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Failure Mode and Effect Analysis

Herkutanto
Herkutanto

KOMITE KESELAMATAN PASIEN


KONSIL KEDOKTERAN, KKI
Guru Besar Fakultas Kedokteran Universitas Indonesia

HERKUTANTO 2
ALASAN UTAMA MELAKUKAN REGULASI

(Schellekens, W : Patient Safety Conference,


European Union Presidency Luxembourg, 4 – 5 April 2005)
TUJUAN PAPARAN
Strategi
Pengendalian Risiko
melalui FMEA

Mengenal langkah2
Failure Mode and
Effect Analysis
HERKUTANTO 4
KUALITAS PELAYANAN
(Donabedian)

OUTCOME

PROCESS

STRUCTURE

HERKUTANTO 5
HERKUTANTO 6
SUMBER

HERKUTANTO 7
SISTIMATIKA PAPARAN

 INTRODUKSI FMEA

 DELAPAN LANGKAH FMEA

 KESIMPULAN
HERKUTANTO 8
INTRODUKSI FMEA & HFMEA

HERKUTANTO 9
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

HERKUTANTO 10
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 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)

HERKUTANTO 11
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.
HERKUTANTO 12
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
HERKUTANTO 13
DELAPAN LANGKAH FMEA

HERKUTANTO 14
LANGKAH-LANGKAH
ANALISIS MODUS KEGAGALAN & DAMPAKNYA
(JCI )

1. Tetapkan Topik FMEA dan Bentuk Tim


2. Gambarkan Alur Proses
3. Identifikas Modus Kegagalan & Dampaknya (Hazard Analysis)
4. Identifikas Prioritas Modus Kegagalan
5. Identifikasi Akar Penyebab Modus Kegagalan
6. Disain ulang Proses
7. Analisis dan Test Proses Baru
8. Implementasi dan Monitor Proses Baru
HERKUTANTO 15
Output setiap langkah
LANGKAH OUTPUT
1 Tetapkan Topik FMEA dan Bentuk Tim Topik dan Tim
2 Gambarkan Alur Proses Alur Proses tergambar
3 Identifikasi Modus Kegagalan & Modus Kegagalan &
Dampaknya Dampaknya

4 Tetapkan Prioritas Modus Kegagalan Daftar Prioritas Modus


Kegagalan
5 Identifikasi Akar Penyebab Modus Akar Penyebab
Kegagalan Modus Kegagalan

6 Disain ulang Proses Proses Baru


7 Analisis dan Uji Coba Proses Baru Hasil Uji COba
8 Implementasi dan Monitor Proses Baru Penerapan Proses Baru
HERKUTANTO 16
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

1 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
TETAPKAN TOPIK & TIM 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO
Monitor Proses
17

Baru
TUJUAN & HASIL

 Terpilihnya Topik FMEA

 Terpilihnya TIM Pelaksana untuk topik


tersebut

 Daftar Tim

HERKUTANTO 18
PEMILIHAN TOPIK FMEA
 Proses spesifik di rumah sakit:
 Highrisk
 Highvolume
 highcost

 Didasarkan pada data incident report


keselamatan pasien
 Data rutin keselamatan pasien
 Sentinel event

HERKUTANTO 19
TUJUAN PEMILIHAN TOPIK
 Fokus pada proses spesifik yang dianggap
prioritas (hospital specific)
 Melakukan tindakan korektif pada proses
melalui redesign proses
 Contoh:
 Proses pelayanan Transfusi darah
 Proses pemberian obat kepada pasien

HERKUTANTO 20
Characteristic of a high risk process
 Variable team

 Complex

 Non standardized

 Tightly coupled

 Heavily dependent on human intervention

 Hierarchical vs team

 Tight time constraints

 Loose time constraints HERKUTANTO 21


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 ___________________

HERKUTANTO 22
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 Assign team members to follow up individual charged with taking
meeting plus 1 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
HERKUTANTO 23
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

2 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Gambarkan Alur Proses 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO
Monitor Proses
24

Baru
TUJUAN & HASIL

 Tergambarnya alur / langkah2 PROSES


dan SUBPROSES pelayanan yang dipilih
dalam suatu bagan yang jelas
 LEMBAR ALUR
PROSES dan SUBPROSES PELAYANAN

HERKUTANTO 25
HERKUTANTO 26
HERKUTANTO 27
HERKUTANTO 28
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

Prescribing, Preparing
Selection & Storage
Ordering, &
Procurement Administration
Trancribing Dispensin
g

Failure Mode Failure Mode Failure Mode Failure Mode Failure Mode

Pemesanan obat Penyimpanan Penulisan obat Peracikan obat Wrong drug


Berlebihan (tdk vaksin tdk dlm R/ tdk jls tdk sesuai dosis
Sesuai kebthn) sesuai suhunya
Wrong dosage

Penulisan Obat R/
tdk R/
Dlm formularium Wrong frequence

Wrong route
administration

HERKUTANTO 29
TELAAH SUB-PROSES PADA FMEA

 Prinsip: the DEVILS are in the DETAILS

 Cari modus / cara suatu langkah dalam


suatu subproses dapat gagal

HERKUTANTO 30
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus
Kegagalan &
3 Dampaknya

4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan

Identifikasi 6 Disain ulang Proses

7 Analisis dan Uji Coba


Modus Kegagalan & Proses Baru

Dampaknya 8 Implementasi dan


HERKUTANTO Monitor Proses31Baru
TUJUAN & HASIL

1. Teridentifikasinya MODUS KEGAGALAN


pada setiap langkah proses pelayanan

2. Teridentifikasinya DAMPAK KEGAGALAN


pada setiap langkah proses pelayanan

HERKUTANTO 32
Hazard analysis: What is it?

Hazard: Potentially dangerous condition,


which is triggered by an event,
called the cause of the hazard.

Risk: hazard that is associated with a


severity and a probability of
occurrence.
HERKUTANTO 33
Hazard, Barrier, Target Analysis

Hazard Barrier Target

High
Dog Fence Child

HERKUTANTO 34
HERKUTANTO 35
HERKUTANTO 36
HERKUTANTO 37
HERKUTANTO 38
HERKUTANTO 39
Hazard, Barrier, Target Analysis

Hazard Barrier Target

Medical Policies
Procedures Patient
Mishaps

HERKUTANTO 40
Hazard analysis: What is it?

General risk assessment


protocol : Establish Analysis Parameters

Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks

Verify Effectiveness

HERKUTANTO 41
Document Results
Hazard analysis: What is it?

Establish Analysis Parameters

Identify Hazards These parameters can


be limits of the
Assess Risks
machine or design,
Derive Risk Rating limits on uses, limits
Reduce Risks
on the scope of the
analysis, or other
Verify Effectiveness
limits.
Document Results HERKUTANTO 42
Hazard analysis: What is it?

Establish Analysis Parameters

Identify Hazards The nature of this


step lends itself to a
Assess Risks
team approach such
Derive Risk Rating as brainstorming.
Reduce Risks

Verify Effectiveness

Document Results HERKUTANTO 43


Hazard analysis: What is it?

Establish Analysis Parameters

Identify Hazards
Two risk factors are used:
Assess Risks
• severity of injury
Derive Risk Rating
• probability of occurrence
Reduce Risks

Verify Effectiveness

Document Results HERKUTANTO 44


Hazard analysis: What is it?

Establish Analysis Parameters


Risk matrix:
Identify Hazards Severity Category
Probability Level Catastrophic Critical Marginal Negligible
Assess Risks Frequent High High Serious Serious
Probable High High Serious Low
Derive Risk Rating Occasional High Serious Low Low
Remote Serious Low Low Low
Reduce Risks Improbable Serious Low Low Low

If the risk is determined to not be acceptable, it


Verify Effectiveness
is necessary to reduce that risk by
implementing protective measures.
Document Results HERKUTANTO 45
Hazard analysis: What is it?

Establish Analysis Parameters


Remedy actions are taken to
Identify Hazards reduce risks following the
hazard hierarchy:
Assess Risks
• Eliminate hazards through the design
Derive Risk Rating  Protect
 Warn the user
Reduce Risks
 Train the user(s)
 Personal protective equipment
Verify Effectiveness

Document Results HERKUTANTO 46


Hazard analysis: What is it?

Establish Analysis Parameters

Identify Hazards This assessment


verifies that the
Assess Risks
remedy actions have
Derive Risk Rating reduced the risks to an
Reduce Risks
acceptable level.

Verify Effectiveness

Document Results HERKUTANTO 47


Hazard analysis: What is it?

Establish Analysis Parameters

Identify Hazards

Assess Risks

Derive Risk Rating

Reduce Risks The documentation can be added to a


technical file for future use.

Verify Effectiveness

Document Results HERKUTANTO 48


Full Hazard Analysis
Proactive Controls Reactive Controls

Recovery People
Threat Barrier Barrier Measures

Recovery Asset
Threat Barrier Barrier Measures Damage
Hazard Top Event
(Incident)
Recovery Environment
Threat Barrier Barrier Measures

Recovery
Measures Reputation
Escalation
controls

HERKUTANTO 49
Completed Hazards & Effects Register

HAZARDS & EFFECTS REGISTER


Risk
Hazard Threats Barriers Top Recovery Consequences Rating Initial Final Remedial
Event Measures Risk Risk Action
P A E R Required

C5
X X X X X X X X X X D4,5 X
E3,4,5

X X X X X X X X

C5
X X X X X X X X X X D4,5
E3,4,5

X X X X X X X X X
HERKUTANTO 50
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim

2 Gambarkan Alur
Proses

3 Identifikasi Modus

4 Kegagalan &
Dampaknya

4 Tetapkan Prioritas
Modus Kegagalan

5 Identifikasi Akar
Penyebab Modus
Kegagalan

6 Disain ulang Proses


Tetapkan Prioritas 7 Analisis dan Uji Coba
Modus Kegagalan Proses Baru

8 Implementasi dan
Monitor Proses Baru
HERKUTANTO 51
TUJUAN & HASIL

 Tersedianya urutan prioritas

 DAFTAR PRIORITAS MODUS


KEGAGALAN

HERKUTANTO 52
HERKUTANTO 53
ANALISIS HAZARD “LEVEL DAMPAK”
DAMPA MINOR MODERAT MAYOR KATASTROPIK
K 1 2 3 4
Kegagalan yang tidak Kegagalan dapat Kegagalan Kegagalan menyebabkan
mengganggu Proses mempengaruhi menyebabkan kerugian kerugian besar
pelayanan kepada proses dan berat
Pasien menimbulkan
kerugian ringan
Pasien Tidak ada cedera, Cedera ringan Cedera luas / berat  Kematian
Tidak ada Ada Perpanjangan Perpanjangan hari  Kehilangan fungsi tubuh
perpanjangan hari rawat rawat secara permanent (sensorik,
hari rawat lebih lama (+> 1 bln) motorik, psikologik atau
Berkurangnya fungsi intelektual) mis :
permanen organ tubuh  Operasi pada bagian atau
(sensorik / motorik / pada pasien yang salah,
psikcologik /  Tertukarnya bayi
intelektual)

Pengunj Tidak ada cedera  Cedera ringan  Cedera luas / berat Kematian
ung Tidak ada  Ada Penanganan  Perlu dirawat Terjadipada > 6 orang
penanganan ringan  Terjadi pada 4 -6 pengunjung
Terjadi pada 1-2 org  Terjadi pada 2 -4 orang
pengunjung pengunjung pengunjung
Staf: Tidak ada cedera Cedera ringan Cedera luas / berat Kematian
Tidak ada  Ada Penanganan /  Perlu dirawat Perawatan > 6 staf
penanganan Tindakan Kehilangan waktu /
HERKUTANTO 54
Terjadi pada 1-2 staf  Kehilangan waktu kecelakaan kerja pada
ANALISIS HAZARD ”LEVEL PROBABILITAS”

LEVEL DESKRIPSI CONTOH


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

3 Kadang-kadang Kemungkinan akan muncul


(Occasional) (dapat terjadi bebearapa kali dalam 1
sampai 2 tahun)

2 Jarang (Uncommon) Kemungkinan akan muncul


(dapat terjadi dalam >2 sampai 5 tahun)
1 Hampir Tidak Pernah Jarang sekali terjadi (dapat terjadi dalam
(Remote) > 5 sampai 30 tahun)

HERKUTANTO 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

HERKUTANTO 56
HERKUTANTO 57
HERKUTANTO 58
Laboratory Test Ordering Process

HERKUTANTO 59
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

5 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Identifikasi Akar Penyebab Proses
7 Analisis dan Uji
Modus Kegagalan Coba Proses
Baru
8 Implementasi dan
HERKUTANTO
Monitor Proses
60

Baru
TUJUAN & HASIL

 Teridentifikasinya AKAR PENYEBAB


modus kegagalan yang telah teridentifikasi

 Lembar AKAR PENYEBAB

HERKUTANTO 61
Possible Characteristics of Root
Causes

 Root causes are systemic.

 Root causes appear far from the origin of


the failure.

 The origins of root causes lie in common-


cause variation of organization systems
HERKUTANTO 62
many of the failure modes
had the same root causes
 Omission errors secondary to automatic stop order
 Suboptimal patient involvement in medication histories
 Suboptimal medication reconciliation by clinicians
 Confusing epidural and patient-controlled analgesia
order sets
 Lack of electronic medication administration record
 Lack of computerized order entry

HERKUTANTO 63
PROBING
to uncover root causes and their relationships

 What could happen? (the failure mode)


 Why could this happen?
 That is, what are the most proximate causes? These
typically involve special-cause variations.

 Why could these proximate causes happen?


 That is, what systems and processes underlie those
proximate causes?
 Common-cause variation here may lead to special-
cause variation in dependent processes.
HERKUTANTO 64
What could happen? - FACTORS
 Human factors
 failure to follow policieson precaution orders or failure
to conduct appropriate staff education/training

 Assessment process factors


 faulty initial assessment process

 Equipment factors
 nonfunctional paging system that delays
communication with the individual’s physician
HERKUTANTO 65
Questions to Uncover Causes
 What safeguards are missing in the process?
 If the process already contains safeguards (for
example, double checks), why might they not work to
prevent the failure every time?

 What would have to go wrong for a failure like


this to happen?

 If this failure occurred, why would the problem


not be identified before it affected an individual?

HERKUTANTO 66
What could happen?

HERKUTANTO
67
Contributory Factors to Suicide
What could happen?

HERKUTANTO 68
DIABETES SCREENING
What could happen?

HERKUTANTO 69
Laboratory Test
Ordering Process

HERKUTANTO 70
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

6 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Proses
Disain Ulang Proses 7 Analisis dan Uji
Coba Proses
Baru
8 Implementasi dan
HERKUTANTO
Monitor Proses
71

Baru
TUJUAN & HASIL

 Teridentifikasinya PROSES BARU yang


bebas dari modus kegagalan

 Lembar langkah2 PROSES BARU

HERKUTANTO 72
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 NO
warrant that it be controlled?
(Hazard score of 8 or
higher)
Is this a single point weakness in
NO
YES the process? (Criticality – failure
results in a system failure?)
CRITICALITY
YES
Does an effective control measure already exist YES
for the identified hazard? STOP
CONTROL THE HAZARD (=BARRIER) Do not proceed
NO to find potential
causes for this
Is this hazard so obvious and readily failure mode
apparent that a control measure is not YES
warranted?
DETECTABILITY NO
(FORESEEABILITY)
Proceed to Potential
HERKUTANTO
Causes for this 73
failure mode
PREPARING TO REDESIGN

 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

HERKUTANTO 74
REDESIGN STRATEGIES
 Prevent the failure from happening
(decrease likelihood of occurrence)
 Prevent the failure from reaching the
individual (increase detectability)
 Protect individuals if a failure occurs
(decrease the severty of the efects)

HERKUTANTO 75
PROSES METODE
RISIKO TINGGI REDESIGN

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

HERKUTANTO 76
REDESIGN PROCESS
Process Failure Potential Potential Redesign PIC Target New Outcome
Mode Effect Causes Recommend Completi Process Measure /
ations on Implementat Monitoring
date ion mechanism
for test date &
Actions

1 2 3 4 5 6 7 8 9

HERKUTANTO 77
Proses
Redesign

Bandingkan :

Analisis & Ranking Analisis & Ranking

Failure Failure
Effect Causes Effect Causes
Mode Mode

Proses Lama Proses Baru


HERKUTANTO 78
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

7 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Analisis dan Uji Coba Proses
7 Analisis dan Uji
Proses Baru Coba Proses
Baru
8 Implementasi dan
HERKUTANTO
Monitor Proses
79

Baru
TUJUAN & HASIL

 Terujinya PROSES BARU dilapangan

 Le

HERKUTANTO 80
SIKLUS PDSA

HERKUTANTO 81
SIKLUS PDSA

HERKUTANTO 82
LEMBAR KERJA
UJI COBA

HERKUTANTO
83
LEMBAR KERJA
UJI COBA

HERKUTANTO
84
LANGKAH
1 Tetapkan Topik
FMEA dan Bentuk
Tim
2 Gambarkan Alur
Proses
3 Identifikasi Modus

8 Kegagalan &
Dampaknya
4 Tetapkan Prioritas
Modus Kegagalan
5 Identifikasi Akar
Penyebab Modus
Kegagalan
6 Disain ulang
Implementasi & Monitor Proses
7 Analisis dan Uji
Proses Baru Coba Proses
Baru
8 Implementasi
HERKUTANTO
dan Monitor 85
Proses Baru
TUJUAN & HASIL

 PENERAPAN PROSES BARU


 Manajemen Perubahan

 Lembar MONITORING PROSES BARU

HERKUTANTO 86
Strategies for Creating and Managing
the Change Process

 Establish a sense of urgency

 Create a guiding coalition

 Develop a vision and strategy

 Communicate the changed vision

 Empower broad-based action

 Generate short-term wins

 Consolidate gains and produce more change

 Anchor new approaches HERKUTANTO


in the culture 87
LEMBAR MONITOR PROSES BARU

HERKUTANTO 88
LEMBAR MONITOR PROSES BARU

HERKUTANTO 89
KESIMPULAN

 PROSES BARU YANG LEBIH AMAN

 KEBIJAKAN & SOP LEBIH BAIK

 RUMAH SAKIT YANG AMAN

HERKUTANTO 90
HERKUTANTO 91

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