An Introduction An Introduction to Patient to Patient Safety Safety Pat Croskerry MD, PhD Pat Croskerry MD, PhD Patient Safety Officer Course CPSI, Ottawa April 2011
An Introduction to An Introduction to Patient SafetyPatient Safety
Pat Croskerry MD, PhDPat Croskerry MD, PhD
Patient Safety Officer CourseCPSI, Ottawa April 2011
‘‘It may seem a strange principle It may seem a strange principle to enunciate as the very first to enunciate as the very first
requirement in a Hospital that it requirement in a Hospital that it should do the sick no harmshould do the sick no harm’’
Florence NightingaleFlorence Nightingale
Notes on HospitalsNotes on Hospitals, 1859, 1859
The The case of case of
Sandra GellerSandra Geller
20042004
Sandra Geller
• 68 y/o with CAD68 y/o with CAD
• Elective CABG - -> Sx went wellElective CABG - -> Sx went well
• Lung infection developed on respiratorLung infection developed on respirator
• Small CVASmall CVA
• ARF -> short term renal dialysisARF -> short term renal dialysis
• 2 weeks in ICU, ready for floor2 weeks in ICU, ready for floor
• Generalised seizureGeneralised seizure
Sandra Geller
• Intubated without difficultyIntubated without difficulty• Did not desaturate significantlyDid not desaturate significantly• CT scan – nothing newCT scan – nothing new• Remained in a coma for 2 weeksRemained in a coma for 2 weeks• Life support withdrawn in accordance with her wishes in living willLife support withdrawn in accordance with her wishes in living will• DiedDied
The Slip in her CareThe Slip in her Care
• 1 hour after seizure1 hour after seizure
• Nurse cleaning up bedside tableNurse cleaning up bedside table
• Found two medication vialsFound two medication vials
• Similar size, shape, with similar labelsSimilar size, shape, with similar labels
• One was heparin, the other insulinOne was heparin, the other insulin
This This is an example of is an example of
an adverse event (AE)an adverse event (AE)
Adverse EventAdverse Event
An event of commission or omission An event of commission or omission arising during clinical care causing arising during clinical care causing
unintended physical or psychological unintended physical or psychological injury to a patient, their family or friends, injury to a patient, their family or friends,
and not due to the underlying disease and not due to the underlying disease process. It may result in prolonged process. It may result in prolonged
hospital stay, temporary or permanent hospital stay, temporary or permanent disability, or deathdisability, or death.
Adverse EventsAdverse Events• Delayed or missed diagnosesDelayed or missed diagnoses• Medication errorsMedication errors• Wrong side surgeryWrong side surgery• Wrong patient surgeryWrong patient surgery• Equipment failureEquipment failure• Patient identityPatient identity• Transfusion errorsTransfusion errors• Mislabeled specimenMislabeled specimen• Patient fallsPatient falls• Time delay errorsTime delay errors• Laboratory errors Laboratory errors • Radiology errorsRadiology errors• Procedural errorProcedural error• Sexual or physical assaultSexual or physical assault
• Lost, delayed, or failures to follow Lost, delayed, or failures to follow up reportsup reports
• Retention of foreign object Retention of foreign object following surgeryfollowing surgery
• Contamination of drugs, equipmentContamination of drugs, equipment
• Intravascular air embolismIntravascular air embolism
• Failure to recognise hypoglycemiaFailure to recognise hypoglycemia
• Failure to treat neonatal Failure to treat neonatal hyperbilirubinemiahyperbilirubinemia
• Stage lll or lV pressure ulcers Stage lll or lV pressure ulcers acquired after admissionacquired after admission
• Wrong gas deliveryWrong gas delivery
• Deaths associated with Deaths associated with restraints/bedrails restraints/bedrails
How do we know an AE has occurred?
• Voluntary reporting
• Mandatory reporting
• Informal
• Direct observation
• Patient complaint
• Medico-legal action
• Medical records
• Chart review
Determinants of Adverse EventsDeterminants of Adverse Events
• The PeopleThe People
• The SystemThe System
HealthcareHealthcareWorkersWorkers
Adverse Adverse EventEvent
TheTheSystemSystem
HFEHFE
Sources of System ErrorSources of System Error• Overall cultureOverall culture
• Education/TrainingEducation/Training
• System design / HFESystem design / HFE
• Resource availabilityResource availability
• Demand/VolumeDemand/Volume
Medical environments are highly Medical environments are highly variable and the safety threats variable and the safety threats
and the barriers to control them and the barriers to control them vary from one to anothervary from one to another
From the relative quiet of an oncology clinic…
Need to hurry
Uncertainty
Short-staffed
Dim lighting
Availability of consultants
Many sick patients
Multi-tasking
Shift work Ambiguity
Home stress
Lack of resources
Faulty communication
Angry patients
Constant interruptions
Violence
Teaching obligations
Faulty or missing processes
Noise
Hunger
Technology won’t work
Long waits to be seen Phone calls
Multi-tasking
New trainees
Work area designFull bladder
Fatigue
How long have we been aware of adverse events?
19981939
Year
120
60
0
1970
19911991 Harvard Medical Practice StudyHarvard Medical Practice Study19951995 Quality in Australian Health Care StudyQuality in Australian Health Care Study19961996 Annenberg conferencesAnnenberg conferences1999 1999 Colorado / Utah StudyColorado / Utah Study19991999 IOM Report: To Err is HumanIOM Report: To Err is Human20002000 BMA/BMJ London Conference on Medical ErrorBMA/BMJ London Conference on Medical Error20002000 SAEM: San Francisco Conference on EM ErrorSAEM: San Francisco Conference on EM Error2000 NHS report: An Organization with a Memory2000 NHS report: An Organization with a Memory________________________________________________________________________________________________________20012001 11stst Halifax Symposium on Medical Error Halifax Symposium on Medical Error 2001 RCPSC National Steering Committee on Patient Safety2001 RCPSC National Steering Committee on Patient Safety2002 RCPSC Report: Building a Safer System2002 RCPSC Report: Building a Safer System20042004 Canadian Institute of Patient SafetyCanadian Institute of Patient Safety2004 Baker-Norton Report on Canadian Adverse events2004 Baker-Norton Report on Canadian Adverse events2002–9 Halifax Series of Symposia on Patient Safety 2002–9 Halifax Series of Symposia on Patient Safety
MILESTONESMILESTONES
Study Adverse Event Rate
(%)
% Due to error or
negligence
NumberOf
Patient Charts
HMPSHMPS 3.7 27.6 30,121
QAHCSQAHCS 16.6 51.2 14,210
UKUK 11.7 48.0 1,014
NZNZ 6.3 36.1 6,579
DenmarkDenmark 9.0
CanadaCanada 7.5 36.9 3,745
SwedenSweden 12.3 1967
10%10%On average, about one in On average, about one in ten hospitalised patients ten hospitalised patients suffer an adverse event suffer an adverse event
50%50%On average, about half of On average, about half of
all adverse events are all adverse events are considered preventableconsidered preventable
Anesthesia as the Principal Cause Anesthesia as the Principal Cause of Deathof Death
1948 (U.K.) Macintosh: ‘all anesthetic deaths are 1948 (U.K.) Macintosh: ‘all anesthetic deaths are preventable’preventable’
• 1955-59 (U.S. Phillips) ~ 6%1955-59 (U.S. Phillips) ~ 6%• 1961 (U.S) ~0.121961 (U.S) ~0.12• 1982 (U.K.) ~ 0.011982 (U.K.) ~ 0.01• Current Current ~ 0.0005 (5 per million) ~ 0.0005 (5 per million)
Comparison of Risk in Health CareComparison of Risk in Health Care With Other IndustriesWith Other Industries
MODERATE RISK
MINIMAL RISK (<1/100,000)
HEALTH CARE
Bungee jumping
Driving
Chemical Manufacturing
Commercial Aviation
Nuclear Power
HIGH RISK (>1/1000)
Number of Encounters
Live
s Lo
st/ Y
ear
Modified from R. Amalberti and L. Leape
The extent of the problem in the USThe extent of the problem in the US
• 100,000 deaths annually due to medical errors 100,000 deaths annually due to medical errors (7 (7 thth leading cause of death) leading cause of death)
• Revised estimate (2004) put rate at 195,000Revised estimate (2004) put rate at 195,000
• Motor vehicle accidents - 43,000Motor vehicle accidents - 43,000
• Breast cancer - 42,000Breast cancer - 42,000
• AIDS - 17,000AIDS - 17,000
• Error cost in mid-1990s: $29 billion annuallyError cost in mid-1990s: $29 billion annually
Error problem
The Canadian Adverse Events Study: The Canadian Adverse Events Study: the incidence of adverse events in the incidence of adverse events in
hospital patients in Canadahospital patients in Canada
Baker, Norton Baker, Norton et alet al., ., CMAJCMAJ 2004 2004
Canadian Adverse Events Study Canadian Adverse Events Study (CAES)(CAES)
• In the year 2000In the year 2000
• 20 acute care hospitals20 acute care hospitals
• 5 provinces (BC, Alberta, Ontario, Quebec, NS)5 provinces (BC, Alberta, Ontario, Quebec, NS)
• 3,745 adult patient charts3,745 adult patient charts
• Medical and surgical admissionsMedical and surgical admissions
• No pediatric, obstetric or psychiatric casesNo pediatric, obstetric or psychiatric cases
CAESCAES
• Adverse event rate 8%Adverse event rate 8% Extrapolates to 185,000 annuallyExtrapolates to 185,000 annually• Preventable adverse events Preventable adverse events ~~ 37% 37% Extrapolated preventable AEs annually Extrapolated preventable AEs annually ~~ 70,000 70,000• 5% AEs had permanent disability5% AEs had permanent disability Extrapolates to 3422 preventable annuallyExtrapolates to 3422 preventable annually• Death rate from preventable AEs was 0.66% with 95% confidence Death rate from preventable AEs was 0.66% with 95% confidence
interval of (0.37-0.95)interval of (0.37-0.95)• Extrapolates to preventable deaths in range 9000-24,000 Extrapolates to preventable deaths in range 9000-24,000
annuallyannually
CAESCAES
• Patients with an AE spent additional 6 days Patients with an AE spent additional 6 days in hospitalin hospital
• Average cost Average cost ~ $5000~ $5000
• Total preventable AEs annually Total preventable AEs annually ~70,000~70,000
• Potential cost saving Potential cost saving >$300 million>$300 million
Why has it taken until now Why has it taken until now to find this out?to find this out?
Striving for PerfectionStriving for Perfection
‘Among the powerful barriers to Among the powerful barriers to making progress in patient safety making progress in patient safety
is an attitude of complacency is an attitude of complacency induced by the rarity of serious induced by the rarity of serious
events and the general human bias events and the general human bias toward assuming that things will toward assuming that things will work as they are supposed to’.work as they are supposed to’. Lucian Leape, 2002Lucian Leape, 2002
The (historical)
Culture of Silence
Culture of SilenceCulture of Silence• First do no HarmFirst do no Harm
• DenialDenial
• Power to HealPower to Heal
• Peer DisapprovalPeer Disapproval
• Professional CensureProfessional Censure
• Legal ImplicationsLegal Implications
• LivelihoodLivelihood
• DiscomfortDiscomfort
Disclosing an adverse eventDisclosing an adverse event(an example from the ED)(an example from the ED)
Ergonomics(Human Factors Engineering)
Poor ergonomic design in healthcarePoor ergonomic design in healthcare
• Space organizationSpace organization• Information TechnologyInformation Technology• Hand-wash stationsHand-wash stations• LightingLighting• MonitorsMonitors• Infusion pumpsInfusion pumps
Poor ErgonomicsPoor Ergonomics• Inconvenience worker and may Inconvenience worker and may
make workplace unsafemake workplace unsafe
• In healthcare setting may also In healthcare setting may also make patient unsafemake patient unsafe
WHY WHY NOTNOT DISCLOSE DISCLOSE ERROR ?ERROR ?
• Error is trivialError is trivial
• Most errors do not cause harmMost errors do not cause harm
• Patient is ignorant about the concept of errorPatient is ignorant about the concept of error
• May impair the patient’s trust in the systemMay impair the patient’s trust in the system
• May force search for alternativesMay force search for alternatives
Change Change began about 15 years agobegan about 15 years ago
Culture of Silence Culture of Silence
to a to a
Culture of SafetyCulture of Safety
Two Major Errors in Two Major Errors in Sandra’s CaseSandra’s Case
• Medication errorMedication error
• Cognitive errorCognitive error
PrescriptionPrescription
TranscriptionTranscription
DispensingDispensing
AdministrationAdministration
MonitoringMonitoring
The The MedicationMedication
Process Process
Medication processMedication process
• Up tp 50 steps between a doctor’s decision Up tp 50 steps between a doctor’s decision to order a medication for a hospitalized to order a medication for a hospitalized patient and the actual delivery of the patient and the actual delivery of the medication to the patientmedication to the patient
• Even if all 50 go right 99% of the time, the Even if all 50 go right 99% of the time, the chances of an error are about 40%chances of an error are about 40%
PrescriptionPrescription
TranscriptionTranscription
DispensingDispensing
AdministrationAdministration
MonitoringMonitoring
MisconnectionMisconnection
DisconnectionDisconnection
ConnectionConnection
ErrorsErrors
MEDICATIONMEDICATIONERRORSERRORS
Medication Error Components in Medication Error Components in Sandra’s CaseSandra’s Case
• Multi-taskingMulti-tasking• Attentional captureAttentional capture• Common final actCommon final act• Look alike vialsLook alike vials• Tight couplingTight coupling• Lack of forcing functionLack of forcing function• OtherOther
Cognitive Error Components in Cognitive Error Components in Sandra’s CaseSandra’s Case
• SettingSetting
• Patient well knownPatient well known
• Search satisficingSearch satisficing
• Premature diagnostic closurePremature diagnostic closure
• Metacognitive failureMetacognitive failure
• OtherOther
33 Main Categories of Error in Main Categories of Error in
Individual PerformanceIndividual Performance • CognitiveCognitive
• ProceduralProcedural
• AffectiveAffective
Procedural ErrorProcedural Error• Error which arises in the performance of a particular Error which arises in the performance of a particular
procedureprocedure
• e.g. sterile technique, suturing, cast-application, chest tube, e.g. sterile technique, suturing, cast-application, chest tube, LP, central line, intubationLP, central line, intubation
• Mostly combined visual/motor/touch skillsMostly combined visual/motor/touch skills
• Critically dependent on teaching/experienceCritically dependent on teaching/experience
• Requires maintenanceRequires maintenance
Weeks
7 11 15 19 23 27 310
24
48
72
96
Bryan and Harter, 1899Bryan and Harter, 1899
Skill Skill
AcquisitionAcquisition
Laparoscopic CholeycystectomyLaparoscopic Choleycystectomy
CBD injuries by X20 after ~12 casesCBD injuries by X20 after ~12 cases
The Hernia FactoryThe Hernia Factory(Boutique hospital)(Boutique hospital)
• Shouldice hospitalShouldice hospital
• About a dozen physiciansAbout a dozen physicians
• Some without surgical trainingSome without surgical training
• Each does ~ 600-800 operations/yearEach does ~ 600-800 operations/year
• Hernia operation ~ 30-45 minutesHernia operation ~ 30-45 minutes
• Recurrence rate Recurrence rate ~~ 1% (vs 10-15%) 1% (vs 10-15%)
• Cost ~ 50% lessCost ~ 50% less
Affective ErrorAffective Error
Occurs when physician’s emotional state Occurs when physician’s emotional state influences clinical decision makinginfluences clinical decision making
… if your mental state is disturbed, full of emotion, it is very difficult to cope with problems, because the mind that is full of emotion is biased, unable to see reality. So whatever you do will be unrealistic and naturally fail.
23 November 2010
Our affective reactions to patients Our affective reactions to patients are often our very first reactions, are often our very first reactions,
occurring automatically and occurring automatically and subsequently guiding information subsequently guiding information
processing, judgment, and decision processing, judgment, and decision making…making…
Zajonc, Zajonc, American PsychologistAmerican Psychologist, 1980, 1980
The Borderline PatientThe Borderline Patient
‘‘The patient presenting with a personality The patient presenting with a personality disorder may often be recognized by the disorder may often be recognized by the
characteristic effect the interaction has on the characteristic effect the interaction has on the physician and medical staff. Antisocial physician and medical staff. Antisocial
patients, for instance, are disliked immediately. patients, for instance, are disliked immediately. They seem to be in control of their behavior, They seem to be in control of their behavior, unlike psychotic or depressed patients, but unlike psychotic or depressed patients, but
nonetheless have repeatedly engaged in nonetheless have repeatedly engaged in maladaptive behaviormaladaptive behavior’’
Sources of Affective Error• Ambient - induced Transitory affective states Environmental Stress, fatigue, other
• Clinical situation - induced Counter Transference Fundamental Attribution Error Specific affective biases
• Endogenous Circadian, infradian, seasonal mood variation Mood disorders Anxiety disorders Emotional dysregulatory states
Diagnostic Failure: A Cognitive In Advances in Patient and Affective Approach Safety: From Research to Implementation, 2005
Pat Croskerry
AbstractDiagnosis is the foundation of medicine. Effective treatment cannot begin until an accurate diagnosis has been made. Diagnostic reasoning is a critical aspect of clinical performance. It is vulnerable to a variety of failings, the most prevalent arising through cognitive and affective influences. The impact of diagnostic failure on patient safety does not appear to have been fully recognized. Ideally, allinformation used in diagnostic reasoning is objective and all thinking is logicaland valid, but these conditions are not always met. Two major phenomena thatmay undermine objectivity and rational thinking are cognitive dispositions torespond (CDRs) and affective dispositions to respond (ADRs) toward the patient.In this report, the determinants and characteristics of the major CDRs and ADRsare reviewed, as are a variety of de-biasing strategies that may mitigate theirinfluence. A retrospective analytical process, the cognitive and affective autopsy,is also described. The purpose of this report is to provide insight into cognitive and affective influences that have resulted in delayed or
missed diagnoses.
Acad Emerg Med, 2007
Lancet, 2008
Cognitive ErrorCognitive Error
• A failure in rational/logical thoughtA failure in rational/logical thought
• Often due to biases or ‘dispositions to respond’Often due to biases or ‘dispositions to respond’
• About fifty known biases existAbout fifty known biases exist
• They are universalThey are universal
• They are predictableThey are predictable
• They can be corrected (cognitive de-biasing)They can be corrected (cognitive de-biasing)
Cognitive Error Cognitive Error OnlyOnly
(28%)(28%)
System-RelatedSystem-RelatedError OnlyError Only
(19%)(19%)
No-Fault Factors No-Fault Factors OnlyOnly(7%)(7%)
Both System-Both System-RelatedRelated
And CognitiveAnd CognitiveFactorsFactors(46%)(46%)
Origins of diagnostic error in 100 patients Origins of diagnostic error in 100 patients (Graber et al 2004)(Graber et al 2004)
30 Cognitive Errors30 Cognitive Errors Aggregate biasAggregate bias Gender biasGender bias Psych-Out ErrorsPsych-Out Errors
AnchoringAnchoring Hindsight biasHindsight bias RepresentativenessRepresentativeness
Ascertainment biasAscertainment bias Multiple Multiple alternatives alternatives
Search satisficingSearch satisficing
AvailabilityAvailability Omission biasOmission bias Sutton’s SlipSutton’s Slip
Base rate neglectBase rate neglect Order effectsOrder effects Triage-CueingTriage-Cueing
Commission biasCommission bias Outcome biasOutcome bias Unpacking principleUnpacking principle
Confirmation biasConfirmation bias OverconfidenceOverconfidence Vertical line failureVertical line failure
Diagnostic creepDiagnostic creep Playing the oddsPlaying the odds Visceral biasVisceral bias
Attribution errorAttribution error Posterior prob.Posterior prob. Ying-Yang OutYing-Yang Out
Gambler’s FallacyGambler’s Fallacy Premature closurePremature closure Zebra retreatZebra retreat