Table Of ContentPatientSafety
Contributors
CONSULTING EDITOR
RONALDF.MARTIN,MD
StaffSurgeon,DepartmentofSurgery,MarshfieldClinic,Marshfield,Wisconsin;Clinical
AssociateProfessor,UniversityofWisconsinSchoolofMedicineandPublicHealth,
Madison,Wisconsin;Colonel,MedicalCorps,UnitedStatesArmyReserve
GUEST EDITOR
JUANA.SANCHEZ,MD,MPA,FACS
ChairmanandProgramDirector,DepartmentofSurgery,SaintMary’sHospital,
Waterbury;ProfessorofSurgery,UniversityofConnecticutHealthCenter,Farmington,
Connecticut
AUTHORS
PAULR.BARACH,MD,MPH
VisitingProfessor,UtrechtMedicalCentre,UniversityofUtrecht,Utrecht,Netherlands;
UniversityofStavanger,SchoolofNursingandMidwifery,Stavanger,Norway
BRYCER.CASSIN,RN,BA(Hons),AFCHSM
Lecturer,UniversityofWesternSydney,SchoolofNursingandMidwifery;PhDCandidate,
UniversityofTechnology,SchooloftheBuiltEnvironment,Sydney,NewSouthWales,
Australia
MICHOLCOOPER,MD,PhD
DepartmentofSurgery,JohnsHopkinsHospital,Baltimore,Maryland
EDWARDJ.DUNN,MD,ScD
AdjunctProfessorofHealthPolicyandManagement,UniversityofKentuckyCollegeof
PublicHealth,Louisville;ChiefofPerformanceImprovementandanEthicsConsultant,
LexingtonVAMedicalCenter,Louisville,Kentucky
AALIYAHEAVES-LEANOS,JD,PhD
HealthLawAttorney,BioethicistandFormerNationalCenterforPatientSafetyFellow
(2009–2010),RiskManagerandEthicsConsultant,LexingtonVAMedicalCenter,
Lexington,Kentucky
ANDREWW.ELBARDISSI,MD,MPH
ClinicalFellowinSurgery,DivisionofCardiacSurgery,BrighamandWomen’sHospital;
DepartmentofSurgery,BrighamandWomen’sHospitalandtheCenterforSurgeryand
PublicHealth,HarvardMedicalSchool,Boston,Massachusetts
iv Contributors
SCOTTJ.ELLNER,DO,MPH,FACS
DirectorofSurgicalQuality,DepartmentofSurgery,SaintFrancisHospitalandMedical
Center,Hartford,Connecticut;AssistantProfessorofSurgery,UniversityofConnecticut
MedicalSchool,Farmington,Connecticut
JACOBGALLINGER,BA
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetworkand
UniversityofToronto,Toronto,Ontario,Canada
PAULW.JOYNER,MD
ChiefSurgicalResident,UniversityofConnecticutResidencyPrograminGeneral
Surgery,DepartmentofSurgery,UniversityofConnecticutHealthCenter,Farmington,
Connecticut
MARYCATHERINEKARL,MBA
Principal,SurgicalSafetyInstitute,Tampa,Florida
RICHARDKARL,MD,FACS
ChairmanEmeritus,DepartmentofSurgery,UniversityofSouthFlorida;Founder,
SurgicalSafetyInstitute,Tampa,Florida
KEVINW.LOBDELL,MD
DirectorofQualityandProgramDirector,CardiothoracicSurgery,SangerHeartand
VascularInstitute,CarolinasHealthCareSystem;ClinicalProfessorofSurgery,University
ofNorthCarolina,SchoolofMedicine,Charlotte,NorthCarolina
SHELLYLUU,BSc
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetworkand
UniversityofToronto;FacultyofMedicine,UniversityofToronto,Toronto,Ontario,
Canada
MARTINA.MAKARY,MD,MPH
DepartmentofSurgery,JohnsHopkinsHospital,Baltimore,Maryland
CAROL-ANNEMOULTON,MBBS,MEd,PhD,FRACS
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetworkand
UniversityofToronto;DepartmentofSurgery,UniversityofToronto,Toronto,Ontario,
Canada
RUSSELLJ.NAUTA,MD,FACS
ProfessorofSurgery,Chair,DepartmentofSurgery,HarvardMedicalSchool,Mount
AuburnHospital,Cambridge,Massachusetts
SHUKONANNIELEUNG,BASc
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetworkand
UniversityofToronto;FacultyofMedicine,UniversityofToronto,Toronto,Ontario,
Canada
PRIYANKAPATEL,BSc
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetworkand
UniversityofToronto;InstituteofMedicalScience,UniversityofToronto,Toronto,
Ontario,Canada
Contributors v
SIMONPATERSON-BROWN,MBBS,MPhil,MS,FRCS(Edin),FRCS(Engl),FCS(HK)
ConsultantGeneralandUpperGastro-intestinalSurgeon,HonorarySeniorLecturer,
RoyalInfirmaryofEdinburgh,EdinburghUniversity,Edinburgh,Scotland,
UnitedKingdom
JUANA.SANCHEZ,MD,MPA,FACS
ChairmanandProgramDirectorinSurgery,DepartmentofSurgery,SaintMary’s
Hospital,Waterbury;ProfessorofSurgery,UniversityofConnecticutHealthCenter,
Farmington,Connecticut
HEENAP.SANTRY,MD,MS
AssistantProfessorofSurgery,andQuantitativeHealthSciences,DepartmentofSurgery,
UniversityofMassachusettsMedicalSchool,Worcester,Massachusetts
HARRYC.SAX,MD,MHCM
ProfessorandViceChair,DepartmentofSurgery;SeniorPhysicianLiaison,Cedars-Sinai
MedicineClinicalTransformationInitiative,Cedars-SinaiMedicalCenter,LosAngeles,
California
LAURENTST-MARTIN,BSc
TheWilsonCentreforResearchinMedicalEducation,UniversityHealthNetwork
andUniversityofToronto;InstituteofMedicalScience,UniversityofToronto,Toronto,
Ontario,Canada
SOTIRISSTAMOU,MD,PhD
AssistantProfessorofCardiothoracicSurgery,FredandLenaMeijerHeartCenter,
MichiganStateUniversity,GrandRapids,Michigan
THORALFM.SUNDT,MD
ProfessorofSurgery,DivisionofCardiacSurgery,MassachusettsGeneralHospital,
HarvardMedicalSchool,Boston,Massachusetts
SHERRYM.WREN,MD
ProfessorofSurgery,AssociateDeanforAcademicAffairs,StanfordUniversitySchool
ofMedicine,Stanford,California;ChiefofGeneralSurgery,DepartmentofSurgery,
PaloAltoVeteransHospital,StanfordUniversityMedicalSchool,PaloAlto,California
STEVENYULE,MA,MSc,PhD,CPsychol
LecturerinSurgery,HarvardMedicalSchool,Boston;DirectorofResearchand
Education,STRATUSCenterforMedicalSimulation,Brigham&Women’sHospital,
Boston,Massachusetts;LecturerinPsychology(Hon.),UniversityofAberdeen,Scotland,
UnitedKingdom
PatientSafety
Contents
Foreword:PatientSafety xiii
RonaldF.Martin
Preface:PatientSafety xvii
JuanA.Sanchez
HighReliabilityOrganizationsandSurgicalMicrosystems:Re-engineering
SurgicalCare 1
JuanA.SanchezandPaulR.Barach
Errorpreventionandmitigationistheprimarygoalinhigh-riskhealthcare,
particularlyinareassuchassurgery.Thereisgrowingconsensusthatsig-
nificantimprovementishardtocomebyasaresultofthevastcomplexity
and inefficient processes of the health care system. Recommendations
and innovations that focus on individual processes do not address the
largerandoftenintangiblesystemicandculturalfactorsthatcreatevulner-
abilities throughout the entire system. This article introduces basic con-
cepts of complexity and systems theory that are useful in redesigning
the surgical work environment to create safety, quality, and reliability in
surgicalcare.
BuildingHigh-PerformanceTeamsintheOperatingRoom 15
HarryC.Sax
Buildingeffectiveteamsrequiresthedelineationofcleargoals,anunder-
standing of each member’s role in reaching that goal, and continuous
feedbackasissuesareidentified.Thesolomentalityrequiredtobecome
ahealthcareproviderneedstobemodifiedtoseeabiggerpicture.Finally,
consistentbuy-inandsupportfromsenioradministrationtodealwithdis-
ruptivepersonalitiesisvitalforlong-termsuccess.
HumanFactorsandOperatingRoomSafety 21
AndrewW.ElBardissiandThoralfM.Sundt
A human factors model is used to highlight the nature of many systems
factors that affect surgical performance, including the OR environment,
teamwork and communication, technology and equipment, tasks and
workloadfactors,andorganizationalvariables.Iffurtherimprovementsin
thesuccessrateandreliabilityofcardiacsurgeryaretoberealized,inter-
ventions needtobedeveloped toreducethe negativeimpact thatwork
system failures can have on surgical performance. Some recommenda-
tionsareproposedhere;however,severalchallengesremain.
Surgeons’Non-technicalSkills 37
StevenYuleandSimonPaterson-Brown
Theimportanceofnon-technicalskillstosurgicalperformanceisgaining
wideacceptance.Thisarticlediscussesthecorecognitiveandsocialskills
viii Contents
categoriesthoughttounderpinmedicalknowledgeandsurgicalexpertise,
anddescribestheriseofnon-technicalskillmodelsofassessmentinsur-
gery. Behavior rating systems such as NOTSS (Non-Technical Skills for
Surgeons) have been developed to support education and assessment
in this regard. We now understand more about these critical skills and
how they impact surgery. The challenge in the future is to incorporate
them into undergraduate teaching, postgraduate training, workplace
assessment,andperhapsevenselection.
AComprehensiveUnit-BasedSafetyProgram(CUSP)inSurgery:Improving
QualityThroughTransparency 51
MicholCooperandMartinA.Makary
Manymedicalerrorscanbeattributedtolargeandcomplexhealthcare
systems in which care is increasingly fragmented. Hospitals with good
safetycultureshavelowercomplicationrates,andimprovedpatientand
staff satisfaction. Transparency in health care is an increasingly recog-
nizedmeanstoimproveoutcomesbyallowingthefreemarkettoreward
hospitals with a strong safety culture, good outcomes, and compliance
withevidence-basedmedicine.Asmoredatabecomeavailableregarding
strategiesthatworktoimprovepatientsafetyandsuchstrategiesaremore
widelyimplemented,significantimprovementsinthequalityofcarethatis
deliverednationwideshouldbecomeapparent.
Hospital-AcquiredInfections 65
KevinW.Lobdell,SotirisStamou,andJuanA.Sanchez
Health-acquiredinfection(HAI)isdefinedasalocalizedorsystemiccon-
dition resulting from an adverse reaction to the presence of infectious
agentsoritstoxins.ThisarticlefocusesonHAIsthatarewellstudied,com-
mon, and costly (direct, indirect, and intangible). The HAIs reviewed are
catheter-relatedbloodstreaminfection,ventilator-associatedpneumonia,
surgical site infection, and catheter-associated urinary tract infection.
ThisarticleexcludesdiscussionofClostridiumdifficileinfectionsandvan-
comycin-resistantEnterococcus.
InformationTechnologiesandPatientSafety 79
ScottJ.EllnerandPaulW.Joyner
Advancesinhealthinformationtechnologyprovidesignificantopportuni-
tiesforimprovementsinsurgicalpatientsafety.Theadoptionanduseof
electronichealthrecordscanenhancecommunicationalongthesurgical
spectrumofcare.Barcodingandradiofrequencyidentificationtechnology
arestrategiestopreventretainedsurgicalspongesandfortrackingtheop-
erating room supply chain. Computerized intraoperative monitoring sys-
tems can improve the performance of the operating room team.
Automateddataregistriescollectpatientinformationtobeanalyzedand
usedforsurgicalqualityimprovement.
AdverseEvents:RootCausesandLatentFactors 89
RichardKarl
Thisarticledescribestheprocessofrootcauseanalysis(RCA),thetheo-
ries of error that underlie the concept of systemic or latent factors that
Contents ix
allowerrorstooccurortobepropagatedwithoutcorrection;thedifference
betweentheprocessinhealthcareandthosefoundinhigh-reliabilityorga-
nizations;andsuggestssomewaystoaugmentthestandardhealthcare
RCAintoamorerobustandhelpfulprocess.
MakingSenseofRootCauseAnalysisInvestigationsofSurgery-Related
AdverseEvents 101
BryceR.CassinandPaulR.Barach
Thisarticlediscussesthelimitationsofrootcauseanalysis(RCA)forsur-
gicaladverseevents.Makingsenseofadverseeventsinvolvesanappre-
ciation of the unique features in a problematic situation, which resist
generalizationtoothercontexts.Thetoppriorityofadverseeventinvesti-
gations must be to inform the design of systems that help clinicians to
adapt and respond effectively in real time to undesirable combinations
ofdesign,performance,andcircumstance.RCAscancreateopportunities
intheclinicalworkplaceforclinicianstoreflectonlocalbarriersandiden-
tifyenablersofsafeandreliableoutcomes.
ResidencyTrainingOversight(s)inSurgery:TheHistoryandLegacyof the
AccreditationCouncilforGraduateMedicalEducationReforms 117
RussellJ.Nauta
DespiteaquartercenturyofdiscoursesinceasentineleventinNewYork
Cityraisedthequestionofappropriateoversightforgraduatemedicaled-
ucation,manyquestionsremainunanswered.EvenwiththeAccreditation
CouncilforGraduateMedicalEducationrulesinplace,someopportunity
remainstoexaminehandoffmethodology,therelationshipofdutyhours
toeducation,andtheimpactoffatigueonresidentperformance.Neuro-
physiologicadjunctsappliedconcomitantlytoevaluationofdidacticper-
formance offer promise for data-driven definition of the optimal shift.
Concurrently,themeritsofspecialty-specificoversightofgraduatemedi-
caleducationremainunderactiveconsideration.
TeachingtheSlowing-downMomentsofOperativeJudgment 125
LaurentSt-Martin,PriyankaPatel,JacobGallinger,andCarol-anneMoulton
Surgicaljudgmenthasbeenanelusiveconstructtodefine,letaloneteach
orassess.Arecentstudyhascharacterizedaphenomenoncalledslowing
downwhenyoushould,andsuggestsitisahallmarkforoperativejudg-
ment.Thisresearchhighlightsareaswheresurgicaljudgmentcanbeiden-
tifiedandthereforetaughtmoreexplicitlyintheoperatingroom.Through
theidentificationoftheseslowing-downmomentsandanunderstanding
of how control is negotiated between surgeon and trainee during these
moments, this article uses several theoretic frameworks to understand
howteachingjudgmentintheoperatingroomcanbeoptimized.
TheRoleofUnconsciousBiasinSurgicalSafetyandOutcomes 137
HeenaP.SantryandSherryM.Wren
Racial,ethnic,andgenderdisparitiesinhealthoutcomesareamajorchal-
lengefortheUShealthcaresystem.Althoughthecausesofthesedispar-
ities are multifactorial, unconscious bias on the part of health care
x Contents
providersplaysarole.Unconsciousbiasoccurswhensubconsciousprej-
udicial beliefs about stereotypical individual attributes result in an auto-
maticandunconsciousreactionand/orbehaviorbasedonthosebeliefs.
Thisarticlereviewstheevidenceinsupportofunconsciousbiasandresul-
tant disparate health outcomes. Although unconscious bias cannot be
entirely eliminated, acknowledging it, encouraging empathy, and under-
standing patients’ sociocultural context promotes just, equitable, and
compassionatecaretoallpatients.
When BadThingsHappentoGoodSurgeons:ReactionstoAdverseEvents 153
ShellyLuu,ShukOnAnnieLeung,andCarol-anneMoulton
Adverseeventsare,unfortunately,commoncomponentsofsurgicalprac-
tice. Much has been done to develop safer systems to prevent these
adverseevents;however,therehasbeenlessfocusonthesurgeonexpe-
riencingtheseevents.Thisarticlepresentsaframeworktounderstandsur-
geons’reactionstoadverseeventsthatwasderivedfromamorerecent
study as well as a review of relevant psychology literatures. This frame-
workisthensituatedwithinthebroaderpictureofmindfulpracticetoex-
plore how the psychological and social dimensions of the surgeon can
affectjudgmentandcognition.
OpenDisclosure ofAdverseEvents:TransparencyandSafetyinHealthCare 163
AaliyahEaves-LeanosandEdwardJ.Dunn
Manypatientssufferingadverseeventsinhealthcareturntothelegalsys-
tem tolearn whathappened tothem and toseek compensation. Health
careprovidershaveethical,professional,andlegaldutiestodisclosethe
harmful effects of care to the patient, regardless of how small the risk.
Thepurposeofopendisclosureistoexplainwhathappenedtothepatient
andtoseekajustoutcomeforpatientandprovider.Thisarticleexplores
our experience of managing and implementing an open disclosure pro-
graminanacuteandchronictertiarycarefacilitywithuniversityaffiliation
intheVeteransHealthAdministration.
Index 179
PatientSafety
Foreword
Patient Safety
RonaldF.Martin,MD
ConsultingEditor
IntheUnitedStatesArmywehaveanexpression—Everyoneisasafetyofficer.That
expression may exist in the other branches as well but I can only vouch for the
Army.Atfirstglanceonemightthinkitisoneofthosecatchyslogansthatgetstossed
abouttomakeeverybodyfeelincluded.Andwhileitmayachievethattosomedegree,
it also means more. It means that it is not just everyone’s opportunity to point out
dangerous behavior, but it is also everyone’s duty to point out dangerous behavior.
Themostjuniorrecruitcaninformafour-stargeneralthatheorsheisdoingsomething
dangerousand,intheory,itshouldbewellreceived.
TheaviationcommunityhasasimilarconceptintheCrewResourceManagement
trainingandpractice.Areviewofsomeofthemorespectacularaviationcatastrophes
revealedthattherewasaculturalissueintheaviationcommunitythatledtoanunnec-
essaryincreaseforriskundersomeconditions.Multiplepartnersintheassessmentof
safety in the aviation industry, such as the Federal Aviation Administration, National
Transportation Safety Board, various pilots and crew organizations, groups such as
FlightSafety International, andothershave worked collaboratively tomake airtravel
saferforyouandme.Tothecreditoftheseorganizations,theyhavemadeasystematic
studyoffailureandhavebeenopenwiththeresults. Icannotsaythatthesystemis
perfect since I do not directly participate in it—perhaps those who do may be able
to point out some issues that escape an outsider’s perspective—but conceptually it
isoneofthemodelsworthstudying.
Wephysicians,andparticularlywesurgeons,havetriedtoborrowtoolsandproce-
duresfromouraviationbrethrenforyears.MyfirstexposurewasataSurgicalGrand
RoundspresentedbyFlightSafetyInternationalorganizedbyDrDavidClarkofMaine
MedicalCenterduringmyresidencyovertwodecadesago.DrClarkwasalwaysintel-
lectuallyfaraheadofthecurveandthiswasjustonemoreexampleofthat.Duringthe
GrandRoundsitbecameabundantlyclearfromreviewingtheflightdataandcockpit
voice recordings just how much preventable error existed—and this in an industry
SurgClinNAm92(2012)xiii–xv
doi:10.1016/j.suc.2011.12.007 surgical.theclinics.com
0039-6109/12/$–seefrontmatter(cid:1)2012ElsevierInc.Allrightsreserved.
xiv Foreword
where the pilots themselves suffer first on impact! If they were not motivated to
improvetheirsystem,whowouldbe?
SincethatfirstintroductiontothisconceptIhavehadtheprivilegeoflisteningto
many presentations on similar topics and how theyimpact safety.Some havebeen
more focused on procedures and checklists, some on communication styles, some
oninformationtransfers,someonfatigueandothertopics.Theyhavevariedabitin
qualityandutility.Somehavebeenthinlyveiledattemptstoshiftcontroloversome-
thing(thedistinctminority)andsomehavebeensopainfullyobviousthatonehasto
wonderhowitispossiblethatitwasn’tknownorstudieddecadesorcenturiesago.
Independentoftheabove,theyhaveallstillcontributedpositivelytothediscussion.
Perhapswithanodtotheaviationindustry,weinsurgeryhavepursuedsimulated
environmenttrainingonboththeindividualscaleandtheteam/facilityscale(awhile
ago we dedicated an entire issue of the Surgical Clinics of North America Clinics to
justthattopic)inthehopethatwouldhelpusimproveouroutcomesandsafety.No
matter how hard one tries though, one serious disconnect from aviation safety and
patientsafetyremains:humansdesignedandbuiltairplanesandwhileonemightclev-
erlymaketheargumentthathumansbuildhumans,wecertainlydidn’tdesignthem.I
wouldsubmitthatthereisfarlessvariabilityamongBoeing737sthanthereisamong
evenacloselyrelatedgroupofhumans,whichmakesitmorechallengingtosimulate
inameaningfulway.
Theothermajorstumblingblockindirectcomparisonofthetwoindustrieshasto
dowiththenecessityofuseoftheproductorperhapsputintoourjargon—indications.
Whenoneflies,itisalmostalwaysamatterofsomechoice(atleastincommercialor
general aviation) and delaying or eliminating the trip altogether usually represents
more inconvenience than threat to life. When someone arrives at the hospital in ex-
tremis, far more often than not engagement in medical care is not optional nor is it
time insensitive. The concept of minimum requirements for providing medical care
isfar lessstringentthan forflight. Theconversealso holdstrue to acertain degree.
Therearemanyproceduresoroperationsthatareeither electiveordebatableasto
theiroverallutilityyettheycarrymanyofthesamerisksaslesselectiveprocedures.
I would like to challenge our surgical community a bit if I may. If we were truly
serious about improving patient safety, we would approach this topic from several
markedly different but ultimately absolutely related approaches. First, we would
acceptthatwithoutaneartotalityofdataacquisitionandanalysisweareunlikelyto
recognizerealtrendsandmakecertainkindsofchanges.Werequireadegreeofstan-
dardizationofdataacquisitionandreportingfromallvenuesandweshouldengage
seriouslyinhowweanalyzethedataanddistributetheresults.
Theobviousbarrierstothisaremoney,moremoney,ego,andpersonalandinsti-
tutionalrisk.Tobeclearer,firstittakesmoneytocollectthedataandthenmoremoney
toanalyzethedata.Thosecostsmustbeborneinitiallybutitmaybethatovertime,
savings may recoup some or all of those expenses. Ego, well, ego is ego and we
have to separate that or we’ll never put patients first. Last, every person and every
institutionwouldprefernottohavetheirdatamadepublicunlesstheyalreadyknow
that they are advantaged by the publication of said data. Even if the “competitive”
nature of making data available were resolved, there is still the fear of legal reprisal
that will always cloud the integrity of voluntarily submitted or self-reported data. If
we (society) were really interested in self-preservation through superior medicine,
thenwewouldaddresstortreformtoremovethisbarriertohonestinformation.
Wedoctors,though,mustmakeatradeifwewanttortreform;wehavetoallowor
engageinbetterpolicingofourranks.Shockingthoughtrue—noteverybodycurrently
workinginthecareofthecitizenryisgoodenoughtoremainonthejob.Somemaybe
