Patient Safety Understanding Systems Error

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Patient SafetyUnderstanding Systems Error

• The 12th G. Rainey Williams Surgical Symposium
• The University of Okalahoma Health Sciences
  Center

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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

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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

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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

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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.

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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.

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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

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Highest Incidence of Adverse Surgical Events
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Highest Incidence of Preventable Adverse Events
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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

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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
intendedincluding problems in practice
,products, procedures and systems
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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)
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Patient Safety Medical Errors Results 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 gt1 PSI
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Patient Safety Medical Errors Incidents per
1000 Hospitalizations

Excludes Failure to Rescue 155

2-3
30
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13
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Industry Tolerance 1 event / 1 million
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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
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Patient Safety Medical Errors Results of Health
Grades Studies 2000-2002

Regional Variation Northeast and Sunbelt gt
Central and West Hospital Classification
Teaching 200 beds gt Non-Teaching Type of
Admission Medical gt Surgical
Best lt 5 deaths/1000 lt 740K /1000
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Patient Safety Medical Errors Conclusions 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
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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

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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

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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

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Anatomy of a Surgical Accident Components of an
Error

Training Experience Cognitive Performance

Hospital Technology Team
System
Physician
Patient
Co-morbidities
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Elements of Organizational Accidents
James T. Reason. The Human Factor in Medical
Accidents. Medical Accidents. Vincent C, Ennis
M, and Audley R. Oxford University Press 1993
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Organizational Accident Causation Model
Defenses
Person/team
Workplace
Organization
Management Decisions Organisational process
Accidents
Latent conditions pathway
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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
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Organizational Accident Causation Model
Defenses
Person/team
Workplace
Organization
Management Decisions Organisational process
Error Violation Producing conditions
Accidents
Latent conditions pathway
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Workplace Conditions Promoting Unsafe Acts

• High Workload
• Inadequate Knowledge, Ability or Experience
• Inadequate Supervision or Instruction
• Stressful Environment
• Mental State
• Change

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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)

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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 Wont Happen
• Low Self-Esteem
• License to Bend Rules
• Ambiguous or Meaningless Rules

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Organizational Accident Causation Model
Defenses
Person/team
Workplace
Organization
Management Decisions Organisational process
Error Violation Producing conditions
Errors violations
Accidents
Latent conditions pathway
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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

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Organizational Accident Causation Model
Defenses
Person/team
Workplace
Organization
Management Decisions Organisational process
Error Violation Producing conditions
Errors violations
Accidents
Latent conditions pathway
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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

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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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The Domino Model
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The Domino Model
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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.
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Case Analysis Organizational Processes Task/Enviro
nment Unsafe Acts Defenses
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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

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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 HP and
  verbal communication and then inability to do IOC
  were invalidated

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The Swiss Cheese Model Bile Duct Injury
Acute Cholecystitis And Portal Hypertension
Double- Booked
Failure of Communication
80 hr week
Inexperienced PGY-1 and Team
Injury
OR Table/ X-ray
Time Constraint
Failure to convert to open

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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

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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

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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

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Thank You !!
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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
  

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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

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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