The Basics of Healthcare Failure Mode and Effect Analysis

The Basics of Healthcare Failure
Mode and Effect Analysis
Failure Mode and Effect Analysis
suatu methode yang sistematis untuk
mengidentifikasi dan mencegah masalah hasil
dan proses sebelum terjadi
David M. Sine, CSP
Director, Risk Assessment and Loss Prevention; Tenet HealthSystem
Kegunaan HFMEA
 Dapat mengantisipasi pencegahan dari
suatu kegagalan
 Tidak harus menunggu adanya
pengalaman buruk/iterjadinya insiden
 Dapat menyusun sistem yang kurang
berisiko terhadap kegagalan sistemik
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FMEA
 digunakan secara luas dalam industri :
Penerbangan
Tenaga Nuklir
 Ruang angkasaAerospace
 Proses Industri Kimia
 Industri Automotive
 Food Processing (HACCP)
 sudah digunakan sejak lebih dari 30 tahun
 tujuan mencegah kegagalan sebelum
terjadi
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Rasionalisasi penggunaan FMEA
dalam Pelayanan Kesehatan
Latar Belakang
Pencegahaan kecelakaan/insiden belum
merupakan fokus utama dalam pengobatan di
RS
Adanya kesalahan persepsi dalam menilai
“kesalahan kinerja ” dari tenaga kesehatan
profesional
Sistem RS yang kompleks tidak didisain untuk
mencegah atau mengurangi kesalahan; lebih
banyak perubahan yang reaktif, belum proaktif
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Rasionalisasi penggunaan FMEA
dalam Pelayanan Kesehatan
Beberapa hal yang rentan terjadi dapat
diketahui dan dicegah dengan penggunaan
FMEA :
 Kegagalan tenaga listrik di Center
Medical Unit
 Kegagalan MRI
 Medical gas medis
 Medication error
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Standar Akreditasi KARS 2012
PMKP 11 EP 1
Pimpinan rumah sakit menerapkan kerangka acuan
manajemen risiko yang meliputi a) sampai f) yang dimuat di
Maksud dan Tujuan.
PMKP 11 EP 2
Paling sedikit setiap tahun rumah sakit melaksanakan dan
mendokumentasikan penggunaan alat pengurangan-proaktifterhadap-risiko dalam salah satu prioritas proses risiko
PMKP 11 EP 2
Berdasarkan analisis, pimpinan rumah sakit membuat rancang
ulang dari proses yang mengandung risiko tinggi.
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Program Manajemen Risiko
•
•
•
•
•
•
identifikasi risiko;
menetapkan prioritas risiko;
pelaporan tentang risiko;
manajemen risiko;
investigasi KTD; dan
Manajemen klaim-klaim yang terkait
manajemen risiko
analisis dari risiko menjadi unsur yang penting
• Untuk mencegah terjadinya kegagalan proses KNC atau
risiko tinggi lainnya
• Mencegah terjadinya kejadian sentinel.
• => alat/tools yang dapat digunakan secara proaktif
melakukan analisis terhadap konsekuensi suatu kejadian
yang berujung pada proses yang kritis dan risiko tinggi
adalah FMEA (failure mode and effect analysis).
• Rumah sakit dapat juga melakukan identifikasi dan
menggunakan alat serupa untuk melakukan identifikasi dan
mengurangi risiko, seperti analisis terhadap kelemahan yang
mengandung bahaya.
So, what are they saying?
•Our systems are too complex to expect
merely extraordinary people to perform perfectly
•Simplify and standardize wherever possible
•Computerization, automation, use forcing functions
•Learn new skills
Process mapping
•Understand new fields
Human Factors
Safety Engineering
•Measure performance to design goals
•Accept that it isn’t a democracy
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JCAHO Standard LD.5.2
 Identifikasi dan tetapkan prioritas pada
proses yang berisiko tinggi
 Pilih minimal satu proses yang berisiko
tinggi setiap tahun
 Identifikasi modus kegagalan yang
potensial
 Identifikasi setiap efek yang mungkin terjadi
akibat modus kegagalan
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JCAHO Standard LD.5.2
 Lakukan rancang ulang proses untuk
mengurangi risiko terjadinya modus kegagalan
untuk melindungi pasien dari efek tsb
 Lakukan uji coba dan laksanakan rancang
ulan tersebut
 Identifikasi alat ukur /indikator dan lakukan
pengukuran thd efektifitasnya
 iImplementasikan suatu strategi untuk
mempertahankan effectifitas dari proses
rancang ulang secara berkesinambungan
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FMEA
• Best applied to devices,
products, components
• Considers “detectability”
• Criticality and frequency
considered separately
vs.
HFMEAtm
• Best applied to systems
and human factors
• “Detectability” not
emphasized
• Criticality combination of
severity and frequency
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HFMEAtm and the RCA Process
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Healthcare FMEA Definitions
Healthcare Failure Mode & Effect Analysis
(HFMEAtm):
(1) sebuah asesmen prospektif yang dapat
mengidentifikasi dan memperbaiki
langkah2 dalam sebuah proses secara
rasional untuk menjamin hasil yang aman
dan diharapkan secara klinis
(2) A systematic approach to identify and
prevent product and process problems
before they occur.
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Definisi Healthcare FMEA
Effective Control Measure:
Suatu barrier yang dapat menghilangkan atau
mengurangi kemungkinan terjadinya bahaya/kejadian
yang berbahaya
Hazard Analysis (HA):
suatu process of pengumpulan dan evalusi informasi
dari kejadian berbahaya yang berhubungan dengan
proses yang dipilih.
Tujuan analisis bahaya (HA) adalah untuk mendapatkan
Daftar kejadian berbahaya yang signifikan / dapat diterima
secararasional tentang hubungannya dengan terjadinya
Kecelakaan /kesakitan apabila tidak dikendalikan secara
efektif
Failure Mode:
Berbagai cara untuk mengantisipasi kegagalan baik dalam proses
maupun subproses
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FMEA Hazard Scoring
Matrix:
A “Filter”
Severity
Probability
Catastrophic
Major
Moderate
Minor
Frequent
16
12
8
4
Occasional
12
9
6
3
Uncommon
8
6
4
2
Remote
4
3
2
1
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Hazard Analysis:
Catastrophic Event
(Traditional
FMEA Rating
of 10 –
SEVERITY
RATING:
kegagalan dapat menyebabkan kematian atau
kecacatan/kecelakaan
Major Event
Patient Outcome:
Kematian atau kehilangan fungsi permanen
(sensory, motor, physiologi, atau intelektual), bunuh
diri, pemerkosaan, rx transfusi hemolytik, salah
prosedur operasi (salah pasien/salah sisi) , bayi
tertukar/diculik
Visitor Outcome:kematian atau re hospitalisasi>
3x
Staff Outcome: kematian atau re hospitalisasi>
3x
* Equipment or facility: kerugian /kerusakan
yang bernilai lebih dari 25.000.000
Fire:kebakaran yg tidak dapat diatasi
Patient Outcome:Permanent lessening of bodily
functioning (sensory, motor, physiologic, or intellectual),
disfigurement, surgical intervention required, increased
length of stay for 3 or more patients, increased level of
care for 3 or more patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome: Hospitalization of 1 or 2 staff or 3 or
more staff experiencing lost time or restricted duty
injuries or illnesses
Equipment or facility: **Damage equal to or more
than $100,000
Fire: Not Applicable – See Moderate and Catastrophic
(Traditional FMEA Rating of 7 –
kegagalan menimbulkan derajat ketidak puana yang
tinggi)
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Hazard Analysis:
SEVERITY RATING:
Moderate Event
(Traditional FMEA Rating of “4” – Failure can be
overcome with modifications to the process or
product, but there is minor performance loss.)
Minor Event
(Traditional FMEA Rating of “1”– Failure would not be
noticeable to the customer and would not affect
delivery of the service or product.)
Patient Outcome: Increased length of stay or
increased level of care for 1 or 2 patients
Visitor Outcome: Evaluation and treatment for 1 or
2 visitors (less than hospitalization)
Staff Outcome: Medical expenses, lost time or
restricted duty injuries or illness for 1 or 2 staff
Equipment or facility: **Damage more than
$10,000 but less than $100,000
Fire: Incipient stage‡ or smaller
Patients Outcome: No injury, nor increased length of
stay nor increased level of care
Visitor Outcome: Evaluated and no treatment
required or refused treatment
Staff Outcome: First aid treatment only with no lost
time, nor restricted duty injuries nor illnesses
Equipment or facility: **Damage less than $10,000 or
loss of any utility♦ without adverse patient outcome
(e.g. power, natural gas, electricity, water,
communications, transport, heat/air conditioning).
Fire: Not Applicable – See Moderate and Catastrophic
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Hazard Analysis:
PROBABILITY RATING:
Frequent - Likely to occur immediately or within a short period
(may happen several times in one year)
Occasional - Probably will occur (may happen several times
in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime in 2 to
5 years)
Remote - Unlikely to occur (may happen sometime in 5 to 30
years)
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HFMEAtm Decision Tree
The HFMEA Decision
Tree…
Does this hazard involve a sufficient
likelihood of occurrence and severity to
warrant that it be controlled?
(e.g. Hazard Score of 8 or higher)
NO
YES
Is this a single point weakness in the
process?
(e.g. failure will result in system failure)
(Criticality)
NO
YES
Does an Effective Control Measure exist for the
identified hazard?
YES
STOP
NO
Is the hazard so obvious and readily
apparent that a control measure is not
warranted?
(Detectability)
YES
NO
Design Countermeasure
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Selecting Counter Measures
MOST EFFECTIVE
1. Forcing functions (Poke Yoke)
2. Automation, computerization
3. Protocols and preprinted orders
4. Standardization (of equipment)
5. Checklists
6. Rules and double-checking
7. Education
8. Information
LEAST EFFECTIVE
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• Forms
• Worksheets
Hazard Scoring Matrix
• Decision Tree
The Healthcare Failure Modes
and Effects Process
Step 1- Select a Process
Step 2 - Assemble the Team
Step 3 - Graphically Describe the Process
Step 4 - Conduct the Analysis
Step 5 - Identify Actions and Outcome Measures
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Healthcare FMEA Process
STEP 1
Define the Scope of the HFMEA along
with a clear definition of the process
to be studied.
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•
•
Step 1. Select the process you want to examine. Define the scope (Be specific and
include a clear definition of the process or product to be studied).
This HFMEA is focused on__________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
_________________________________________________________________
Healthcare FMEA Process
STEP 2
Assemble the Team – Multidisciplinary
team with Subject Matter Expert(s)
plus advisor
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Step 2. Assemble the Team
FMEA Number_____________
Date Started ________ Date Completed ________
• Team Members
• 1.__________________
• 2.__________________
• 3.__________________
• 4.______________________ 5.______________________
6.______________________
• Team Leader ____________________________________
Are all affected areas represented? YES / NO
Are different levels and types of knowledge represented on the team? YES
/ NO Who will take minutes and maintain
records?____________________________
Healthcare FMEA Process
STEP 3 - Graphically Describe the Process
A. Develop and Verify the Flow Diagram (what happens not
what happened)
B. Consecutively number each process step identified in the
process flow diagram.
C. If the process is complex identify the area of the process
to focus on (apply arbitrary boundaries for a manageable
bite)
D. Identify all sub processes under each block of this flow
diagram. Consecutively letter these sub-steps.
E. Create a flow diagram composed of the sub processes.
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Healthcare FMEA Process
STEP 3 - Graphically Describe the Process
1
2
Penulisan
resep
Penerimaan
resep
3
Penyiapan obat
4.
Penyerahan
obat
5 pemberian
obat
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STEP 3 - Graphically Describe the Process
1 penulisan resep
• dr/drg menulis
resep
•resep secara
lengkap
termasuk Dosis
dan rute obat
suntuik
2.Penerimaan
resep
•Apotker
melakukan
telaah 6 benar
•Apoteker
mengkonfirmasi
kpd dokter bila
resep tidak
;engkap/tidak
jelas
•Hasil telaah
diberikan kpd
petugas
penyiapan obat
3.Penyiapan obat
4.Penyerahan Obat
•
Petugas farmasi
menyiapkan obat
sesuai kebutuhan
pasien
• Konfirmasi rute
dan dosis obat
tidak
dilakukan
• Penulisan label
tidak lengkap
• Obat diberikan
sejumlah resep
•
Obat diberikan
sekaligus sesuai resep
• Perawat itdak
mengkonfirmasi
kpd apoteker cara
pemberian (rute dan
dosis)
5. Pemberian obat
•Perawat tidak
mencocokan label
dengan KIO
•Perawat ruangan
tidak memeriksa
kelengkapan 6 benar
dari obat yg
diberikan
Penulisan resep
• Modus
kegagalan
• Tulisan tdk jelas
• Umur dan berat
badan tidak
ditulis
• Dosis dan rute
obat tidak ditulis
Penerimaan resep
• Modus
kegagalan
• Apoteker tidak
melakukan
telaah 6 benar
• Apoteker tidak
mengkonfirmasi
kepada dokter
Penyiapan obat
revisi
Penulisan resep
• Modus
kegagalan
• resep tidak
terbaca
Penerimaan resep
• Modus
kegagalan
• Apoteker tidak
melakukan
telaah 6 benar
• Apoteker tidak
mengkonfirmasi
kepada dokter
Penyiapan obat
Healthcare FMEA Process
STEP 4 - Conduct a Hazard Analysis
A. List Failure Modes (all the ways the
process step could fail)
B. Determine Severity & Probability (Filter)
C. Use the Decision Tree (Proceed?)
D. List all Failure Mode Causes
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Hazard Analysis
SEVERITY RATING:
Catastrophic Event
(Traditional FMEA Rating of 10 - Failure could cause
death or injury)
Major Event
Patient Outcome:Death or major permanent loss of
function (sensory, motor, physiologic, or intellectual),
suicide, rape, hemolytic transfusion reaction,
Surgery/procedure on the wrong patient or wrong
body part, infant abduction or infant discharge to the
wrong family
Visitor Outcome: Death; or hospitalization of 3 or
more.
Staff Outcome: * A death or hospitalization of 3 or
more staff
Equipment or facility: **Damage equal to or more
than $250,000
Fire: Any fire that grows larger than an incipient
Patient Outcome:Permanent lessening of bodily
functioning (sensory, motor, physiologic, or intellectual),
disfigurement, surgical intervention required, increased
length of stay for 3 or more patients, increased level of
care for 3 or more patients
Visitor Outcome: Hospitalization of 1 or 2 visitors
Staff Outcome: Hospitalization of 1 or 2 staff or 3 or
more staff experiencing lost time or restricted duty
injuries or illnesses
Equipment or facility: **Damage equal to or more
than $100,000
Fire: Not Applicable – See Moderate and Catastrophic
(Traditional FMEA Rating of 7 – Failure causes a high
degree of customer dissatisfaction.)
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Hazard Analysis
SEVERITY RATING:
Moderate Event
(Traditional FMEA Rating of “4” – Failure can be
overcome with modifications to the process or
product, but there is minor performance loss.)
Minor Event
(Traditional FMEA Rating of “1”– Failure would not
be noticeable to the customer and would not affect
delivery of the service or product.)
Patient Outcome: Increased length of stay or
increased level of care for 1 or 2 patients
Visitor Outcome: Evaluation and treatment for 1 or
2 visitors (less than hospitalization)
Staff Outcome: Medical expenses, lost time or
restricted duty injuries or illness for 1 or 2 staff
Equipment or facility: **Damage more than
$10,000 but less than $100,000
Fire: Incipient stage‡ or smaller
Patients Outcome: No injury, nor increased length of
stay nor increased level of care
Visitor Outcome: Evaluated and no treatment
required or refused treatment
Staff Outcome: First aid treatment only with no lost
time, nor restricted duty injuries nor illnesses
Equipment or facility: **Damage less than $10,000 or
loss of any utility♦ without adverse patient outcome
(e.g. power, natural gas, electricity, water,
communications, transport, heat/air conditioning).
Fire: Not Applicable – See Moderate and Catastrophic
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Hazard Analysis
PROBABILITY RATING:
Frequent - Likely to occur immediately or within a short period
(may happen several times in one year)
Occasional - Probably will occur (may happen several times
in 1 to 2 years)
Uncommon - Possible to occur (may happen sometime in 2 to
5 years)
Remote - Unlikely to occur (may happen sometime in 5 to 30
years)
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HFMEAtm Hazard Scoring Matrix
Severity
Probability
Catastrophic
Major
Moderate
Minor
Frequent
16
12
8
4
Occasional
12
9
6
3
Uncommon
8
6
4
2
Remote
4
3
2
1
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HFMEAtm Decision Tree
The HFMEA Decision
Tree…
Does this hazard involve a sufficient
likelihood of occurrence and severity to
warrant that it be controlled?
(e.g. Hazard Score of 8 or higher)
NO
YES
Is this a single point weakness in the
process?
(e.g. failure will result in system failure)
(Criticality)
NO
YES
Does an Effective Control Measure exist for the
identified hazard?
YES
STOP
NO
Is the hazard so obvious and readily
apparent that a control measure is not
warranted?
(Detectability)
YES
NO
PROCEED
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Healthcare FMEA Process
STEP 5 - Actions and Outcome Measures
A. Decide to “Eliminate,” “Control,” or “Accept” the
failure mode cause.
B. Describe an action for each failure mode cause that
will eliminate or control it.
C. Identify outcome measures that will be used to
analyze and test the re-designed process.
D. Identify a single, responsible individual by title to
complete the recommended action.
E. Indicate whether top management has concurred
with the recommended actions
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