Dr Arjaty W Daud MARS

STRATEGI REDUKSI RISIKO

IDENTIFIKASI PROSES YG RISIKO
TINGGI
REDISAIN PROSES :
- FMEA
- AMKD / HFMEA

- AMKDP / HFMECA

Arjaty/ IMRK 2
RISK REDUCTION STRATEGIES DIFFICULTY &
LONG TERM EFFECTIVENESS
Types of actions Degree of Long term
difficulty effectiveness

Easy Low
1. Punitive
2. Retraining / counseling
3. Process redesign
4. Paper vs practice
5. Technical system enhance
6. Culture change
Difficult High
Arjaty/ IMRK 3
 STRATEGI REDUKSI RISIKO

Identifikasi risiko dgn bertanya 3 pertanyaan dasar :

1. Apa prosesnya ?
2. Dimana risk points / cause?
3. Apa yg dapat dimitigate pada dampak
risk points ?

Definisi Proses
Transformasi input menjadi output yg berkaitan dgn
Kejadian, aktivitas dan mekanisme yg terstruktur

Arjaty/ IMRK 4
STRATEGI REDUKSI RISIKO
RISK
POINTS /
COMMON CAUSES

RENCANA
REDUKSI RISIKO

Design Proses u/ Design Proses u/

Design Proses u/
Meminimalkan Mengurangi
Meminimalkan
risiko Dampak
risiko
Kegagalan terjadi Kegagalan terjadi
kegagalan
Pada
Arjaty/ pasien
IMRK pada pasien
5
 IDENTIFYING RISK PRONE SYSTEM

Variable input
Complex systems
Non standardized systems
Tightly coupled systems
Systems with tight time constraints
Systems with hierarchical

Arjaty/ IMRK 6
 Variable input
Pasien
Penyakit berat
Penyakit penyerta
Pernah mendapatkan pengobatan
Usia

Pemberi Pelayanan
Tingkat keterampilan
Cara pendekatan

Proses Pelayanan harus dapat mengakomodasi

variabilitas yang tdk dapat dihindarkan dan tidak
dapat dikontrol ini.

Arjaty/ IMRK 7
 Complexitas

Pelayanan rumah sakit sangat kompleks

Memerlukan beragam langkah yang sangat
mungkin berhadapan dengan kegagalan
Semakin banyak langkah semakin besar
kemungkinan gagal
Donald Berwick :

1 langkah -- error 1 %
25 langkah -- error 22%
100 langkah -- error 63%

Arjaty/ IMRK 8
 Lack of Standardization
Standard - -- proses tidak dapat berjalan
sesuai dengan harapan
Individu yang menjalankan proses harus
melaksanakan langkah langkah yang telah
ditetapkan secara konsisten
Variabilitas individual sangat tinggi -

perlu standard mis : SPO, Parameter, Protokol,

Clinical Pathways dapat membatasi pengaruh
dari variabel yang ada.

Arjaty/ IMRK 9
Heavily dependent on human Intervention
Ketergantungan yang tinggi akan intervensi
seseorang dalam proses dapat menimbulkan
variasi penyimpangan.
Tidak semua improvisasi bersifat buruk, dikenal

creating safety at the sharp end

Pelayanan kesehatan sangat tergantung pada
intervensi manusia
Petugas harus mampu mengendalikan situasi
yang tidak terduga demi keselamatan pasien
Sangat tergantung pada pendidikan dan pelatihan
yang memadai sesuai dengan tugas & fungsinya

Arjaty/ IMRK 10
 Tightly Coupled
Perpindahan langkah dari suatu proses sering sangat
ketat, kadang baru disadari terjadi penyimpangan
pada langkah yang telah lanjut.

Keterlambatandalam 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
Arjaty/ IMRK 11
 Hierarchical culture
Suatu proses akan menghadapi risiko kegagalan lebih tinggi
dalam unit kerja dengan budaya hirarki dibandingkan dengan
unit kerja yang budayanya berorientasi pada team

Staf enggan berkomunikasi & berkolaborasi satu dengan yang

lain

Perawat enggan bertanya kepada dokter atau petugas farmasi

tentang medikasi, dosis, serta element perawatan lainnya

Budaya hirarki sering tercipta misalnya dalam menentukan

penggunaan obat, verifikasi lokasi pembedahan oleh tim
bedah.

Tata cara berkomunikasi antar staf dalam proses pelayanan

kesehatan sangat menentukan hasilnya.
Arjaty/ IMRK 12
 Implementing Safety Cultures in Medicine:
What We Learn by Watching Physicians
Timothy J. Hoff, Henry Pohl, Joel Bartfield

Residen di Kamar Bedah : ~ Commission

~ Suasana hierarki tinggi
~ Kesalahan Teknis
Residen di MICU : ~ Ommission
Suasana hierarki lebih
datar
~ Kesalahan Pengambilan
Keputusan

Arjaty/ IMRK 13
 What is FMEA ?
Adalah metode perbaikan kinerja dgn
mengidentifikasi dan mencegah potensi
kegagalan sebelum terjadi. Hal tersebut
didesain untuk meningkatkan keselamatan
pasien.

Adalah proses proaktif, dimana kesalahan dpt

dicegah & diprediksi. Mengantisipasi kesalahan
akan meminimalkan dampak buruk

Arjaty/ IMRK 14
 FMEA Terminology
ProcessFMEA - Conduct an FMEA on a
process that is already in place
DesignFMEA Conduct an FMEA before
a process is put into place
Implementing an electronic medical records or
other automated systems
Purchasing new equipment
Redesigning Emergency Room, Operating
Room, Floor, etc.
Arjaty/ IMRK 15
 FAILURE MODE AND EFFECTS ANALYSIS

FAILURE (F) : When a system or part of a system

performs in a way that is not
intended or desirable
MODE (M) : The way or manner in which
something such as a failure can
happen. Failure mode is the
manner in which something can
fail.
EFFECTS (E) : The results or consequences of a
failure mode
Analysis (A) : The detailed examination of the
elements or structure of a process

Arjaty/ IMRK 16
 Why should my organization
conduct an FMEA ?
Can prevent errors & nearmisses protecting
patients from harm.
Can increase the effectiveness & efficiency of
process
Taking a proactive approach to patient safety
also makes good business sense in a health
care environment that is increasingly facing
demands from consumers, regulators & payers
to create culture focused on reducing risk &
increasing accountability
Arjaty/ IMRK 17
 Where did FMEA come from ?
FMEA has been around for over 30 years
Recently gained widespread appeal
outside of safety area
New to healthcare
Frequently used reliability & system safety
analysis techniques
Long industry track record

Arjaty/ IMRK 18
 LANGKAH2 FMEA, HFMEA, HFMECA
FMEA HFMEA HFMECA
Original By : VA NCPS By IMRK
1 Select a high risk process & Define the HFMEA Select a high risk process &
assemble a team Topic assemble a team
2 Diagram the process Assemble the Team Diagram the process

3 Brainstorm potential failure Graphically describe Brainstorm potential failure

modes & determine their effects
(P X Da X De)
4 Prioritize failure modes
5 Identify root causes of failure
modes
(P X Da X De)
6 REDESIGN THE PROCESS
the Process modes & Prioritize failure modes
(P X Da) x K X De, Bands
Conduct a Hazard Brainstorm potential effects of
Analysis failure modes
(P X Da) x K X De, Bands
Actions & Outcome Identify root causes of failure
Measures modes
(P X Da) x K X De, Bands
CALCULATE TOTAL RPN

7 Analyze & test the new process REDESIGN THE PROCESS

8 Implement & monitor the Analyze & test the new process
redesigned process
9 Arjaty/ IMRK Implement & monitor the 19
redesigned process
 What is HFMEA ?
Modified by VA NCPS

Focus on preventing defects, enhancing safety, increase

positive outcome and increase patient satisfaction

The objective is to look for all ways for process or product

can fail

The famous question : What is could happen? Not What

does happen ?

Hybrid prospective analysis model combines concepts :

FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis Critical Control Points)
RCA (Root Cause Analysis)
Arjaty/ IMRK 20
 LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS

1. Tetapkan Topik AMKD

2. Bentuk Tim
3. Gambarkan Alur Proses
4. Buat Hazard Analysis
5. Tindakan dan Pengukuran Outcome
HFMEA Components and Their Origins
Concepts HFMEA FMEA HACCP RCA

Team membership V V V

Diagramming V V V
process
Failure mode & V V
causes
Hazard Scoring V V
Matrix
Severity & Probability V # V
Definitions
Decision Tree V V

Actions & Outcomes V # V

Responsible person V # V
& management
concurrence
HACCP : Hazard Analysis Critical Control Point
Arjaty/ IMRK 22
 TIME LINE AND TEAM ACTIVITIES

Premeeting Identify Topic and notivy the team (Step 1 & 2)

1st team meeting Diagram the process, identify subprocess, verify the scope
2rd team meeting Visit the worksite to observe the process, verify that all process &
subprocess steps are correct (Step 3)
3 rd team meeting Brainstorming failure modes, assign individual team members to
consult with process users (Step 3)
4rd team meeting Identify failure modes causes, assign individual team members to
consult with process users for additional input (Step 3)
5th team meeting Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the
hazard analysis (Step 4)
Identify corrective actios and assign follow up responsibilities (Step 5)
6th,7th , 8th. team Assign team members to follow up individual charged with taking
meeting plus 1 corrective action
team meeting plus 2 Refine corrective actions based on feedback
team meeting plus 3 Test the proposed changes
team meeting plus 4 Meet with Top Management to obtain approval for all actions
Postteam meeting The advisor or his/ her designee follow up until all actions are
completed
Arjaty/ IMRK 23
 LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI

Pilih Proses berisiko tinggi yang akan dianalisa.

Judul Proses :
__________________________________________________________________________
_________________________________________________________
_________________________________________________________
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 24
Arjaty/ IMRK 25
Arjaty/ IMRK 26
Arjaty/ IMRK 27
 ANALISIS HAZARD LEVEL DAMPAK
DAMPA MINOR MODERAT MAYOR KATASTROPIK
K 1 2 3 4
Kegagalan yang tidak Kegagalan dapat Kegagalan menyebabkan Kegagalan menyebabkan
mengganggu Proses mempengaruhi proses kerugian berat kerugian besar
pelayanan kepada dan menimbulkan
Pasien kerugian ringan
Pasien Tidak ada cedera, Cedera ringan Cedera luas / berat Kematian
Tidak ada Ada Perpanjangan Perpanjangan hari Kehilangan fungsi tubuh
perpanjangan hari rawat rawat secara permanent (sensorik,
hari rawat lebih lama (+> 1 bln) motorik, psikologik atau
Berkurangnya fungsi intelektual) mis :
permanen organ tubuh Operasi pada bagian atau
(sensorik / motorik / pada pasien yang salah,
psikcologik / Tertukarnya bayi
intelektual)

Pengunju Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
ng Tidak ada penanganan Ada Penanganan Perlu dirawat Terjadipada > 6 orang
Terjadi pada 1-2 org ringan Terjadi pada 4 -6 pengunjung
pengunjung Terjadi pada 2 -4 orang
pengunjung pengunjung

Staf: Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
Tidak ada penanganan Ada Penanganan / Perlu dirawat Perawatan > 6 staf
Terjadi pada 1-2 staf Tindakan Kehilangan waktu /
Tidak ada kerugian Kehilangan waktu / kecelakaan kerja pada
waktu / keckerja kec kerja : 2-4 staf 4-6 staf

Fasilitas Kerugian < 1 000,,000 Kerugian Arjaty/

KerugianIMRK Kerugian > 50,000,00028
Kes atau tanpa menimbulkan 1,000,000 - 10,000,000 - 50,000,000
 ANALISIS HAZARD LEVEL PROBABILITAS

LEVEL DESKRIPSI CONTOH

4 Sering (Frequent) Hampir sering muncul dalam waktu yang
relative singkat (mungkin terjadi
beberapa kali dalam 1 tahun)

3 Kadang-kadang Kemungkinan akan muncul

(Occasional) (dapat terjadi bebearapa kali dalam 1
sampai 2 tahun)

2 Jarang (Uncommon) Kemungkinan akan muncul

(dapat terjadi dalam >2 sampai 5 tahun)
1 Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam
(Remote) > 5 sampai 30 tahun)

Arjaty/ IMRK 29
 HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK MAYOR MODERAT MINOR
4 3 2 1

SERING 16 12 8 4
4

KADANG 12 9 6 3
3

JARANG 8 6 4 2
2

HAMPIR TIDAK 4 3 2 1
PERNAH
1

Arjaty/ IMRK 30
 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 NO
warrant that it be
controlled?
(Hazard score of 8 or
higher) Is this a single point weakness in
NO
YES the process? (Criticality failure
results in a system failure?)
CRITICALY
YES
Does an effective control measure YES
already exist for the identified hazard? STOP
CONTROL Do not proceed
NO to find potential
causes for this
Is this hazard so obvious and readily failure mode
apparent that a control measure is not YES
warranted?
DETECTABILITY Proceed to
NO Potential
Causes for
Arjaty/ IMRK this failure 31
mode
Arjaty/ IMRK 32
Arjaty/ IMRK 33
 What is HFMECA

Prospective analysis model combines

concepts :
FMEA (Failure Mode and Effects Analysis)
RCA (Root Cause Analysis)

Modified by IMRK :
Brainstorming : Failure mode, Effect, Causes
(Da X P) x K X De, Bands

Arjaty/ IMRK 34
 LANGKAH -LANGKAH
ANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB
(AMKDP)/
HEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYS
(HFMECA)

1. Pilih Proses yang berisiko tinggi dan Bentuk

Tim
2. Gambarkan Alur Proses
3. Diskusikan & Prioritaskan Modus Kegagalan
4. Brainstorming Dampak Modus Kegagalan
5. Identifikasi Penyebab Modus Kegagalan
6. Hitung Total NPR (Nilai Prioritas Risiko) / RPN
7. Disain ulang proses / Re-disain Proses
8. Analisa & uji Proses baru
9. Implementasi & Monitor Proses baru
Arjaty/ IMRK 35
 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 36
 STEP 2 DIAGRAM THE PROCESS
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 2 3 4 5

Prescribing, Preparing
Selection & Storage
Ordering, &
Procuremen Administration
Trancribing Dispensin
t
g

Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode

Pemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drug

Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis
Sesuai kebthn) sesuai suhunya
Wrong dosage

Penulisan Obat R/
tdk R/
Dlm formularium Wrong frequence

Wrong route
administration

Arjaty/ IMRK 37
Arjaty/ IMRK 38
 RATING SYSTEM
(Modified by IMRK)

Rating Probabilitas DAMPAK Kontrol Deteksi

(P) (D) (K) (D)
1 Remote Minor effect Easy Certain to detect

2 Low likelihood Moderate effect Mpderate High likelihood

Easy

3 Moderate Minor injury Moderate Moderate

likelihood difficult likelihood

4 High likelihood Major injury Difficult Low likelihood

5 Certain to Catastrophic Almost certain

occur effect / terminal not to detect
injury, death

Risk Priority Number (RPN) / Criticaly Index (CI) = (Da x P) x K x De

Arjaty/ IMRK 39
 Sample Severity Scale
(Modified by IMRK)

Rating Description Definition

1 Minor effect or No effect May affect the individual served & would
result in some effect on the process or
Would not be noticeable to individual served
& would not affect the process

2 Moderate effect May affect the individual served & would

result in a major effect on the process

3 Minor injury Would affect the individual and result in a

major effect on the process

4 Major injury Would result in a major injury for the

individual served and have major effect on
the process

5 Catastrophic effect, a Extremely dangerous, failure would result

terminal injury or death death of the individual served and have a
major effect on the process

Source : JCR : Joint Commision Resources Arjaty/ IMRK 40

 Sample Probability of Occurrence Scale
(Modified by IMRK)

Rating Description Probability Definition

1 Remote to 1 in 10,000 No or little known occurrence highly

non existent unlikely that condition will ever occur

2 Low 1 in 5000 Possible, but no known data, the

Likelihood condition occurs in isolated cases, but
chances are low

3 Moderate 1 in 200 Documented, but infrequently, the

likelihood condition has a reasonable chance to
occur

4 High 1 in 100 Documented and frequent, the

likelihood condition occurs very regularly and / or
during a reasonable amount of time

5 Certain to 1 in 20 Documented, almost certain, the

occur condition will inevitably occur during
long periods typical for the step or link
Arjaty/ IMRK 41
 Sample Detectability Scale
(Modified by IMRK)

Rating Description Probability Definition

of
Detection

1 Certain to 10 out to 10 Almost always detected

detect immediately

2 High likelihood 7 out of 10 Likely to be detected

3 Moderate 5 out of 10 Moderate likelihood of detection

likelihood

4 Low likelihood 2 out 0f 10 Unlikely to be detected

5 Almost certain 0 out of 10 Detection not possible at any point

not to detect

Arjaty/ IMRK 42
Arjaty/ IMRK 43
 STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES
Failure Potentia Poten Severity Probabilit R Risk Control Detection RPN
Mode l effect tial y is Categor (5X8
cause k ies / X9)
s S Bands
c
o
r
e
(3
X
4)

1 2 3 4 5 1 2 3 4 5 1- L MH E 1 2 3 4 1 2 3 4 5
2
5

1 2 3 4 5 6 7 8 9 10
Wrong Death No X X 1 E X X 40
route Traini 0
administrat ng
ion
Wrong Injury No X X 1 E X X 24
frequency with recor 2
perman d in
ent loss Chart
of
function Arjaty/ IMRK 44
>
 STEP 6 CALCULATE TOTAL RPN
No Failure RPN Potential RPN Potential RPN Total Rank
Mode Failure effect effect Causes Causes RPN
Mode

1 2 3 4 5 6 7 8 9

1 Wrong route 60 Death 40 No 40 1

administrati Traini 140
on ng

2 Wrong 48 Injury with 12 No record 24 84 3

frequency permane in
nt loss Chart
of
function

3 Wrong dosage 36 No injury 36 Miss read 32 104 2

with no instru
permane ction
nt loss
of
function

4 Wrong drug 36 No injury but 16 Miss 16 68 4

LOS > > identi
ficati
on
Arjaty/ IMRK 45
 STEP 7 REDESIGN PROCESS

Process Failure Potential Potential Redesign PIC Target New Outcome

Mode Effect Causes Recommen Comple Process Measure /
datio tio Implementa Monitoring
ns n tion mechanism
date date &
for test Actions

1 2 3 4 5 6 7 8 9

Arjaty/ IMRK 46
 PREPARING TO REDESIGN
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 47
 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 48
 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

Arjaty/ IMRK 49
 REDISAIN PROSES

Decreasing variability
Variable input
Simplify
Complex Standardizing
Nonstandarized Loosen coupling of process
Tightly Coupled Use technology
Dependent on Optimise Redundancy
human intervention Built in fail safe mechanism
Documentation
Time constraints
Establishing a culture of
Hierarchical culture teamwork

Arjaty/ IMRK 50
 AMKD / HFMEA
Proses lama
yg high risk

Alur
Potential Cause Efek / Decision Tindakan
Proses
Dampak Tree
Failure K
K
Mode HS
K
E
D
T
Desain Hazard
Proses baru Kritis Kontrol
Score Kontrol Eliminasi
Deteksi Terima

Arjaty/ IMRK 51
 AMKDP / HFMECA

Total RPN Analisis &

PROSES Uji Proses
Prioritas LAMA Baru Total Implementasi
Redisign RPN
risiko PROSES BARU
Failure Proses PROSES
BARU
Mode,
Dampak,
Failure
Mode,
Penyebab Dampak,
Total RPN Penyebab
30-50%?

Arjaty/ IMRK 52
 KESIMPULAN
Building a safe
healthcare system

C K
L S F K D O
U R A R O
L T E E E N
E N T E
T P E A V M T T
A R K E R
U O A R E U
R L A U K O
R M N R N
E I I E I S L
T W I I
I S N N K I
O N
N I T I S A
R G
G S Y N I S
K
G I
L E A D E R S H I
Arjaty/ IMRK 53
P
Safety begins with you
Dont wait for someone else

Arjaty/ IMRK 54