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Dr Dr Arjaty Arjaty W W Daud Daud MARS MARS

HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS /
ANALISIS MODUS KEGAGALAN DAN DAMPAK
HEALTHCARE FAILURE MODE EFFECT AND CAUSES ANALYSIS /
ANALISIS MODUS KEGAGALAN DAN DAMPAK
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PENDAHULUAN
PENDAHULUAN

STRATEGI REDUKSI RISIKO
STRATEGI REDUKSI RISIKO

REDISIGN PROSES :
REDISIGN PROSES :
-
-
HFMEA / AMKD
HFMEA / AMKD
-
-
HFMECA / AMKDP
HFMECA / AMKDP
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PRINSIP UTAMA
PRINSIP UTAMA

Bangun
Bangun
sistem
sistem
yang
yang
mudah
mudah
agar
agar
ORANG MUDAH
ORANG MUDAH
UNTUK BERBUAT BENAR
UNTUK BERBUAT BENAR

Pastikan
Pastikan
bahwa
bahwa
perubahan
perubahan
yang
yang
dibuat
dibuat
dapat
dapat
dinilai
dinilai
,
,
dievaluasi
dievaluasi
risikonya
risikonya
dan
dan
berkesinambungan
berkesinambungan
pada
pada
jangka
jangka
panjang
panjang
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RISK REDUCTION STRATEGIES DIFFICULTY
RISK REDUCTION STRATEGIES DIFFICULTY
& LONG TERM EFFECTIVENESS
& LONG TERM EFFECTIVENESS
Types of actions Degree of Long Types of actions Degree of Long term term
difficulty difficulty effectiveness effectiveness
Easy Easy Low Low
Punitive Punitive
Retraining / counseling Retraining / counseling

Process redesign
Process redesign
“ “Paper Paper vs vs practice practice” ”
Technical system enhance Technical system enhance
Culture change Culture change
Difficult Difficult High High
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STRATEGI MEREDUKSI RI SI KO
STRATEGI MEREDUKSI RI SI KO

Identifikasi
Identifikasi
risiko
risiko
dgn
dgn
bertanya
bertanya
3
3
pertanyaan
pertanyaan
dasar
dasar
:
:

1.
1.
Apa
Apa
prosesnya
prosesnya
?
?
2.
2.
Dimana
Dimana


risk points
risk points


?
?
3.
3.
Apa
Apa
yg
yg
dapat
dapat
dimitigate
dimitigate
pada
pada
dampak
dampak


risk points
risk points


?
?
Definisi Proses
Transformasi input menjadi output yg berkaitan dgn
Kejadian, aktivitas dan mekanisme yg terstruktur
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STRATEGI DESI GN MEREDUKSI RI SI KO
STRATEGI DESI GN MEREDUKSI RI SI KO
RENCANA
REDUKSI RISIKO
Design Proses u/
Meminimalkan
risiko
kegagalan
Design Proses u/
Mengurangi
Dampak
Kegagalan terjadi
pada pasien
Design Proses u/
Meminimalkan
risiko
Kegagalan terjadi
Pada pasien
RISK
POINTS /
COMMON CAUSES
STRATEGI REDUKSI
RISIKO
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CONTOH STRATEGI DESIGN REDUKSI RISIKO CONTOH STRATEGI DESIGN REDUKSI RISIKO
“ “SALAH BAGIAN YG DIOPERASI SALAH BAGIAN YG DIOPERASI ” ”
REDUKSI RISIKO
SALAH
OPERASI
REDUKSI KEGAGALAN PREOP :
• Tandai bgn yg akan Dioperasi
• informed consent
•Verifikasi pasien/keluarga o/SpB
& SpAn
•Review X-ray
• Recheck alat
REDUKSI KEGAGALAN DI OK :
• Verifikasi sebelum“prep & drape”
• Pastikan “tanda” masih terlihat
setelah “draping”
• “Timeout” / Verifikasi verbal
Komunikasi
Pre operatif
Komunikasi
Di OK
Komunikasi
Berdsrkan
Hirarki
Komunikasi dgn
Pasien
/Kelurga
Ketersediaan
Informasi
Akurasi
X-ray
RISK
POINTS
STRATEGI
REDUKSI
RISIKO
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REDISIGN PROSES
REDISIGN PROSES
PROAKTIF RISK ASSESSMENT
PROAKTIF RISK ASSESSMENT
•FMEA
•HFMEA / AMKD
•HFMECA / AMKDP
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Systematic method of identifying &
Systematic method of identifying &
preventing process and product problems
preventing process and product problems
before they occur.
before they occur.

Proactive risk assessment tool
Proactive risk assessment tool

A team based, systematic, and proactive
A team based, systematic, and proactive
approach for identifying the ways a
approach for identifying the ways a
process or design can fail, why it might
process or design can fail, why it might
fail, and how it can be made safer.
fail, and how it can be made safer.
What is FMEA?
What is FMEA?
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FMEA Terminology
FMEA Terminology

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

Design FMEA
Design FMEA


Conduct an FMEA before a
Conduct an FMEA before a
process is put into place
process is put into place


Implementing an electronic medical records
Implementing an electronic medical records
or other automated systems
or other automated systems


Purchasing new equipment
Purchasing new equipment


Redesigning Emergency Room, Operating
Redesigning Emergency Room, Operating
Room, Floor, etc.
Room, Floor, etc.
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FAI LURE MODE AND EFFECTS ANALYSI S
FAI LURE MODE AND EFFECTS ANALYSI S
FAILURE (F) FAILURE (F) : When a system or part of a system : When a system or part of a system
performs in a way that is not performs in a way that is not
intended or desirable intended or desirable
MODE (M) MODE (M) : The way or manner in which : The way or manner in which
something such as a failure can something such as a failure can
happen. Failure mode is the happen. Failure mode is the
manner in which something can manner in which something can
fail. fail.
EFFECTS (E) EFFECTS (E) : The results or consequences of a : The results or consequences of a
failure mode failure mode
Analysis (A) Analysis (A) : The detailed examination of the : The detailed examination of the
elements or structure of a process elements or structure of a process
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Can prevent errors &
Can prevent errors &
nearmisses
nearmisses

protecting
protecting
patients from harm.
patients from harm.

Can increase the effectiveness & efficiency of
Can increase the effectiveness & efficiency of
process
process

Taking a proactive approach to patient safety
Taking a proactive approach to patient safety
also makes
also makes
goodbusiness
goodbusiness
sense in a health care
sense in a health care
environment that is increasingly facing demands
environment that is increasingly facing demands
from consumers, regulators & payers to create
from consumers, regulators & payers to create
culture focused on reducing risk & increasing
culture focused on reducing risk & increasing
accountability
accountability
Why should my organization
Why should my organization
conduct an FMEA ?
conduct an FMEA ?
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FMEA has been around for over 30 years
FMEA has been around for over 30 years

Recently gained widespread appeal
Recently gained widespread appeal
outside of safety area
outside of safety area

New to healthcare
New to healthcare


Frequently used reliability & system safety
Frequently used reliability & system safety
analysis techniques
analysis techniques


Long industry track record
Long industry track record
Where did FMEA come from ?
Where did FMEA come from ?
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What is HFMEA ?
What is HFMEA ?
Modified by VA NCPS Modified by VA NCPS
Focus on preventing defects, enhancing safety, increase Focus on preventing defects, enhancing safety, increase
positive outcome and increase patient satisfaction positive outcome and increase patient satisfaction
The objective is to look for all ways for process or product The objective is to look for all ways for process or product
can fail can fail
The famous question : The famous question : “ “What is could happen? What is could happen?” ” Not Not “ “What What
does happen ? does happen ?” ”
Hybrid prospective analysis model combines concepts : Hybrid prospective analysis model combines concepts :
FMEA (Failure Mode and Effects Analysis) FMEA (Failure Mode and Effects Analysis)
HACCP (Hazard Analysis Critical Control Points) HACCP (Hazard Analysis Critical Control Points)
RCA (Root Cause Analysis) RCA (Root Cause Analysis)
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HFMEA Components and Their Origins
HFMEA Components and Their Origins
V V # # V V Responsible person Responsible person
& management & management
concurrence concurrence
V V # # V V Actions & Outcomes Actions & Outcomes
V V V V Decision Tree Decision Tree
V V # # V V Severity & Severity &
Probability Probability
Definitions Definitions
V V V V Hazard Scoring Hazard Scoring
Matrix Matrix
V V V V Failure mode & Failure mode &
causes causes
V V V V V V Diagramming Diagramming
process process
V V V V V V Team membership Team membership
RCA RCA HACCP HACCP FMEA FMEA HFMEA HFMEA Concepts Concepts
HACCP : Hazard Analysis Critical Control Point
1.
1.
Tetapkan
Tetapkan
Topik
Topik
AMKD
AMKD
2.
2.
Bentuk
Bentuk
Tim
Tim
3.
3.
Gambarkan
Gambarkan
Alur
Alur
Proses
Proses
4.
4.
Buat
Buat
Hazard Analysis
Hazard Analysis
5.
5.
Tindakan
Tindakan
dan
dan
Pengukuran
Pengukuran
Outcome
Outcome
LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS
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LANGKAH 1 : PI LI H PROSES YANG BERISIKO TINGGI LANGKAH 1 : PI LI H PROSES YANG BERISIKO TINGGI
Pilih Pilih Proses Proses berisiko berisiko tinggi tinggi yang yang akan akan dianalisa dianalisa. .
J udul J udul Proses Proses : :
________________________________________________________________ __________________________________________________________________________ __________
_________________________________________________________ _________________________________________________________
_________________________________________________________ _________________________________________________________
LANGKAH 2 : BENTUK TI M LANGKAH 2 : BENTUK TI M
Ketua Ketua : ________________________________________ : ____________________________________________________________ ____________________
Anggota Anggota 1. _______________ 1. _______________ 4. ________________________________________ 4. ________________________________________
2. _______________ 5 2. _______________ 5. ________________________________________ . ________________________________________
3. _______________ 6 3. _______________ 6. ________________________________________ . ________________________________________
Notulen Notulen? ? _________________________________________ _________________________________________
Apakah Apakah semua semua Unit yang Unit yang terkait terkait dalam dalamProses Proses sudah sudah terwakili terwakili ? ? YA / TIDAK YA / TIDAK
Tanggal Tanggal dimulai dimulai ____________________ ____________________ Tanggal Tanggal selesai selesai ______________________________ ______________________________
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ANALISIS HAZARD ANALISIS HAZARD “ “LEVEL DAMPAK LEVEL DAMPAK” ”
Kerugian >50,000,000 Kerugian >50,000,000 Kerugian Kerugian
10,000,000 10,000,000 - - 50,000,000 50,000,000
Kerugian Kerugian
1,000,000 1,000,000 - - 10,000,000 10,000,000
Kerugian <1 000,,000 / Kerugian <1 000,,000 /
tnp menimbulkan dampak tnp menimbulkan dampak
terhadap pasien terhadap pasien
Fasilita Fasilita
s Kes s Kes
Kematian Kematian
Perawatan >6 staf Perawatan >6 staf
Cedera luas / berat Cedera luas / berat
Perlu dirawat Perlu dirawat
K Kehilangan waktu / ehilangan waktu /
kecelakaan kerja kecelakaan kerja pada pada
4 4- -6 staf 6 staf
Cedera ringan Cedera ringan
Ada Penanganan / Ada Penanganan /
Tindakan Tindakan
K Kehilangan waktu / ehilangan waktu /
kec kerja kec kerja : 2 : 2- -4 staf 4 staf
Tidak ada cedera Tidak ada cedera
Tidak ada penanganan Tidak ada penanganan
Terjadi pada 1 Terjadi pada 1- -2 staf 2 staf
Tidak ada kerugian Tidak ada kerugian
waktu / kec kerja waktu / kec kerja
Staf: Staf:
Kematian Kematian
Terjadi pada >6 orang Terjadi pada >6 orang
pengunjung pengunjung
Cedera luas / berat Cedera luas / berat
Perlu dirawat Perlu dirawat
Terjadi pada 4 Terjadi pada 4 - -6 orang 6 orang
pengunjung pengunjung
Cedera ringan Cedera ringan
Ada Penanganan Ada Penanganan
Terjadi pada 2 Terjadi pada 2 - -4 4
pengunjung pengunjung
Tidak ada cedera Tidak ada cedera
Tidak ada penanganan Tidak ada penanganan
Terjadi pada 1 Terjadi pada 1- -2 org 2 org
pengunjung pengunjung
Pengun Pengun
jung jung
Kematian Kematian
Kehilangan fungsi tubuh Kehilangan fungsi tubuh
sec permanent (sensorik, sec permanent (sensorik,
motorik, psikologik / motorik, psikologik /
intelektual) intelektual)
Operasi pada bagian / pd Operasi pada bagian / pd
pasien yg salah, pasien yg salah,
Tertukarnya bayi Tertukarnya bayi
Cedera luas / berat Cedera luas / berat
Perpanjangan hari rawat Perpanjangan hari rawat
lebih lama ( lebih lama (+ +>1 bln) >1 bln)
Berkurangnya fungsi Berkurangnya fungsi
permanen organ tubuh permanen organ tubuh
(sensorik / motorik / (sensorik / motorik /
psikcologik / intelektual) psikcologik / intelektual)
Cedera ringan Cedera ringan
Ada Perpanjangan Ada Perpanjangan
hari rawat hari rawat
Tidak ada cedera, Tidak ada cedera,
Tidak ada perpanjangan Tidak ada perpanjangan
hari rawat hari rawat
Pasien Pasien
Kegagalan menyebabkan Kegagalan menyebabkan
kerugian besar kerugian besar
Kegagalan Kegagalanmenyebabkan menyebabkan
kerugian berat kerugian berat
Kegagalan dapat Kegagalan dapat
mempengaruhi proses mempengaruhi proses
dan menimbulkan dan menimbulkan
kerugian ringan kerugian ringan
Kegagalan Kegagalanyang yang tidak tidak
mengganggu menggangguProses Proses
pelayanan pelayanankepada kepadaPasien Pasien
KATASTROPIK KATASTROPIK
4 4
MAYOR MAYOR
3 3
MODERAT MODERAT
2 2
MINOR MINOR
1 1
DAMPA DAMPA
K K
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ANALISIS ANALISIS HAZARD HAZARD ” ”LEVEL PROBABILITAS LEVEL PROBABILITAS” ”
Jarang sekali terjadi (dapat terjadi dalam Jarang sekali terjadi (dapat terjadi dalam
> 5 sampai 30 tahun) > 5 sampai 30 tahun)
Hampir Tidak Pernah Hampir Tidak Pernah
(Remote) (Remote)
1 1
Kemungkinan akan muncul Kemungkinan akan muncul
(dapat terjadi dalam >2 sampai 5 tahun) (dapat terjadi dalam >2 sampai 5 tahun)
Jarang Jarang (Uncommon) (Uncommon) 2 2
Kemungkinan Kemungkinan akan akan muncul muncul
( (dapat dapat terjadi terjadi bebearapa bebearapa kali kali dalam dalam 1 1
sampai sampai 2 2 tahun tahun) )
Kadang Kadang- -kadang kadang
(Occasional) (Occasional)
3 3
Hampir sering muncul dalam waktu yang Hampir sering muncul dalam waktu yang
relative singkat (mungkin terjadi relative singkat (mungkin terjadi
beberapa kali dalam 1 tahun) beberapa kali dalam 1 tahun)
Sering Sering (Frequent) (Frequent) 4 4
CONTOH CONTOH DESKRIPSI DESKRIPSI LEVEL LEVEL
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1 1 2 2 3 3 4 4
HAMPIR TIDAK HAMPIR TIDAK
PERNAH PERNAH
1 1
2 2 4 4 6 6 8 8
JARANG JARANG
2 2
3 3 6 6 9 9 12 12
KADANG KADANG
3 3
4 4 8 8 12 12 16 16
SERING SERING
4 4
MINOR MINOR
1 1
MODERAT MODERAT
2 2
MAYOR MAYOR
3 3
KATASTROPIK KATASTROPIK
4 4
TINGKAT BAHAYA TINGKAT BAHAYA
HAZARD SCORE
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Does this hazard involve a
sufficient likelihood of
occurrence and severity to
warrant that it be
controlled?
(Hazard score of 8 or
higher)
Is this a single point weakness in
the process? (Criticality – failure
results in a system failure?)
CRITICALY
Does an effective control measure
already exist for the identified hazard?
CONTROL
Is this hazard so obvious and readily
apparent that a control measure is not
warranted?
DETECTABILITY
STOP
NO
NO
NO
NO
YES
YES
YES
YES
Proceed to
Potential
Causes for
this failure
mode
Do not proceed
to find potential
causes for this
failure mode
Decision Tree
Decision Tree
Gunakan Gunakan Decision Tree Decision Tree utk utk menentukan menentukan apakah apakah modus modus perlu perlu tindakan tindakan lanjut lanjut
di di“ “Proceed Proceed” ”. .. .
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STEP 4 & 5
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LANGKAH LANGKAH - -LANGKAH LANGKAH
ANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB ANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB
(AMKDP)/ (AMKDP)/
HEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYS HEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYS
(HFMECA) (HFMECA)
1. 1.
Pilih
Pilih
Proses
Proses
yang
yang
berisiko
berisiko
tinggi
tinggi
dan
dan
Bentuk
Bentuk
Tim
Tim
2. 2.
Gambarkan
Gambarkan
Alur
Alur
Proses
Proses
3.
3.
Diskusikan
Diskusikan
&
&
Prioritaskan
Prioritaskan
Modus
Modus
Kegagalan
Kegagalan
4.
4.
Brainstorming
Brainstorming
Dampak
Dampak
Modus
Modus
Kegagalan
Kegagalan
5.
5.
Identifikasi
Identifikasi
Penyebab
Penyebab
Modus
Modus
Kegagalan
Kegagalan
6.
6.
Hitung
Hitung
Total NPR
Total NPR
(
(
Nilai
Nilai
Prioritas
Prioritas
Risiko
Risiko
)
)
7.
7.
Disain
Disain
ulang
ulang
proses
proses
/
/
Re
Re
-
-
disain
disain
Proses
Proses
8.
8.
Analisa
Analisa
&
&
uji
uji
Proses
Proses
baru
baru
9.
9.
Implementasi
Implementasi
& Monitor
& Monitor
Proses
Proses
baru
baru
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LANGKAH 1 : LANGKAH 1 :
PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM
Pilih Pilih Proses Proses berisiko berisiko tinggi tinggi yang yang akan akan dianalisa dianalisa. .
J udul J udul Proses Proses : ___________________________________________ : ___________________________________________
BENTUK TIM BENTUK TIM
Ketua Ketua : :
____________________________________________________________ ____________________________________________________________
Anggota Anggota 1. _______________ 1. _______________ 4. 4.
________________________________________ ________________________________________
2. _______________ 5 2. _______________ 5. .
________________________________________ ________________________________________
3. _______________ 6 3. _______________ 6. .
________________________________________ ________________________________________
Notulen Notulen _________________________________________ _________________________________________
Apakah Apakah semua semua Unit yang Unit yang terkait terkait dalam dalamProses Proses sudah sudah terwakili terwakili ? ? YA / TIDAK YA / TIDAK
Tanggal Tanggal dimulai dimulai _________________ _________________ Tanggal Tanggal selesai selesai _______________________ _______________________
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Input yang
Input yang
bervariasi
bervariasi

Kompleks
Kompleks

Tidak
Tidak
ada
ada
standard
standard

Sangat
Sangat
tergantung
tergantung
pada
pada
individu
individu

Tingkat
Tingkat
hirarki
hirarki
terlalu
terlalu
kaku
kaku

Beban
Beban
kerja
kerja
berlebihan
berlebihan

Banyak
Banyak
waktu
waktu
terbuang
terbuang
KARAKTERISTIK PROSES
KARAKTERISTIK PROSES
BERI SI KO TI NGGI
BERI SI KO TI NGGI
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Administering
Failure points where medication errors occur Failure points where medication errors occur
Transcribing
Prescribing
Dispensing
39% 12% 11% 38%
J AMA 1995 J ul 5,274(1):29-34
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STEP 2 DIAGRAM THE PROCESS STEP 2 DIAGRAM THE PROCESS
PROCESS STEPS : PROCESS STEPS :
Describe the process graphically, according to your policy & pro Describe the process graphically, according to your policy & procedure for the activity and number each one cedure for the activity and number each one
If the process is complex you may want to select one process st If the process is complex you may want to select one process step or sub process to work on ep or sub process to work on
1 2 3 1 2 3 4 5 4 5
Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode
Pemesanan Pemesanan obat obat Penyimpanan Penyimpanan Penulisan Penulisan obat obat Peracikan Peracikan obat obat Wrong drug Wrong drug
Berlebihan (tdk vaksin tdk dl Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis m R/ tdk jls tdk sesuai dosis
Sesuai Sesuai kebthn kebthn) ) sesuai sesuai suhunya suhunya
Wrong dosage Wrong dosage
Penulisan Penulisan Obat R/ Obat R/
tdk tdk R/ R/ Dlm Dlmformularium formularium Wrong Wrong frequence frequence
Wrong route Wrong route
administration administration
Selection &
Procuremen
t
Storage
Prescribing,
Ordering,
Trancribing
Preparing
&
Dispensin
g
Administration
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Langkah
Langkah
2,3
2,3
Gambarkan
Gambarkan
Alur
Alur
Proses
Proses
Diskusikan
Diskusikan
&
&
Prioritaskan
Prioritaskan
Modus
Modus
Kegagalan
Kegagalan
Selection,
Procurement &
Storage
Prescribing /
Ordering &
Transcribing
Preparing
&
Dispensing
Administration
The Medication Management Processes
Physician writen order
Medication order
Order pulled from chart
Order transcribed
by clerk
•Writing illegible
•Order incomplete
•Non formulary drug
Failure Mode
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RATING SYSTEM
RATING SYSTEM
(Modified by IMRK) (Modified by IMRK)
Certain to occur Certain to occur
High likelihood High likelihood
Moderate Moderate
likelihood likelihood
Low likelihood Low likelihood
Remote Remote
Probabilitas Probabilitas
(P) (P)
Difficult Difficult
Moderate Moderate
difficult difficult
Mpderate Mpderate Easy Easy
Easy Easy
Kontrol Kontrol
(K) (K)
High likelihood High likelihood Moderate effect Moderate effect 2 2
Almost certain Almost certain
not to detect not to detect
Catastrophic effect / Catastrophic effect /
terminal injury, death terminal injury, death
5 5
Low likelihood Low likelihood Major injury Major injury 4 4
Moderate Moderate
likelihood likelihood
Minor injury Minor injury 3 3
Certain to detect Certain to detect Minor effect Minor effect 1 1
Deteksi Deteksi
(D) (D)
DAMPAK DAMPAK
(D) (D)
Rating Rating
Risk Priority Number (RPN) / Criticaly Index (CI) = (D x P) x K xD
8/7/2006 8/7/2006 Arjaty Arjaty 41 41
DETERMINING RISK & CRITICALITY FOR PRIORITY RANKING DETERMINING RISK & CRITICALITY FOR PRIORITY RANKING
48 48 4 4 3 3 4 4 E 4a E 4a FM 4 FM 4
2 2 72 72 27 27 3 3 3 3 3 3 E 3b E 3b
2 2 72 72 24 24 3 3 2 2 4 4 E 4b E 4b
45 45 3 3 3 3 5 5 E 3a E 3a FM 3 FM 3
3 3 51 51 24 24 2 2 3 3 4 4 E 2b E 2b
27 27 3 3 3 3 3 3 E 2a E 2a FM 2 FM 2
1 1 116 116 80 80 5 5 4 4 4 4 E 1b E 1b
36 36 4 4 3 3 3 3 E 1a E 1a FM 1 FM 1
Rank Rank Crit Crit RPN RPN Det Det Prob Prob Sev Sev Effect Effect Failure Failure
Mode Mode
Most critical Failure mode
Most severe effect
?
8/7/2006 8/7/2006 Arjaty Arjaty 42 42
Sample Severity Scale
(Modified by IMRK)
Extremely dangerous, failure would result Extremely dangerous, failure would result
death of the individual served and have a death of the individual served and have a
major effect on the process major effect on the process
Catastrophic effect, a Catastrophic effect, a
terminal injury or death terminal injury or death
5 5
Would result in a major injury for the Would result in a major injury for the
individual served and have major effect on individual served and have major effect on
the process the process
Major injury Major injury
4 4
Would affect the individual and result in a Would affect the individual and result in a
major effect on the process major effect on the process
Minor injury Minor injury
3 3
May affect the individual served & would May affect the individual served & would
result in a major effect on the process result in a major effect on the process
Moderate effect Moderate effect
2 2
May affect the individual served & would May affect the individual served & would
result in some effect on the process or result in some effect on the process or
Would not be noticeable to individual served Would not be noticeable to individual served
& would not affect the process & would not affect the process
Minor effect or No effect Minor effect or No effect
1 1
Definition Definition Description Description Rating Rating
Source : JCR : Joint Commision Resources
8/7/2006 8/7/2006 Arjaty Arjaty 43 43
1 in 20 1 in 20
1 in 100 1 in 100
1 in 200 1 in 200
1 in 5000 1 in 5000
1 in 10,000 1 in 10,000
Probability Probability
Documented, almost certain, the Documented, almost certain, the
condition will inevitably occur during condition will inevitably occur during
long periods typical for the step or link long periods typical for the step or link
Certain to Certain to
occur occur
5 5
Documented and frequent, the Documented and frequent, the
condition occurs very regularly and / or condition occurs very regularly and / or
during a reasonable amount of time during a reasonable amount of time
High High
likelihood likelihood
4 4
Documented, but infrequently, the Documented, but infrequently, the
condition has a reasonable chance to condition has a reasonable chance to
occur occur
Moderate Moderate
likelihood likelihood
3 3
Possible, but no known data, the Possible, but no known data, the
condition occurs in isolated cases, but condition occurs in isolated cases, but
chances are low chances are low
Low Low
Likelihood Likelihood
2 2
No or little known occurrence highly No or little known occurrence highly
unlikely that condition will ever occur unlikely that condition will ever occur
Remote to Remote to
non existent non existent
1 1
Definition Definition Description Description Rating Rating
Sample Probability of Occurrence Scale
(Modified by IMRK)
8/7/2006 8/7/2006 Arjaty Arjaty 44 44
Sample Detectability Scale
(Modified by IMRK)
0 out of 10 0 out of 10
2 out 0f 10 2 out 0f 10
5 out of 10 5 out of 10
7 out of 10 7 out of 10
10 out to 10 10 out to 10
Probability of Probability of
Detection Detection
Detection not possible at any point Detection not possible at any point Almost certain Almost certain
not to detect not to detect
5 5
Unlikely to be detected Unlikely to be detected Low likelihood Low likelihood
4 4
Moderate likelihood of detection Moderate likelihood of detection Moderate Moderate
likelihood likelihood
3 3
Likely to be detected Likely to be detected High likelihood High likelihood
2 2
Almost always detected immediately Almost always detected immediately Certain to detect Certain to detect
1 1
Definition Definition Description Description Rating Rating
8/7/2006 8/7/2006 Arjaty Arjaty 45 45
CONTROLLABILITY
Controls and Status are unknown or Residual risk Difficult 4
Controls are either not practically in place not effective, not
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
Moderate
difficult
3
Sufficient effective controls procedures are substantially in place
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
Moderate
easy
2
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
Easy 1
Definition Desription Rating
8/7/2006 8/7/2006 Arjaty Arjaty 46 46
LANGKAH 3 LANGKAH 3
BRAINSTORMING POTENSIAL MODUS KEGAGALAN & BUAT BRAINSTORMING POTENSIAL MODUS KEGAGALAN & BUAT
PRI ORI TAS MODUS PRI ORI TAS MODUS KEGAGALAN KEGAGALAN
1 1 60 60 x x x x x x 15 15 x x x x Wrong route Wrong route
administratio administratio
n n
2 2 48 48 X X X X X X 12 12 X X X X Wrong Wrong
Frequence Frequence
3 3 36 36 X X X X X X 9 9 X X X X Wrong dose Wrong dose
4 4 36 36 X X X X X X 6 6 X X x x Wrong drug Wrong drug Admini Admini
stratio stratio
n n
5 5
5 5
4 4 3 3 2 2 1 1 4 4 3 3 2 2 1 1 E E H H M M L L 1 1- -
25 25
5 5 4 4 3 3 2 2 1 1 5 5 4 4 3 3 2 2 1 1
10 10 9 9 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1
Ranki Ranki
ng ng
Modu Modu
s s
Kegag Kegag
alan alan
NP NP
R R
(5X (5X
7X 7X
8 8
Deteksi Deteksi Kontro Kontro
l l
Bands Bands Sk Sk
or or
Ri Ri
si si
ko ko
(3 (3
X4 X4
) )
Probabilit Probabilit
as as
Bahaya Bahaya Modus Modus
Kegagalan Kegagalan
Proses Proses
8/7/2006 8/7/2006 Arjaty Arjaty 47 47
STEP 4 BRAINSTORMING EFFECTS OF FAILURE MODES STEP 4 BRAINSTORMING EFFECTS OF FAILURE MODES
16 16 X X X X M M 8 8 X X X X No injury but No injury but
LOS > > LOS > >
Wrong drug Wrong drug
36 36 X X X X H H 12 12 X X X X No injury with No injury with
no permanent no permanent
loss of function loss of function
Wrong Wrong
dosage dosage
12 12 X X X X E E 12 12 X X X X Injury with Injury with
permanent loss permanent loss
of function of function
Wrong Wrong
frequency frequency
40 40 X X X X E E 10 10 X X X X Death Death Wrong Wrong
route route
administrati administrati
on on
5 5 4 4 3 3 2 2 1 1 4 4 3 3 2 2 1 1 E E H H M M L L 1 1- -25 25 5 5 4 4 3 3 2 2 1 1 5 5 4 4 3 3 2 2 1 1
R R
P P
N N
(5 (5
X X
8 8
X X
9) 9)
Detection Detection Control Control Risk Risk
Categori Categori
es / es /
Bands Bands
Risk Risk
Scor Scor
e e
(3X4 (3X4
) )
Probability Probability Severity Severity Potential effect Potential effect Failure Failure
Mode Mode
10 10 9 9 8 8 6 6 5 5 4 4 3 3 2 2 1 1
8/7/2006 8/7/2006 Arjaty Arjaty 48 48
STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES
16 16 X X X X H H 4 4 X X X X Miss Miss
identific identific
ation ation
No injury but No injury but
LOS > LOS >
Wrong drug Wrong drug
32 32 X X X X H H 8 8 X X X X Miss Miss
read read
instruct instruct
ion ion
No injury No injury
with no with no
permanent permanent
loss of loss of
function function
Wrong Wrong
dosage dosage
24 24 X X X X E E 1 1
2 2
X X X X No No
record record
in Chart in Chart
Injury with Injury with
permanent permanent
loss of loss of
function > function >
Wrong Wrong
frequency frequency
40 40 X X X X E E 1 1
0 0
X X X X No No
Training Training
Death Death Wrong Wrong
route route
administrati administrati
on on
5 5 4 4 3 3 2 2 1 1 4 4 3 3 2 2 1 1 E E H H M M L L 1 1- -
2 2
5 5
5 5 4 4 3 3 2 2 1 1 5 5 4 4 3 3 2 2 1 1
RPN RPN
(5X8X9) (5X8X9)
Detection Detection Control Control Risk Risk
Categor Categor
ies / ies /
Bands Bands
Ri Ri
sk sk
Sc Sc
or or
e e
(3 (3
X X
4) 4)
Probabilit Probabilit
y y
Severity Severity Potenti Potenti
al al
causes causes
Potential Potential
effect effect
Failure Failure
Mode Mode
10 10 9 9 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1
8/7/2006 8/7/2006 Arjaty Arjaty 49 49
Identify root causes of failure modes
Identify root causes of failure modes
8/7/2006 8/7/2006 Arjaty Arjaty 50 50
STEP 6 CALCULATE TOTAL RPN STEP 6 CALCULATE TOTAL RPN
4 4
68 68
16 16 Miss Miss
iden iden
tifica tifica
tion tion
16 16 No injury No injury
but LOS but LOS
> > > >
36 36 Wrong drug Wrong drug 4 4
2 2
104 104
32 32 Miss Miss
read read
instr instr
uctio uctio
n n
36 36 No injury No injury
with no with no
perman perman
ent loss ent loss
of of
function function
36 36 Wrong dosage Wrong dosage 3 3
3 3
84 84
24 24 No No
reco reco
rd in rd in
Char Char
t t
12 12 Injury with Injury with
perman perman
ent loss ent loss
of of
function function
48 48 Wrong frequency Wrong frequency 2 2
1 1
140 140
40 40 No No
Trai Trai
ning ning
40 40 Death Death 60 60 Wrong route Wrong route
administratio administratio
n n
1 1
Rank Rank
Total Total
RPN RPN
RPN RPN
Causes Causes
Potenti Potenti
al al
Causes Causes
RPN RPN
effect effect
Potential Potential
effect effect
RPN RPN
Failure Failure
Mode Mode
Failure Failure
Mode Mode
No No
9 9
8 8
7 7 6 6 5 5 4 4 3 3 2 2 1 1
8/7/2006 8/7/2006 Arjaty Arjaty 51 51
STEP 7 REDESIGN PROCESS STEP 7 REDESIGN PROCESS
Outcome Outcome
Measure / Measure /
Monitoring Monitoring
mechanism mechanism
New New
Process Process
I mplement I mplement
ation ation
date & date &
Actions Actions
Target Target
Completi Completi
on on
date date
for test for test
PIC PIC Redesign Redesign
Recomme Recomme
ndatio ndatio
ns ns
Potenti Potenti
al al
Causes Causes
Potenti Potenti
al al
Effect Effect
Failure Failure
Mode Mode
Proces Proces
s s
9 9 8 8 7 7 6 6 5 5 4 4 3 3 2 2 1 1
8/7/2006 8/7/2006 Arjaty Arjaty 52 52

TAKE A DEEP BREATH
TAKE A DEEP BREATH

Conduct a literature search to gather
Conduct a literature search to gather
relevant information from the professional
relevant information from the professional
literature. Do not reinvent the wheel
literature. Do not reinvent the wheel

Network with colleagues
Network with colleagues

Recommit to out of the box thinking
Recommit to out of the box thinking
Preparing to Redesign
Preparing to Redesign
8/7/2006 8/7/2006 Arjaty Arjaty 53 53
Ways to Redesign
Ways to Redesign

Decrease variability
Decrease variability

Standardize
Standardize

Simplify
Simplify

Optimize redundancy
Optimize redundancy

Use technology to automate
Use technology to automate

Build in fail safe mechanisms
Build in fail safe mechanisms

Document
Document

Loosen coupling of process steps
Loosen coupling of process steps
Redesign the process
Redesign the process
8/7/2006 8/7/2006 Arjaty Arjaty 54 54
Langkah
Langkah
8
8
Analisis
Analisis
dan
dan
Uji
Uji
Proses
Proses
baru
baru

The team again
The team again
completes steps 2, step 3
completes steps 2, step 3
and step 4
and step 4

Then the team should calculate a new
Then the team should calculate a new
criticality index (CI) or RPN. Design
criticality index (CI) or RPN. Design
improvements should bring reduction in
improvements should bring reduction in
the CI / RPN. Ex: 30
the CI / RPN. Ex: 30


50% reduction ?
50% reduction ?
8/7/2006 8/7/2006 Arjaty Arjaty 55 55
Langkah
Langkah
9
9
Implementasi
Implementasi
dan
dan
Monitoring
Monitoring
Proses
Proses
Strategies for Creating & Managing the Change Process : Strategies for Creating & Managing the Change Process :
1. 1. Establish a sense of urgency Establish a sense of urgency
2. 2. Create a guiding coalition Create a guiding coalition
3. 3. Develop a vision and strategy Develop a vision and strategy
4. 4. Communicate the changed vision Communicate the changed vision
5. 5. Empower broad based action Empower broad based action
6. 6. Generate short term wins Generate short term wins
7. 7. Consolidate gains and produce more change Consolidate gains and produce more change
8. 8. Anchor new approaches in the culture Anchor new approaches in the culture
8/7/2006 8/7/2006 Arjaty Arjaty 56 56
FMEA , HFMEA, HFMECA
FMEA , HFMEA, HFMECA
V V V V Redesign Process Redesign Process
V V
V V
Risk Priority Number : Risk Priority Number :
(P X D X D) (P X D X D)
(P X D) x K X D, Bands (P X D) x K X D, Bands
V V V V # # Responsible person & Responsible person &
management concurrence management concurrence
V V V V # # Actions & Outcomes Actions & Outcomes
V V V V Analyze & Test New Process Analyze & Test New Process
V V Decision Tree Decision Tree
(K,K,D) (K,K,D)
V V V V Hazard Scoring Matrix Hazard Scoring Matrix
(P X D) (P X D)
V V V V V V Failure mode, effect & causes Failure mode, effect & causes
V V V V V V Diagramming process Diagramming process
V V V V V V Team membership Team membership
HFMECA HFMECA HFMEA HFMEA FMEA FMEA Concepts Concepts
P : Probability, D : Dampak, K : Kontrol D : Deteksi,
KKD : Kritis, Kontrol, Deteksi
8/7/2006 8/7/2006 Arjaty Arjaty 57 57
Redesign the process Redesign the process Analyze & test the new Analyze & test the new
process process
7 7
Actions & Outcome Measures Actions & Outcome Measures
Conduct a Hazard Analysis Conduct a Hazard Analysis
Graphically describe the Graphically describe the
Process Process
Assemble the Team Assemble the Team
Define the HFMEA Topic Define the HFMEA Topic
HFMEA HFMEA
By : VA NCPS By : VA NCPS
Implement & monitor the Implement & monitor the
redesigned process redesigned process
9 9
Analyze & test the new process Analyze & test the new process Implement & monitor the Implement & monitor the
redesigned process redesigned process
8 8
Calculate total RPN Calculate total RPN Redesign the process Redesign the process 6 6
Identify Identify causes causes of failure of failure
modes modes
Identify root causes of failure Identify root causes of failure
modes modes
5 5
Brainstorm potential Brainstorm potential effects effects
of failure modes of failure modes
Prioritize failure modes Prioritize failure modes 4 4
Brainstorm potential Brainstorm potential failure failure
modes modes & Prioritize failure & Prioritize failure
modes modes
Brainstorm potential failure Brainstorm potential failure
modes & determine their modes & determine their
effects effects
3 3
Diagram the process Diagram the process Diagram the process Diagram the process 2 2
Select a high risk process & Select a high risk process &
assemble a team assemble a team
Select a high risk process & Select a high risk process &
assemble a team assemble a team
1 1
HFMECA HFMECA
By IMRK By IMRK
FMEA FMEA
LANGKAH2 FMEA, HFMEA, HFMECA
LANGKAH2 FMEA, HFMEA, HFMECA
8/7/2006 8/7/2006 Arjaty Arjaty 58 58
Proses lama
yg high risk
Desain
Proses baru
Proses
Potential Cause
Failure
Mode
HS
Efek /
Dampak
Decision
Tree
K
K
D
T
K
E
Tindakan
AMKD / HFMEA
8/7/2006 8/7/2006 Arjaty Arjaty 59 59
AMKDP / HFMECA
Prioritas Prioritas
risiko risiko
RPN / NPR RPN / NPR
Failure Failure
Mode, Mode,
Dampak Dampak, ,
Penyebab Penyebab
Redisign Redisign
Proses Proses
Analisis Analisis
& &
Uji Uji
Proses Proses
Baru Baru : :
Re RPN Re RPN
/NPR /NPR
Implementasi Implementasi
PROSES BARU PROSES BARU
8/7/2006 8/7/2006 Arjaty Arjaty 60 60
Differences FMEA & RCA
Differences FMEA & RCA
FMEA / HFMEA FMEA / HFMEA
Proactive Proactive
– – Specific Process Specific Process
Diagram process flow Diagram process flow
“ “What could occur? What could occur?” ”
Focusing on a processes Focusing on a processes
potential system failures potential system failures
Prevents failures Prevents failures
before they occur before they occur
RCA RCA
Reactive Reactive
– – Specific Event Specific Event
Diagram chronological steps Diagram chronological steps
“ “What occurred? What occurred?” ”
Focus on an event Focus on an event’ ’s system s system
failures failures
Prevents failures from Prevents failures from
reoccurring reoccurring
8/7/2006 8/7/2006 Arjaty Arjaty 61 61