icu safety: to err is human can we prevent adverse events ? pr b guidet, medical icu hôpital saint...
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ICU safety: to err is humanICU safety: to err is humanCan we prevent adverse events ?Can we prevent adverse events ?
Pr B Guidet, Medical ICU
Hôpital Saint Antoine, Paris, France
Acknowledgment :
Airbus industrie , Jean-Jacques Speyer ; Henri Petit
SEE : Andreas Valentin
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Leape L. Error in Medicine. JAMA 1994 – 4% of all hospital stays
– mortality rate of14%
Committee on Quality of Health Care in America, Institute of Medicine. 2000.– Death related to adverse events:
44000 à 98000 patients each year
8th cause of mortality
Incidence and Incidence and consequences consequences
of adverses eventsof adverses events
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Unintended Event : An occurrence that harmed or could have harmed a patient
SEE: multicenter, multinational, single day study in ICU
Reporting by all ICU staff members : Voluntarily – Anonymously - Confidential
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Selected EventsSelected Events
• Medication wrong drug, dose, or route
• Airway unplanned extubationartificial airway obstructioncuff leakage
• Lines, Drains dislodgementCatheters inappropriate opening/disconnection
• Equipment power supply, oxygen supply,
failure ventilator, infusion pump
• Alarms inappropriate turn off
SEE STUDYSEE STUDY
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SEE Study – participating CountriesSEE Study – participating Countries
1
1
1
1
1
11
1
1
1
1
2
2
2
2
22
3
6
7
7
8
11
12
14
1922
27
28
35
0 5 10 15 20 25 30 35 40
AustraliaUSA
EstoniaIndonesia
MacedoniaNorwayPoland
RomaniaSingapore
LatviaSlovakiaAlbaniaFinland
BrasilBelgium
NetherlandsSlovenia
HongkongGreece
DenmarkIndia
FranceSwitzerland
GermanyCzech Republic
SpainPortugal
UKAustria
Italy
Number of ICUs
220 ICUs in 29 countries
2090 patients
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AdultsAdults
Patients: 1913
Sex: 61 % m / 39 % w
Age (mean): 62,3 ± 16,3 (18 – 99 a)
NEMS (median): 27 (18;38)
SOFA (median): 4 (2;7)
Events: 584
Pts with 1 Event: 393
At least 1 sentinel event: 73% of ICUs
SEE STUDYSEE STUDY
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20 pts22 pts81 pts
268 pts
1522 pts
0
10
20
30
40
50
60
70
80
90
0 1 2 3 >3
# of events
Per
cen
t
# of events in patients (adults)# of events in patients (adults)
SEE STUDYSEE STUDY
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Alarms n=17 Lines,
Drains, Catheters
n=158
Medicationn=136
Equipmentn=112
Airwayn=47
391 affected patients391 affected patients
SEE STUDYSEE STUDY
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Events /
100 pt days
lower
95% CI
upper
95% CI
All 38.8 34.7 42.9
Lines, drains 14.5 12.0 16.9
MedicationPrescriptionAdministration
10.5 5.7
4.8
8.6 4.4
3.6
12.4 7.1
6.0
Equipment 9.2 7.4 11.1
Airway 3.3 2.4 4.3
Alarms 1.3 0.6 1.9
SEE STUDYSEE STUDY
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Variables in final model
Unexplained variables
SEE studySEE study
Explanatory power of measured variables
risc-timeorganfailures
ICU as random component
nemsinterventionicu
patients per nurse
Explanatory power within the final model
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Time - pattern of eventsTime - pattern of events
0
5
10
15
20
25
30
35
40
45
50
# o
f ev
en
ts
A look into the nature and causes of human errors in the ICUDonchin et al, Crit Care 1995
SEE study
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SEE studySEE study
0
2
4
6
8
10
12
14
16
Airway
Drug prescription
Drug administration
Lines, catheters
Equipment
Alarms Drug prescription
Drug administration
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Information
www.hsro-esicm.org
Contact:
SSENTINEL ENTINEL EEVENTS VENTS EEVALUATION VALUATION (SEE)(SEE)
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Adverse events in ICUAdverse events in ICU
Frequent and in relation with– Severity of the patients– Procedures
Impact on : (Zhan C, Miller MR. Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization. JAMA,
2003, 290:1868-1874) – Morbidity and mortality– Finance :
Iatrogenic pneumothorax : 17,312 US$ DVP and post operative pulmonary emboli : 21,709 US$
Legal issues Psychology of the team Preventability ?
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If you hear this If you hear this
“I am proud to say that “I am proud to say that I have no adverse event I have no adverse event
in my ICU”in my ICU”
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You should conclude that You should conclude that this is a very dangerous ICUthis is a very dangerous ICU
No documentation of eventsNo evaluationNo corrective action
May be even no patient in that ICU……
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Medicine and AviationMedicine and Aviation
Safety is primary goal
Technological innovation
Multiple sources of threat
Teamwork is essential
18 March 2000
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Lessons from Aviation safetyLessons from Aviation safety
1960 - 1970– Old planes– Pilots trained during world war II
1970 -1980 :– Check list– Simulators– Flight analysis
« non punishment act » Collective corrective action
1980 - 1990 :– New planes– Human factors
1990 – 2000– Instrumentation – automation– Generalisation of human factors assessment– Improvement of logistic
Same language communication
40 years
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Different Approaches in Health Care vs Different Approaches in Health Care vs AviationAviation
Health care
You will not make a mistake !
Individual Responsibility,
The Best is not to screw up!
Aviation
People will make mistakes !
TRAP and MITIGATE THEM!TRAP and MITIGATE THEM! Collective Responsibility with
SYSTEMS APPROACHSYSTEMS APPROACH
Systemic Return of Experience Periodic Control of Competencies
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Cultural safety ParadigmsCultural safety Paradigms
“Traditional paradigm “Ideal” paradigm
safety: universal valuehuman error: causeaccidents caused by individualsaccident investigationblame and punishment
safety: a social valuehuman error: symptomaccidents caused by system flawsincident investigationnormal process monitoring
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•Constantly changing environmentsConstantly changing environments
•Incomplete informationIncomplete information
•Time urgencyTime urgency
•Inherent riskInherent risk
Aviation and MedicineAviation and Medicine
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•Interdisciplinary (everyone present at one time)Interdisciplinary (everyone present at one time)
•Patient and family included as part of the care teamPatient and family included as part of the care team
•Collaborative CommunicationCollaborative Communication
•Respectful, open environment; flat hierarchyRespectful, open environment; flat hierarchy
Collaborative RoundsCollaborative Rounds
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Pilots’ and Doctors’ AttitudesPilots’ and Doctors’ Attitudes
0 10 20 30 40 50 60 70 80 90 100
Pilot Doctor
Decision making as good inemergencies as normal
Effective pilot/doctor canleave behind personal problems
Performance the same with inexperienced team
Perform effectively whenfatigued
%
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Our Biggest Challenge:
Operators Who Are- Highly Trained
- Competent- Experienced,
-Trying to Do the Right Thing, and- Proud of Doing It Well
. . . Yet They Still Commit
Inadvertent
Human Errors
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Human factorsHuman factors
Basic training (i.e. CoBaTrice)Periodic control of competencyWork as a teamWorking condition
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Airbus Training : Simulation RealismAirbus Training : Simulation Realism
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Work as a teamWork as a team
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Fatigue as ThreatFatigue as Threat
24 hours of sleep deprivation have performance effects comparable to a blood alcohol content of 0.1% (Drew Dawson – Nature, 1997)
Aviation flight time limits
– 8 hours in one day, 30 hours in one week, 100 hours in one month, 1,000 hours per year
U.S. Resident workrules (July 2003)– 24 hours in one shift
– 80 hours in one week
– No limit for month or year
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Extended work shifts and the risk of motor vehicle Extended work shifts and the risk of motor vehicle crashes among interns : Barger, NEJM 2005, 352 : 125crashes among interns : Barger, NEJM 2005, 352 : 125
2737 residentsExtended work shift :
– 3.9 /month
– Average duration : 32 hours
Odd Ratio after an extended work shift :
– Motor vehicle crash: 2.3
– Near-miss: 5.9
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Effect of Reducing Interns' Work Hours on Serious Effect of Reducing Interns' Work Hours on Serious Medical Errors in Intensive Care UnitsMedical Errors in Intensive Care UnitsLandrigan CP, for the Harvard Work Hours, Health and Safety Group Landrigan CP, for the Harvard Work Hours, Health and Safety Group NEJM 2004, 351:1838NEJM 2004, 351:1838 interns working
according to a traditional schedule with extended (24 hours or more) work shifts every other shift
while working according to an intervention schedule that eliminated extended work shifts and reduced the number of hours worked per week
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Human Error in Aviation SafetyHuman Error in Aviation Safety
Management of Human Error?– Select the right people and Train them properly,
– Tailor Procedures to operational requirements,
– Monitor Performance on a continuous basis,
– Provide Feedback to identify and correct problemsthrough improved Design , Selection,Training and Procedures,
– Create a Safety Culture in the Work environment
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Structure Structure - -
equipmentequipment
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Evolution from the early days...Evolution from the early days...
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To today’s Human Machine Interfaces...To today’s Human Machine Interfaces...
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Bar Coding for Patient SafetyBar Coding for Patient SafetyNEJM 2005, 353:329-331 NEJM 2005, 353:329-331 Alexi A. Wright, M.D., and Ingrid T. Katz, M.D., M.H.S.Alexi A. Wright, M.D., and Ingrid T. Katz, M.D., M.H.S.
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Newer technology doesn’t eliminate errorNewer technology doesn’t eliminate error
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Improving the System By:
- Collecting,
- Analyzing, and
- Sharing
Safety Information
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The Tip of the IcebergThe Tip of the Iceberg
(1) (1) Serious AccidentSerious Accident
(15)(15)
Minor accidents Minor accidents with damage and injurywith damage and injury
(300)(300)
Incidents and near missesIncidents and near misses
(15 000) (15 000)
Observed work errorsObserved work errors
Pledging for the consideration of more common events Pledging for the consideration of more common events in aviation.in aviation.
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Flight Surveys(LOAS)
Flight Crew Reporting
(AIRS)
Flight Data Analysis(FOQA)
Flight Data Analysis(FOQA)
Tools for Detection of deviations
Analysis:
Risk Assessment Decision making
Actions:Flight Operations
Actions : Training
WHATWHAT WHYWHY
What & Why
Flight Operations Monitoring conceptFlight Operations Monitoring concept
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Cockpit Crew : Cockpit Crew : 1 day Workshop
“Situation Control”Transition trainingError managementAutomation
+ simulator sessions briefings+ simulator sessions debriefings
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Improvement of security is cost-effectiveImprovement of security is cost-effective
Passenger/crew death and injury
Aircraft physical damage
Site contamination and clearance
Loss of aircraft resale value
Loss of aircraft use
Loss of staff investment
Loss of cargo
Search and rescue
Airline response
Accident investigation
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OrganizationalOrganizational CultureScheduling & Staffing
Experience levelsWork LoadError policy
Equipment issues
System - levelNational culture
Health-care policyand regulation
Payment modalitiesMedical coverage
ProfessionalProficiency
FatigueMotivation
Culture(Invulnerability)
Patient**Primary illness
Secondary illnessRisk Factors
Atypical responseto treatment
Ongoing management
Expected Events and RisksUnexpected Events and Risks
** Well known and expected
Threats to Safety in MedicineThreats to Safety in Medicine
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Conclusion (1)Conclusion (1)Building a Safety Culture Building a Safety Culture
Define a clear policy regarding human error
– Accept error but not intentional non-compliance
Institute formal procedures where appropriate
Recognize the dangers in fatigue
Use confidential reporting systems to uncover threats
and sources of error
Analyze near miss/adverse/sentinel
Provide formal training in threat and error management
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Conclusion (2)Conclusion (2)ProceduresProcedures
Standard Operating Procedures (SOP) were
aviation’s first countermeasures against threat and
error
Aviation is arguably over-proceduralized
Medicine is under-proceduralized
– Example: Checklists are critical error countermeasures
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Conclusion (end)Conclusion (end)Training TopicsTraining Topics
Human limitations as sources of error The nature of error and error management Culture and communications Expert decision-making Training in using specific behaviors and procedures as
countermeasures against threat and error– Briefings
– Inquiry
– Sharing mental models
– Conflict resolution
– Fatigue and alertness management
Analysis of incidents and accidents– both positive and negative aspects