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CT scan – nothing newCT scan – nothing new• Remained in a coma for 2 weeksRemained in a coma for 2 weeks• Life support withdrawn in accordance with her wishes in living willLife support withdrawn in accordance with her wishes in living will• DiedDied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