Oleh :

Ketua Komite PMKP Rumkit Tk. II Dustira

dr. Prihati Pujowaskito, Sp.JP. (K) M.M.RS
• STRATEGI REDUKSI RISIKO
• IDENTIFIKASI PROSES YG RISIKO
TINGGI
• REDISAIN PROSES :
- FMEA
- AMKD / HFMEA
®

- AMKDP / HFMECA
®

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
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

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 pasien pada pasien5
 IDENTIFYING RISK PRONE SYSTEM

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

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.

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%

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.

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

10
 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

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. 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

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

14
 FMEA Terminology
• Process FMEA - Conduct an FMEA on a
process that is already in place

• Design FMEA – 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.
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

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
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

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

8 Implement & monitor the Analyze & test the new process
redesigned process
9 Implement & monitor the
redesigned process
19
 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)

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

22
HACCP : Hazard Analysis Critical Control Point
 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….η team Assign team members to follow up individual charged with taking
meeting plus 1 corrective action
η team meeting plus 2 Refine corrective actions based on feedback
η team meeting plus 3 Test the proposed changes
η 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

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 ___________________

24
25
26
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 Terjadi pada > 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 Kerugian Kerugian > 50,000,00028

Kes atau tanpa 1,000,000 - 10,000,000 - 50,000,000
menimbulkan dampak 10,000,000
 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)

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

30
 Decision Tree
Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
di“Proceed”..
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
31
this failure
mode
32
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

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

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 _______________________

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

37
Failure points where medication errors occur

Prescribing Transcribing Dispensing Administering

39% 12% 11% 38%

38
J AMA 1995 J ul 5,274(1):29-34
 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

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 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

42
 CONTROLLABILITY
Rating Desription Definition
1 Easy Comprehensive effective controls fully in place, communicated,
complied with, maintained, monitored, reviewed & tested
regularly. All that is practicable to be done is being done or
Risk can be introduced 1 month / or low cost or
2 Moderate Sufficient effective controls procedures are substantially in place
easy for specific circumstances, communicated & are complied with
periodic reviews are conducted or
Controls can be introduced to reduce risk to an acceptable level
within 1 year – or at cost
3 Moderate Controls are either not practically in place not effective, not
difficult communicated and or not complied with no reviews undertaken or
Controls can be introduced to reduce risk to an acceptable level but
will take longer than 1 year or entail significant effort or expensive
4 Difficult Controls and Status are unknown or Residual risk

43
 STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES
Failure Mode Potential Potenti Severity Probabilit Ri Risk Control Detection RPN
effect al y sk Categor (5X8X
causes S ies / 9)
co Bands
re
(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
25

1 2 3 4 5 6 7 8 9 10
Wrong route Death No X X 10 E X X 40
administratio Trainin
n g
Wrong Injury No X X 12 E X X 24
frequency with record
permanen in
t loss of Chart
function
>
Wrong No injury Miss X X 8 H X X 32
dosage with no read
permanen instruc
t loss of tion
function
Wrong drug No injury Miss X X 4 H X X 44 16
but LOS > identifi
 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
administrati
60 Death 40 No
Traini
40
140 1
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
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 mechanis
date date & m
for test Actions

1 2 3 4 5 6 7 8 9

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

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 ?
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

49
 REDISAIN PROSES

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

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

51
 AMKDP / HFMECA

Total RPN Analisis &

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

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 P
53
Safety begins with you
Don’t wait for someone else

Arjaty/ IMRK 54