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 difficulty Easy
1. 2.

Long term effectiveness Low

Punitive Retraining / counseling

3.
4. 5. 6.

Process redesign
Paper vs practice Technical system enhance Culture change Difficult
Arjaty/ IMRK

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
Arjaty/ IMRK 4

STRATEGI REDUKSI RISIKO

RISK POINTS / COMMON CAUSES

RENCANA REDUKSI RISIKO

Design Proses u/ Meminimalkan risiko kegagalan

Design Proses u/ Meminimalkan risiko Kegagalan terjadi Arjaty/ IMRK Pada pasien

Design Proses u/ Mengurangi Dampak Kegagalan terjadi pada pasien5

IDENTIFYING RISK PRONE SYSTEM

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

Arjaty/ IMRK

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

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. 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
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 Arjaty/ IMRK pelayanan kesehatan sangat menentukan hasilnya.

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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

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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

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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.

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

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LANGKAH2 FMEA, HFMEA, HFMECA

FMEA Original
1 2 3 Select a high risk process & assemble a team Diagram the process Brainstorm potential failure modes & determine their effects (P X Da X De) Prioritize failure modes

HFMEA By : VA NCPS
Define the HFMEA Topic Assemble the Team Graphically describe the Process Conduct a Hazard Analysis Actions & Outcome Measures

HFMECA By IMRK
Select a high risk process & assemble a team Diagram the process Brainstorm potential failure modes & Prioritize failure modes (P X Da) x K X De, Bands Brainstorm potential effects of failure modes (P X Da) x K X De, Bands Identify root causes of failure modes (P X Da) x K X De, Bands CALCULATE TOTAL RPN REDESIGN THE PROCESS Analyze & test the new process

Identify root causes of failure modes (P X Da X De) REDESIGN THE PROCESS Analyze & test the new process Implement & monitor the redesigned process

6 7 8 9

Arjaty/ IMRK

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Implement & monitor the

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
Team membership
Diagramming process Failure mode & causes Hazard Scoring Matrix Severity & Probability Definitions Decision Tree

HFMEA
V
V V V V V

FMEA
V
V V

HACCP
V

RCA
V

V # V V

Actions & Outcomes

Responsible person & management concurrence

V
V

#
#

V
V

Arjaty/ IMRK

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HACCP : Hazard Analysis Critical Control Point

TIME LINE AND TEAM ACTIVITIES

Premeeting 1st team meeting 2rd team meeting Identify Topic and notivy the team (Step 1 & 2) Diagram the process, identify subprocess, verify the scope Visit the worksite to observe the process, verify that all process & subprocess steps are correct (Step 3)

3 rd team meeting
4rd team meeting 5th team meeting

Brainstorming failure modes, assign individual team members to consult with process users (Step 3)
Identify failure modes causes, assign individual team members to consult with process users for additional input (Step 3) Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the hazard analysis (Step 4) Identify corrective actios and assign follow up responsibilities (Step 5) Assign team members to follow up individual charged with taking corrective action Refine corrective actions based on feedback Test the proposed changes Meet with Top Management to obtain approval for all actions The advisor or his/ her designee follow up until all actions are completed
Arjaty/ IMRK 23

6th,7th , 8th. team meeting plus 1 team meeting plus 2 team meeting plus 3 team meeting plus 4 Postteam meeting

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

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Arjaty/ IMRK

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Arjaty/ IMRK

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Arjaty/ IMRK

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ANALISIS
DAMPA K MINOR 1 Kegagalan yang tidak mengganggu Proses pelayanan kepada Pasien Pasien
Tidak

HAZARD LEVEL DAMPAK

MODERAT 2 MAYOR 3 Kegagalan menyebabkan kerugian berat KATASTROPIK 4 Kegagalan menyebabkan kerugian besar

Kegagalan dapat mempengaruhi proses dan menimbulkan kerugian ringan

Cedera

ada cedera, Tidak ada perpanjangan hari rawat

ringan Ada Perpanjangan hari rawat

Cedera

luas / berat Perpanjangan hari rawat lebih lama (+> 1 bln) Berkurangnya fungsi permanen organ tubuh (sensorik / motorik / psikcologik / intelektual) Cedera luas / berat Perlu dirawat Terjadi pada 4 -6 orang pengunjung
Cedera

Kematian Kehilangan fungsi tubuh secara permanent (sensorik, motorik, psikologik atau intelektual) mis : Operasi pada bagian atau pada pasien yang salah, Tertukarnya bayi
Kematian Terjadi

Pengunju ng

Tidak

ada cedera Tidak ada penanganan Terjadi pada 1-2 org pengunjung
Tidak

Cedera ringan Ada Penanganan ringan Terjadi pada 2 -4 pengunjung

Cedera

pada > 6 orang pengunjung

Staf:

ada cedera Tidak ada penanganan Terjadi pada 1-2 staf Tidak ada kerugian waktu / keckerja Kerugian < 1 000,,000 atau tanpa menimbulkan dampak terhadap pasien

ringan Ada Penanganan / Tindakan Kehilangan waktu / kec kerja : 2-4 staf Kerugian 1,000,000 10,000,000

luas / berat Perlu dirawat Kehilangan waktu / kecelakaan kerja pada 4-6 staf

Kematian Perawatan

> 6 staf

Fasilitas Kes

Kerugian 10,000,000 - 50,000,000 Arjaty/ IMRK

Kerugian > 50,000,000

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ANALISIS HAZARD LEVEL PROBABILITAS

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

Kadang-kadang (Occasional) Jarang (Uncommon)

Kemungkinan akan muncul (dapat terjadi bebearapa kali dalam 1 sampai 2 tahun) Kemungkinan akan muncul (dapat terjadi dalam >2 sampai 5 tahun)

2 1

Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam (Remote) > 5 sampai 30 tahun)
Arjaty/ IMRK 29

HAZARD SCORE
TINGKAT BAHAYA

KATASTROPIK 4 SERING 4
KADANG 3 JARANG 2 HAMPIR TIDAK PERNAH 1

MAYOR 3

MODERAT 2

MINOR 1

16 12
8 4

12 9
6 3

8 6
4 2

4 3
2 1

Arjaty/ IMRK

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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

Is this a single point weakness in the process? (Criticality failure results in a system failure?) CRITICALY YES Does an effective control measure already exist for the identified hazard? CONTROL NO Is this hazard so obvious and readily apparent that a control measure is not warranted? DETECTABILITY NO
Arjaty/ IMRK

NO

YES

STOP
Do not proceed to find potential causes for this failure mode

YES

Proceed to Potential Causes for this failure mode

31

Arjaty/ IMRK

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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

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

1. 2.

3. 4. 5. 6. 7. 8. 9.

Pilih Proses yang berisiko tinggi dan Bentuk Tim Gambarkan Alur Proses Diskusikan & Prioritaskan Modus Kegagalan Brainstorming Dampak Modus Kegagalan Identifikasi Penyebab Modus Kegagalan Hitung Total NPR (Nilai Prioritas Risiko) / RPN Disain ulang proses / Re-disain Proses Analisa & uji Proses baru 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

Selection & Procuremen t

Storage

Prescribing, Ordering, Trancribing

Preparing & Dispensin g

Administration

Failure Mode Pemesanan obat Berlebihan (tdk Sesuai kebthn)

Failure Mode Penyimpanan vaksin tdk sesuai suhunya

Failure Mode Penulisan obat dlm R/ tdk jls

Failure Mode Peracikan obat tdk sesuai dosis

Failure Mode Wrong drug

Wrong dosage Penulisan Obat R/ tdk R/ Dlm formularium

Wrong frequence Wrong route administration

Arjaty/ IMRK

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Failure points where medication errors occur

Prescribing Transcribing Dispensing Administering

39%

12%

Arjaty/ IMRK

11%

38%

38

JAMA 1995 Jul 5,274(1):29-34

RATING SYSTEM (Modified by IMRK) Rating

1 2

Probabilitas (P)
Remote Low likelihood

DAMPAK (D)
Minor effect Moderate effect

Kontrol (K)
Easy Mpderate Easy Moderate difficult Difficult

Deteksi (D)
Certain to detect High likelihood

3 4 5

Moderate likelihood High likelihood Certain to occur

Minor injury Major injury Catastrophic effect / terminal injury, death

Moderate likelihood Low likelihood Almost certain not to detect

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

Arjaty/ IMRK 39

Sample Severity Scale

(Modified by IMRK)

Rating 1

Description
Minor effect or No effect

Definition
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
3

Moderate effect
Minor injury Major injury

May affect the individual served & would result in a major effect on the process
Would affect the individual and result in a major effect on the process Would result in a major injury for the individual served and have major effect on the process Extremely dangerous, failure would result death of the individual served and have a major effect on the process
Arjaty/ IMRK 40

4
5

Catastrophic effect, a terminal injury or death

Source : JCR : Joint Commision Resources

Sample Probability of Occurrence Scale

(Modified by IMRK) Rating Description Remote to non existent Low Likelihood Moderate likelihood High likelihood Probability 1 in 10,000 Definition No or little known occurrence highly unlikely that condition will ever occur Possible, but no known data, the condition occurs in isolated cases, but chances are low Documented, but infrequently, the condition has a reasonable chance to occur Documented and frequent, the condition occurs very regularly and / or during a reasonable amount of time

1 2 3 4

1 in 5000

1 in 200

1 in 100

Certain to occur

1 in 20

Documented, almost certain, the condition will inevitably occur during long periods typical for the step or41link Arjaty/ IMRK

Sample Detectability Scale

(Modified by IMRK) Rating Description Probability of Detection 10 out to 10 Definition

Certain to detect

Almost always detected immediately

2
3

High likelihood

7 out of 10

Likely to be detected

Moderate likelihood

5 out of 10

Moderate likelihood of detection

4
5

Low likelihood

2 out 0f 10

Unlikely to be detected

Almost certain not to detect

0 out of 10

Detection not possible at any point

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CONTROLLABILITY
Rating 1 Desription Easy Definition 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 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 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 Controls and Status are unknown or Residual risk

Moderate easy

Moderate difficult

Difficult

Arjaty/ IMRK

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STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES

Failure Mode Potential effect Potenti al causes Severity Probabilit y Ri sk Sc or e (3 X4 ) Risk Catego ries / Bands Control Detection

RPN (5X8X 9)

1 2 3 4 5 1 2 3 4 5 1 Wrong route administratio n Wrong frequency 2 Death 3 No Trainin g No record in Chart X 4 X X 5

1- L M H E 1 2 3 4 1 2 3 4 5 25 6 10 7 E X 8 X 9 10 40

Injury with permanen t loss of function >

12

24

Wrong dosage

No injury with no permanen t loss of function

No injury but LOS >

Miss read instruct ion

Miss identifi cation

32

Wrong drug

X
Arjaty/ IMRK

X
44

16

STEP 6 CALCULATE TOTAL RPN

No Failure Mode 2 Wrong route administrati on Wrong frequency RPN Failure Mode 3 60 Death Potential effect 4 RPN effect 5 40 No Traini ng 48 Injury with permane nt loss of function No injury with no permane nt loss of function No injury but LOS > > 12 No record in Chart 24 Potential Causes 6 RPN Causes 7 40 Total RPN 8 Rank

1 1

140
84

Wrong dosage

36

36

Miss read instru ction

32

104

Wrong drug

36

16

Miss identi ficati on

16

68

Arjaty/ IMRK

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STEP 7 REDESIGN PROCESS

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

Arjaty/ IMRK

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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

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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 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

Variable input Complex Nonstandarized Tightly Coupled Dependent on human intervention Time constraints Hierarchical culture
Arjaty/ IMRK

Decreasing variability Simplify Standardizing Loosen coupling of process Use technology Optimise Redundancy Built in fail safe mechanism Documentation Establishing a culture of teamwork
50

AMKD / HFMEA
Proses lama yg high risk Alur Proses

Potential Cause
Failure Mode

Efek / Dampak
HS

Decision Tree
K K D

Tindakan
K E T

Desain Proses baru

Hazard Score

Kritis Kontrol Deteksi

Kontrol Eliminasi Terima

Arjaty/ IMRK

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AMKDP / HFMECA
Total RPN PROSES LAMA

Prioritas risiko

Failure Mode, Dampak, Penyebab

Redisign Proses

Analisis & Uji Proses Baru Total RPN PROSES BARU

Implementasi PROSES BARU

Total RPN 30-50%?

Failure Mode, Dampak, Penyebab

Arjaty/ IMRK

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KESIMPULAN
Building a safe healthcare system

L E A D Arjaty/ EIMRK R S H I P

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Safety begins with you

Dont wait for someone else

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