Académique Documents
Professionnel Documents
Culture Documents
Arjaty/ IMRK 2
Historical Perspective
Hingga saat ini, pencegahan kesalahan medis belum
Until recently, error prevention has not been a
menjadi fokus utama bidang kedokteran
primary focus of medicine
Kelainan Sistem atau proses diidentifikasi dari
System/process defects are identified by
kejadian yang tidak diharapkan atau disembunyikan
adverse
oleh events
tenaga medis or dealt with silently by health
care personnel
Sebagian besar sistem pelayanan kesehatan tidak
Most health
didesain untukcare delivery
mencegah atausystems are not
mengkompensasi
designed
suatu to prevent and / or compensate for
kesalahan
errors
Arjaty/ IMRK 3
Rationale for FMEA in healthcare
Historically
Pencegahan .......insiden belum menjadi fokus
Accident
utama pelayanan
prevention rumah
has not
sakit
been a primary
focus
Adanyaof hospital
persepsimedicine
yang salah tentang
Misguided
kegagalanreliance on faultles
dalam pelayanan performance
oleh profesi
by healthcare professionals
kesehatan
Hospital systems were not designed to
Sistem rumah sakit tidak didesain untuk
prevent or absorb error, they just reactively
mencegah kesalahan, mereka hanya
changed and were not typically proactive reaktif
dan tidak proaktif
Arjaty/ IMRK NCPS 4
JCAHO Standards
PI.3.20*
An
Anongoing,
ongoing,proactive
proactiveprogram
programfor
foridentifying
identifyingand
and
reducing
reducingunanticipated
unanticipatedadverse
adverseevents
eventsand
andsafety
safety
risks
riskstotopatients
patientsisisdefined
definedand
andimplemented.
implemented.
At leastsedikit,
Paling one high-risk process
pilih satu is chosen
masalah annually,
berisiko thetahunnya,
tinggi tiap choice
should be basedpilihin part on information
berdasarkan published
evaluasi periodikperiodically
by the Joint Commission about the most frequent sentinel
events and risks.
Arjaty/ IMRK 5
*2005 Comprehensive Accreditation Manual for Hospitals: The
Official Handbook JCAHO 2005
JCAHO Standard LD 5.2
(efective July 2001)
Leaders
Pimpinanensure
perlu memastikan
that an ongoing,
bahwa
proactive
seluruhprogram
upaya
berjalan
for identifying
dalam penerapan
risks to patient
program
safetysecara
andreducing
proaktif
medical
mengidentifikasi
/ health care
risikoerrors
yangistujuannya
defined and
bagi
keselamatan pasien implemented
dan mereduksi kesalahan medis
The organization
Organisasi seeksmereduksi
akan berusaha to reduce the riskkejadian
risiko of sentinel events and
berbahaya ataumedical
/ healthmedis
kesalahan care system
denganerror relatedusaha
melakukan occurrences
proaktifbymenggunakan
conducting itsinformasi
own
yangproactive
tersediarisk
dariassessment
kejadian lainactivities and bykesamaan
yang memiliki using available information
pelayanan dan
about sentinel events known to occur in healthcare organizations that
sistem
provide similar care & services.
Upaya untuk redesain ulang proses fungsi dan pelayanan sehingga dapat
Thiskejadian
dicegah effort is undertaken so that
yang merugikan processes, functions & services can be
organisasi
DESIGNED or REDEDIGNED to prevent such occurrences in the
organization.
Arjaty/ IMRK 6
JCAHO Standard LD 5.2
(efective July 2001)
Arjaty/ IMRK 7
JCAHO Standard LD 5.2
(efective July 2001)
Arjaty/ IMRK 8
RISK REDUCTION STRATEGIES DIFFICULTY &
LONG TERM EFFECTIVENESS
Types of actions Degree of Long term
difficulty effectiveness
Easy Low
1. Punitive
2. Retraining / counseling
3. Process redesign
4. Paper vs practice
5. Technical system enhance
6. Culture change
Difficult High
Arjaty/ IMRK 9
Definition of a Process
Arjaty/ IMRK 10
STRATEGI REDUKSI RISIKO
Arjaty/ IMRK 11
STRATEGI REDUKSI RISIKO
RISK
POINTS /
COMMON CAUSES
RENCANA
REDUKSI RISIKO
Arjaty/ IMRK 13
IDENTIFYING RISK PRONE SYSTEM
Variable input
Complex systems
Non standardized systems
Tightly coupled systems
Systems with tight time constraints
Systems with hierarchical
Arjaty/ IMRK 14
Variable input
Pasien
Penyakit berat
Penyakit penyerta
Pernah mendapatkan pengobatan
Usia
Pemberi Pelayanan
Tingkat keterampilan
Cara pendekatan
Arjaty/ IMRK 15
Complexitas
Arjaty/ IMRK 16
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 17
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 18
Tightly Coupled
Perpindahan langkah dari suatu proses sering sangat
ketat, kadang baru disadari terjadi penyimpangan pada
langkah yang telah lanjut.
Arjaty/ IMRK 19
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.
Arjaty/ IMRK 20
Implementing Safety Cultures in Medicine:
What We Learn by Watching Physicians
Timothy J. Hoff, Henry Pohl, Joel Bartfield
Arjaty/ IMRK 21
REDISAIN PROSES
FMEA
Arjaty/ IMRK 22
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 23
FMEA
Whats the point?
Eliminating
Denganor reducing
mengeliminasi
the riskatau
of the
mereduksi
failure modes
risiko kegagalancan result
akan in a
menghasilkan suatu
SAFER YANG
SISTEM AND MORE
AMANEFFICIENT
DAN LEBIHSYSTEMEFISIEN
from which BAGI
both you
RS and
DANyour patients benefit.
PASIEN.
Arjaty/ IMRK 24
What is Failure Mode and Effect Analysis
(FMEA) ?
A tool to :
-Analyze a process to see where it is likely to fail
-See how changes you are considering might affect
the safety of the process
Arjaty/ IMRK 25
Failure Mode and Effects Analysis
Arjaty/ IMRK 28
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 29
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
Arjaty/ IMRK 30
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
Arjaty/ IMRK 31
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
Arjaty/ IMRK 32
Arjaty/ IMRK 33
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
Arjaty/ IMRK 34
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
Arjaty/ IMRK 35
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.
Arjaty/ IMRK 36
Step Eight
Arjaty/ IMRK 37
Arjaty/ IMRK 38
LANGKAH2 FMEA, HFMEA, HFMECA
FMEA HFMEA HFMECA
Original By : VA NCPS By IMRK
1 Select a high risk process & Define the HFMEA Select a high risk process &
assemble a team Topic assemble a team
2 Diagram the process Assemble the Team Diagram the process
3 Brainstorm potential failure modes & Graphically describe Brainstorm potential failure modes
determine their effects the Process (P X S) x K X De, Bands
(P X S X De)
4 Prioritize failure modes Conduct a Hazard Prioritize failure modes
Analysis
5 Identify root causes of failure modes Actions & Outcome Identify root causes of failure modes
(P X S X De) Measures (P X S) x K X De, Bands
8 Implement & monitor the redesigned Analyze & test the new process
process
9 Arjaty/ IMRK Implement & monitor the redesigned
39
process
RATING SYSTEM
(Modified by IMRK)
The objective is to look for all ways for process or product can
fail
Team membership V V V
Diagramming process V V V
Arjaty/ IMRK 43
LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAK (AMKD)
(HEALTHCARE FAILURE MODE EFFECT AND ANALYSIS)
(HFMEA)
By : VA NCPS
Step 2
Multidisiplinary team with Subject matter
expert(s) plus advisor
Arjaty/ IMRK 45
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
Arjaty/ IMRK 46
Step 4
List Failure modes
Determine Severity & Probability
Use the Decision tree
List all Failure mode causes
Arjaty/ IMRK 47
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
Arjaty/ IMRK 48
FORM & TOOLS
Form
Worksheets
Hazard Scoring matrix
Decision tree
Arjaty/ IMRK 49
LANGKAH 1 : PILIH PROSES YANG BERISIKO TINGGI
Judul Proses :
__________________________________________________________________________
_________________________________________________________
_________________________________________________________
LANGKAH 2 : BENTUK TIM
Ketua : ____________________________________________________________
Notulen? _________________________________________
Apakah semua Unit yang terkait dalam Proses sudah terwakili ? YA / TIDAK
Tanggal dimulai ____________________ Tanggal selesai ___________________
Arjaty/ IMRK 50
Contoh kasus 1
Arjaty/ IMRK 51
Arjaty/ IMRK 52
Arjaty/ IMRK 53
ANALISIS HAZARD LEVEL DAMPAK
DAMPAK MINOR MODERAT MAYOR KATASTROPIK
1 2 3 4
Kegagalan yang tidak Kegagalan dapat Kegagalan menyebabkan Kegagalan menyebabkan kerugian
mengganggu Proses mempengaruhi proses kerugian berat besar
pelayanan kepada Pasien dan menimbulkan
kerugian ringan
Pasien Tidak ada cedera, Cedera ringan Cedera luas / berat Kematian
Tidak ada perpanjangan Ada Perpanjangan Perpanjangan hari rawat Kehilangan fungsi tubuh
hari rawat hari rawat lebih lama (+> 1 bln) secara permanent (sensorik,
Berkurangnya fungsi motorik, psikologik atau
permanen organ tubuh intelektual) mis :
(sensorik / motorik / Operasi pada bagian atau
psikcologik / intelektual) pada pasien yang salah,
Tertukarnya bayi
Pengunju Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
ng Tidak ada penanganan Ada Penanganan Perlu dirawat Terjadipada > 6 orang
Terjadi pada 1-2 org ringan Terjadi pada 4 -6 orang pengunjung
pengunjung Terjadi pada 2 -4 pengunjung
pengunjung
Staf: Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
Tidak ada penanganan Ada Penanganan / Perlu dirawat Perawatan > 6 staf
Terjadi pada 1-2 staf Tindakan Kehilangan waktu /
Tidak ada kerugian Kehilangan waktu / kecelakaan kerja pada
waktu / keckerja kec kerja : 2-4 staf 4-6 staf
Fasilitas Kerugian < 1 000,,000 Kerugian Kerugian Kerugian > 50,000,000
Kes atau tanpa menimbulkan 1,000,000 - 10,000,000 - 50,000,000
Arjaty/ IMRK 54
dampak terhadap pasien 10,000,000
ANALISIS HAZARD LEVEL PROBABILITAS
Arjaty/ IMRK 55
HAZARD SCORE
TINGKAT BAHAYA
KATASTROPIK MAYOR MODERAT MINOR
4 3 2 1
SERING 16 12 8 4
4
KADANG 12 9 6 3
3
JARANG 8 6 4 2
2
HAMPIR TIDAK 4 3 2 1
PERNAH
1
Arjaty/ IMRK 56
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 NO
warrant that it be controlled?
(Hazard score of 8 or
higher)
Is this a single point weakness in the
NO
YES process? (Criticality failure results
in a system failure?)
CRITICALY
YES
Does an effective control measure already YES
exist for the identified hazard? STOP
CONTROL Do not proceed to
NO find potential
causes for this
Is this hazard so obvious and readily failure mode
apparent that a control measure is not YES
warranted?
DETECTABILITY Proceed to
NO Potential
Arjaty/ IMRK Causes for 57
this failure
Arjaty/ IMRK 58
Arjaty/ IMRK 59
Contoh kasus 2
PROSES KEGIATAN PAGI HARI MENUJU TEMPAT KERJA
Arjaty/ IMRK 60
Arjaty/ IMRK 61
Arjaty/ IMRK 62
Arjaty/ IMRK 63
Arjaty/ IMRK 64
Arjaty/ IMRK 65
Arjaty/ IMRK 66
Arjaty/ IMRK 67
LEMBAR AMKD ( FORM HFMEA )
AMKD Langkah 4 - Analisis Hazard AMKD Langkah 5 - Identifikasi Tindakan & Outcome
Yang Bertanggung
Ukuran Outcome
Manajemen Tim
Kegagalan : Tindakan /
kontrol/pengen
Apakah mudah
Tipe
Poin Tunggal
Kelemahan ?
Probabilitas
Nilai Hazard
Alasan untuk
Apakah ada
Kegawatan
Evaluasi awal POTENSI
didteksi ?
Tindakan
Jawab
Proses ?
dalian?
modus PENYEBAB mengakhiri
(Kontrol,
kegagalan terima,
sebelum Eliminasi)
Arjaty/ IMRK 68
Alur
Potential Cause Efek / Decision Tindakan
Proses
Dampak Tree
Failure K
K
Mode HS
K
E
D
T
Desain Hazard
Proses baru Kritis Kontrol
Score Kontrol Eliminasi
Deteksi Terima
Arjaty/ IMRK 69
AMKDP / HFMECA
Total RPN
30-50%?
Arjaty/ IMRK 70
CONTOH IMPLEMENTASI KESELAMATAN PASIEN
The JCI 2007
International Patient Safety Goals
Check back
Teach back
Arjaty/ IMRK 72
Tingkatkan keamanan untuk pemberian
obat
LASA / NORUM
CHECK BACK
5 BENAR
JANGAN GUNAKAN
SINGKATAN
Arjaty/ IMRK 73
LOOK ALIKE SOUND ALIKE
Arjaty/ IMRK 74
JANGAN GUNAKAN SINGKATAN
Arjaty/ IMRK 75
Arjaty/ IMRK 76
BELAJAR DARI PENGALAMAN
Arjaty/ IMRK 77
KESIMPULAN
Building a safe healthcare system
L E A D E R S H I P
Arjaty/ IMRK 78
Arjaty/ IMRK 79