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Arjaty/ IMRK/FMEA/2008
Historical Perspective
Hingga
saat ini,
pencegahan
Until recently,
error
preventionkesalahan
has not
medis
menjadi
fokus
utama bidang
been abelum
primary
focus of
medicine
kedokteran
z System/process defects are identified by
adverse events or dealt with silently by
health care personnel
z Sebagian besar sistem pelayanan
healthtidak
caredidesain
delivery untuk
systems
are not
z Most
kesehatan
mencegah
designed
to prevent
and / or compensate
atau mencegah
/ mengatasi
error
for errors
z
z
Arjaty/ IMRK/FMEA/2008
Identify
anddan
prioritize
high risk
processes
Identifikasi
proritaskan
PROSES
Annually
select at least
one high risk
YANG
BERISIKO
TINGGI
process
z Identifikasi POTENSI MODUS
Identify potential
z KEGAGALAN
failure modes
each
failure
mode, identify
possible
z
Setiap
modus
kegagalan,
IDENTIFIKASI
z For
effects
DAMPAK YANG MUNGKIN TERJADI
thesetiap
most dampak
critical effects,
conduct a root
z
Untuk
yang kritis,
z For
cause
analysis
LAKUKAN
ANALISIS AKAR MASALAH.
z
z
z
Arjaty/ IMRK/FMEA/2008
REDISAIN
the
zzRedesign
PROSES
untuk the risk of that
process
to minimize
failure
mode or to protect
its
meminimalisasi
risiko patients
modus from
kegagalan
effects
atau mencegah dampaknya pada pasien
z Test and implement the redesigned process
z UJI COBA DAN IMPLEMENTASI
z Identify and implement measures of
REDISAIN PROSES
effectiveness
z IDENTIFIKASI DAN NILAI EFEKTIVITAS
z Implement a strategy for maintaining the
IMPLEMENTASI
effectiveness
of the redesigned process over
proses redisain. STRATEGI untuk
IMPLEMENTASIKAN
ztimeatau
efektivitas maintanance
Arjaty/ IMRK/FMEA/2008
Arjaty/ IMRK/FMEA/2008
6
Advanced Patient safety in US since 1999, NPCS,
August 2004, www,patientsafety.gov
Degree of
difficulty
Long term
effectiveness
Easy
Low
2.
Punitive
Retraining / counseling
3.
Process redesign
4.
Paper vs practice
Technical system enhance
Culture change
1.
5.
6.
Difficult
Arjaty/ IMRK/FMEA/2008
High
7
Definition of a Process
A goal-directed interrelated series of
events, activities, actions, mechanisms,
or steps that transform inputs into
outputs
(CAMH Glossary)
INPUT
PROSES
Arjaty/ IMRK/FMEA/2008
OUTPUT
Arjaty/ IMRK/FMEA/2008
RENCANA
REDUKSI RISIKO
Design Proses u/
Meminimalkan
risiko
Kegagalan terjadi
Arjaty/ IMRK/FMEA/2008
Pada pasien
Design Proses u/
Meminimalkan
risiko
kegagalan
Design Proses u/
Mengurangi
Dampak
Kegagalan terjadi
10
pada pasien
MEMILIH PROSES
z
in the literature
z Identified by JCAHO
z Identified through safety alerts
Arjaty/ IMRK/FMEA/2008
11
Arjaty/ IMRK/FMEA/2008
12
REDISAIN PROSES
FMEA
z
z
z
z
z
z
z
Variable input
Complex
Nonstandarized
Tightly Coupled
Dependent on human
intervention
Time constraints
Hierarchical culture
z
z
z
z
z
z
z
z
z
Arjaty/ IMRK/FMEA/2008
Decreasing variability
Simplify
Standardizing
Loosen coupling of process
Use technology
Optimise Redundancy
Built in fail safe mechanism
Documentation
Establishing a culture of
teamwork
13
Variable input
Pasien
z Penyakit berat
z Penyakit penyerta
z Pernah mendapatkan pengobatan
z Usia
Pemberi Pelayanan
z Tingkat keterampilan
z Cara pendekatan
Proses Pelayanan harus dapat mengakomodasi
variabilitas yang tdk dapat dihindarkan dan tidak dapat
dikontrol ini.
Arjaty/ IMRK/FMEA/2008
14
Complexitas
z
z
z
z
15
Lack of Standardization
z
16
z
z
z
z
17
Tightly Coupled
z
18
Hierarchical culture
z
19
Arjaty/ IMRK/FMEA/2008
20
What is FMEA ?
z
z
z
Arjaty/ IMRK/FMEA/2008
21
FMEA
Whats the point?
Eliminating
Dengan mengeliminasi
or reducing theatau
risk mereduksi
of the failure
modes
canmenghasilkan
result in a
risiko kegagalan
akan
suatu
SAFER YANG
AND MORE
SISTEM
AMANEFFICIENT
DAN LEBIHSYSTEM
EFISIEN
from which BAGI
both you
patients
benefit.
RS and
DANyour
PASIEN
.
Arjaty/ IMRK/FMEA/2008
22
4. Corrective action.
Arjaty/ IMRK/FMEA/2008
23
FMEA Terminology
z
24
25
26
z Frequently
27
LANGKAH FMEA
1.
2.
3.
4.
5.
6.
7.
8.
Arjaty/ IMRK/FMEA/2008
28
Step One
Select a process to evaluate with FMEA
Recruit a multi disciplinary team
Step Two
Have the team meet together to list all the
steps in the process
Number every step in the process and be as
specific as possible
Arjaty/ IMRK/FMEA/2008
29
Step Three
Have the team list failure modes and effect
z List anything that could go wrong including
minor and rare problems
z Identify all possible causes for each failure mode
For each failure mode, determine the potential effect on the patient
Likelihood of occurrence
Likelihood of detection
Severity
Arjaty/ IMRK/FMEA/2008
30
Arjaty/ IMRK/FMEA/2008
31
RATING SYSTEM
(Modified by IMRK)
Rating
Probabilitas
(P)
Severity
(S)
Deteksi
(D)
Remote
Minor effect
Certain to detect
Low likelihood
Moderate effect
High likelihood
Moderate
likelihood
Minor injury
Moderate
likelihood
High likelihood
Major injury
Low likelihood
Certain to
occur
Catastrophic effect
/ terminal injury,
death
Almost certain
not to detect
32
Step four
Prioritize failure mode
Step five
Have the team list effect of failure mode
For each failure mode, determine the potential cause on the patient
Likelihood of occurrence
Likelihood of detection
Severity
Arjaty/ IMRK/FMEA/2008
33
Step Six
z
z
z
z
z
z
REDESIGN PROCESS
Determine which failures to work on
Calculate the RISK PRIORITY NUMBER (RPN):
Likelihood x Severity x Detection
Identify the failure modes with the top 10 RPNs
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/FMEA/2008
34
Step Seven
Analyze and test the new process
Use RPNs to plan improvement efforts
z
35
Step Eight
Implement & monitor the redesigned
process
z
Arjaty/ IMRK/FMEA/2008
36
What is HFMEA ?
Modified by VA NCPS
z
37
HFMEA
FMEA
HACCP
RCA
Team membership
Diagramming
process
Hazard Scoring
Matrix
Decision Tree
Responsible person
& management
concurrence
V
V
V
#
V
V
Arjaty/ IMRK/FMEA/2008
38
Visit the worksite to observe the process, verify that all process &
subprocess steps are correct (Step 3)
3 rd team meeting
Postteam meeting
The advisor or his/ her designee follow up until all actions are
completed
Arjaty/ IMRK/FMEA/2008
39
LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS
Step 1
z
Step 2
z
41
Step 3
z
z
z
z
42
Step 4
List Failure modes
z Determine Severity & Probability
z Use the Decision tree
z List all Failure mode causes
z
Arjaty/ IMRK/FMEA/2008
43
Step 5
z
z
z
z
z
44
HFMEA
By : VA NCPS
HFMECA
By IMRK
Graphically describe
the Process
Conduct a Hazard
Analysis
45
Probabilitas
(P)
Severity
(S)
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
Certain to
occur
Catastrophic effect
/ terminal injury,
death
Almost certain
not to detect
46
Arjaty/ IMRK/FMEA/2008
47
_________________________________________________________
_________________________________________________________
LANGKAH 2 : 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/FMEA/2008
48
Contoh kasus 1
Arjaty/ IMRK/FMEA/2008
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Arjaty/ IMRK/FMEA/2008
50
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51
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52
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53
ANALISIS
DAMPA
K
Pasien
MODERAT
2
MAYOR
3
Kegagalan dapat
mempengaruhi proses
dan menimbulkan
kerugian ringan
Kegagalan menyebabkan
kerugian berat
Kegagalan menyebabkan
kerugian besar
zCedera ringan
zAda Perpanjangan
zCedera
luas / berat
zPerpanjangan hari
rawat
lebih lama (+> 1 bln)
zBerkurangnya fungsi
permanen organ tubuh
(sensorik / motorik /
psikcologik / intelektual)
zKematian
zCedera
zKematian
MINOR
1
perpanjangan
hari rawat
Pengunju
ng
Staf:
Fasilitas
Kes
hari rawat
z Cedera ringan
z Ada Penanganan
pengunjung
ringan
z Terjadi pada 2 -4
pengunjung
zCedera ringan
z Ada Penanganan /
waktu / keckerja
Tindakan
z Kehilangan waktu /
kec kerja : 2-4 staf
Kerugian
Kerugian
10,000,000 - 50,000,000
1,000,000 - Arjaty/ IMRK/FMEA/2008
10,000,000
org
luas / berat
z Perlu dirawat
zKehilangan waktu /
kecelakaan kerja pada
4-6 staf
KATASTROPIK
4
Kematian
z Kehilangan fungsi tubuh
secara permanent (sensorik,
motorik, psikologik atau
intelektual) mis :
z Operasi pada bagian atau
pada pasien yang salah,
z Tertukarnya bayi
zTerjadi
zPerawatan
> 6 staf
DESKRIPSI
CONTOH
Hampir sering muncul dalam waktu yang
relative singkat (mungkin terjadi
beberapa kali dalam 1 tahun)
Sering (Frequent)
Kadang-kadang
(Occasional)
Jarang (Uncommon)
55
HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK
4
MAYOR MODERAT
3
2
MINOR
1
SERING
4
16
12
KADANG
3
12
JARANG
2
HAMPIR TIDAK
PERNAH
1
Arjaty/ IMRK/FMEA/2008
56
Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
diProceed..
Does this hazard involve a
sufficient likelihood of
occurrence and severity to
warrant that it be
controlled?
(Hazard score of 8 or
higher)
YES
NO
NO
YES
STOP
YES
Proceed to
Potential
Causes for
this failure
mode
Do not proceed
to find potential
causes for this
failure mode
57
Contoh kasus 2
PROSES KEGIATAN PAGI HARI MENUJU TEMPAT KERJA
Arjaty/ IMRK/FMEA/2008
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Arjaty/ IMRK/FMEA/2008
HFMEA : Healthcare Failure Mode Effect and Analysis
Eliminate
Tindakan /
Alasan
untuk
mengakhiri
Purchased
new clock
Purc
hase
d by
cert
ain
date
.....
Manajemen Tim
Occa
sional
Tipe
Tindakan
(Kontrol,
Kontrol,
terima,
terima,
Eliminasi)
Eliminasi)
Yang Bertanggung
Jawab
major
Proses ?
Apakah mudah
didteksi ?
occas
ional
Apakah ada
kontrol/pengen
dalian?
major
Poin Tunggal
Kelemahan ?
Missed
snooze button
Nilai Hazard
Probabilitas
POTENSI
PENYEBAB
Ukuran Outcome
SKORING
Kegawatan
MODUS
Kegagalan :
Evaluasi awal
modus
kegagalan
sebelum
Mr..
Yes
66
AMKD / HFMEA
Proses lama
yg high risk
Alur
Proses
Potential Cause
Failure
Mode
Efek /
Dampak
Decision
Tree
HS
K
K
Tindakan
K
E
D
T
Desain
Proses baru
Hazard
Score
Arjaty/ IMRK/FMEA/2008
Kritis
Kontrol
Deteksi
Kontrol
Eliminasi
Terima
67
AMKDP / HFMECA
Prioritas
risiko
Total RPN
PROSES
LAMA
Failure
Redisign
Proses
Mode,
Dampak,
Penyebab
Analisis &
Uji Proses Baru
Total RPN
PROSES
BARU
Implementasi
PROSES BARU
Failure
Mode,
Dampak,
Penyebab
Total RPN
30-50%?
Arjaty/ IMRK/FMEA/2008
68
KESIMPULAN
Building a safe healthcare system
A
R
T
L
E
N
E
T
P
A
U
A
O
L
R
M
R
I
E
W
T
S
I
O
I
N
R
S
G
K
U
L
E
A
R
N
I
N
G
S
E
V
E
R
I
T
Y
K
F K
D
O
R
E
N
T E O
T
T
R K M
E
R
U
A U
O
K
N
I
L
S
E
I
N N
I
K
I
A
S
N I
S
G
I
L E A D E R S H I P
Arjaty/ IMRK/FMEA/2008
69
Team Work ?
Arjaty/ IMRK/FMEA/2008
70