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LANGKAH 7

Dr Arjaty W Daud MARS

1.

2. 3. 4.

LATAR BELAKANG PERLUNYA REDESAIN PROSES DI PELAYANAN KESEHATAN STRATEGI REDUKSI RISIKO IDENTIFIKASI PROSES YG RISIKO TINGGI REDISAIN PROSES : - FMEA - AMKD / HFMEA

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Historical Perspective
Hingga saat ini, pencegahan kesalahan Until recently, error prevention has not medisabelum menjadi of medicine bidang been primary focus fokus utama kedokteran System/process defects are identified by adverse events or dealt with silently by health care personnel Sebagian besar sistem pelayanan Most health caredidesain untuk mencegah kesehatan tidak delivery systems are not designed to prevent and / or error atau mencegah / mengatasi compensate for errors
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JCAHO Standard LD 5.2


(efective July 2001)

Identify anddan proritaskan PROSES Identifikasi prioritize high risk processes Annually select at TINGGI YANG BERISIKO least one high risk process Identifikasi POTENSI MODUS Identify potential KEGAGALAN failure modes For each failure mode, identify possible Setiap modus kegagalan, IDENTIFIKASI effects DAMPAK YANG MUNGKIN TERJADI For the most dampak yang kritis, Untuk setiap critical effects, conduct a root cause analysis LAKUKAN ANALISIS AKAR MASALAH.
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JCAHO Standard LD 5.2


(efective July 2001)

REDISAIN PROSES untuk Redesign the process to minimize the risk of that failure mode or to protect patients from its meminimalisasi risiko modus kegagalan effectsmencegah dampaknya pada pasien atau Test and implement IMPLEMENTASI the redesigned process UJI COBA DAN Identify and implement measures of REDISAIN PROSES effectiveness IDENTIFIKASI DAN NILAI EFEKTIVITAS Implement a strategy for maintaining the IMPLEMENTASI effectiveness of the redesigned process over timeatau proses redisain. STRATEGI untuk IMPLEMENTASIKAN efektivitas maintanance
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Advanced Patient safety in US since 1999, NPCS, August 2004, www,patientsafety.gov

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
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High
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Definition of a Process
A goal-directed interrelated series of events, activities, actions, mechanisms, or steps that transform inputs into outputs
(CAMH Glossary)

INPUT

PROSES

OUTPUT

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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 ?

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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/FMEA/2008 Pada pasien

Design Proses u/ Mengurangi Dampak Kegagalan terjadi 10 pada pasien

MEMILIH PROSES
High Risk processes
Identified in the literature Identified by JCAHO Identified through safety alerts

New or redefined process Staff recommendations

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IDENTIFYING RISK PRONE SYSTEM Variable input Complex systems Non standardized systems Tightly coupled systems Systems with tight time constraints Systems with hierarchical

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REDISAIN PROSES

FMEA

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

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
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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
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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/FMEA/2008 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

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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

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FMEA Whats the point?


Eliminatingmengeliminasi atau mereduksi Dengan or reducing the risk of the failure modes can result in a risiko kegagalan akan menghasilkan suatu SAFER AND MORE EFFICIENT SYSTEM SISTEM YANG AMAN DAN LEBIH EFISIEN from which BAGI you and your patients benefit. both RS DAN PASIEN.

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Failure Mode and Effects Analysis


1. Define failure mode.
what could go wrong?

2. Identify cause of failure. 3. Identify effects of failure


why would the failure happen? what would be the consequences of each failure?
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4. Corrective action.

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.
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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
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Why should my organization conduct an FMEA ?


Can prevent errors & near misses 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
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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 : Aviation,

Nuclear power, Aerospace, Chemical process industries, Automoive


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LANGKAH FMEA
1. 2. 3.

4. 5. 6. 7. 8.

Select a high risk process & assemble a team Diagram the process Brainstorm potential failure modes & determine their effects (P X S X D) Prioritize failure modes Identify root causes of failure modes (P X S X D) REDESIGN THE PROCESS Analyze & test the new process Implement & monitor the redesigned process

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Step One
Select a process to evaluate with FMEA Recruit a multi disciplinary team

Be sure to include everyone who is involved at any point in the process

Step Two
Have the team meet together to list all the steps in the process Number every step in the process and be as specific as possible
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Step Three
Have the team list failure modes and effect List anything that could go wrong including minor and rare problems Identify all possible causes for each failure mode
For each failure mode, determine the potential effect on the patient Likelihood of occurrence Likelihood of detection Severity

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RATING SYSTEM (Modified by IMRK) Rating


1 2

Probabilitas (P)
Remote Low likelihood

Severity (S)
Minor effect Moderate effect

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) = (P x S) x D


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Step four
Prioritize failure mode

Step five
Have the team list effect of failure mode
For each failure mode, determine the potential cause on the patient Likelihood of occurrence Likelihood of detection Severity
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Step Six
REDESIGN PROCESS Determine which failures to work on Calculate the RISK PRIORITY NUMBER (RPN): Likelihood x Severity x Detection Identify the failure modes with the top 10 RPNs
TAKE A DEEP BREATH Conduct a literature search to gather relevant information from the professional literature. Do not reinvent the wheel Network with colleagues RECOMMIT TO OUT OF THE BOX THINKING
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Step Seven
Analyze and test the new process Use RPNs to plan improvement efforts Failure modes with high RPNs are usually the most important parts of the process to concentrate improvement efforts. 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.
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Step Eight
Implement & monitor the redesigned process Design improvements should bring reduction in the CI / RPN. Ex: 30 50% reduction ?

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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)
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HFMEA Components and Their Origins


Concepts
Team membership Diagramming process Failure mode & causes Hazard Scoring Matrix Severity & Probability Definitions Decision Tree Actions & Outcomes Responsible person & management concurrence

HFMEA
V V V V V V V V

FMEA
V V V

HACCP

RCA
V

V # V # #
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V V
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HACCP : Hazard Analysis Critical Control Point

TIME LINE AND TEAM ACTIVITIES


Premeeting 1st team meeting 2rd team meeting 3 rd team meeting 4rd team meeting 5th 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) 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
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6th,7th , 8th. team meeting plus 1 team meeting plus 2 team meeting plus 3 team meeting plus 4 Postteam meeting

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

Step 1
Define the Scope of HFMEA along with a clear definition of the process to be studied

Step 2
Multidisiplinary team with Subject matter expert(s) plus advisor
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Step 3
Develop and verify the flow Diagram (this is a process vs chronological diagram) Consecutively number each process step identified in the process flow diagram If the process is complex identify the area of the process to focus on (manageable bite) Identify all sub processes under each block of this flow diagram. Consecutively letter these sub steps Create a flow diagram composed of the sub processes
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Step 4
List Failure modes Determine Severity & Probability Use the Decision tree List all Failure mode causes

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Step 5
Decide to Eliminate Control or Accept the failure mode cause Describe an action for each failure mode cause that will eliminate or control it. Identify outcome measures that will be used to analyze and test the re-designed process Identify a single, responsible individual by title to complete the recommended action Indicate whether top management has concurred with the recommended actions
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FMEA vs HFMEA vs 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 S X D) Prioritize failure modes Identify root causes of failure modes (P X S X D) REDESIGN THE PROCESS Analyze & test the new process Implement & monitor the redesigned process
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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 (P X S) x K X D, Bands Prioritize failure modes Identify root causes of failure modes (P X S) x K X D, Bands CALCULATE TOTAL RPN REDESIGN THE PROCESS Analyze & test the new process Implement & monitor the redesigned process
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4 5

6 7 8 9

RATING SYSTEM HFMECA (Modified by IMRK) Rating


1 2

Probabilitas (P)
Remote Low likelihood

Severity (S)
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) = (P x S) x K x D


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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 ___________________

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Contoh kasus 1

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ANALISIS
DAMPA K MINOR 1 Kegagalan yang tidak mengganggu Proses pelayanan kepada Pasien Pasien Tidak ada cedera, Tidak ada perpanjangan hari rawat

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

Kematian Kehilangan fungsi tubuh secara permanent (sensorik, motorik, psikologik atau intelektual) mis : Operasi pada bagian atau pada pasien yang salah, Tertukarnya bayi Kematian Terjadi pada > 6 orang pengunjung

Pengunju ng

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

Cedera ringan Ada Penanganan ringan Terjadi pada 2 -4 pengunjung Cedera ringan Ada Penanganan / Tindakan Kehilangan waktu / kec kerja : 2-4 staf

Staf:

Kematian Perawatan > 6 staf

Fasilitas Kes

Kerugian Kerugian 10,000,000 - 50,000,000 1,000,000 - Arjaty/ IMRK/FMEA/2008 10,000,000

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

Kadang-kadang (Occasional) Jarang (Uncommon)

2 1

Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam (Remote) > 5 sampai 30 tahun)
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HAZARD SCORE
TINGKAT BAHAYA KATASTROPIK 4 SERING 4 KADANG 3 JARANG 2 HAMPIR TIDAK PERNAH 1 MAYOR MODERAT 3 2 MINOR 1

16 12 8 4

12 9 6 3

8 6 4 2

4 3 2 1

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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
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NO

YES

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

YES

Proceed to Potential Causes for this failure

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Contoh kasus 2
PROSES KEGIATAN PAGI HARI MENUJU TEMPAT KERJA

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LEMBAR AMKD ( FORM HFMEA )


AMKD Langkah 4 - Analisis Hazard
MODUS Kegagalan : Evaluasi awal modus kegagalan sebelum SKORING Analisis Pohon Keputusan Tipe Tindakan (Kontrol, Kontrol, terima, terima, Eliminasi) Eliminasi) Tindakan / Alasan untuk mengakhiri AMKD Langkah 5 - Identifikasi Tindakan & Outcome Yang Bertanggung Jawab Ukuran Outcome Ukuran Outcome Manajemen Tim

Apakah ada Apakah ada kontrol/pengen kontrol/pengen dalian?

Apakah mudah didteksi ? didteksi ?

Poin Tunggal Poin Tunggal Kelemahan ? Kelemahan ?

Probabilitas Probabilitas

Nilai Hazard

Kegawatan

POTENSI PENYEBAB

Turn off alarm

major

occas ional

Proses ? Proses ?

Missed snooze button

major

Occa sional

Eliminate

Purchased new clock

Purc hase d by cert ain date .....

Mr..

Yes

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AMKD / HFMEA
Proses lama yg high risk Alur Proses Potential Cause Failure Mode Efek / Dampak HS Decision Tree K K D T Desain Proses baru Hazard Score
Kritis Kontrol Deteksi Kontrol Eliminasi Terima

Tindakan K E

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AMKDP / HFMECA
Total RPN PROSES LAMA Failure Mode, Dampak, Penyebab Total RPN 30-50%? Analisis & Uji Proses Baru Total RPN PROSES BARU Failure Mode, Dampak, Penyebab

Prioritas risiko

Redisign Proses

Implementasi PROSES BARU

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KESIMPULAN
Building a safe healthcare system

A R L E T N E T P A U A O L R M R I E W T S I O I N R S G K
U

L E A R N I N G

S E V E R I T Y

L E A D E R S H I P
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K F K D O R O E N T E T T R K M E R U A U O K N I L S E I N N I K I A S N I S G I
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Team Work ?

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