ASAASA

Building Safer SystemsBuilding Safer Systems

ASAASA

Without data, you Without data, you are just another are just another person with an person with an opinion.opinion.

ASAASA

SafetySafety

Safety is not a specific thing.Safety is not a specific thing.

In complex organizations, safety is In complex organizations, safety is created by people as they do their created by people as they do their work.work.

There are strategies and designs that There are strategies and designs that favor safe performance.favor safe performance.

Safety is Produced by Safety is Produced by SocioTechnical SystemsSocioTechnical Systems

….“preventing errors and improving safety require a systems approach….”

“The problem is not bad people; the problem is that the system needs to be made safer.”

“Safety is a characteristic of systems and not of their components. Safety is an emergent property of systems.”

“….healthcare organizations must develop a systems orientation to patient safety….”

“Reducing risk and ensuring safety require greater attention to systems that help prevent and mitigate errors.”

“….this higher level of quality cannot be achieved by further stressing current systems of care… Trying harder will not work.” IOM 2001

ASAASA

HRO’s: High Reliability HRO’s: High Reliability Organizations: CharacteristicsOrganizations: Characteristics

Process auditing and other active searches Process auditing and other active searches (eg, equip testing) for possible failures.(eg, equip testing) for possible failures.

High quality standardsHigh quality standards

Risk perception: examining even small but Risk perception: examining even small but unexpected events.unexpected events.

Command and control:Command and control:– Fluid decision-making (flex hierarchy)Fluid decision-making (flex hierarchy)– Formal rules and procedures (but flexible)Formal rules and procedures (but flexible)– Constant trainingConstant training

Karlene Roberts, 2005Karlene Roberts, 2005

ASAASA

Safety in Medicine: Needed Safety in Medicine: Needed ChangesChanges

Specify limits to maximum Specify limits to maximum performance. [How many cases performance. [How many cases should we do?] should we do?] Decrease individual autonomy:Decrease individual autonomy:– Regulations – the minimum necessaryRegulations – the minimum necessary– TeamworkTeamwork– specializationspecialization

Fatigue, overtime, excessive work Fatigue, overtime, excessive work schedules, staff shortages, stress.schedules, staff shortages, stress.

Amalberti R, 2005Amalberti R, 2005

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Accident ModelsAccident Models

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hazards

Some holes due to active failures

Other holes due to latent conditions (resident pathogens)

losses

Successive layers of defenses, barriers, and safeguards

This model is being increasingly criticized as an example of how to understand accidents. It is too static; the defects are often transient; and the whole system is more dynamic than the model suggests.

ASAASA

Sequential accident models inevitably lead to a root cause, which is the basis of the root cause analysis. The search for a root cause (often a human), tends to perpetuate the blame-the-person outcome. It also suggests that eliminating a root cause will solve the problem.

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A detailed inquiry finds multiple parallel factors that led to the event considered to be the root cause.

Systemic (not sequential) accident model

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Systemic Accident ModelSystemic Accident Model

Before the accident.

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Systemic Accident Model Systemic Accident Model

Retrospective analysis might suggest that the outcome of the actions taken was predictable.

We have not completely escaped blame-&-train.

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System FeaturesSystem Features

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Aviation has achieved a 10-6 rate of injurious accidents.

Surgery is said to have a 10-4 rate.

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“In the medical arena, the most common system failure is in education. The person at the sharp end (eg, the surgeon) did not know enough or was not experienced enough to make the correct judgment or action.”

TrainingTrainingExperienceExperienceHigh/low volumeHigh/low volume

VA Hernia Trial: 85% of participating surgeons were still climbing the learning curve.

System

Features

Who is responsible?

ASAASA1965 1975 1985 1995 2005 2015

Year

Hull loss accidentsper year

Hull loss accident rate

Airplanes in service

Millions of departures

25,400

2015

Business as usual

19,077

2004

Ac

cid

en

t R

ate

/ M

illi

on

De

pa

rtu

re

Our Goal

Departures 2004

17.5 Million

438

1960

The Evolution ofThe Evolution ofAviation SafetyAviation Safety

1965 - 20041965 - 2004

Boeing 2004 Statistical Data – May 2005

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TeamsTeams in Aviation & Medicine in Aviation & MedicineImproved safety in commercial aviation, stemmed Improved safety in commercial aviation, stemmed from better aircraft, better system designs, from better aircraft, better system designs, automation, and rule-making.automation, and rule-making.Work in aviation and medicine is done by teams.Work in aviation and medicine is done by teams.Aviation: CRM reduced cockpit hierarchy, and Aviation: CRM reduced cockpit hierarchy, and communication improved. Moved on the LOSA & communication improved. Moved on the LOSA & TEM.TEM.Medicine is practiced by teams, and team Medicine is practiced by teams, and team development is now a major issue. That leads to development is now a major issue. That leads to CRM; better communication; and observational CRM; better communication; and observational studies of surgical work (LOSA).studies of surgical work (LOSA).

System

Features

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System

Features Importance of Teams in Importance of Teams in

Surgical PerformanceSurgical PerformanceError Management in Pediatric Cardiac Surgery: Carthey, J et al (unpublished)

Multicenter study of neonatal arterial switch operation in GB. 173 ASO’s observed by experts in error management. Errors defined as major or minor, and compensated or uncompensated.

The total number of minor errors in a case, whether compensated or not, was directly related to the chances that a major error would not be corrected, and a serious complication or death would result. Minor errors and uncompensated major errors and deaths were less common with stable teams.

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O.R.Viciou

sCycle

High nurseturnover

NurseDissatisfaction

Nurseless able

Random caseassignments

SPDdysfunctional

Equipmentmissing

Surgeonangry

Flowinterrupted

Case moredifficult

O.R. tensionmounts

Performancedrop

Dysfunctional Dysfunctional teamteam..

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Hypothetical staffing pattern during a four-hour case. Nurses, surgeon, and anesthesiologists can be a different mix several times per hour. No stable teams; communication affected; information lost.

System

Features

ASAASA

System

Features O.R. Communication – A Team O.R. Communication – A Team ActivityActivity

Lingard L et al. Communication failures in the O.R. Qual Saf Health Care 2004;13:330.

Lingard L et al. Getting teams to talk. Qual Saf Health Care 2004;14:340

Lingard L et al. Team Communications in the O.R.: Patterns and sites of tension. Acad Med 2002;77:232.

Seek harmony to preserve teams and avoid unsafe behaviors. How the surgeon acts is key.

Bottom Line:

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Loose coupling

Tight coupling Tight coupling connects parts of the system so rigidly that actions at one place are immediately transmitted throughout. Prediction and control become harder, and accidents increase.

An Important Failure Mode: Tight Coupling

In systems-talk, this is “going solid.”

System

Features

ASAASA

System

FeaturesEveryday Examples of Tight Everyday Examples of Tight CouplingCoupling

No hospital bedsNo hospital bedsNo ICU bedsNo ICU bedsOverbooked IR scheduleOverbooked IR scheduleShortage of surgical instruments: cases Shortage of surgical instruments: cases delayeddelayedInadequate resources to staff O.R. casesInadequate resources to staff O.R. casesLengthy queues for operations. Elective Lengthy queues for operations. Elective surgery in off hours.surgery in off hours.Long queues for routine outpatient Long queues for routine outpatient appointments.appointments. Examples of failing to set

production limits that match production capacity.

ASAASA

The Useful Concept of GapsThe Useful Concept of Gaps

SBAR (or SCAP)SBAR (or SCAP)

Read-backRead-back

Face-to-faceFace-to-face

Hand-off IT (van Eaton)Hand-off IT (van Eaton)

ChecklistsChecklists

Standardized ordersStandardized orders

Complexity creates gaps in care, where information can be lost. Every transition in care constitutes a gap. The increasing fragmentation of medical care is producing more gaps.

Information loss at gaps can be decreased by handoff routines and checklists.

HANDOFFS CHECKLISTS & ETC.

System

Features

ASAASA

Checklists & Standardized OrdersChecklists & Standardized Orders

Pre-op planningPre-op planningO.R. schedulingO.R. schedulingAdmission Admission schedulingschedulingNight before Night before checklistchecklistPre-op checklist Pre-op checklist (briefing)(briefing)Post-op care Post-op care checklistchecklist

Admission and pre-Admission and pre-op ordersop ordersPostop ordersPostop ordersTransition ordersTransition ordersDischarge ordersDischarge ordersDischarge Discharge instructionsinstructions

As many as 11 checklists between evaluation in the clinic and discharge from the hospital.

Checklists Orders

System

Features

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Anesthesia1

Patient Surgeon

Prepare

SurgicalWard

Clinic

R.R.

OperationO.R.Nurses

O.R.Nurses

Anesthesia2

O.R. SuitePreOp

Home

Nurses

Nurses

ReferringReferringMDMD

Nurses

Nurses

Surgical Patient Flowchart

System

Features

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Anesthesia1

Patient Surgeon

Prepare

SurgicalWard

Clinic

R.R.

OperationO.R.Nurses

O.R.Nurses

Anesthesia2

O.R. SuitePreOp

Home

Nurses

Nurses

ReferringReferringMDMD

Nurses

Nurses

1.2.

3.

4.

5.

6.

7.

8.

9.&10.

11.

·Eleven handoffs·Eight procedural subsystems·Eight procedural subsystems

1.1.

2.2.

3.3.4.4.

5.5.

6.6.

7.7.

8.8.

System

Features

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Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159.

Communication Communication deficits during the deficits during the operation -- lost operation -- lost information.information.

Poorly synchronized Poorly synchronized multitasking that multitasking that delayed case delayed case progress.progress.

Observational study of O.R. systems Observational study of O.R. systems during general surgery cases.during general surgery cases.

Hand-offs during Hand-offs during inappropriate times -- inappropriate times -- information loss.information loss.

Counting protocol Counting protocol delayed case and of delayed case and of questionable quality.questionable quality.

Circulating nurses Circulating nurses performed retrieval performed retrieval errands too often.errands too often.

Good work: LW

System

Features

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Demonstrates how investigations done in Demonstrates how investigations done in the O.R. by surgeons can detect system the O.R. by surgeons can detect system faults.faults.And eliminate unsafe practices.And eliminate unsafe practices.And presumably, improve efficiency.And presumably, improve efficiency.The findings of this study could probably The findings of this study could probably be replicated in most large hospitals.be replicated in most large hospitals.As surgeons troubleshoot O.R. systems, As surgeons troubleshoot O.R. systems, surgeons require a share of administrative surgeons require a share of administrative authority to implement the changes .authority to implement the changes .

Christian CK, Zinner MJ, Dierks MM: A prospective study of patient safety in the operating room. Surgery 2006;139:159.

System

Features

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ConclusionsConclusionsProgress in understandingProgress in understanding– The systems nature of safetyThe systems nature of safety– The nature of surgical systemsThe nature of surgical systems– System faults that affect safetySystem faults that affect safety– And how to fix themAnd how to fix them

Surgeons must be directly involved in 1) Surgeons must be directly involved in 1) O.R. administration and 2) observational O.R. administration and 2) observational studies of the surgical system to bring studies of the surgical system to bring about the required changes.about the required changes.

ASAASA

ASA

““To Err is Human. . . Or Is It?To Err is Human. . . Or Is It?

ACS Efforts – Error Prevention ACS Efforts – Error Prevention and Patient Safetyand Patient Safety

Thomas R. Russell, MD, FACS Thomas R. Russell, MD, FACS April 20, 2006 April 20, 2006

ASAOmnibus per artem fidemque prodesseOmnibus per artem fidemque prodesse

ASA

The American College of The American College of SurgeonsSurgeons

““Dedicated to improving the care of the Dedicated to improving the care of the

surgical patient and to safeguarding surgical patient and to safeguarding

standards of care in an optimal and standards of care in an optimal and

ethical practice environment.”ethical practice environment.”

ASA

ASA

Institutes of MedicineInstitutes of Medicine

Three reports, starting with Three reports, starting with To Err Is Human: To Err Is Human: Building a Safer Health System, Building a Safer Health System, published in published in 2000.2000.

• Demonstrate that our current health care system Demonstrate that our current health care system neither controls spending nor ensures access to neither controls spending nor ensures access to quality carequality care

• Clarion call for all to reevaluate their roleClarion call for all to reevaluate their role– QualityQuality– CostCost

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• Shift from saving lives by preventing errors Shift from saving lives by preventing errors to implementing evidence-based practices to implementing evidence-based practices to improve qualityto improve quality

• Domain of effectiveness of service, test or Domain of effectiveness of service, test or therapy to create better outcomes – i.e. therapy to create better outcomes – i.e. “statistical lives”“statistical lives”

To Err Is HumanTo Err Is Human

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ASA

Quality Surgical CareQuality Surgical Care

• Correct DiagnosisCorrect Diagnosis

• Proper StagingProper Staging

• Proper Risk AssessmentProper Risk Assessment– DiseaseDisease

– TreatmentTreatment

• Proper TreatmentProper Treatment– Best evidenceBest evidence

– Best technologyBest technology

– Best techniqueBest technique

• Proper OutcomeProper Outcome– SurvivalSurvival

– No complicationsNo complications

– Disease curedDisease cured

– Symptoms relievedSymptoms relieved

– Function restoredFunction restored

– Death with dignityDeath with dignity

• ACS is working in all ACS is working in all these areasthese areas

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Quality Surgical CareQuality Surgical Care

• StructureStructure

• ProcessProcess

• OutcomesOutcomes

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EducationEducation

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ACGME/ABMS Core ACGME/ABMS Core CompetenciesCompetencies

• • Medical KnowledgeMedical Knowledge

• • Patient CarePatient Care

• • Interpersonal and Communication SkillsInterpersonal and Communication Skills

• • ProfessionalismProfessionalism

• • Practice-based Learning and ImprovementPractice-based Learning and Improvement

• • Systems-based PracticeSystems-based Practice

ASA

ASA

ASA

American College of SurgeonsAmerican College of SurgeonsCase Logging SystemCase Logging System

Practice-Based Learning & Practice-Based Learning & ImprovementImprovement

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Closed Claims ProjectClosed Claims Project

• A standardized collection of reviews of A standardized collection of reviews of claims involving surgical mishaps from claims involving surgical mishaps from records kept by liability insurance records kept by liability insurance companiescompanies

• 461 claims reviewed to date461 claims reviewed to date• Purpose – to identify common problems Purpose – to identify common problems

and develop best practices and protective and develop best practices and protective systems to improve patient safety systems to improve patient safety

ASA

ASA

ASA

EducationEducation

Program for Accreditation of Educational Program for Accreditation of Educational InstitutesInstitutes

• Will serve as regional sites where surgeons Will serve as regional sites where surgeons may learn new procedures, emerging may learn new procedures, emerging technologies, and rarely performed technologies, and rarely performed proceduresprocedures

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ACS Efforts to Enhance ACS Efforts to Enhance Education in Surgical SkillsEducation in Surgical Skills

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EducationEducation

E-FACS.orgE-FACS.org

• Content in clinical areas and broad-based Content in clinical areas and broad-based subjects of interestsubjects of interest

• Supports e-learning, case logs, and sharing Supports e-learning, case logs, and sharing information about their practicesinformation about their practices

• Maintain and submit documentation Maintain and submit documentation regarding MOC-related activitiesregarding MOC-related activities

ASA

ASA

ACS Efforts to Define Curriculum Content ACS Efforts to Define Curriculum Content for Entering Surgery Residentsfor Entering Surgery Residents

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Research and Optimal Patient Research and Optimal Patient CareCare

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Current ACS Quality Current ACS Quality Improvement ProgramsImprovement Programs

• Facility Certification ProgramsFacility Certification Programs– Trauma centersTrauma centers– Cancer centersCancer centers– Bariatric centersBariatric centers

• Continuous Quality ImprovementContinuous Quality Improvement– ACS National Surgical Quality Improvement Program (NSQIP)ACS National Surgical Quality Improvement Program (NSQIP)– American College of Surgeons Oncology GroupAmerican College of Surgeons Oncology Group

• National Outcomes Data BasesNational Outcomes Data Bases– National Trauma DataBankNational Trauma DataBank– National Cancer Data BaseNational Cancer Data Base– NSQIPNSQIP

ASA

ASA

Development of ACOSOGDevelopment of ACOSOG

• May 1998:May 1998: Initial NCI AwardInitial NCI Award

• March 1999:March 1999: 1st trial opens1st trial opens

• September 1999:September 1999: NCI Site visit in NCI Site visit in ChicagoChicago

• May 2000:May 2000: 5 Year NCI Award5 Year NCI Award

ASA

Future DirectionsFuture Directions

• Expand clinical trials to include studies in Expand clinical trials to include studies in trauma, burns / critical care, vascular and trauma, burns / critical care, vascular and cardiovascular diseasescardiovascular diseases

• Expand Center’s programs in Continuing Expand Center’s programs in Continuing Medical Education to educate surgeons in the Medical Education to educate surgeons in the performance of new operations and use of new performance of new operations and use of new technologytechnology

ASA

American College of American College of Surgeons Data BasesSurgeons Data Bases

• National Cancer Data Base- NCDBNational Cancer Data Base- NCDB• National Trauma Data Base- NTDBNational Trauma Data Base- NTDB• American College of Surgeons National Surgical American College of Surgeons National Surgical

Quality Improvement Program- ACS NSQIPQuality Improvement Program- ACS NSQIP• ACS Bariatric Surgery Data BaseACS Bariatric Surgery Data Base• ACS Individual Fellow Self-Reporting Data BaseACS Individual Fellow Self-Reporting Data Base• Collaborations in ProgressCollaborations in Progress

– SAGESSAGES– STSSTS– AAOSAAOS– SVSSVS

ASA

Collaborative EffortsCollaborative Efforts• CMS Surgical Care Improvement Project (steering CMS Surgical Care Improvement Project (steering

committee) committee) (SCIP)(SCIP)• Physicians Consortium for Quality Improvement Physicians Consortium for Quality Improvement (AMA)(AMA)

– Perioperative Care Work Group (co-chair) Perioperative Care Work Group (co-chair)

• National Quality Forum National Quality Forum (NQF)(NQF)• Ambulatory Care Quality Alliance (steering committee) Ambulatory Care Quality Alliance (steering committee)

(AQA)(AQA)– Subgroup on Surgery and Procedures (chair)Subgroup on Surgery and Procedures (chair)

• Surgical Quality Alliance (chair) Surgical Quality Alliance (chair) (SQA)(SQA)– Developing quality measure priorities and consensus across Developing quality measure priorities and consensus across

surgical specialtiessurgical specialties

ASA

National Quality ForumNational Quality Forum

• Cancer Care Quality IndicatorsCancer Care Quality Indicators– Colon CancerColon Cancer

• Colonoscopy preoperative or within 6 monthsColonoscopy preoperative or within 6 months• At least 12 nodes resected for non-metastatic At least 12 nodes resected for non-metastatic

diseasedisease• Adjuvant chemotherapy for node positive Adjuvant chemotherapy for node positive

diseasedisease

ASA

MembershipMembership

ASA

MembershipMembership

Expanded membership baseExpanded membership base

• RAS-ACSRAS-ACS

• Affiliate Member categoryAffiliate Member category

ASA

ASA

MembershipMembership

Innovative methods of communicating with Innovative methods of communicating with membershipmembership

• Journal of the American College of SurgeonsJournal of the American College of Surgeons now distributed to all ACS Fellows free of now distributed to all ACS Fellows free of chargecharge

• Surgery News,Surgery News, new monthly newspaper new monthly newspaper• Electronic methods: Electronic methods: ACS NewsScope,ACS NewsScope, e-mail e-mail

alerts, College’s Web site, and Web portalalerts, College’s Web site, and Web portal

ASA

ASA

THANK YOU!THANK YOU!