Dr Arjaty W Daud MARSDr Arjaty W Daud MARS
Arjaty/ IMRKArjaty/ IMRK 22
STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO IDENTIFIKASI PROSES YG RISIKO IDENTIFIKASI PROSES YG RISIKO
TINGGI TINGGI REDISAIN PROSES :REDISAIN PROSES : - FMEA- FMEA - AMKD- AMKD®® / HFMEA / HFMEA - AMKDP- AMKDP®® / HFMECA / HFMECA
Arjaty/ IMRKArjaty/ IMRK 33
RISK REDUCTION STRATEGIES DIFFICULTY & RISK REDUCTION STRATEGIES DIFFICULTY & LONG TERM EFFECTIVENESSLONG TERM EFFECTIVENESS
Types of actions Degree of Long term Types of actions Degree of Long term difficulty effectivenessdifficulty effectiveness
Easy LowEasy Low1.1. PunitivePunitive2.2. Retraining / counselingRetraining / counseling
3.3. Process redesignProcess redesign4.4. ““Paper vs practice”Paper vs practice”5.5. Technical system enhanceTechnical system enhance6.6. Culture changeCulture change
Difficult HighDifficult High
Arjaty/ IMRKArjaty/ IMRK 44
STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO
Identifikasi risiko dgn bertanya 3 pertanyaan dasar :Identifikasi risiko dgn bertanya 3 pertanyaan dasar : 1. Apa 1. Apa prosesnya prosesnya ?? 2. Dimana 2. Dimana “risk points” / “cause“risk points” / “cause”?”? 3. Apa yg dapat 3. Apa yg dapat “dimitigate”“dimitigate” pada dampak pada dampak “ “risk points” ?risk points” ?
Definisi ProsesTransformasi input menjadi output yg berkaitan dgn Kejadian, aktivitas dan mekanisme yg terstruktur
Arjaty/ IMRKArjaty/ IMRK 55
STRATEGI REDUKSI RISIKOSTRATEGI REDUKSI RISIKO
RENCANA REDUKSI RISIKO
Design Proses u/ Meminimalkan
risikokegagalan
Design Proses u/Mengurangi
DampakKegagalan terjadi
pada pasien
Design Proses u/ Meminimalkan
risikoKegagalan terjadi
Pada pasien
RISKPOINTS /
COMMON CAUSES
Arjaty/ IMRKArjaty/ IMRK 66
IDENTIFYING RISK PRONE SYSTEMIDENTIFYING RISK PRONE SYSTEM
Variable inputVariable inputComplex systemsComplex systemsNon standardized systems Non standardized systems Tightly coupled systemsTightly coupled systemsSystems with tight time constraintsSystems with tight time constraintsSystems with hierarchicalSystems with hierarchical
Arjaty/ IMRKArjaty/ IMRK 77
Variable inputPasien 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/ IMRKArjaty/ IMRK 88
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/ IMRKArjaty/ IMRK 99
Lack of Standardization Standard - --Standard - -- proses tidak dapat berjalan proses tidak dapat berjalan sesuai dengan harapansesuai dengan harapan Individu yang menjalankan proses harus Individu yang menjalankan proses harus
melaksanakan langkah langkah yang telah melaksanakan langkah langkah yang telah ditetapkan secara konsistenditetapkan secara konsisten
Variabilitas individual sangat tinggi -Variabilitas individual sangat tinggi - perlu standard mis : SPO, Parameter, Protokol, perlu standard mis : SPO, Parameter, Protokol,
Clinical Pathways Clinical Pathways dapat membatasi pengaruh dapat membatasi pengaruh dari variabel yang ada. dari variabel yang ada.
Arjaty/ IMRKArjaty/ IMRK 1010
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/ IMRKArjaty/ IMRK 1111
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/ IMRKArjaty/ IMRK 1212
Hierarchical culture Suatu proses akan menghadapi risiko kegagalan lebih tinggi
dalam unit kerja dengan budaya hirarki dibandingkan dengan unit kerja yang budayanya berorientasi pada team
Staf enggan berkomunikasi & berkolaborasi satu dengan yang lain
Perawat enggan bertanya kepada dokter atau petugas farmasi tentang medikasi, dosis, serta element perawatan lainnya
Budaya hirarki sering tercipta misalnya dalam menentukan penggunaan obat, verifikasi lokasi pembedahan oleh tim bedah.
Tata cara berkomunikasi antar staf dalam proses pelayanan kesehatan sangat menentukan hasilnya.
Arjaty/ IMRKArjaty/ IMRK 1313
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 TeknisResiden di MICU : ~ Ommission Suasana hierarki lebih datar ~ Kesalahan Pengambilan
Keputusan
Arjaty/ IMRKArjaty/ IMRK 1414
What is FMEA ?What is FMEA ? Adalah metode perbaikan kinerja dgn Adalah metode perbaikan kinerja dgn
mengidentifikasi dan mencegah potensi mengidentifikasi dan mencegah potensi kegagalan sebelum terjadi. Hal tersebut kegagalan sebelum terjadi. Hal tersebut didesain untuk meningkatkan keselamatan didesain untuk meningkatkan keselamatan pasien. pasien.
Adalah proses proaktif, dimana kesalahan dpt Adalah proses proaktif, dimana kesalahan dpt dicegah & diprediksi. Mengantisipasi kesalahan dicegah & diprediksi. Mengantisipasi kesalahan akan meminimalkan dampak burukakan meminimalkan dampak buruk
Arjaty/ IMRKArjaty/ IMRK 1515
FMEA TerminologyFMEA Terminology
Process FMEAProcess FMEA - Conduct an FMEA on a - Conduct an FMEA on a process that is already in placeprocess that is already in place
Design FMEADesign FMEA – Conduct an FMEA before – Conduct an FMEA before a process is put into placea process is put into place Implementing an electronic medical records or Implementing an electronic medical records or
other automated systemsother automated systemsPurchasing new equipmentPurchasing new equipmentRedesigning Emergency Room, Operating Redesigning Emergency Room, Operating
Room, Floor, etc.Room, Floor, etc.
Arjaty/ IMRKArjaty/ IMRK 1616
FAILURE MODE AND EFFECTS ANALYSISFAILURE MODE AND EFFECTS ANALYSIS
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 desirableintended or desirableMODE (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 modefailure modeAnalysis (A)Analysis (A) : The detailed examination of the : The detailed examination of the elements or structure of a processelements or structure of a process
Arjaty/ IMRKArjaty/ IMRK 1717
Can prevent errors & nearmisses Can prevent errors & nearmisses protecting protecting patients from harm.patients from harm.
Can Can increase the effectiveness & efficiency of increase the effectiveness & efficiency of processprocess
Taking a proactive approach to patient safety Taking a proactive approach to patient safety also makes good business sense in a health also makes good business sense in a health care environment that is increasingly facing care environment that is increasingly facing demands from consumers, regulators & payers demands from consumers, regulators & payers to create culture focused on to create culture focused on reducing risk & reducing risk & increasing accountabilityincreasing accountability
Why should my organization Why should my organization conduct an FMEA ?conduct an FMEA ?
Arjaty/ IMRKArjaty/ IMRK 1818
FMEA has been around for over 30 yearsFMEA has been around for over 30 yearsRecently gained widespread appeal Recently gained widespread appeal
outside of safety areaoutside of safety areaNew to healthcareNew to healthcare
Frequently used reliability & system safety Frequently used reliability & system safety analysis techniquesanalysis techniques
Long industry track recordLong industry track record
Where did FMEA come from ?Where did FMEA come from ?
Arjaty/ IMRKArjaty/ IMRK 1919
FMEAOriginal
HFMEA By : VA NCPS
HFMECA®By IMRK
11 Select a high risk process & assemble a team
Define the HFMEA Topic
Select a high risk process & assemble a team
22 Diagram the process Assemble the Team Diagram the process
33 Brainstorm potential failure modes & determine their effects (P X Da X De)
Graphically describe the Process
Brainstorm potential failure modes & Prioritize failure modes(P X Da) x K X De, Bands
44 Prioritize failure modes Conduct a Hazard Analysis
Brainstorm potential effects of failure modes (P X Da) x K X De, Bands
55 Identify root causes of failure modes(P X Da X De)
Actions & Outcome Measures
Identify root causes of failure modes (P X Da) x K X De, Bands
66 REDESIGN THE PROCESS CALCULATE TOTAL RPN
77 Analyze & test the new process REDESIGN THE PROCESS
88 Implement & monitor the redesigned process
Analyze & test the new process
99 Implement & monitor the redesigned process
LANGKAH2 FMEA, HFMEA, HFMECA®LANGKAH2 FMEA, HFMEA, HFMECA®
Arjaty/ IMRKArjaty/ IMRK 2020
What is HFMEA ?What is HFMEA ?Modified by VA NCPSModified 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)
1. 1. Tetapkan Topik AMKD Tetapkan Topik AMKD 2. Bentuk Tim2. Bentuk Tim3. Gambarkan Alur Proses3. Gambarkan Alur Proses4. Buat Hazard Analysis4. Buat Hazard Analysis5. Tindakan dan Pengukuran Outcome5. Tindakan dan Pengukuran Outcome
LANGKAH-LANGKAHANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)®
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS) (HFMEA)
By : VA NCPS
Arjaty/ IMRKArjaty/ IMRK 2222
HFMEA Components and Their OriginsHFMEA Components and Their OriginsConceptsConcepts HFMEAHFMEA FMEAFMEA HACCPHACCP RCARCA
Team membershipTeam membership VV VV VV
Diagramming Diagramming processprocess
VV VV VV
Failure mode & Failure mode & causescauses
VV VV
Hazard Scoring Hazard Scoring MatrixMatrix
VV VV
Severity & Probability Severity & Probability DefinitionsDefinitions
VV ## VV
Decision TreeDecision Tree VV VV
Actions & OutcomesActions & Outcomes VV ## VV
Responsible person Responsible person & management & management concurrenceconcurrence
VV ## VV
HACCP : Hazard Analysis Critical Control Point
Arjaty/ IMRKArjaty/ IMRK 2323
TIME LINE AND TEAM ACTIVITIES
Premeeting Identify Topic and notivy the team (Step 1 & 2)
1st team meeting Diagram the process, identify subprocess, verify the scope
2rd team meeting Visit the worksite to observe the process, verify that all process & subprocess steps are correct (Step 3)
3 rd team meeting Brainstorming failure modes, assign individual team members to consult with process users (Step 3)
4rd team meeting Identify failure modes causes, assign individual team members to consult with process users for additional input (Step 3)
5th team meeting Transfer FM & Causes to the HFMEA Worksheet (Step3). Begin the hazard analysis (Step 4) Identify corrective actios and assign follow up responsibilities (Step 5)
6th,7th , 8th….η team meeting plus 1
Assign team members to follow up individual charged with taking corrective action
η team meeting plus 2 Refine corrective actions based on feedback
η team meeting plus 3 Test the proposed changes
η team meeting plus 4 Meet with Top Management to obtain approval for all actions
Postteam meeting The advisor or his/ her designee follow up until all actions are completed
Arjaty/ IMRKArjaty/ IMRK 2424
LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGILANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI
Pilih Proses berisiko tinggi yang akan dianalisa. Pilih Proses berisiko tinggi yang akan dianalisa.
Judul Proses :Judul Proses :________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________LANGKAH 2 : BENTUK TIMLANGKAH 2 : BENTUK TIM
Ketua : Ketua : ________________________________________________________________________________________________________________________
Anggota 1. _______________ Anggota 1. _______________ 4. 4. ________________________________________________________________________________
2. _______________ 5. 2. _______________ 5. ________________________________________ ________________________________________
3. _______________ 6. 3. _______________ 6. ________________________________________________________________________________
Notulen?Notulen? __________________________________________________________________________________Apakah semua Unit yang terkait dalam Proses sudah terwakili ?Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAKYA / TIDAKTanggal dimulai ____________________ Tanggal selesai ___________________Tanggal dimulai ____________________ Tanggal selesai ___________________
Arjaty/ IMRKArjaty/ IMRK 2525
Arjaty/ IMRKArjaty/ IMRK 2626
Arjaty/ IMRKArjaty/ IMRK 2727
Arjaty/ IMRKArjaty/ IMRK 2828
ANALISIS HAZARD “LEVEL DAMPAK”ANALISIS HAZARD “LEVEL DAMPAK”DAMPADAMPA
KKMINOR MINOR
11MODERAT MODERAT
22MAYOR
3KATASTROPIK
4
Kegagalan yang tidak Kegagalan yang tidak mengganggu Proses mengganggu Proses pelayanan kepada pelayanan kepada PasienPasien
Kegagalan dapat Kegagalan dapat mempengaruhi proses mempengaruhi proses dan menimbulkan dan menimbulkan kerugian ringankerugian ringan
Kegagalan menyebabkan kerugian berat
Kegagalan menyebabkan kerugian besar
Pasien Pasien Tidak ada cedera,Tidak ada cedera,Tidak ada Tidak ada perpanjangan perpanjangan hari rawat hari rawat
Cedera ringan Cedera ringan Ada Perpanjangan Ada Perpanjangan hari rawat hari rawat
Cedera luas / beratPerpanjangan hari rawat lebih lama (+> 1 bln)Berkurangnya fungsi permanen organ tubuh (sensorik / motorik / psikcologik / intelektual)
Kematian Kehilangan fungsi tubuh secara permanent (sensorik, motorik, psikologik atau intelektual) mis : Operasi pada bagian atau pada pasien yang salah, Tertukarnya bayi
PengunjuPengunjungng
Tidak ada cederaTidak ada cederaTidak ada penangananTidak ada penangananTerjadi pada 1-2 org Terjadi pada 1-2 org pengunjungpengunjung
Cedera ringan Cedera ringan Ada Penanganan Ada Penanganan ringanringan Terjadi pada 2 -4Terjadi pada 2 -4 pengunjungpengunjung
Cedera luas / berat Perlu dirawat Terjadi pada 4 -6 orang pengunjung
Kematian Terjadi pada > 6 orang pengunjung
Staf:Staf: Tidak ada cederaTidak ada cederaTidak ada penangananTidak ada penangananTerjadi pada 1-2 stafTerjadi pada 1-2 stafTidak ada kerugian Tidak ada kerugian waktu / keckerjawaktu / keckerja
Cedera ringan Cedera ringan Ada Penanganan / Ada Penanganan / TindakanTindakan KKehilangan waktu / ehilangan waktu / kec kerja kec kerja : 2-4 staf: 2-4 staf
Cedera luas / berat Perlu dirawat Kehilangan waktu / kecelakaan kerja pada 4-6 staf
KematianPerawatan > 6 staf
Fasilitas Fasilitas KesKes
Kerugian < 1 000,,000 Kerugian < 1 000,,000 atau tanpa atau tanpa menimbulkan dampak menimbulkan dampak terhadap pasienterhadap pasien
Kerugian Kerugian 1,000,000 - 1,000,000 - 10,000,00010,000,000
Kerugian 10,000,000 - 50,000,000
Kerugian > 50,000,000
Arjaty/ IMRKArjaty/ IMRK 2929
ANALISIS ANALISIS HAZARDHAZARD ”LEVEL PROBABILITAS” ”LEVEL PROBABILITAS”
LEVELLEVEL DESKRIPSIDESKRIPSI CONTOH CONTOH
44 Sering Sering (Frequent)(Frequent) 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)
33 Kadang-kadang Kadang-kadang (Occasional)(Occasional)
Kemungkinan akan muncul Kemungkinan akan muncul (dapat terjadi bebearapa kali dalam 1 (dapat terjadi bebearapa kali dalam 1
sampai 2 tahun)sampai 2 tahun)
22 Jarang Jarang (Uncommon)(Uncommon) Kemungkinan akan muncul Kemungkinan akan muncul (dapat terjadi dalam >2 sampai 5 tahun)(dapat terjadi dalam >2 sampai 5 tahun)
11 Hampir Tidak Pernah Hampir Tidak Pernah (Remote)(Remote)
Jarang sekali terjadi (dapat terjadi dalam Jarang sekali terjadi (dapat terjadi dalam > 5 sampai 30 tahun)> 5 sampai 30 tahun)
Arjaty/ IMRKArjaty/ IMRK 3030
TINGKAT BAHAYATINGKAT BAHAYA
KATASTROPIKKATASTROPIK44
MAYORMAYOR33
MODERAT MODERAT 22
MINORMINOR11
SERINGSERING44
1616 1212 88 44
KADANGKADANG33
1212 99 66 33
JARANGJARANG22
88 66 44 22
HAMPIR TIDAK HAMPIR TIDAK PERNAHPERNAH
11
44 33 22 11
HAZARD SCORE
Arjaty/ IMRKArjaty/ IMRK 3131
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 potentialcauses for this failure mode
Decision TreeDecision Tree Gunakan Decision Tree utk menentukan apakah modus perlu tindakan lanjut
di“Proceed”..
Arjaty/ IMRKArjaty/ IMRK 3232
Arjaty/ IMRKArjaty/ IMRK 3333
Arjaty/ IMRKArjaty/ IMRK 3434
What is HFMECA®
Prospective analysis model combines Prospective analysis model combines concepts :concepts :
FMEA (Failure Mode and Effects Analysis)FMEA (Failure Mode and Effects Analysis) RCA (Root Cause Analysis)RCA (Root Cause Analysis)
Modified by IMRK :Modified by IMRK :Brainstorming : Failure mode, Effect, CausesBrainstorming : Failure mode, Effect, Causes
(Da X P) x(Da X P) x KK X De,X De, BandsBands
Arjaty/ IMRKArjaty/ IMRK 3535
LANGKAH -LANGKAHANALISIS MODUS KEGAGALAN, DAMPAK & PENYEBAB
(AMKDP)®/HEALTHCARE FAILURE MODE EFFECT & CAUSES
ANALYSYS (HFMECA)®
1. Pilih Proses yang berisiko tinggi dan Bentuk Tim
2. Gambarkan Alur Proses3. Diskusikan & Prioritaskan Modus Kegagalan4. Brainstorming Dampak Modus Kegagalan5. Identifikasi Penyebab Modus Kegagalan 6. Hitung Total NPR (Nilai Prioritas Risiko) / RPN7. Disain ulang proses / Re-disain Proses8. Analisa & uji Proses baru9. Implementasi & Monitor Proses baru
Arjaty/ IMRKArjaty/ IMRK 3636
LANGKAH 1 : LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI & BENTUK TIMPILIH PROSES YANG BERISIKO TINGGI & BENTUK TIM
Pilih Proses berisiko tinggi yang akan dianalisa. Pilih Proses berisiko tinggi yang akan dianalisa.
Judul Proses : ___________________________________________Judul Proses : ___________________________________________
BENTUK TIMBENTUK TIM
Ketua : Ketua : ________________________________________________________________________________________________________________________
Anggota 1. _______________ Anggota 1. _______________ 4. 4. ________________________________________________________________________________
2. _______________ 5. 2. _______________ 5. ________________________________________ ________________________________________
3. _______________ 6. 3. _______________ 6. ________________________________________________________________________________
NotulenNotulen __________________________________________________________________________________Apakah semua Unit yang terkait dalam Proses sudah terwakili ?Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAKYA / TIDAKTanggal dimulai _________________ Tanggal selesai _______________________Tanggal dimulai _________________ Tanggal selesai _______________________
Arjaty/ IMRKArjaty/ IMRK 3737
STEP 2 DIAGRAM THE PROCESSSTEP 2 DIAGRAM THE PROCESSPROCESS STEPS :PROCESS STEPS :Describe the process graphically, according to your policy & procedure for the activity and number each oneDescribe the process graphically, according to your policy & procedure for the activity and number each oneIf the process is complex you may want to select one process step or sub process to work on If the process is complex you may want to select one process step or sub process to work on
1 2 3 4 5 1 2 3 4 5
Failure Mode Failure Mode Failure Mode Failure Mode Failure ModeFailure Mode Failure Mode Failure Mode Failure Mode Failure Mode
Pemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drugPemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drug Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis Sesuai kebthn)Sesuai kebthn) sesuai suhunya sesuai suhunya Wrong dosage Wrong dosage Penulisan Penulisan Obat R/ Obat R/ tdk tdk R/ R/ Dlm formularium Wrong frequence Dlm formularium Wrong frequence Wrong routeWrong route administrationadministration
Selection & Procurement
Storage Prescribing,Ordering,
Trancribing
Preparing &
Dispensing
Administration
Arjaty/ IMRKArjaty/ IMRK 3838
Administering
Failure points where medication errors occurFailure points where medication errors occur
TranscribingPrescribing Dispensing
39% 12% 11% 38%J AMA 1995 J ul 5,274(1):29-34
Arjaty/ IMRKArjaty/ IMRK 3939
RATING SYSTEM(Modified by IMRK)
Rating Probabilitas (P)
DAMPAK (D)
Kontrol(K)
Deteksi(D)
1 Remote Minor effect Easy Certain to detect
2 Low likelihood Moderate effect Mpderate Easy
High likelihood
3 Moderate likelihood
Minor injury Moderate difficult
Moderate likelihood
4 High likelihood Major injury Difficult Low likelihood
5 Certain to occur
Catastrophic effect / terminal
injury, death
Almost certain not to detect
Risk Priority Number (RPN) / Criticaly Index (CI) = (Da x P) x K x De
Arjaty/ IMRKArjaty/ IMRK 4040
Sample Severity Scale(Modified by IMRK)
Rating Description Definition1 Minor effect or No effect May affect the individual served & would
result in some effect on the process or Would not be noticeable to individual served & would not affect the process
2 Moderate effect May affect the individual served & would result in a major effect on the process
3 Minor injury Would affect the individual and result in a major effect on the process
4 Major injury Would result in a major injury for the individual served and have major effect on the process
5 Catastrophic effect, a terminal injury or death
Extremely dangerous, failure would result death of the individual served and have a major effect on the process
Source : JCR : Joint Commision Resources
Arjaty/ IMRKArjaty/ IMRK 4141
Rating Description Probability Definition
1 Remote to non existent
1 in 10,000 No or little known occurrence highly unlikely that condition will ever occur
2 Low Likelihood
1 in 5000 Possible, but no known data, the condition occurs in isolated cases, but chances are low
3 Moderate likelihood
1 in 200 Documented, but infrequently, the condition has a reasonable chance to occur
4 High likelihood
1 in 100 Documented and frequent, the condition occurs very regularly and / or during a reasonable amount of time
5 Certain to occur
1 in 20 Documented, almost certain, the condition will inevitably occur during long periods typical for the step or link
Sample Probability of Occurrence Scale(Modified by IMRK)
Arjaty/ IMRKArjaty/ IMRK 4242
Sample Detectability Scale(Modified by IMRK)
RatingRating DescriptionDescription Probability Probability ofof
DetectionDetection
DefinitionDefinition
11 Certain to Certain to detectdetect
10 out to 1010 out to 10 Almost always detected Almost always detected immediatelyimmediately
22 High likelihoodHigh likelihood 7 out of 107 out of 10 Likely to be detectedLikely to be detected
33 Moderate Moderate likelihoodlikelihood
5 out of 105 out of 10 Moderate likelihood of detectionModerate likelihood of detection
4 Low likelihood 2 out 0f 10 Unlikely to be detected
55 Almost certain Almost certain not to detectnot to detect
0 out of 100 out of 10 Detection not possible at any pointDetection not possible at any point
Arjaty/ IMRKArjaty/ IMRK 4343
CONTROLLABILITY
Controls and Status are unknown or Residual riskDifficult4
Controls are either not practically in place not effective, not communicated and or not complied with no reviews undertaken orControls 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 orControls can be introduced to reduce risk to an acceptable levelwithin 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 orRisk can be introduced 1 month / or low cost or
Easy1
DefinitionDesriptionRating
Arjaty/ IMRKArjaty/ IMRK 4444
STEP 5 IDENTIFY ROOT CAUSES OF FAILURE MODES Failure Mode Potential
effectPotent
ial cause
s
Severity Probability
Risk Score(3X4)
Risk Categor
ies / Bands
Control Detection RPN(5X8X
9)
1 2 3 4 5 1 2 3 4 5 1-25
L M H E 1 2 3 4 1 2 3 4 5
1 2 3 4 5 6 7 8 9 10Wrong route administration
Death No Training
X X 10 E X X 40
Wrong frequency
Injury with permanent loss of function >
No record in Chart
X X 12 E X X 24
Wrong dosage
No injury with no permanent loss of function
Miss read instruction
X X 8 H X X 32
Wrong drug No injury but LOS >
Miss identification
X X 4 H X X 16
Arjaty/ IMRKArjaty/ IMRK 4545
STEP 6 CALCULATE TOTAL RPNSTEP 6 CALCULATE TOTAL RPNNo Failure
ModeRPN
FailureMode
Potential effect
RPNeffect
PotentialCauses
RPNCauses
TotalRPN
Rank
1 2 3 4 5 6 7 8 9
1 Wrong route administration
60 Death 40 No Training
40 140 1
2 Wrong frequency
48 Injury with permanent loss of function
12 No record in Chart
24 84 3
3 Wrong dosage 36 No injury with no permanent loss of function
36 Miss read instruction
32 104 2
4 Wrong drug 36 No injury but LOS > >
16 Miss identification
16 68 4
Arjaty/ IMRKArjaty/ IMRK 4646
STEP 7 REDESIGN PROCESSSTEP 7 REDESIGN PROCESS Process Failure
ModePotential
EffectPotential Causes
Redesign Recommen
dations
PIC Target Comple
tion
date for test
NewProcess
Implementation
date & Actions
Outcome Measure / Monitoring mechanism
1 2 3 4 5 6 7 8 9
Arjaty/ IMRKArjaty/ IMRK 4747
TAKE A DEEP BREATHTAKE A DEEP BREATHConduct a literature search to Conduct a literature search to gather gather
relevant information from the professional relevant information from the professional literatureliterature. Do not reinvent the wheel. Do not reinvent the wheel
Network with colleaguesNetwork with colleaguesRecommit to out of the box thinkingRecommit to out of the box thinking
PREPARING TO REDESIGNPREPARING TO REDESIGN
Arjaty/ IMRKArjaty/ IMRK 4848
LANGKAH 8ANALISIS 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/ IMRKArjaty/ IMRK 4949
LANGKAH 9LANGKAH 9IMPLEMENTASI DAN MONITORING PROSESIMPLEMENTASI DAN MONITORING PROSES
Strategies for Creating & Managing the Change Process :Strategies for Creating & Managing the Change Process :1.1. Establish a sense of urgencyEstablish a sense of urgency2.2. Create a guiding coalitionCreate a guiding coalition3.3. Develop a vision and strategyDevelop a vision and strategy4.4. Communicate the changed visionCommunicate the changed vision5.5. Empower broad based actionEmpower broad based action6.6. Generate short term winsGenerate short term wins7.7. Consolidate gains and produce more changeConsolidate gains and produce more change8.8. Anchor new approaches in the cultureAnchor new approaches in the culture
Arjaty/ IMRKArjaty/ IMRK 5050
REDISAIN PROSESREDISAIN PROSES
Variable inputVariable input ComplexComplex NonstandarizedNonstandarized Tightly CoupledTightly Coupled Dependent on Dependent on
human interventionhuman intervention Time constraintsTime constraints Hierarchical cultureHierarchical culture
Decreasing variabilityDecreasing variability SimplifySimplify Standardizing Standardizing Loosen coupling of process Loosen coupling of process Use technologyUse technology Optimise RedundancyOptimise Redundancy Built in fail safe mechanismBuilt in fail safe mechanism DocumentationDocumentation Establishing a culture of Establishing a culture of
teamworkteamwork
Arjaty/ IMRKArjaty/ IMRK 5151
Proses lama yg high risk
Desain Proses baru
AlurProses Potential Cause
FailureMode HS
Efek /Dampak
Decision Tree
KK
DT
K
E
Tindakan
AMKD / HFMEA
KontrolEliminasiTerima
KritisKontrolDeteksi
HazardScore
Arjaty/ IMRKArjaty/ IMRK 5252
AMKDP / HFMECA
Prioritas Prioritas risikorisiko
Total RPN Total RPN PROSES PROSES LAMALAMA
FailureFailure Mode,Mode, Dampak, Dampak, PenyebabPenyebab
RedisignRedisignProsesProses
Analisis &Analisis & Uji Proses Uji Proses
Baru Total Baru Total RPN RPN
PROSES PROSES BARU BARU
FailureFailure Mode,Mode, Dampak, Dampak, PenyebabPenyebab
Implementasi Implementasi PROSES BARUPROSES BARU
Total RPN30-50%?
Arjaty/ IMRKArjaty/ IMRK 5353
KESIMPULANKESIMPULANBuilding a safe Building a safe healthcare systemhealthcare system
DETEKSI
KONTROL
SEVERITY
FREKUENSI
LEARNING
RE
PO
RT
IN
G
ANALISIS
KOMUNIKASI
CU
LT
UR
E
TRAINING
TE
AM
WO
RK
L E A D E R S H I P
Arjaty/ IMRKArjaty/ IMRK 5454
Safety begins with youDon’t wait for someone else