Clinical Anesthesia

Chapter 4

Anesthetic Risk, Quality Improvement and Liability

Karen L. Posner

Karen B. Domino

Key Points

1. Anesthetic mortality has decreased, but accidental deaths and disabling complications still occur.

2. Risk management programs are broadly oriented toward reducing the liability exposure of the organization. Risk management programs complement quality improvement programs in minimizing liability exposure while maximizing quality of patient care.

3. Quality improvement programs are generally guided by the requirements of the Joint Commission that accredits healthcare organizations. Quality improvement programs focus on improving the structure, process, and outcome of care.

4. Continuous quality improvement (CQI) is a systems approach to identifying and improving quality of care.

5. Medical malpractice refers to the legal concept of professional negligence. The patient-plaintiff must prove that the anesthesiologist owed the patient a duty, failed to fulfill this duty, that the anesthesiologist's actions caused an injury, and that the injury resulted from a breach in the standard of anesthesia care.

6. The most common lawsuits against anesthesiologists (excluding dental injuries) are for death, brain damage, nerve damage, and airway injury.

In anesthesia, as in other areas of life, everything does not always go as planned. Undesirable outcomes 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 risk of practice, while assuring the highest quality of care for patients. Payers such as Medicare are increasingly depending on accreditation through bodies such as the Joint Commission to ensure that mechanisms are in place to deliver quality and safe care to all patients. In addition, there has been a move toward performance measurement linked to reimbursement. The legal aspects of American medical practice have also become increasingly important as the public has turned to the courts for economic redress when their expectations of medical treatment are not met.

This chapter discusses anesthetic mortality and morbidity, risk management, continuous quality improvement, performance measurement, and medical liability. The chapter provides background for the practitioner concerning the role of risk management activity in minimizing and managing liability exposure. Also described is the medical legal system, the most frequent causes of lawsuits for anesthesiologists, and appropriate actions for physicians to take in the event of a malpractice suit.

Anesthesia Risk

Mortality and Major Morbidity Related to Anesthesia

Estimates of anesthesia-related morbidity and mortality are difficult to quantify. Not only are there difficulties obtaining data on complications, but different methods yield different estimates of anesthesia risk. Studies differ in their definitions of complications, length of follow-up, and especially in approaches to evaluation of the contribution of anesthesia care to patient outcomes. A comprehensive review of anesthesia complications is beyond the scope of this chapter. A sampling of studies of anesthesia mortality and morbidity will be presented to provide historical perspective plus a limited overview of relatively recent findings.

Early studies estimated the anesthesia-related mortality rate as 1 per 1,560 anesthetics.1 More recent studies using data from the 1990s estimate the anesthesia-related death rate in the United States to be <1 per 10,000 anesthetics.2,3,4,5 Some examples of modern estimates of anesthesia-related death from throughout the world are provided in Table 4-1.2,3,4,5,6,7,8,9,10,11,12,13 Differences in estimates may be influenced by different reporting

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methods, definitions, anesthesia practices, patient population, as well as actual differences in underlying complication rates. Nevertheless, it is generally accepted that anesthesia safety has improved over the past 50 years.

Table 4-1 Estimates of Anesthesia-Related Death

REFERENCE

COUNTRY

TIME

DATA SOURCES/METHODS

RATE OF DEATH

Flick et al4

USA

1988–2005

Perioperative cardiac arrest in pediatric patients at a tertiary referral hospital (n = 92,881 anesthetics)

Anesthesia-attributed deaths = 0.22/10,000 anesthetics

Biboulet et al8

France

1989–1995

ASA 1–4 patients undergoing anesthesia (n = 101,769 anesthetics); cardiac arrest within 12 hr postanesthesia (n = 24)

Anesthesia-related death = 0.6/10,000 anesthetics

Newland et al2

USA

1989–1999

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

Death related to anesthesia-attributable perioperative cardiac arrest = 0.55/10,000 anesthetics

Eagle and Davis6

Western Australia

1990–1995

Deaths within 48 hr or deaths in which anesthesia was considered a contributing factor (n = 500 deaths)

Anesthesia-related death = 1/40,000 anesthetics

Lagasse3

USA

(a) 1992–1994

(a) Suburban teaching hospital (n = 115 deaths; n = 37,924 anesthetics)

Anesthesia-related death = (a) 0.79/10,000 anesthetics

(b) 1995–1999

(b) Urban teaching hospital (n = 232 deaths; n = 146,548 anesthetics)

(b) 0.75/10,000 anesthetics

Davis7

Australia

1994–1996

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

Anesthesia-related death = 0.16/10,000 anesthetics

Morray et al5

USA

1994–1997

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

Anesthesia-related death = 0.36/10,000 anesthetics

Kawashima et al10

Japan

1994–1998

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

Death totally attributable to anesthesia = 0.21/10,000 anesthetics

Arbous et al9

Holland

1995–1997

All deaths within 24 hr or patients who remained unintentionally comatose 24 hr postanesthesia (n = 811 in 869,483 anesthetics)—64 hospitals

Anesthesia-related death = 1.4/10,000 anesthetics

Lienhart et al13

France

1999

Nationwide survey of anesthesia-related deaths

Death totally related to anesthesia = 0.069/10,000
Death partially related to anesthesia = 0.47/10,000

Kawashima et al11

Japan

1999

Questionnaires to training hospitals (n = 793,840 anesthetics)

Death totally attributable to anesthesia = 0.13/10,000 anesthetics

Irita et al12

Japan

1999–2002

Deaths as a result of life-threatening events in the operating room (n = 3,855,384 anesthetics) in training hospitals

Death totally attributable to anesthetic management = 0.1/10,000 anesthetics

Other complications related to anesthesia that have received relatively recent attention include postoperative nerve injury, awareness during general anesthesia, eye injuries and visual deficits, dental injury, and postoperative cognitive dysfunction in elderly patients. Ulnar neuropathy is one of the most common nerve injuries leading to anesthesia malpractice claims in the United States.14 The incidence of ulnar neuropathy has been estimated between 3.7 and 50 per 10,000 patients (Table 4-2).15,16,17 Lower extremity neuropathy following surgery in the lithotomy position was observed in 2.7 per 10,000 patients (Table 4-2).18 Permanent neurologic injury following neuraxial anesthesia was estimated at 0 to 4.2 per 10,000 spinal anesthetics and 0 to 7.6 per 10,000 epidural anesthetics.19 Awareness during general anesthesia has been estimated to occur in 1 to 2 per 1,000 patients in tertiary care settings,20,21 but may occur with lower frequency in ambulatory patients.22

Eye injuries are a risk of anesthesia, including corneal abrasions as well as more rare complications such as blindness from ischemic optic neuropathy or central retinal artery occlusion (Table 4-2).23,24 Eye injury after nonocular surgery was observed in 5.6 per 10,000 patients.23 New-onset blurred

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vision has been observed in 4.2% of patients (Table 4-2).24 New-onset visual loss or changes lasting more than 30 days after noncardiac surgery were observed in 1 per 125,234 patients.24

Table 4-2 Rates of Selected Anesthesia Complications

COMPLICATION

REFERENCE

COUNTRY

TIME

SPECIFIC COMPLICATION

RESULTS

Nerve injury

Warner et al18

USA

1957–1991

Lower extremity motor neuropathy following surgery in lithotomy position

1/3,608 procedures

Warner et al16

USA

1957–1991

Persistent ulnar neuropathy following diagnostic or noncardiac procedures with anesthesia

1/2,729 patients

Alvine and Schurrer15

USA

1980–1981

Ulnar neuropathy after general anesthesia

0.26%

Brull et al19

Various

1987–1999

Radiculopathy or peripheral neuropathy after spinal anesthesia

3.78/10,000 anesthetics

Radiculopathy or peripheral neuropathy after epidural anesthesia

2.19/10,000 anesthetics

Permanent neurologic injury after spinal anesthesia

0–4.2/10,000 anesthetics

Permanent neurologic injury after epidural anesthetic

0–7.6/10,000 anesthetics

Varies

Transient neurologic deficit after interscalene block

2.84/10,000 anesthetics

Warner et al17

USA

1995

Ulnar neuropathy in adults following noncardiac surgery

0.5%

Awareness and recall

Sandin et al20

Sweden

1997–1998

Awareness and recall associated with general anesthesia

18/11,785 procedures

Sebel et al21

USA

2001–2002

Awareness with recall in patients ≥ 18 yr old in seven academic medical centers

0.13%

Pollard et al22

USA

2002–2004

Awareness and recall in a regional medical center

1/14,560 patients

Eye injuries and visual changes

Warner et al23

USA

1986–1998

New-onset visual loss or visual changes lasting >30 days after noncardiac surgery

1/125,234 patients

Warner et al24

USA

1999

New-onset blurred vision lasting ≥ 3 days

4.2%

Dental injury

Warner et al25

USA

1987–1997

Dental injuries within 7 days of anesthesia that required intervention

1/4,537 patients

Damage to teeth or dentures is perhaps the most common injury leading to anesthesia malpractice claims. Dental injury complaints are usually resolved by a hospital risk management department. Dental injuries requiring intervention were observed in 1 per 4,537 patients.25

Cognitive dysfunction is observed in many adult patients after major surgery, but only the elderly are at significant risk for long-term cognitive problems.26 The cause for postoperative cognitive dysfunction is unknown.

Risk Management

Conceptual Introduction

Risk management and quality improvement programs work hand in hand in minimizing liability exposure while maximizing quality of patient care. Although the functions of these programs vary from one institution to another, they overlap in their focus on patient safety. They can generally be distinguished by their basic difference in orientation. A hospital risk management program is broadly oriented toward reducing the liability exposure of the organization. This includes not only professional liability (and therefore patient safety) but also contracts, employee safety, public safety, and any other liability exposure of the institution. Quality improvement programs have as their main goal the continuous maintenance and improvement of the quality of patient care. These programs may be broader in their patient safety focus than strictly risk management. Quality improvement (sometimes calledpatient safety) departments are responsible for providing the resources to provide safe, patient-centered, timely, efficient, effective, and equitable patient care.27

Risk Management in Anesthesia

Those aspects of risk management that are most directly relevant to the liability exposure of the anesthesiologist include prevention of patient injury, adherence to standards of care, documentation, and patient relations.

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The key factors in the prevention of patient injury are vigilance, up-to-date knowledge, and adequate monitoring.28 Physiologic monitoring of cardiopulmonary function, combined with monitoring of equipment function, might be expected to reduce anesthetic injury to a minimum. This was the rationale for the adoption by the American Society of Anesthesiologists (ASA) of Standards for Basic Anesthetic Monitoring.a

The ASA Web site should be reviewed yearly for any changes in these standards. It would also be reasonable to review the Guidelines and Statements published on the ASA Web site. It should be noted that, although membership in the ASA is not required for the practice of anesthesiology, expert witnesses will, with virtual certainty, hold any practitioner to the ASA standards. It is also possible that, as a risk management strategy, a professional liability insurer or hospital may hold an individual anesthesiologist to standards higher than those promulgated by the ASA.

Another risk management tool is the use of checklists prior to each case, or at least daily, in an attempt to reduce equipment-related mishaps.29,30,31 A regular schedule of equipment maintenance should be established as well as procedures to follow whenever equipment malfunction is suspected of contributing to patient injury. The ASA Web site has recommendations for preanesthesia checkout proceduresb as well as guidelines for determining anesthesia machine obsolescence.c If equipment malfunction is suspected to have contributed to a complication, the device should be impounded and examined concurrently by the representatives of the hospital, the anesthesiologist, and the manufacturer.

Although it may seem obvious, qualified anesthesia personnel should be in continuous attendance during the conduct of all anesthetics. The only exceptions should be those that lay people (i.e., judge and jury) can understand, such as radiation hazards or an unexpected life-threatening emergency elsewhere. Even then, provisions should be made for monitoring the patient adequately. Adequate supervision of nurse anesthetists and residents is also important, as is good communication with surgeons when adverse anesthetic outcomes occur.

Informed Consent

Informed consent regarding anesthesia should be documented with a general surgical consent, which should include a statement to the effect that, “I understand that all anesthetics involve risks of complications, serious injury, or, rarely, death from both known and unknown causes.” In addition, there should be a note in the patient's record that the risks of anesthesia and alternatives were discussed, and that the patient accepted the proposed anesthetic plan. A brief documentation in the record that the common complications of the proposed technique were discussed is helpful. In some institutions, a separate written anesthesia consent form may be used, which may include more detail about risks. If it is necessary to change the agreed-on anesthesia plan significantly after the patient is premedicated or anesthetized, the reasons for the change should be documented in the record.

Record Keeping

Good records can form a strong defense if they are adequate; however, records can be disastrous if inadequate. The anesthesia record itself should be as accurate, complete, and as neat as possible. The use of automated anesthesia records may be helpful in the defense of malpractice cases,32 but they may also serve as damaging evidence for the lack of vigilance prior to an adverse event. In addition to documenting vital signs at least every 5 minutes, special attention should be paid to ensure that the patient's ASA classification, the monitors used, fluids administered, and doses and times of all administered drugs are accurately charted. Because the principal causes of hypoxic brain damage and death during anesthesia are related to ventilation and/or oxygenation, all respiratory variables that are monitored should be documented accurately. It is important to note when there is a change of anesthesia personnel during the conduct of a case. Sloppy, inaccurate anesthesia records, with gaps during critical events, can be extremely damaging to the defense when enlarged and placed before a jury.

What To Do After an Adverse Outcome

If a critical incident occurs during the conduct of an anesthetic, the anesthesiologist should document, in narrative form, what happened, which drugs were used, the time sequence, and who was present. This should be documented in the patient's progress notes, as a catastrophic intra-anesthetic event cannot be summarized adequately in a small amount of space on the usual anesthesia record. The critical incident note should be written as soon as possible. The report should be as consistent as possible with concurrent records, such as the anesthesia, operating room, recovery room, and cardiac arrest records. If significant inconsistencies exist, they should be explained. Records should never be altered after the fact. If an error is made in record keeping, a line should be drawn through the error, leaving it legible, and the correction should be initialed and timed. Litigation is a lengthy process, and a court appearance to explain the incident to a jury may be years away, when memories have faded.

If anesthetic complications occur, the anesthesiologist should be honest with both the patient and family about the cause. The providers should provide the facts about the event, express regret to the patient and family about the outcome, and give a formal apology if the unanticipated outcome is the result of an error or system failure.33 Some states have laws mandating disclosure of serious adverse events to patients, and disclosure has been incorporated into quality reporting. Some states prohibit use of disclosure discussions as evidence in malpractice litigation. Whenever an anesthetic complication becomes apparent, appropriate consultation should be obtained quickly, and the departmental or institutional risk management group should be notified. If the complication is apt to lead to prolonged hospitalization or permanent injury, the liability insurance carrier should be notified. The patient should be followed closely while in the hospital, with telephone follow-up, if indicated, after discharge. The anesthesiologist(s), surgeon(s), consulting physicians and the institution should coordinate and be consistent in their explanations to the patient or the patient's family as to the cause of any complication.

Special Circumstances: “Do Not Attempt Resuscitation” and Jehovah's Witnesses

It is important to recognize that patients have well-established rights, and that among these is the right to refuse specific treatments. Two situations most relevant to anesthesia care are “Do Not Attempt Resuscitation” (DNAR) orders and the special circumstance of blood transfusion for Jehovah's Witnesses.

Patients with severe medical conditions may elect to forgo resuscitation attempts in the event of cardiac arrest. Such DNAR orders may be specified at hospital admission or may

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be in place in the form of an advance directive prior to admission. DNAR orders or advance directives may be general or specific, such as refusal of tracheal intubation or mechanical ventilation. When a patient with DNAR status presents 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 immediate perioperative period since the cause for a cardiac arrest may be easily identified and treated. In other institutions, the patient may choose to suspend the DNAR order during the entire perioperative period. It should be clarified when the DNAR order should be reinstated (e.g., discharge from recovery or possibly later, when the patient has recovered from the procedure) and documented in the patient's chart. The perioperative status of DNAR orders should also be clarified with the surgeon and other providers who will be involved in the patient's perioperative care. The ASA has published Ethical Guidelines of the Anesthesia Care of Patients with Do-Not-Resuscitate Orders.d

In the case of Jehovah's Witnesses, the treatment that may be refused is the administration of blood or blood products. A central religious belief of many Jehovah's Witnesses is that the faithful will be forbidden the pleasures of the afterlife if they receive blood or blood products. Thus, for them to receive a transfusion is a mortal sin, and many Jehovah's Witnesses would actually rather die in grace than live with no possibility of salvation. Anesthesiologists must recognize and respect these beliefs, but may also be cognizant that these convictions may conflict with their own personal, religious, or ethical codes.

As a general rule, physicians are not obligated to treat all patients who apply for treatment in elective situations. It is well within the rights of a physician to decline to care for any patient who wishes to place burdensome constraints on the physician or to unacceptably limit the physician's ability to provide optimal care. When presented with the opportunity to provide elective care for a Jehovah's Witness, the physician may decline to provide any care or may limit, by mutual consent with the patient, his or her obligation to adhere to the patient's religious beliefs. If such an agreement is reached, it must be documented clearly in the medical record, and it is desirable to have the patient co-sign the note. Not all Jehovah's Witnesses have identical beliefs regarding blood transfusions or which methods of blood preservation or sequestration will be allowed. Some patients will not allow any blood that has left the body to be reinfused, yet others will accept autotransfusion if their blood remains in constant contact with the body (via tubing). Therefore, it is important to reach a clear understanding of which techniques for blood preservation are to be used and to document this plan in the record. Parents of a minor child may not legally prevent that child from receiving blood. It may be necessary to obtain a court order in this circumstance.

National Practitioner Data Bank

It is usually the obligation of the hospital risk management department to make reports and inquiries to the National Practitioner Data Bank (NPDB), a nationwide information system that theoretically allows licensing boards and hospitals a means of detecting adverse information about physicians.34 Simply moving into another state would no longer provide safe haven for incompetent physicians.

The NPDB requires input from five sources: (1) medical malpractice payments, (2) license actions by medical boards, (3) professional review or clinical privilege actions taken by hospitals and other health care entities (including professional societies), (4) actions taken by the Drug Enforcement Agency, and (5) Medicare/Medicaid exclusions. There has been a great deal of effort to establish a minimum malpractice payment below which no report is necessary, but to date, any payment made on behalf of a physician in response to a written complaint or claim must be reported. Settlements made by cancellation of bills or settlements made on verbal complaints are not considered a reportable payment.

Once a report has been submitted, the physician is notified and may dispute the accuracy of the report. At this time, the reporting entity may correct the form or void it. Failing that, the physician has the option of putting a brief statement in the file or appealing to the U.S. Secretary of Health and Human Services, who may also either correct or void the form. A practitioner may make a query about his or her file at any time. A physician may also add a statement to a report at any time. Such statements will be included in any reports that are sent in response to inquiries. The existence of the NPDB reporting requirements has made physicians reluctant to allow settlement of nuisance suits because it will cause their names to be added to the data bank.

Quality Improvement and Patient Safety in Anesthesia

Quality is a concept that has continued to elude precise definition in medical practice. However, it is generally accepted that attention to quality will improve patient safety and satisfaction with anesthesia care. The field of quality improvement is continually evolving, as is the terminology used to describe such efforts. A more recent trend is emphasis on patient safety, the prevention of harm from medical care. At the time of this writing, patient safety initiatives are evolving and a movement toward “pay for performance” (direct linkage between care processes and outcomes and reimbursement) is on the horizon. These will be discussed in a separate section.

Anesthesia quality improvement programs at the service level are generally guided by requirements of the Joint Commission that accredits hospitals and health care organizations. Quality improvement programs are basically oriented toward improvement of the structure, process, and outcome of health care delivery. An understanding of the fundamental principles of quality improvement may clarify the relationship between the continually evolving Joint Commission requirements and mandated quality improvement and other reporting initiatives.

Structure, Process, and Outcome: The Building Blocks of Quality

Although quality of care is difficult to define, it is generally accepted that it is composed of three components: structure, process, and outcome.35 Structure refers to the setting in which care was provided; for example, personnel and facilities used to provide health care services and the manner in which they are organized. This includes the qualifications and licensing of personnel, ratio of practitioners to patients, standards for the facilities and equipment used to provide care, and the organizational structure within which care is delivered. The process of care includes the sequence and coordination of patient care activities; that is, what was actually done. Was a preanesthetic evaluation performed and documented? Was the patient continuously attended and monitored throughout the anesthetic? Outcome of care refers to changes in health status of the patient following the delivery of medical care. A quality

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improvement program focuses on measuring and improving these basic components of care.

Continuous quality improvement (CQI) takes a systems approach to identifying and improving quality of care.36,37 The operator is just one part of a complex system. An important underlying premise is that poor results may be a result of either random or systematic error. Random errors are inherently difficult to prevent and programs focused in this direction are misguided. System errors, however, should be controllable and strategies to minimize them should be within reach. CQI is basically the process of continually evaluating anesthesia practice to identify systematic problems (opportunities for improvement) and implementing strategies to prevent their occurrence.

A CQI program may focus on undesirable outcomes as a way to identify opportunities for improvement in the structure and process of care. The focus is not on blame but rather on identification of the causes of undesirable outcomes. Instead of asking which practitioners have the highest patient mortality rates, a CQI program may focus on the relationship between the process of care and patient mortality. What proportion of deaths was related to the patient's disease process or debilitated condition? Are these patients being appropriately evaluated for anesthesia and surgery? Were there any controllable causes, such as a lack of extra help during resuscitation? The latter may lead to a modification of personnel resources (structure) or assignments (process) to be sure that adequate personnel are available at all times.

Formally, the process of CQI involves the identification of opportunities for improvement through the continual assessment of important aspects of care. It is a process that is instituted from the bottom up, by those who are actually involved in the process to be improved, rather than from the top down by administrators. Identification of opportunities for improvement may be carried out by various means, from brainstorming sessions focusing on a systematic evaluation of care activities to the careful measurement of indicators of quality (such as morbidity and mortality). In any event, once areas are identified for improvement, their current status is measured and documented. This may involve measurement of outcomes, such as delayed recovery from anesthesia or peripheral nerve injury. The process of care leading to these problems is then analyzed. If a change is identified that should lead to improvement, it is implemented. After an appropriate time, the status is then measured again to determine whether improvement actually resulted. Attention may then be directed to continuing to improve this process or turning to a different process to target for improvement.

Difficulty of Outcome Measurement in Anesthesia

Improvement in quality of care is often measured by a reduction in the rate of adverse outcomes. However, adverse outcomes are relatively rare in anesthesia, making measurement of improvement difficult. For example, if an institution lowers its mortality rate of surgery patients from 1 in 1,000 to 0.5 in 1,000, this difference may not be statistically significant. In other words, it may be impossible to know if the change in outcome resulted from changes in care, or are simply random fluctuations. Many adverse outcomes in anesthesia are sufficiently rare to render them problematic as quality improvement measures.

To complement outcome measurement, anesthesia CQI programs can focus on critical incidents, sentinel events, and human errors. Critical incidents are events that cause, or have the potential to cause, patient injury if not noticed and corrected in a timely manner. For example, a partial disconnect of the breathing circuit may be corrected before patient injury occurs, yet has the potential for causing hypoxic brain injury or death. Critical incidents are more common than adverse outcomes. Measurement of the occurrence rate of important critical incidents may serve as a proxy measure for rare outcomes in anesthesia in a CQI program designed to improve patient safety and prevent injury.

Sentinel events are single, isolated events that may indicate a systemic problem. The Joint Commission has a specific definition of sentinel events that will be discussed later. In general, a sentinel event may be a significant or alarming critical incident that did not result in patient injury, such as a syringe swap and administration of a potentially lethal dose of medication that was noted and treated promptly, avoiding catastrophe. Or a sentinel event may be an unexpected significant patient injury such as intraoperative death. In either case, a CQI program may investigate sentinel events in an attempt to uncover systemic problems in the delivery of care that can be corrected. For example, a syringe swap may be analyzed for confusing or unclear labeling of medications or unnecessary medications routinely stocked on the anesthesia cart, setting the scene for unintended mix-up. In the case of death, all aspects of the patient's hospital course from selection for surgery to anesthetic management may be analyzed to determine if similar deaths can be prevented by a change in the care delivery system.

Human error has garnered much attention since a government report that 98,000 Americans may die annually from medical errors in hospitals.38 Human errors are inevitable yet potentially preventable by appropriate system safeguards. Errors of planning involve use of a wrong plan to achieve an aim.39 Errors of execution are the failure of a planned action to be completed as intended.39 Modern anesthesia equipment is designed with safeguards such as alarm systems to detect errors that could lead to patient injury. Other anesthesia care processes are also amenable to human factors design principles, such as color coding of drug labels. A quality improvement program may identify human errors and institute safety systems to aid in error prevention.

Joint Commission Requirements for Quality Improvement

Joint Commission requirements for quality improvement activities are updated on an annual basis. In general, a hospital must adopt a method for systematically assessing and improving important functions and processes of care and their outcomes in a cyclical fashion. The general outline for this CQI cycle is the design of a process or function, measurement of performance, assessment of performance measures through statistical analysis or comparison with other data sources, and improvement of the process or function. Then the cycle repeats. The Joint Commission provides specific standards that must be met, with examples of appropriate measures of performance. The goal of this cycle of design, measurement, assessment, and improvement of performance of important functions and processes is to improve patient safety and quality of care.

Anesthesia care is one important function of the care of patients monitored by the Joint Commission. It is important that policies and procedures for administration of anesthesia be consistent in all locations within the organization.

The Joint Commission has adopted and annually updates patient safety goals for accredited organizations. Recent patient safety goals include improved accuracy of patient identification, improved effectiveness of communication

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among caregivers including handoffs, improved safety of medication usage including anticoagulation therapy, reduction of health care-associated infections, and improved recognition and response to changes in a patient's condition. Joint Commission accreditation visits are unannounced, and involve the inspector watching patient care to see that safe and acceptable practices are routinely implemented. In the intraoperative environment, this may involve such processes as timely administration of antibiotics and proper labeling of all syringes on the anesthesia cart. The Joint Commission also requires all sentinel events (any unexpected occurrences involving death or serious physical or psychological injury or risk thereof) to undergo root cause analysis.e A root cause analysis is typically facilitated by the hospital and includes everyone involved in the care of the affected patient in reconstructing the events to identify system process flaws that facilitated medical error. Any surgery on the wrong patient or wrong body part is included in this policy. The Joint Commission publishes a sentinel event alert so health care organizations can learn from the experiences of others and prevent future medical errors.

Pay for Performance

A relatively recent development related to quality improvement is P4P or “pay for performance.” P4P programs provide monetary incentives for implementation of safe practices, measuring performance, and/or achieving performance goals. This is a recent and evolving trend, so only a conceptual introduction will be provided here. Anesthesia providers and service groups will need to be cognizant of any P4P initiatives that are operative in their location and with their payers.

At the time of this writing, P4P is being driven by the Leapfrog Group, the Institute of Healthcare Improvement, the Center for Medicare and Medicaid Services (CMS), and the National Quality Forum. The basic concept involves payment for quality rather than simply payment for services. In some cases, quality incentive payments are provided for simply measuring processes. However, as measurement systems are implemented, it is expected that benchmarks for quality performance will be established and providers will need to show that they are meeting such performance benchmarks to receive incentive payments. Eventually, providers falling short of benchmark performance may see their reimbursements reduced. P4P is being implemented at both the hospital and specific provider level. CMS and other payers may eventually link reimbursement to individual provider profiles.

A multitude of performance measures are being developed to meet the benchmarking challenge. At present, individual institutions are not being held to particular benchmarks but are expected to adopt some of the major quality indicators for measurement and improvement. These include “never events,” which are serious adverse events that should never occur. Never events include surgery on the wrong patient or location, unintentional retention of a foreign body after surgery, patient death resulting from a medication error, and perioperative death of an ASA 1 patient. At the end of 2007, there were 28 never events established by the National Quality Forum. Many, but not all of these events are relevant to anesthesia care. The list of never events is periodically updated.f

Professional Liability

This section addresses the basic concepts of medical liability. A more detailed discussion of the steps of the lawsuit process and appropriate actions for physicians to take when sued is available from the ASA.g

The Tort System

Although physicians may become involved in the criminal law system in a professional capacity, they more commonly become involved in the legal system of civil laws. Civil law is broadly divided into contract law and tort law. A tort may be loosely defined as a civil wrongdoing; negligence is one type of tort. Malpractice actually refers to any professional misconduct but its use in legal terms typically refers to professional negligence.

To be successful in a malpractice suit, the patient–plaintiff must prove four things:

1.   Duty: that the anesthesiologist owed the patient a duty;

2.   Breach of duty: that the anesthesiologist failed to fulfill his or her duty;

3.   Causation: that a reasonably close causal relation exists between the anesthesiologist's acts and the resultant injury; and

4.   Damages: that actual damage resulted because of a breach of the standard of care.

Failure to prove any one of these four elements will result in a decision for the defendant–anesthesiologist.

Duty

As a physician, the anesthesiologist establishes a duty to the patient when a doctor–patient relationship exists. When the patient is seen preoperatively, and the anesthesiologist agrees to provide anesthesia care for the patient, a duty to the patient has been established. In the most general terms, the duty the anesthesiologist owes to the patient is to adhere to the standard of care for the treatment of the patient. Because it is virtually impossible to delineate specific standards for all aspects of medical practice and all eventualities, the courts have created the concept of the reasonable and prudent physician. For all specialties, there is a national standard that has displaced the local standard.

There are certain general duties that all physicians have to their patients, and breaching these duties may also serve as the basis for a lawsuit. One of these general duties is that of obtaining informed consent for a procedure. Consent may be written, verbal, or implied. Oral consent is just as valid, albeit harder to prove years after the fact, as written consent. Implied consent for anesthesia care may be present in circumstances in which the patient is unconscious or unable, for any reason, to give his or her consent, but where it is presumed that any reasonable and prudent patient would give consent.

Although there are exceptions to the requirement that consent be obtained, anesthesiologists should be sure to obtain consent whenever possible. Failure to do so could, in theory, expose the anesthesiologist to possible prosecution for battery.

The requirement that the consent be informed is somewhat more opaque. The guideline is determining whether the patient received a fair and reasonable account of the proposed procedures and the risks inherent in these procedures. Most states

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have adopted a “reasonable patient” standard, which requires that the physician disclose risks that a reasonable patient under similar circumstances would want to know to make an informed decision. Besides disclosure of common risks, risks that would be important in deciding whether or not to undertake the proposed therapy should also be discussed. For regional anesthesia, these should include both the common risks (e.g., local pain/discomfort, infection, headache, transient neuropathy), as well as those that are rare, but of major consequence (e.g., seizure, cardiac arrest, permanent neuropathy, paralysis, and death).

Breach of Duty

In a malpractice action, expert witnesses will review the medical records of the case and determine whether the anesthesiologist acted in a reasonable and prudent manner in the specific situation and fulfilled his or her duty to the patient. If they find that the anesthesiologist either did something that should not have been done, or failed to do something that should have been done, then the duty to adhere to the standard of care has been breached. Therefore, the second requirement for a successful suit will have been met.

Causation

Judges and juries are interested in determining whether the breach of duty was the proximate cause of the injury. If the odds are better than even that the breach of duty led, however circuitously, to the injury, this requirement is met.

There are two common tests employed to establish causation. The first is the but for test, and the second is the substantial factor test. If the injury would not have occurred but for the action of the defendant-anesthesiologist, or if the act of the anesthesiologist was a substantial factor in the injury despite other causes, then proximate cause is established.

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 (literally, “the thing speaks for itself”). Applying this doctrine requires proving that:

1.   the injury is of a kind that typically would not occur in the absence of negligence,

2.   the injury must be caused by something under the exclusive control of the anesthesiologist,

3.   the injury must not be attributable to any contribution on the part of the patient, and

4.   the evidence for the explanation of events must be more accessible to the anesthesiologist than to the patient.

Because anesthesiologists render patients insensible to their surroundings and unable to protect themselves from injury, the doctrine of res ipsa loquitur may be invoked in anesthesia malpractice cases. While this argument was commonly used in the past in lawsuits for nerve injuries, it is less commonly used successfully today.

Damages

The law allows for three different types of damages. General damages are those such as pain and suffering that directly result from the injury. Special damages are those actual damages that are a consequence of the injury, such as medical expenses, lost income, and funeral expenses. Punitive damages are intended to punish the physician for negligence that was reckless, wanton, fraudulent, or willful. Punitive damages are exceedingly rare in medical malpractice cases. More likely in the case of gross negligence is a loss of the license to practice anesthesia. In extreme cases, criminal charges may be brought against the physician, although this is rare. Determination of the dollar amount is usually based on some assessment of the plaintiff's condition versus the condition he or she would have been in had there been no negligence. Plaintiffs' attorneys generally charge a percentage of the damages and will, therefore, seek to maximize the award given.

Standard of Care

Because medical malpractice usually involves issues beyond the comprehension of lay jurors and judges, the court establishes the standard of care in a particular case by the testimony of expert witnesses. These 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. Although any licensed physician may be an expert, information will be sought regarding the witness's education and training, the nature and scope of the person's practice, memberships and affiliations, and publications. The purpose in gathering this information is not only to establish the qualifications of the witness to provide expert testimony, but also to determine the weight to be given to that testimony by the jury. In many cases the success of a lawsuit depends primarily on the stature and believability of the expert witnesses.

Unfortunately, there is a tendency for experts to link severe injury with inappropriate care (i.e., a bias that “bad outcomes mean bad care”). To investigate the influence of the severity of the injury on the assessment of standard of care, a group of 112 practicing anesthesiologists judged appropriateness of care in 21 cases involving adverse anesthetic outcomes.40 The original outcome in each case was either temporary or permanent. For each original case, a matching alternate case was created that was identical to the original in every respect, except that a plausible outcome of the opposite severity was substituted. Reviewers judged the standard of care in each case. Knowledge of the severity of injury produced a significant inverse effect on the judgment of appropriateness of care (Fig. 4-1).40 The proportion of ratings for appropriate care decreased when the outcome was changed from temporary to permanent, and increased when the outcome was changed from permanent to temporary. These results suggest that outcome bias in the assessment of standard of care may contribute to the frequency and size of payments.

Figure 4-1. Effect of outcome on physician judgments of appropriateness of care. (Adapted from Caplan et al. Effect of outcome on physician judgements of appropriateness of care. JAMA 1991;265: 1957–1960.)

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In certain circumstances, the standard of care may also be determined from published societal guidelines, written policies of a hospital or department, or textbooks and monographs. Some medical specialty societies have carefully avoided applying the term standards to their guidelines in the hope that no binding behavior or mandatory practices have been created. The essential difference between standards and guidelines is that guidelines should be adhered to and standards must be adhered to. The ASA publishes standards and guidelines for a variety of anesthesia-related activities.

Causes of Anesthesia-Related Lawsuits

Relatively few adverse outcomes end up in a malpractice suit. It has been estimated that less than 1 of 25 patient injuries result in malpractice litigation.41 The ASA Committee on Professional Liability has conducted a nationwide analysis of malpractice claims against anesthesiologists, excluding dental damage, since 1985 (i.e., the Closed Claims Project).42,43The leading injuries in malpractice claims in the 1990s were death (24%), nerve damage (22%), permanent brain damage (8%), and airway injury (7%; Fig. 4-2). The causes of death and permanent brain damage were predominantly problems in airway management (e.g., inadequate ventilation, difficult intubation, premature extubation) and other complications such as pulmonary embolism, inadequate fluid therapy, stroke, hemorrhage, and myocardial infarction.44 Nerve damage, especially to the ulnar nerve, often occurs despite apparently adequate positioning.14,16 Spinal cord injury was the most common cause of nerve damage claims against anesthesiologists in the 1990s.14 Chronic pain management is an increasing source of malpractice claims against anesthesiologists.45

The anesthesiologist is likely to be the target of a lawsuit if an untoward outcome occurs because the physician–patient relationship is usually tenuous at best. The patient rarely chooses the anesthesiologist, the preoperative visit is brief, and the anesthesiologist who sees the patient preoperatively may not actually anesthetize the patient. Communication between anesthesiologists and surgeons about complications is often lacking and the tendency is for the surgeon to “blame anesthesia.” In addition, anesthesiologists are often sued along with the surgeon in the case of an adverse outcome. This may occur even if the outcome was in no way related to the anesthetic care.

Figure 4-2. Most common injuries leading to anesthesia malpractice claims. Other category includes 3% each for newborn injury, pneumothorax, myocardial infarction, stroke, burns, headache, and back pain; and 1.5% for awareness/recall. Damage to teeth and dentures excluded. American Society of Anesthesiologists' Closed Claims Project (N = 7,328).

What to Do When Sued

A lawsuit begins when the patient-plaintiff's attorney files a complaint and demand for jury trial with the court. The anesthesiologist is then served with the complaint and a summons requiring an answer to the complaint. Until this happens, no lawsuit has been filed. Insurance carriers must be notified immediately after the receipt of the complaint. The anesthesiologist will need assistance in answering the complaint, and there is a time limit placed on the response.

Specific actions at this point include the following:

1.   Do not discuss the case with anyone, including colleagues who may have been involved, operating room personnel, or friends.

2.   Never alter any records.

3.   Gather together all pertinent records, including a copy of the anesthetic record, billing statements, and correspondence concerning the case.

4.   Make notes recording all events recalled about the case.

5.   Cooperate fully with the attorney provided by the insurer.

The first task the anesthesiologist must perform with an attorney is to prepare an answer to the complaint. The complaint contains certain facts and allegations with which the defense may either agree or disagree. Defense attorneys rely on the frank and totally candid observations of the physician in preparing an answer to the complaint. Physicians should be willing to educate their attorneys about the medical facts of the case, although most medical malpractice attorneys will be knowledgeable and medically sophisticated.

The next phase of the malpractice suit is called discovery. The purpose of discovery is the gathering of facts and clarification of issues in advance of the trial. In all likelihood the anesthesiologist will initially receive a written interrogatory, which will request factual information. In consultation with the defense attorney, the interrogatory should be answered in writing because carelessly or inadvertently misstated facts can become troublesome later.

Depositions are a second mechanism of discovery. The defendant–anesthesiologist will be deposed as a fact witness, and depositions will be obtained from other anesthesiologists who will act as expert witnesses. A nationally recognized expert in the area in question, recommended by the defendant but who is not a personal friend, and who agrees with the defense position, may be very valuable.

The plaintiff's attorney, not the defense attorney, will depose the anesthesiologist. Despite the apparent informality of the deposition, the anesthesiologist must be constantly aware that what is said during the deposition carries as much weight as what would be said in court. It is important to be factually prepared for the deposition by review of personal notes, the anesthetic record, and the medical record. The physician should dress conservatively and professionally because appearance and image are very important. The opposition is assessing the physician to see how he or she will appear to a jury. Answer only the question asked, and do not volunteer information. Rely on one's attorney for assistance when preparing for a deposition.

There will be depositions from expert witnesses, both for the plaintiff and for the defense. The anesthesiologist should work with his or her attorney to suggest questions and rebuttals. The better educated the attorney is about the medical facts, the reasons the anesthesiologist did what was done, and

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the alternative approaches, the better able the attorney will be to conduct these expert depositions.

If there is some merit in the case but the damages are minimal, or if proof of innocence will be difficult, there will probably be a settlement offer. There is a high cost incurred by both plaintiffs and defendants in pursuing a malpractice claim up through a jury trial. Unless there is a strong probability of a large dollar award, reputable plaintiffs' attorneys are not likely to pursue the claim. Thus, even if physicians believe that they are totally innocent of any wrongdoing, they should not be offended or angered about settling of the case: this is solely a matter of money, not medicine.

If a settlement is not reached during the discovery phase, a trial will occur. Only about 1 in 20 malpractice cases ever reach the point of a jury trial. Only those cases in which both sides think they can win, and which are likely to have significant financial impact, will proceed to trial.

The discussion of deposition testimony also applies to testimony in court, but there are a few additional points to consider during the trial. The members of the jury will not be as sophisticated medically as the attorneys who deposed the anesthesiologist during discovery. However, do not underestimate the intelligence of the jury. Talking down to them will create an unfavorable impression. If the answer to a question is not known, avoid guessing. If specific facts cannot be remembered, say so. Nobody expects total recall of events that may have occurred years before.

The defendant-physician should be present during the entire trial, even when not testifying, and should dress professionally. Displays of anger, remorse, relief, or hostility will hurt the physician in court. The physician should be able to give his or her testimony without using notes or documents. When it is necessary to refer to the medical record, it will be admitted into evidence. The anesthesiologist's goal is to convince the jury that he or she behaved in this case as any other competent and prudent anesthesiologist would have behaved.

It is important to keep in mind that proof in a malpractice case means only “more likely than not.” The patient-plaintiff must “prove” the four elements of negligence, not to absolute certainty, but only to a probability greater than 50%. On the positive side, this means that the defendant-anesthesiologist must only show that his or her actions were, more likely than not, within an acceptable standard of care.

Acknowledgments

The authors wish to thank F. W. Cheney, MD, and D. A. Kroll, MD, whose material from previous editions of this chapter has been retained in the current edition. The authors also thank Gene Peterson, MD, PhD for his helpful suggestions on this revision.

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