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

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

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

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

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

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

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

Alarms n=17 Lines,

Drains, Catheters

n=158

Medicationn=136

Equipmentn=112

Airwayn=47

391 affected patients391 affected patients

SEE STUDYSEE STUDY

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

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

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

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

Information

www.hsro-esicm.org

Contact:

andreas.valentin@meduniwien.ac.at

SSENTINEL ENTINEL EEVENTS VENTS EEVALUATION VALUATION (SEE)(SEE)

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 ?

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”

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……

Medicine and AviationMedicine and Aviation

Safety is primary goal

Technological innovation

Multiple sources of threat

Teamwork is essential

18 March 2000

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

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

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

•Constantly changing environmentsConstantly changing environments

•Incomplete informationIncomplete information

•Time urgencyTime urgency

•Inherent riskInherent risk

Aviation and MedicineAviation and Medicine

•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

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

%

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

Human factorsHuman factors

Basic training (i.e. CoBaTrice)Periodic control of competencyWork as a teamWorking condition

Airbus Training : Simulation RealismAirbus Training : Simulation Realism

Work as a teamWork as a team

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

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

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

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

Structure Structure - -

equipmentequipment

Evolution from the early days...Evolution from the early days...

To today’s Human Machine Interfaces...To today’s Human Machine Interfaces...

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.

Newer technology doesn’t eliminate errorNewer technology doesn’t eliminate error

Improving the System By:

- Collecting,

- Analyzing, and

- Sharing

Safety Information

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.

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

Cockpit Crew : Cockpit Crew : 1 day Workshop

“Situation Control”Transition trainingError managementAutomation

+ simulator sessions briefings+ simulator sessions debriefings

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

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

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

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

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