patient safety understanding systems error the 12 th g. rainey williams surgical symposium the...
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Patient SafetyUnderstanding Systems
ErrorThe 12th G. Rainey Williams Surgical
SymposiumThe 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
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
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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
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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 intended…[including] 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 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
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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
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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 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
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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
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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 AccidentComponents of an Error
Physician
Patient
System
Training
Experience
Cognitive
Performance
Co-morbidities
Hospital
Technology
Team
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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
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ManagementDecisions
& Organisational
process
Accidents
DefensesPerson/teamWorkplaceOrganization
Latent conditions pathway
Organizational Accident Causation Model
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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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ManagementDecisions
& Organisational
process
Error &Violation
Producingconditions
Accidents
DefensesPerson/teamWorkplaceOrganization
Latent conditions pathway
Organizational Accident Causation Model
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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
Won’t Happen”• Low Self-Esteem• License to Bend
Rules• Ambiguous or
Meaningless Rules
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ManagementDecisions
& Organisational
process
Error &Violation
Producingconditions
Errors &violations Accidents
DefensesPerson/teamWorkplaceOrganization
Latent conditions pathway
Organizational Accident Causation Model
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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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ManagementDecisions
& Organisational
process
Error &Violation
Producingconditions
Errors &violations Accidents
DefensesPerson/teamWorkplaceOrganization
Latent conditions pathway
Organizational Accident Causation Model
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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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So
cia
l en
viro
nm
en
t &
an
cest
ry
Fa
ult
of
Pe
rso
n
Un
safe
act
or
ph
ysic
al c
on
diti
on
Acc
ide
nt
Inju
ry
The Domino Model
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Soci
al e
nviro
nmen
t & a
nces
try
Faul
t of P
erso
n
Uns
afe
act o
r phy
sica
l con
ditio
n
Accident
Injury
The Domino Model
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So
cia
l en
viro
nm
en
t &
an
cest
ry
Fa
ult
of
Pe
rso
n
Un
safe
act
or
ph
ysic
al c
on
diti
on
Acc
ide
nt
Inju
ry
The Domino Model
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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
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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/Environment
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 H&P and
verbal communication and then inability to do IOC were invalidated
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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
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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