risks in RSUP Dr. Hasan Sadikin

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

MAIN ACTIVITIES AND DETAILED ACTIVITIES OF RISK

Main activities in Program of Risk Management of RSUP Dr.

1. Defines Context (coverage of risk management)

3. Treating the Risk

4. Monitoring and Review

5. Arranging Report and socializing (Communication and

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

Program of Risk Management and patient safety are

Composition of the Committee of Quality and Patient Safety

Main activities of risk management is translated into the

1. Defining the coverage of risk management of RSUP Dr. Hasan

Defining the coverage of risk management is carried out with

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

management consists of:

1) Corporate risk: the event that can result in negative

2) Non-clinical (physical) risk: potential danger results from

3) Clinical risk: potential danger results from clinical service

4) Financial risk: risk that affects negatively on the capability

Risk assessment consists of identification, analyisis, and

Identification is important element in risk management

Some information sources that can be used including

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

Risk analysi is subsequent step in risk management after

Evaluating risk is conducted to assessment how far is the

Approach that can be used to manage and control risk is:

1) Avoiding risk : One of methods to control pure risk is to

a) Reject possess/receive/undertake an activities though

b) Hand-over back the risk that has been accepted or

2) Controlling detriment by preventing and reducing against

a) Minimizing the potential to occur detriments by

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

b) Reducing the severity when the detriment really occurs

3) Accepting the risk and handled by the Hospital. This means

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

C. Method to implement activities

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

Program of Risk Management of RSUP Dr. Hasan Sadikin has the

1. Arrangement of Risk Registry of RSUP Dr. Hasan Sadikin.

2. Arrangement of RCA report of every sentinel case and

3. Arrangement of FMEA report for 1 (one) risky process. The

4. Arrangement of HVA report, including analysis of hazard

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015

E. Activity implementation schedule

*every case of sentinel or unexpected event

Program Manajemen Risiko RSUP dr. Hasan Sadikin Tahun 2015