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 6 .

Variable input Pasien  Penyakit berat  Penyakit penyerta  Pernah mendapatkan pengobatan  Usia Pemberi Pelayanan  Tingkat keterampilan  Cara pendekatan Proses Pelayanan harus dapat mengakomodasi variabilitas yang tdk dapat dihindarkan dan tidak dapat dikontrol ini. Arjaty/ IMRK 7 .

Complexitas     Pelayanan rumah sakit sangat kompleks Memerlukan beragam langkah yang sangat mungkin berhadapan dengan kegagalan Semakin banyak langkah semakin besar kemungkinan gagal Donald Berwick : 1 langkah -- error 1 % 25 langkah -- error 22% 100 langkah -- error 63% Arjaty/ IMRK 8 .

Arjaty/ IMRK 9 . Clinical Pathways dapat membatasi pengaruh dari variabel yang ada. Parameter.-- 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. Protokol.Lack of Standardization    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 Arjaty/ IMRK 10 .

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    .Tightly Coupled  Perpindahan langkah dari suatu proses sering sangat ketat.

Tata cara berkomunikasi antar staf dalam proses Arjaty/ IMRK pelayanan kesehatan sangat menentukan hasilnya. verifikasi lokasi pembedahan oleh tim bedah.     12 .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.

Hoff.Implementing Safety Cultures in Medicine: What We Learn by Watching Physicians Timothy J. Joel Bartfield Residen di Kamar Bedah : ~ Commission ~ Suasana hierarki tinggi ~ Kesalahan Teknis Residen di MICU : ~ Ommission Suasana hierarki lebih datar ~ Kesalahan Pengambilan Keputusan Arjaty/ IMRK 13 . Henry Pohl.

Adalah proses proaktif.What is FMEA ?  Adalah metode perbaikan kinerja dgn mengidentifikasi dan mencegah potensi kegagalan sebelum terjadi. dimana kesalahan dpt dicegah & diprediksi. Mengantisipasi kesalahan akan meminimalkan dampak buruk  Arjaty/ IMRK 14 . Hal tersebut didesain untuk meningkatkan keselamatan pasien.

 Arjaty/ IMRK 15  . Floor.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. etc.FMEA Terminology  Process FMEA . Operating Room.

Failure mode is the manner in which something can fail.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. 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 .

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.Why should my organization conduct an FMEA ?    Can prevent errors & nearmisses  protecting patients from harm. regulators & payers to create culture focused on reducing risk & increasing accountability Arjaty/ IMRK 17 .

Where did FMEA come from ? FMEA has been around for over 30 years  Recently gained widespread appeal outside of safety area  New to healthcare   Frequently used reliability & system safety analysis techniques Long industry track record  Arjaty/ IMRK 18 .

Bands CALCULATE TOTAL RPN REDESIGN THE PROCESS Analyze & test the new process 4 5 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 19 Implement & monitor the . HFMEA. Bands Identify root causes of failure modes (P X Da) x K X De.LANGKAH2 FMEA. Bands Brainstorm potential effects of failure modes (P X Da) x K X De. 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.

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  .What is HFMEA ? Modified by VA NCPS  Focus on preventing defects.

Tindakan dan Pengukuran Outcome . Gambarkan Alur Proses 4. Bentuk Tim 3.LANGKAH-LANGKAH ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)® (HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS) (HFMEA) By : VA NCPS 1. Buat Hazard Analysis 5. Tetapkan Topik AMKD 2.

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 22 HACCP : Hazard Analysis Critical Control Point .

identify subprocess. 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.η team meeting plus 1 η team meeting plus 2 η team meeting plus 3 η team meeting plus 4 Postteam meeting . assign individual team members to consult with process users for additional input (Step 3) Transfer FM & Causes to the HFMEA Worksheet (Step3). 8th…. verify the scope Visit the worksite to observe the process.TIME LINE AND TEAM ACTIVITIES Premeeting 1st team meeting 2rd team meeting Identify Topic and notivy the team (Step 1 & 2) Diagram the process.7th . 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.

_______________ 5. ________________________________________ 2.LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI Pilih Proses berisiko tinggi yang akan dianalisa. ________________________________________ 3. _______________ 4. _______________ 6. ________________________________________ Notulen? _________________________________________ Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK Tanggal dimulai ____________________ Tanggal selesai ___________________ Arjaty/ IMRK 24 . Judul Proses : __________________________________________________________________________ _________________________________________________________ _________________________________________________________ LANGKAH 2 : BENTUK TIM Ketua : ____________________________________________________________ Anggota 1.

Arjaty/ IMRK 25 .

Arjaty/ IMRK 26 .

Arjaty/ IMRK 27 .

000 10.50.000.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.000 28 .000 Arjaty/ IMRK Kerugian > 50.000.000. psikologik atau intelektual) mis :  Operasi pada bagian atau pada pasien yang salah.000.000 ..  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. motorik.000.000 luas / berat  Perlu dirawat Kehilangan waktu / kecelakaan kerja pada 4-6 staf Kematian Perawatan > 6 staf Fasilitas Kes Kerugian 10.000 atau tanpa menimbulkan dampak terhadap pasien ringan  Ada Penanganan / Tindakan  Kehilangan waktu / kec kerja : 2-4 staf Kerugian 1.

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) 3 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 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 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 32 .

Arjaty/ IMRK 33 .

Effect.What is HFMECA ® Prospective analysis model combines concepts :   FMEA (Failure Mode and Effects Analysis) RCA (Root Cause Analysis) Modified by IMRK : Brainstorming : Failure mode. Bands Arjaty/ IMRK 34 . Causes (Da X P) x K X De.

3. 7.LANGKAH -LANGKAH ANALISIS MODUS KEGAGALAN. 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 . 2. 8. 9. DAMPAK & PENYEBAB (AMKDP)®/ HEALTHCARE FAILURE MODE EFFECT & CAUSES ANALYSYS (HFMECA)® 1. 5. 6. 4.

_______________ 4. Judul Proses : ___________________________________________ BENTUK TIM Ketua : ____________________________________________________________ Anggota 1. _______________ 5.LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM Pilih Proses berisiko tinggi yang akan dianalisa. ________________________________________ 2. ________________________________________ 3. ________________________________________ Notulen _________________________________________ Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK Tanggal dimulai _________________ Tanggal selesai _______________________ Arjaty/ IMRK 36 . _______________ 6.

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. 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 37 . Ordering.

274(1):29-34 .Failure points where medication errors occur Prescribing Transcribing Dispensing Administering 39% 12% Arjaty/ IMRK 11% 38% 38 JAMA 1995 Jul 5.

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 .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.

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 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.

Sample Probability of Occurrence Scale (Modified by IMRK) Rating Description Remote to non existent Low Likelihood Moderate likelihood High likelihood Probability 1 in 10. almost certain. but infrequently. but chances are low Documented. but no known data.000 Definition No or little known occurrence highly unlikely that condition will ever occur Possible. the condition will inevitably occur during long periods typical for the step or41link Arjaty/ IMRK . 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 5 Certain to occur 1 in 20 Documented. the condition occurs in isolated cases.

Sample Detectability Scale (Modified by IMRK) Rating Description Probability of Detection 10 out to 10 Definition 1 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 Arjaty/ IMRK 42 .

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 2 Moderate easy 3 Moderate difficult 4 Difficult Arjaty/ IMRK 43 . 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. reviewed & tested regularly. maintained. monitored. complied with. 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.CONTROLLABILITY Rating 1 Desription Easy Definition Comprehensive effective controls fully in place.

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 > X 12 E X X 24 Wrong dosage No injury with no permanen t loss of function No injury but LOS > Miss read instruct ion Miss identifi cation X X 8 H X X 32 Wrong drug X X Arjaty/ IMRK 4 H X 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 9 140 84 1 2 3 3 Wrong dosage 36 36 Miss read instru ction 32 104 2 4 Wrong drug 36 16 Miss identi ficati on 16 68 4 Arjaty/ IMRK 45 .

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 1 2 3 4 5 6 7 8 9 Arjaty/ IMRK 46 .

PREPARING TO REDESIGN TAKE A DEEP BREATH  Conduct a literature search to gather relevant information from the professional literature. Do not reinvent the wheel  Network with colleagues  Recommit to out of the box thinking  Arjaty/ IMRK 47 .

LANGKAH 8 ANALISIS DAN UJI PROSES BARU The team again completes steps 2 (diagram the process). Ex: 30 – 50% reduction ?  Arjaty/ IMRK 48 .  Design improvements should bring reduction in the CI / RPN. 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.

Generate short term wins 7.LANGKAH 9 IMPLEMENTASI DAN MONITORING PROSES Strategies for Creating & Managing the Change Process : 1. Empower broad based action 6. Anchor new approaches in the culture Arjaty/ IMRK 49 . Consolidate gains and produce more change 8. Develop a vision and strategy 4. Create a guiding coalition 3. Establish a sense of urgency 2. Communicate the changed vision 5.

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 51 .

Dampak. Dampak. Penyebab Redisign Proses Analisis & Uji Proses Baru Total RPN PROSES BARU  Implementasi PROSES BARU     Total RPN 30-50%? Failure Mode.AMKDP / HFMECA Total RPN PROSES LAMA  Prioritas risiko Failure Mode. Penyebab Arjaty/ IMRK 52 .

KESIMPULAN Building a safe healthcare system L E A D Arjaty/ EIMRK R S H I P 53 .

Safety begins with you Don’t wait for someone else Arjaty/ IMRK 54 .