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TUJUAN PAPARAN
Strategi Pengendalian
Risiko melalui HVA,
ICRA, FMEA
Mengenal langkah2
Failure Mode and
Effect Analysis
Herkutanto
Herkutanto 2009
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Is this required?
Hazard and
Vulnerability
Assessment
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Preparedness
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Models
There are a number of models for an HVA.
Two well known models are from
Kaiser Foundation
Model 2001
Human Events
Natural Events
Technological Events
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Human Events
Natural Events
Technological Events
Hazmat Events
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References
American Society of Healthcare Engineering 2001
WWW.ashe.org
FEMA. Emergency Management Institute Hazard
vulnerability analysis and risk assessment. Unit 2
http://www.training.fema.gov/emiweb/EMICourses/E464
CM/02%20Unit%202.pdf
Joint Commission Resources Hazard vulnerability
analysis (HVA), May/Jun 2002, 2-3
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Definisi Proses
Transformasi input menjadi output yg berkaitan dgn
Kejadian, aktivitas dan mekanisme yg terstruktur
Arjaty/ IMRK
Long term
effectiveness
Easy
Low
2.
3.
Process redesign
4.
Paper vs practice
Technical system enhance
Culture change
5.
6.
RISK
POINTS /
COMMON CAUSES
RENCANA
REDUKSI RISIKO
Difficult
Arjaty/ IMRK
Degree of
difficulty
Punitive
Retraining / counseling
1.
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17
High
18
Design Proses u/
Meminimalkan
risiko
Kegagalan terjadi
Arjaty/ IMRK Pada pasien
Design Proses u/
Meminimalkan
risiko
kegagalan
Design Proses u/
Mengurangi
Dampak
Kegagalan terjadi
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pada pasien
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Variable input
Complex systems
Non standardized systems
Tightly coupled systems
Systems with tight time constraints
Systems with hierarchical
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Variable input
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Standard - --
Pemberi Pelayanan
Tingkat keterampilan
Cara pendekatan
Proses Pelayanan harus dapat mengakomodasi
variabilitas yang tdk dapat dihindarkan dan tidak dapat
dikontrol ini.
Arjaty/ IMRK
Lack of Standardization
Pasien
Penyakit berat
Penyakit penyerta
Pernah mendapatkan pengobatan
Usia
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Complexitas
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Hierarchical culture
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Tightly Coupled
Perpindahan langkah dari suatu proses sering sangat
ketat, kadang baru disadari terjadi penyimpangan
pada langkah yang telah lanjut.
Keterlambatan dalam suatu langkah akan
mengakibatkan gangguan pada seluruh proses
Kekeliruan dalam suatu langkah akan mengakibatkan
penyimpangan pada langkah berikut ( cascade of
faillure )
Kesalahan biasanya terjadi pada saat perpindahan
langkah atau adanya langkah yang terabaikan
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Arjaty/ IMRK
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FMEA Terminology
Process FMEA - Conduct an FMEA on a
process that is already in place
Arjaty/ IMRK
What is FMEA ?
Arjaty/ IMRK
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FMEA
Original
HFMEA
By : VA NCPS
HFMECA
By IMRK
Graphically describe
the Process
Conduct a Hazard
Analysis
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What is HFMEA ?
Modified by VA NCPS
Arjaty/ IMRK
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LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS
1.
3.
4.
2. Bentuk Tim
3. Gambarkan Alur Proses
4. Buat Hazard Analysis
5. Tindakan dan Pengukuran Outcome
c u -tr a c k
LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS
2.
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5.
6.
7.
8.
Premeeting
Visit the worksite to observe the process, verify that all process &
subprocess steps are correct (Step 3)
3 rd team meeting
_________________________________________________________
_________________________________________________________
LANGKAH 2 : BENTUK TIM
Ketua
:
____________________________________________________________
Postteam meeting
Judul Proses :
__________________________________________________________________________
Anggota
1. _______________
4.
________________________________________
2. _______________
5.
________________________________________
3. _______________
6.
________________________________________
Notulen? _________________________________________
Apakah semua Unit yang terkait dalam Proses sudah terwakili ?
YA / TIDAK
Tanggal dimulai ____________________ Tanggal selesai ___________________
The advisor or his/ her designee follow up until all actions are
completed
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Arjaty/ IMRK
ANALISIS
DAMPA
K
MINOR
1
Kegagalan yang tidak
mengganggu Proses
pelayanan kepada
Pasien
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MAYOR
3
Kegagalan dapat
mempengaruhi proses
dan menimbulkan
kerugian ringan
Kegagalan menyebabkan
kerugian berat
KATASTROPIK
4
Kegagalan menyebabkan
kerugian besar
Pasien
Cedera ringan
Ada Perpanjangan
hari rawat
Kematian
Kehilangan fungsi tubuh
secara permanent (sensorik,
motorik, psikologik atau
intelektual) mis :
Operasi pada bagian atau
pada pasien yang salah,
Tertukarnya bayi
Pengunju
ng
Cedera ringan
Ada Penanganan
ringan
Terjadi pada 2 -4
pengunjung
Kematian
Terjadi pada > 6 orang
pengunjung
Staf:
Cedera ringan
Ada Penanganan /
Tindakan
Kehilangan waktu /
kec kerja : 2-4 staf
Fasilitas
Kes
Kerugian
1,000,000 10,000,000
10,000,000
Arjaty/ IMRK
Kematian
Perawatan > 6 staf
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2
1
DESKRIPSI
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
diProceed..
CONTOH
Sering (Frequent)
Kadang-kadang
(Occasional)
Jarang (Uncommon)
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Decision Tree
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NO
NO
YES
STOP
YES
Proceed to
Potential
Causes for
this failure
mode
Do not proceed
to find potential
causes for this
failure mode
47
HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK
4
MAYOR
3
MODERAT
2
MINOR
1
SERING
4
16
12
KADANG
3
12
JARANG
2
HAMPIR TIDAK
PERNAH
1
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Arjaty/ IMRK
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LANGKAH 1 :
PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM
Pilih Proses berisiko tinggi yang akan dianalisa.
Judul Proses : ___________________________________________
BENTUK TIM
Ketua
:
____________________________________________________________
Anggota
1. _______________
4.
________________________________________
2. _______________
5.
________________________________________
3. _______________
6.
________________________________________
Notulen _________________________________________
Apakah semua Unit yang terkait dalam Proses sudah terwakili ?
YA / TIDAK
Tanggal dimulai _________________ Tanggal selesai _______________________
Arjaty/ IMRK
49
Arjaty/ IMRK
STEP 2
LANGKAH -LANGKAH
FAILURE MODE & EFFECT ANALYSIS
PROCESS STEPS :
Describe the process graphically, according to your policy & procedure for the activity and number each one
If the process is complex you may want to select one process step or sub process to work on
1
1.
2.
3.
4.
5.
6.
7.
8.
51
Selection &
Procuremen
t
Failure Mode
Pemesanan obat
Berlebihan (tdk
Sesuai kebthn)
Storage
Failure Mode
Penyimpanan
vaksin tdk
sesuai suhunya
Prescribing,
Ordering,
Trancribing
Failure Mode
Penulisan obat
dlm R/ tdk jls
Preparing
&
Dispensin
g
Administration
Failure Mode
Failure Mode
Peracikan obat
tdk sesuai dosis
Wrong drug
Wrong dosage
Penulisan Obat R/
tdk R/
Dlm formularium
Wrong frequence
Wrong route
administration
Arjaty/ IMRK
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Arjaty/ IMRK
RATING SYSTEM
(Modified by IMRK)
HFMEA
Potential Cause
Failure
Mode
c u -tr a c k
Herkutanto 2009
53
Rating
Probabilitas
(P)
DAMPAK
(D)
Kontrol
(K)
Deteksi
(D)
Remote
Minor effect
Easy
Certain to detect
Low likelihood
Moderate effect
Mpderate
Easy
High likelihood
Moderate
likelihood
Minor injury
Moderate
difficult
Moderate
likelihood
High likelihood
Major injury
Difficult
Low likelihood
Kontrol
Eliminasi
Terima
Certain to
occur
Catastrophic effect
/ terminal injury,
death
Proses lama
yg high risk
Alur
Proses
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Efek /
Dampak
HS
Decision
Tree
K
K
Tindakan
K
E
D
Desain
Proses baru
Hazard
Score
Kritis
Kontrol
Deteksi
Almost certain
not to detect
54
Arjaty/ IMRK
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(Modified by IMRK)
(Modified by IMRK)
Rating
Description
Definition
Rating
Certain to
detect
10 out to 10
High likelihood
7 out of 10
Likely to be detected
Description
Definition
Probability
of
Detection
Moderate effect
Minor injury
5 out of 10
Major injury
Moderate
likelihood
Low likelihood
2 out 0f 10
Unlikely to be detected
Catastrophic effect, a
terminal injury or death
Almost certain
not to detect
0 out of 10
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Arjaty/ IMRK
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Description
Probability
Definition
Remote to
non existent
1 in 10,000
Low
Likelihood
1 in 5000
Moderate
likelihood
1 in 200
High
likelihood
1 in 100
Certain to
occur
1 in 20
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Potential
effect
Potenti
al
causes
Severity
Probabilit
y
Ri
sk
Sc
or
e
(3
X4
)
Risk
Catego
ries /
Bands
Control
RPN
(5X8X
9)
Detection
Process
Failure
Mode
Potential
Effect
Potential
Causes
Redesign
Recommen
datio
ns
PIC
Target
Comple
tio
n
date
for test
New
Process
Implementa
tion
date &
Actions
Outcome
Measure /
Monitoring
mechanism
1 2 3 4 5 1 2 3 4 5 1- L M H E 1 2 3 4 1 2 3 4 5
25
1
Wrong route
administratio
n
Death
No
Trainin
g
Wrong
frequency
Injury with
permanen
t loss of
function >
No
record
in
Chart
Wrong
dosage
No injury
with no
permanen
t loss of
function
Miss
read
instruct
ion
Wrong drug
No injury
but LOS >
Miss
identifi
cation
Arjaty/ IMRK
10
12
10
40
24
32
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61
Failure
Mode
RPN
Failure
Mode
Potential
effect
RPN
effect
Potential
Causes
RPN
Causes
Total
RPN
Rank
Wrong route
administrati
on
60
40
140
Wrong
frequency
48
Injury with
permane
nt loss
of
function
12
No record
in
Chart
24
84
Wrong dosage
36
No injury
with no
permane
nt loss
of
function
36
Miss read
instru
ction
32
104
Wrong drug
36
No injury but
LOS > >
16
Miss
identi
ficati
on
16
68
Death
40
No
Traini
ng
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Arjaty/ IMRK
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PREPARING TO REDESIGN
(step 6)
TAKE A DEEP BREATH
Conduct a literature search to gather
relevant information from the professional
literature. Do not reinvent the wheel
Network with colleagues
Recommit to out of the box thinking
Arjaty/ IMRK
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REDESIGN STRATEGIES
Prevent the failure from happening
(decrease likelihood of occurrence)
Prevent the failure from reaching the
individual (increase detectability)
Protect individuals if a failure occurs
(decrease the severty of the efects)
Arjaty/ IMRK
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REDISAIN PROSES
Decreasing variability
Simplify
Standardizing
Loosen coupling of process
Use technology
Optimise Redundancy
Built in fail safe mechanism
Documentation
Establishing a culture of
teamwork
Variable input
Complex
Nonstandarized
Tightly Coupled
Dependent on human
intervention
Time constraints
Hierarchical culture
Arjaty/ IMRK
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LANGKAH 8
ANALISIS DAN UJI PROSES BARU
The team again completes steps 2 (diagram the
process), step 3 (brainstorm potential failure
modes & determine their effect) and step 4
(prioritize failure modes) of the FMEA process
Then the team should calculate a new criticality
index (CI) or RPN.
Design improvements should bring reduction in
the CI / RPN.
Ex: 30 50% reduction ?
Arjaty/ IMRK
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Prioritas
risiko
Penyebab
73
Failure
Mode
Analisis &
Uji Proses Baru
Total RPN
PROSES
BARU
Implementasi
PROSES BARU
Failure
Mode,
Dampak,
Penyebab
Total RPN
30-50%?
Arjaty/ IMRK
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KESIMPULAN
Building a safe healthcare
system
Proses lama
yg high risk
Potential Cause
Failure
Redisign
Proses
Dampak,
AMKD / HFMEA
Alur
Proses
Total RPN
PROSES
LAMA
Mode,
Arjaty/ IMRK
c u -tr a c k
AMKDP / HFMECA
LANGKAH 9
IMPLEMENTASI DAN MONITORING PROSES
Strategies for Creating & Managing the Change Process :
1.
Establish a sense of urgency
2.
Create a guiding coalition
3.
Develop a vision and strategy
4.
Communicate the changed vision
5.
Empower broad based action
6.
Generate short term wins
7.
Consolidate gains and produce more change
8.
Anchor new approaches in the culture
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Efek /
Dampak
Decision
Tree
HS
K
K
Tindakan
K
E
D
T
Desain
Proses baru
Hazard
Score
Arjaty/ IMRK
Kritis
Kontrol
Deteksi
Kontrol
Eliminasi
Terima
74
L E A D Arjaty/
EIMRKR S H I P
76
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