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Closed Claims Analysis and Patient Safety in Anesthesia Practice

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1. Introduction

• 1954: Beecher & Todd's landmark study of 599,548 anesthesias established the first rigorous mortality data
• 1984: Dr Ellison Pierce (ASA President) created the Patient Safety and Risk Management Committee and the Anesthesia Patient Safety Foundation (APSF)
• 1999: Institute of Medicine (IOM) report To Err Is Human: Building a Safer Healthcare System extended safety principles across all of medicine
• 2001: IOM follow-up Crossing the Quality Chasm explored variation reduction in practice

"Patient safety is not a fad. It is not a preoccupation of the past. It is not an objective that has been fulfilled or a problem that has been solved. It is an ongoing necessity. It must be sustained by research, training, and daily application in the workplace." — Dr Ellison Pierce

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2. The ASA Closed Claims Project

Definition and Purpose

• Identify common events leading to claims
• Recognize patterns of injury
• Develop strategies for injury prevention

Methodology and Limitations

• Represents a "snapshot" of liability, NOT a study of complication incidence
• Incidence cannot be determined because: (a) not all patients who experience complications file suit, and (b) the denominator (total anesthetics performed) is unknown
• Claims may be filed in the absence of negligent care; not all critical incidents generate claims

Companion Database — UK National Health Service

• Anesthesia-related claims = 2.5% of total NHS claims (2.4% of total value)
• Regional anesthesia = 44% of anesthesia-related claims
• Obstetric anesthesia = 29% of anesthesia-related claims

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3. Anesthetic Mortality and Morbidity

1. Death — 22%
2. Nerve injury — 18%
3. Brain damage — 9%

• Death
• Brain damage
• Nerve damage
• Airway injury
• Chronic pain management claims (an increasing category)

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4. Causes of Preventable Anesthetic Accidents

Human Errors Leading to Preventable Accidents

Equipment Malfunctions

Situational Awareness Errors

1. Perception — detection of relevant information
2. Comprehension — using perceived information to arrive at a diagnosis
3. Projection — predicting clinical course and mitigating potential harm

A review of closed claims found that situational awareness errors contributed to three-fourths of claims for death and brain injury from 2002 to 2013.

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5. Mortality and Brain Injury — Closed Claims Trends

• Difficult airway
• Esophageal intubation
• Unexpected extubation
• Inadequate ventilation

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6. Specific Injury Categories from Closed Claims

A. Airway Claims

• Airway-related claims lead to higher awards and poorer outcomes than non-airway claims (NHS Litigation Authority 2010)
• Airway manipulation and central venous catheterization claims most associated with patient death
• Airway trauma: esophageal or tracheal rupture
• Postintubation mediastinitis must be considered after repeated failed airway attempts

B. Vascular Cannulation Claims

• Central venous access claims associated with patient death 47% of the time

C. Nerve Injury Claims

• Second most common category (18% in 1990s data)
• Includes ulnar neuropathy, brachial plexus injury, lower extremity neuropathies (particularly in lithotomy position)

D. Monitored Anesthesia Care (MAC) Claims

• The ASA Closed Claims Database shows claims related to non-operating room anesthesia (NORA) have greater severity of injury than OR-based anesthesia claims
• Monitored anesthesia care was the primary technique in >50% of NORA claims
• Risk mechanism: hypoventilation and excessive sedation

E. Obstetric Anesthesia Closed Claims

• Delays in care
• Miscommunication about urgency of cesarean delivery
• Management failures during difficult intubation or high spinal block
• Lapses in documentation/record keeping

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7. Quality Improvement (QI) and Patient Safety

IOM Definition of Quality

"The degree to which health care services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge."

1. Effectiveness
2. Efficiency
3. Equity
4. Patient-centeredness
5. Safety
6. Timeliness

Continuous Quality Improvement (CQI)

• Structure — physical resources, staffing, equipment
• Process — how care is delivered (guidelines compliance, monitoring standards)
• Outcome — patient results, complication rates, mortality

Joint Commission Requirements

Anesthesia Quality Institute (AQI)

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8. Risk Management in Anesthesia

• A nationwide information system allowing licensing boards and hospitals to detect adverse information about physicians
• Prevents physicians from hiding problematic histories by moving states
• Reports required for: malpractice payments, license actions, negative peer review findings, adverse clinical privilege actions, adverse professional society actions
• Any payment made on behalf of a physician in response to a written complaint must be reported (no minimum threshold)

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9. Professional Liability (Medico-legal Aspects)

The Tort System

Four Elements a Plaintiff Must Prove

Res Ipsa Loquitur ("The Thing Speaks for Itself")

1. The injury would not typically occur absent negligence
2. The injury was caused by something under exclusive control of the anesthesiologist
3. The patient did not contribute to the injury
4. Evidence is more accessible to the anesthesiologist than the patient

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10. Patient Safety Infrastructure

Key Organizations

Landmark Safety Achievement

• Reduction in brain damage/death from ventilation mishaps
• Decline in medical liability insurance premiums for anesthesiologists

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11. Critical Incident Analysis vs. Closed Claims Analysis

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12. High-Yield Points for MD Examination

1. The ASA Closed Claims Project cannot determine the incidence of complications — only liability patterns
2. Anesthesiology was the first specialty to adopt mandatory safety guidelines
3. Situational awareness failures account for 3/4 of death and brain injury claims (2002–2013)
4. Shift from respiratory to cardiovascular causes of death/brain injury was due to introduction of pulse oximetry and capnometry
5. NORA/MAC claims have greater severity of injury than OR-based claims
6. Obstetric claims trigger payments mainly for delays in care and difficult airway management
7. The four elements of malpractice: Duty → Breach → Causation → Damages
8. Res ipsa loquitur shifts burden of proof to the anesthesiologist
9. The NPDB reports any malpractice payment regardless of amount
10. IOM Quality domains: Effectiveness, Efficiency, Equity, Patient-centeredness, Safety, Timeliness

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