Patient SafetyUnderstanding Systems

ErrorThe 12th G. Rainey Williams Surgical

SymposiumThe University of Okalahoma Health

Sciences Center

Patient Safety and SystemsObjectives

• Define the scope of the problem• Terminology• Error analysis

– Root Cause– Systems

• Application of error analysis to surgical injury• Get you involved with patient safety

Error Analysis in High –Risk Industries

• Improvement follows learning – Accidents– Near- misses

• Well developed methods• No “Blame and Shame”• Corporate ownership

– The error– The process– The solution

• Effective implementation of change

Error Analysis in the Healthcare Industry

• Regulators give little priority to safety

• Medicolegal environment– Inhibits open discussion– Prevents learning from errors

• Lack of safety culture

• Heavy workloads

• Errors occur one patient at a time

Terms Related to Patient Safety

• An adverse event is an injury that was caused by medical management and that results in measurable disability.

• An error is the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. Errors can include problems in practice, products, procedures, and systems.

• A preventable adverse event is an adverse event that is attributable to error.

• An unpreventable adverse event is an adverse event resulting from a complication that cannot be prevented given the current state of knowledge.

Terms Related to Patient safety

• A near miss is an event or situation that could have resulted in accident, injury, or illness but did not, either by chance or through timely intervention.

• A medical error is an adverse event or near miss that is preventable with the current state of medical knowledge.

• A system is a regularly interacting or interdependent group of items forming a unified whole.

• A systems error is an error that is not the result of an individual's actions but the predictable outcome of a series of actions and factors that make up a diagnostic or treatment process.

Patient SafetyThe Problem

• Harvard Medical Practice Study 1984– Incidence of adverse events 4%– 50% in surgical patients

• Colorado/Utah Study 1992– Annual incidence of adverse surgical events 3%– 54% preventable– Cause in one -half

• Technique, wound infection, post-op bleeding

Highest Incidence of Adverse Surgical Events

ProcedureIncidence of Adverse

Events (%)Confidence Interval (%)

AAA repair 18.9 8.3–37.5

Lower extremity arterial bypass 14.1 6.0–29.7

CABG/valve replacement 12.3 7.9–18.7

Colon resection 6.8 2.9–14.8

Cholecystectomy 5.9 3.7–9.3

Prostatectomy 5.9 2.3–14.3

TURP/TURBT 5.5 2.7–10.7

Knee/hip replacements 4.9 2.9–8.4

Spinal surgery 4.5 2.8–7.3

Hysterectomy 4.4 2.9–6.8

Appendectomy 3 1.4–6.6

Highest Incidence of Preventable Adverse Events

ProcedureIncidence of Preventable Adverse Events (%)

Confidence Interval (%)

AAA repair 8.1 2.2–25.5

Lower extremity arterial bypass 11 4.2–26.1

CABG/valve replacement 4.7 2.3–9.7

Colon resection 5.9 2.4–13.8

Cholecystectomy 3 1.6–5.8

TURP/TURBT 3.9 1.7–8.7

Hysterectomy 2.8 1.6–4.7

Appendectomy 1.5 0.5–4.5

The Problem

• Retention of surgical instruments and sponges ( Gwande NEJM 2003)– 1/8,801 to 1/18,760 in patient operations

• Wrong-site surgery– Florida Board of Medicine 1999-2000

• 44 wrong site operations

– JACHO 2001• 150 wrong-site operations

Patient Safety The Problem

IOM “To Err is Human” 1999 - 98,000 preventable deaths/yr

Patient Safety“ freedom from accidental injury due to medical care or medical errors”Medical Errors“ the failure of a planned action to be completed as intended…[including] problems in practice ,products, procedures and systems”

Patient Safety & Medical Errors

Agency for Healthcare Research and Quality(AHRQ) - Patient Safety Indicators (PSI) - Screening hospital administrative data PSI - Accidental puncture or laceration - Complications of anesthesia - Death in low mortality DRG - Decubitus ulcer - Postop( hemorrhage,hip fx, metabolic, PE, sepsis, wound dehisence, resp failure, transfusion rxn)

Patient Safety & Medical ErrorsResults of Health Grades Studies 2000-2002

1.14 million incidents/37 million hospitalizations

323,993 deaths in patients with one or more PSI

263,864 deaths attributed directly to PSI ( 81%)

Most Common: Failure to rescue

Decubitus Ulcer

Post-op sepsis

Mortality 25% if >1 PSI

Patient Safety & Medical ErrorsIncidents per 1000 Hospitalizations

DecubitusSepsisPE/DVTResp FailDehisenceInjuryInfectionBleeding

30

1313

8

2-3

Excludes Failure to Rescue 155

Industry Tolerance 1 event / 1 million

Patient Safety & Medical Errors Health Grades Studies 2000-2002: Economic Impact

Excess inpatient cost $8.54 billion / 3 years

Decubitus Ulcer ~ $ 2.57 billion

Post-op PE/DVT ~ $ 1.4 billion

Sepsis/Infection ~ $ 1.71 billion

$2.85 billion/yr

Patient Safety & Medical ErrorsResults of Health Grades Studies 2000-2002

Regional Variation

Northeast and Sunbelt > Central and West

Hospital Classification

Teaching & 200 beds > Non-Teaching

Type of Admission

Medical > Surgical

Best < 5 deaths/1000

< $740K /1000

Patient Safety & Medical ErrorsConclusions of Health Grades Studies 2000-2002

1.Medical errors and patient injuries are an epidemic

2.No big improvements since IOM 1999 3.Improvements will not follow creation of

reporting systems for medical errors alone

4.Failure of improvement

Lack of acknowledgement “Blame and Shame” Resource constraints

Best practices not diffused

Patient Safety & SurgeryHypothesis

• The continued incidence of surgical error and injury is secondary to a combination of factors– Individual performance– System failures – Invalidated defenses– Failure to integrate above into solutions– Failure to adopt a culture of safety

Patient SafetyRoot Cause Analysis

• Purpose to find the cause

• “Tracing” methodology

• Misleading – Not always a single cause– Does not reveal gaps an deficiencies in the

system

Systems Analysis

• Goal is to understand how the mistake occurred

• Identify the “Unsafe Act”

• Identify the “conditions” that contributed to the error

• Identify management actions or inactions that influenced outcome

Anatomy of a Surgical AccidentComponents of an Error

Physician

Patient

System

Training

Experience

Cognitive

Performance

Co-morbidities

Hospital

Technology

Team

Elements of Organizational Accidents

Task &EnvironmentalConditions

Organizational ProcessesFailed

Defenses

IndividualUnsafe Acts

James T. Reason. The Human Factor in Medical Accidents. Medical Accidents.

Vincent C, Ennis M, and Audley R. Oxford University Press 1993

ManagementDecisions

& Organisational

process

Accidents

DefensesPerson/teamWorkplaceOrganization

Latent conditions pathway

Organizational Accident Causation Model

Elements of Organizational Failure

• Incompatible Goals• Organizational Structural Deficiency• Inadequate Communications• Poor Planning and Scheduling • Inadequate Control and Monitoring• Design Failures• Deficient Training • Inadequate Maintenance Management

JT Reason 1993

ManagementDecisions

& Organisational

process

Error &Violation

Producingconditions

Accidents

DefensesPerson/teamWorkplaceOrganization

Latent conditions pathway

Organizational Accident Causation Model

Workplace Conditions Promoting Unsafe Acts

• High Workload

• Inadequate Knowledge, Ability or Experience

• Inadequate Supervision or Instruction

• Stressful Environment

• Mental State

• Change

WorkplaceError Producing Conditions

• Unfamiliarity(x17)• Time Shortage(x11)• Poor Human-System

Interface (x8)• Information Overload

(x6)• Negative Transfer(x5)• Misperception of Risk

(x4)

• Inexperience Not Lack of Training (x3)

• Inadequate Checking (x3)

• Poor Instructions(x3)• Educational

Mismatch (x2)• Disturbed Sleep

(x1.6)

Work EnvironmentViolation Producing Conditions

• Lack of Safety Culture• Management/Staff

Conflict• Poor Morale• Poor Supervision• Condones Violations• Misperception of

Hazard• Lack of Management

Concern

• Little Pride in Work• Macho Culture• “Bad outcomes

Won’t Happen”• Low Self-Esteem• License to Bend

Rules• Ambiguous or

Meaningless Rules

ManagementDecisions

& Organisational

process

Error &Violation

Producingconditions

Errors &violations Accidents

DefensesPerson/teamWorkplaceOrganization

Latent conditions pathway

Organizational Accident Causation Model

Person /TeamIndividual Unsafe Acts

• Errors– Attentional Slips and memory lapses (Intrusions,

omissions)– Mistakes

• Rule –based• Knowledge-based

• Violations( deliberate deviation from regulation)– Routine ( shortcuts)– Optimizing Violations – Exceptional– Deliberate

ManagementDecisions

& Organisational

process

Error &Violation

Producingconditions

Errors &violations Accidents

DefensesPerson/teamWorkplaceOrganization

Latent conditions pathway

Organizational Accident Causation Model

Defenses

• Protection: provide a barrier• Detection: detect an abnormal condition• Warning: signal the presence• Recovery: Restore the system to safe

state• Containment: Restrict the spread of the

hazard• Escape: Evacuation

System Analysis

• Errors are expected

• Errors occur in a dynamic environment, not in isolation

• Dynamic interaction– The Domino Effect– The Swiss Cheese Model

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The Domino Model

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Faul

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Accident

Injury

The Domino Model

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The Domino Model

Reason’s “Swiss Cheese” Metaphor

Organizational Factors

Line Management Factors

Supervision

& Control

Latent Conditions

Individual / Team Factors

Preconditions

Latent Conditions

Active Conditions

Active Conditions

Triggers

Failure in Decision Making

Trajectory of system failure when Loopholes in the firewall of the system lineup

Latent & Active Conditions

Blunt End Sharp End

Anatomy of a Bile Duct Injury

A 60 year old man is admitted with suspected acute cholecystitis. The diagnosis of gallstones is confirmed by ultrasound. The day after admission a laparoscopic cholecystectomy is performed. On the first postoperative day the patient is slightly jaundice with a total bilirubin of 3.8 mg/dl( direct bilirubin 2.0 mg/dl). The following day the total bilirubin is 7.0 mg/dl. The patient has no pain. An ERCP is performed and shows complete obstruction of the common bile duct . The patient undergoes repair of the bile duct injury. The case is referred to quality management for review.

Case Analysis

Organizational Processes

Task/Environment

Unsafe Acts

Defenses

Case Analysis

• Organizational Processes– Failure to communicate in “hand-off”

• Task/Environment– Error-Producing Conditions

• Intern and Staff unfamiliar with the procedure• Surgeon 2

– Time Shortage– Misperceived risk

– Violation-Producing Conditions• Poor supervision of OR nurses

Case Analysis• Unsafe Acts

– Resident omitted history of portal hypertension– Surgeon 1 permitted himself to be double-

booked– Surgeon 2 performed LS procedure in portal

hypertension

• Defenses– Protection and Detection through poor H&P and

verbal communication and then inability to do IOC were invalidated

Acute CholecystitisAnd Portal Hypertension

Injury

The Swiss Cheese ModelBile Duct Injury

Double-

Booked

OR Table/ X-rayTime Constraint

Failure of Communication

80 hr week

Inexperienced PGY-1 and Team

Failure to convert to open

Surgical ErrorsSummary

• The incidence of surgical error is constant despite– Recognition and acknowledgement– More experience– Better equipment

• Surgical error is the result of a complex interaction of the surgeon with the health care system

Surgical ErrorConclusions

• Surgical Errors are normal occurrences

• Efforts to improve reduce the incidence by direct attack on errors have not been successful.

• Improving patient safety will result from error analysis driven system intervention

Surgical Error Proposed Solutions

• Develop a culture of safety• Surgeon involvement in process• Identify risks , hazards and cause of injury

– System and individual analysis

• Avoid “ Blame and Shame “• Identify and design practices that eliminate

errors and monitor• Involve the patient

Thank You !!

Surgically Relevant Quality Improvement Practices

• Use of pressure-relieving bedding materials to prevent pressure ulcers

• Use of real-time ultrasound guidance during central line placement to prevent complications

• Patient self-management for warfarin to achieve appropriate outpatient anticoagulation and prevent complications

• Appropriate provision of nutrition, with particular emphasis on early enteral nutrition in critically ill and surgical patients

• Use of antibiotic-impregnated central venous catheters to prevent catheter-related infections

Surgically Relevant Quality Improvement Practices

• Appropriate use of prophylaxis to prevent venous thromboembolism in patients at risk

• Use of perioperative beta blockers in appropriate patients to prevent perioperative morbidity and mortality

• Use of maximum sterile barriers while placing central venous catheters to prevent infection

• Appropriate use of antibiotic prophylaxis to prevent postoperative infections

• Requesting that patients recall and state what they have been told during the informed consent process

• Continuous aspiration of subglottic secretions to prevent ventilator-associated pneumonia

Nonmedical System Techniques

• Simplify or reduce handoffs • Reduce reliance on memory • Standardize procedures • Improve information access • Use constraining or forcing functions design for errors • Adjust work schedules • Adjust the environment • Improve communication and teamwork • Decrease reliance on vigilance • Provide adequate safety training • Choose the right staff for the job