Handbook of Clinical Anesthesia

Chapter 4

Anesthetic Risk, Quality Improvement and Liability

In anesthesia, (Posner KL, Domino KB: Anesthetic risk, quality improvement, and liability. In Clinical Anesthesia. Edited by Barash PG, Cullen BF, Stoelting RK, Cahalan MK, Stock MC. Philadelphia: Lippincott Williams & Wilkins, 2009, pp 82–92) as in other areas of life, everything does not always go as planned. Undesirable outcomes may occur regardless of the quality of care provided. An anesthesia risk management program can work in conjunction with a program for quality improvement to minimize the liability risks of practice while ensuring the highest quality of care for patients.

  1. Anesthesia Risk
  2. Mortality and Major Morbidity Related to Anesthesia.Estimates of anesthesia-related morbidity and mortality are difficult to quantify because of different methodologies, definitions of complications, lengths of follow-up, and evaluation of contribution of anesthesia care to patient outcomes (Table 4-1). It is generally accepted that anesthesia safety has improved over the past 50 years. However, several recent complications related to anesthesia have received increasing attention (Table 4-2).
  3. Risk Management
  4. Conceptual Introduction.Risk management and quality improvement programs work hand in hand in minimizing liability exposure while maximizing quality of patient care. Quality improvement (sometimes called patient safety) departments are responsible for providing the resources to provide safe, patient-centered, timely, efficient, effective, and equitable patient care.
  5. Risk Management.Aspects of risk management most directly relevant to the liability exposure of

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anesthesiologists include prevention of patient injury, adherence to standards of care, documentation, and patient relations.

Table 4-1 Recent Estimates of Anesthesia-Related Death

Time Period

Country

Data Sources and Methods

Anesthesia-Related Death

1989–1999

USA

Cardiac arrests within 24 hr of surgery (72,959 anesthetics) in a teaching hospital

0.55/10,000 anesthetics

1992–1994

USA

Suburban teaching hospital (37,924 anesthetics and 115 deaths)

0.79/10,000 anesthetics

1995–1997

USA

Urban teaching hospital (146,548 anesthetics and 232 deaths)

0.75/10,000 anesthetics

1995–1997

Holland

All deaths within 24 hr or patients who remained comatose 24 hr after surgery (869,483 anesthetics and 811 deaths)

1.4/10,000 anesthetics

1990–1995

Western Australia

Deaths within 48 hr or deaths in which anesthesia was considered a contributing factor

1/40,000 anesthetics

1994–1996

Australia

Deaths reported to the committee (8,500,000 anesthetics)

0.16/10,000 anesthetics

1992–2002

Japan

Deaths caused by life-threatening events in the operating room (3,855,384 anesthetics) in training hospitals

0.1/10,000 anesthetics

1994-1998

Japan

Questionnaires to training hospitals (2,363,038 anesthetics)

0.21/10,000 anesthetics

1989–1995

France

ASA 1–4 patients under-going anesthesia (101,769 anesthetics and 24 cardiac arrests within 12 hr after anesthesia)

0.6/10,000 anesthetics

1994–1997

USA

Pediatric patients from 63 hospitals (1,089,200 anesthetics)

0.36/10,000 anesthetics

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Table 4-2 Complications Related to Anesthesia

Postoperative nerve injury
   Ulnar nerve injury
   Lower extremity neuropathy after surgery in the lithotomyg position
   After neuraxial anesthesia (0.4–4.2/10,000 spinal anesthetics)
Awareness during general anesthesia (estimated to occur in 1–2 per 1,000 patients in a tertiary care setting)
Eye injuries and visual deficits
   Corneal abrasion
   Ischemic optic neuropathy
   Central retinal artery occlusion
Dental injury (1/4,537 patients require intervention)
Postoperative cognitive dysfunction in elderly patients (cause unknown)

  1. The key factors in the prevention of patient injury are vigilance, up-to-date knowledge, and adequate monitoring. The website of the American Society of Anesthesiologists (ASA) may be reviewed for any changes in ASA Standards of Practice as well as a review of ASA guidelines.
  2. Another risk management tool is the use of checklists before each case or at least daily in an attempt to reduce equipment-related problems.
  3. Informed consentregarding anesthesia should be documented along with a note in the patient's chart that the risks of anesthesia and alternatives were discussed.
  4. Record Keeping.The anesthesia record should be as accurate, complete, and as neat as possible. The use of automated records may be helpful in the defense of malpractice cases.
  5. What to Do After an Adverse Event
  6. If a critical incident occurs during the conduct of an anesthetic, it is helpful to write a note in the patient's medical record describing the event, the drugs used, the time sequence, and who was present.
  7. If anesthetic complications occur, the anesthesiologist should be honest with both the patient and family about the cause. A formal apology should be issued if the unanticipated outcome is the result of an error or

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system failure. Some states have laws mandating disclosure of serious adverse events to patients. (Disclosure discussions may be prohibited as evidence in malpractice litigation.)

  1. Whenever an anesthetic complication becomes apparent after surgery, appropriate consultation should be obtained and the department or institutional risk management group should be notified. If the complication is likely to lead to prolonged hospitalization or permanent injury, the liability insurance carrier should be notified.
  2. Special Circumstances: “Do Not Attempt Resuscitation” and Jehovah's Witnesses.Patients have well-established rights, and among them is the right to refuse specific treatments.
  3. Do Not Attempt Resuscitation (DNAR).When a patient with DNAR status present for anesthesia care, it is important to discuss this with the patient or patient's surrogate to clarify the patient's intentions. In many hospitals, the institutional policy is to suspend the DNAR order during the perioperative period because the cause of cardiac arrest may be easily identified and treated during surgery.
  4. Jehovah's Witnesses.The administration of blood or blood products may be refused because of a belief that the afterlife is forbidden if they receive blood.
  5. As a general rule, physicians are not obligated to treat all patients who seek treatment in elective situations.
  6. Emergency medical care imposes greater constraints on the treating physician because there is limited to no opportunity to provide continuity of care in a life-threatening situation without the initial physician's continued involvement.
  7. Exceptions to patients' rights include parturients and adults who are the sole support of minor children. In these instances, it may be necessary to seek a court order to proceed with a refused medical therapy such as a blood transfusion.
  8. National Practitioner Data Bank(Table 4-3)

III. Quality Improvement and Patient Safety in Anesthesia

It is generally accepted that attention to quality improves patient safety and satisfaction with anesthesia care. There

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may be an emphasis on patient safety and the prevention of harm from medical care. Quality improvement programs are generally guided by requirements of The Joint Commission, which accredits hospitals and health care organizations.

Table 4-3 Sources of Input for the National Practitioner Data Bank

Medical malpractice payments (any payment made on behalf of a physician in response to a written complaint or claim)
License actions by medical boards
Professional review or clinical privilege actions taken by hospitals and other health care entities (professional societies)
Actions taken by the Drug Enforcement Agency
Medicare or Medicaid exclusions

  1. Structure, Process, and Outcome: The Building Blocks of Quality
  2. Although quality of care is difficult to define, it is generally accepted that it is composed of three components: structure (setting in which care is provided), process of care (preanesthetic evaluation plus continual attendance and monitoring during anesthesia), and outcome. A quality improvement program focuses on measuring and improving these basic components of care.
  3. Continuous quality improvement (CQI)focuses on system errors, which are controllable and solvable as opposed to random errors, which are difficult to prevent. A CQI program may focus on undesirable outcomes as a way of identifying opportunities for improvement in the structure and process of care. Peer review is critical to this process.
  4. Difficulty of Outcome Measurement in Anesthesia
  5. Improvement in quality of care is often measured by a decrease in the rate of adverse outcomes.
  6. Adverse outcomes are rare in anesthesia, making measurement of improvement difficult. To complement outcome measurements, anesthesia CQI programs can focus on critical incidents (events that cause or have the potential to cause patient injury if not noticed or corrected in a timely manner [e.g., ventilator disconnect]), sentinel events, and human errors [inevitable yet potentially preventable by appropriate system safeguards].

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Table 4-4 The Joint Commission Patient Safety Goals for Accredited Organizations

Improved accuracy of patient identification
Improved effectiveness of communication among caregivers (handoffs)
Improved safety of medication usage (e.g., anticoagulation therapy)
Reduction of health care–related infections
Improved recognition and response to changes in a patient's condition

  1. The Joint Commission's Requirement for Quality Improvement
  2. Anesthesia care is an important function of patient care that has been identified by The Joint Commission. It is important that policies and procedures for administration of anesthesia be consistent in all locations within the hospital.
  3. The Joint Commission has adopted and annually updates patient safety goals for accredited organizations (Table 4-4).
  4. The Joint Commission's accreditation visits are unannounced and involve the inspector observing patient care to confirm that safe practices (e.g., timely administration of antibiotics, proper labeling of all syringes on the anesthesia cart) are routinely implemented.
  5. The Joint Commission requires that all sentinel events(i.e., unexpected occurrences involving death or serious physical or psychological injury) undergo root cause analysis.
  6. Pay for Performance
  7. Conceptually, the goal is to provide monetary incentives for implementation of safe practices, measuring performance, and achieving performance goals (e.g., payment for quality rather than simply payment for services).
  8. The stimulus for pay for performance comes from the Leapfrog Group, the Institute for Healthcare Improvement, the Center for Medicare and Medicaid Services, and the National Quality Forum.
  9. Benchmarks as indicators for measurement and improvement may include “never events” (e.g., surgery on the wrong patient or site, unintentional retention of a foreign body, patient death from a medication error, perioperative death of an ASA I patient).

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  1. Professional Liability
  2. The Tort System
  3. A tort may be loosely defined as a civil wrongdoing. Negligenceis one type of tort. Malpractice refers to any professional misconduct, but its use in legal terms typically refers to professional negligence.
  4. To be successful in a malpractice suit, the patient/plaintiff must prove four elements of negligence (Table 4-5).
  5. Duty.The anesthesiologist establishes a duty to the patient when a doctor–patient relationship exists. When the patient is seen before surgery and the anesthesiologist agrees to provide anesthesia care for the patient, a duty to the patient has been established. Because it would be impossible to delineate specific standards for all aspects of medical practices and all eventualities, the courts have created the concept of a reasonable and prudent physician. A general duty is obtaining informed consent that includes common risks, and in the case of regional anesthesia, risks that are rare but are of major consequence, including seizure, cardiac arrest, permanent neuropathy, and paralysis.
  6. Breach of Duty.In a malpractice action, expert witnesses review the medical records and determine whether the anesthesiologist acted in a reasonable manner in the specific situation and fulfilled his or her duty to the patient.
  7. Causation.Although the burden of proof of causation ordinarily falls on the patient/plaintiff, it may, under special circumstances, be shifted to the physician/defendant under the doctrine of res ipsa loquitur (“the thing speaks for itself”) (Table 4-6).

Table 4-5 Elements Required to Prove Malpractice

Duty (established when the patient is seen after surgery)
Breach of duty (often determined by expert witnesses)
Causation (the judge and jury determine if the breach of duty was the proximate cause of the injury)
Damages (breach of standard of care was the cause of damage)

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Table 4-6 Elements Necessary to Prove Res Ipsa Loquitur

The injury would not typically occur in the absence of negligence.
The injury was caused by something under the exclusive control of the anesthesiologist.
The injury must not be attributable to any contribution on the part of the patient.
The evidence for the explanation of events is more accessible to the anesthesiologist than to the patient.

  1. Damagesin a malpractice suit are characterized as general damages (pain and suffering as a direct result of the injury), special damages (medical expenses, lost income), andpunitive damages (rarely invoked in malpractice suits). Determining the dollar amount of damages is the responsibility of the jury.
  2. Standard of Care
  3. Because medical malpractice usually involves issues beyond the comprehension of lay jurors and judges, the court establishes the standard of care in each case with the testimony of expert witnesses. Expert witnesses differ from factual witnesses mainly in that they may give opinions. The trial court judge has sole discretion in determining whether a witness may be qualified as an expert.
  4. There is a tendency for experts to link severe injury with inappropriate care (a bias that bad outcomes mean bad care).
  5. The essential difference between standards and guidelines is that guidelines should beadhered to and standards must be adhered to. The ASA publishes standards and guidelines for a variety of anesthesia-related activities.
  6. Causes of Anesthesia-Related Lawsuits
  7. Relatively few adverse outcomes end in a malpractice suit. It is estimated that <1 per 25 patient injuries result in malpractice litigation.
  8. The leading causes of injuries for which suits are filed against anesthesiologists are death, nerve damage (spinal cord injury, peripheral nerve injury), and brain damage. The causes of death and brain damage most often reflect airway management problems. Nerve damage, especially to the ulnar nerve, often occurs despite apparently adequate positioning. Chronic pain management is an increasing source of malpractice claims against anesthesiologists.

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Table 4-7 Steps to Take When Named in a Lawsuit

Do not discuss the case with others.
Never alter any records.
Gather all pertinent records.
Make notes relating to your recall of events.
Work closely with your attorney.

  1. Anesthesiologists are more likely to be the target of lawsuits if an untoward outcome of a procedure occurs because the physician–patient relationship is often incomplete (e.g., the patient rarely chooses the anesthesiologist, the preoperative visit is brief, and a different anesthesiologist may administer the anesthesia).
  2. What to Do If Sued(Table 4-7)

Editors: Barash, Paul G.; Cullen, Bruce F.; Stoelting, Robert K.; Cahalan, Michael K.; Stock, M. Christine

Title: Handbook of Clinical Anesthesia, 6th Edition

Copyright ©2009 Lippincott Williams & Wilkins

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