Anesthetic Risk, Quality Improvement, and Liability

Karen L. Posner

Saint Adeogba

Karen B. Domino

Key Points

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

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.

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

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

Medical malpractice refers to the legal concept of professional negligence. The patient-plaintiff must prove that the anesthesiologist owed the patient a duty and 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.

The most common lawsuits against anesthesiologists (excluding dental injuries) are for death, brain damage, nerve damage, and airway injury. Chronic pain management is an increasing source of malpractice claims against anesthesiologists.

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 (CQI), 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 are 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, in 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 and later estimate the anesthesia-related death rate in the United States to be <1 per 10,000 anesthetics.²,³,⁴,⁵,⁶ Some examples of modern estimates of anesthesia-related death from throughout the world are provided in Table 4-1.²,³,⁴,⁵,⁶,⁷,⁸,⁹,¹⁰,¹¹,¹²,¹³,¹⁴,¹⁵,¹⁶,¹⁷,¹⁸,¹⁹ Differences in estimates may be influenced by different reporting 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.

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 (Table 4-2).²⁰,²¹,²²,²³,²⁴,²⁵,²⁶,²⁷,²⁸,²⁹,³⁰,³¹,³²,³³,³⁴,³⁵,³⁶,³⁷,³⁸,³⁹,⁴⁰,⁴¹,⁴² The incidence of ulnar neuropathy has been estimated to be 47 per 10,000 patients (Table 4-2).²¹ Lower extremity neuropathy following surgery in the lithotomy position was observed in 151 per 10,000 patients (Table 4-2).²² 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.²⁰,²⁴,²⁵ Peripheral nerve injury following peripheral nerve blocks was estimated to occur at a rate of 1.7 to 4.2 per 10,000 anesthetics.²³,²⁴,²⁶ Awareness during general anesthesia has been estimated to occur in 15 to 100 per 10,000 patients.²⁷,²⁸,²⁹,³⁰,³¹

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).³²,³³,³⁴,³⁵,³⁶,³⁷,³⁸,³⁹ Corneal abrasion has occurred at a rate of 1.4 to 15.1 per 10,000 procedures.³²,³⁴,³⁹ Ischemic optic neuropathy has been observed at 0.57 to 2.8 per 10,000 spine surgeries.³²,³⁵ Risk factors for ischemic optic neuropathy after spinal fusion have recently been identified and include a variety of patient, surgical, and anesthetic factors.⁴³ Among these include use of a Wilson surgical bed frame, obesity, and long anesthetic durations. All can contribute to increased venous congestion in the optic canal and potentially reduce optic nerve perfusion pressure. There was insufficient evidence to conclude that intraoperative anemia or transient periods of hypotension were causative factors.

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 after general endotracheal anesthesia were observed in 3.6 per 10,000 patients in the United States.⁴⁰

Cognitive dysfunction is observed in many adult patients after major surgery, but only the elderly are at significant risk for long-term cognitive problems.⁴⁴ The cause for postoperative cognitive dysfunction is unknown.

Risk Management

Conceptual Introduction

Risk management and quality improvement programs work hand in hand to minimize 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 called patient safety) departments are responsible for providing the resources to provide safe, patient-centered, timely, efficient, effective, and equitable patient care.⁴⁵

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.

The key factors in the prevention of patient injury are vigilance, up-to-date knowledge, and adequate monitoring.⁴⁶ 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 Detailed information on anesthesia monitoring techniques can be found in Chapter 25.

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 to prevent errors. Since the first pilot’s checklists were developed for the military, checklists have been adopted by many industries wherein processes are too numerous and/or complex to rely on human memory. A checklist is a simple, yet powerful, tool that ensures no important detail is forgotten, and it removes variability, enhances consistency, and decreases likelihood of error. This patient safety tool helps to remind providers of key steps and thus works to facilitate a safe and effective health-care delivery.

Historically, checklists have been used in anesthesia for anesthesia machine checkout procedures. Information pertaining to anesthesia workstation pre-use procedures as well as safety considerations for workstations can be found in Chapter 24. Recently,

checklists for clinical care have been promoted to improve patient safety and medical management in various clinical settings, for example, central venous catheterization, intraoperative emergencies, and perioperative care. Catheter-related bloodstream infections were reduced significantly with the implementation of a standardized process that included a checklist for catheter placement and management.⁴⁷ The ASA has recently developed a checklist for central venous catheter access.⁴⁸ During simulated emergency scenarios, checklists have improved performance in the management of local anesthesia systemic toxicity⁴⁹ and
improved management of intraoperative crises such as malignant hyperthermia or massive hemorrhage.⁵⁰

Table 4-1. Estimates of Anesthesia-Related Death

Reference	Country	Time	Data Sources/ Methods	Rate of Death
Flick et al.⁴	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 al.⁷	France	1989–1995	ASA 1–4 patients undergoing anesthesia (n—101,769 anesthetics); cardiac arrest within 12 h postanesthesia (n—24)	Anesthesia-related death—0.6/10,000 anesthetics
Newland et al.²	USA	1989–1999	Cardiac arrests within 24 h 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 Davis⁸	Western Australia	1990–1995	Deaths within 48 h or deaths in which anesthesia was considered a contributing factor (n—500 deaths)	Anesthesia-related death—0.025/10,000 anesthetics
Lagasse³	USA	(a) 1992–1994 (b) 1995–1999	(a) Suburban teaching hospital (n—115 deaths; n—37,924 anesthetics) (b) Urban teaching hospital (n—232 deaths; n—146,548 anesthetics)	Anesthesia-related death: (a) 0.79/10,000 anesthetics (b) 0.75/10,000 anesthetics
Khan and Khan⁹	Pakistan	1992–2003 (a) 1992–1998 (b) 1999–2003	University hospital. Deaths within 24 h of anesthesia (n—111,289 anesthetics)	3.14/10,000 anesthetics; deaths totally attributable to anesthesia 0.35/10,000; anesthesia partially responsible for death 0.7/10,000 (a) 0.68/10,000 anesthetics (b) 0.18/10,000 anesthetics
Ahmed et al.¹⁰	Pakistan	1992–2006	Perioperative cardiac arrest in pediatric patients at a university hospital (n—20,216 anesthetics)	Deaths primarily anesthesia-related 0.49/10,000 anesthetics
Davis¹¹	Australia	1994–1996	Deaths reported to the committee (n—8,500,000 anesthetics)	Anesthesia-related death—0.16/10,000 anesthetics
Morray et al.⁵	USA	1994–1997	Pediatric patients from 63 hospitals (n—1,089,200 anesthetics)	Anesthesia-related death—0.36/10,000 anesthetics
Kawashima et al.¹²	Japan	1994–1998	Questionnaires to training hospitals (n—2,363,038 anesthetics)	Death totally attributable to anesthesia—0.21/10,000 anesthetics
Arbous et al.¹³	Holland	1995–1997	All deaths within 24 h or patients who remained unintentionally comatose 24 h postanesthesia (n—811 in 869,483 anesthetics)—64 hospitals	Anesthesia-related death—1.4/10,000 anesthetics
Braz et al.¹⁴	Brazil	1996–2005	Tertiary general teaching hospital (n—53,718 anesthetics)	Anesthesia-related death—1.12/10,000 anesthetics Totally attributed—0,56/10,000 Partially attributed—0.56/10,000
Lienhart et al.¹⁵	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 al.¹⁶	Japan	1999	Questionnaires to training hospitals (n—793,840 anesthetics)	Death totally attributable to anesthesia—0.13/10,000 anesthetics
Irita et al.¹⁷	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
Li et al.⁶	USA	1999–2005	Deaths with anesthesia-related complication codes from death certificate data (a) Population data from census records (b) National hospital discharge survey data (inpatients)	Anesthesia-related deaths (a) 1.1/million population/year (b) 8.2/million hospital surgical discharges
Charuluxananan et al.¹⁸	Thailand	2003–2004	Perioperative deaths within 24 h of surgery—20 hospitals (n—163,403 anesthetics)	Death directly related to anesthesia—1.7/10,000 Death partially related to anesthesia—4.0/10,000
Gibbs¹⁹	Australia	2003–2005	Deaths reported to Anesthesia Mortality Committees (n—5,983,704 anesthetics)	Anesthesia-related deaths 0.19/10,000

Table 4-2. Rates of Selected Anesthesia Complications

Complication	Reference	Country	Time	Specific Complication	Results
Nerve injury	Brull et al.²⁰	Various	1987–1999	Radiculopathy or peripheral neuropathy after spinal anesthesia	3.78/10,000 spinal anesthetics
				Radiculopathy or peripheral neuropathy after epidural anesthesia	2.19/10,000 epidural anesthetics
				Permanent neurologic injury after spinal anesthesia	0–4.2/10,000 spinal anesthetics
				Permanent neurologic injury after epidural anesthetic	0–7.6/10,000 epidural anesthetics
			Varies	Transient neurologic deficit after interscalene block	2.84/10,000 anesthetics
	Warner et al.²¹	USA	1995	Ulnar neuropathy in adults following noncardiac surgery (n—1,502)	47/10,000
	Warner et al.²²	USA	1997–1998	Lower extremity neuropathy in adult patients ≥18 under general anesthesia (GA) while in lithotomy position (n—991)	151/10,000
	Welch et al.²³	USA	1997–2007	Peripheral nerve injury within 48 h of sedation or anesthesia (n—380,680)	2.9/10,000
	Auroy et al.²⁴	France	1998–1999	Serious peripheral neuropathy related to regional anesthesia	Non-obstetric spinal blocks (SBs) (n—35,439): 3.4/10,000
					obstetric SBs (n—5,640): 3.5/10,000
					Upper limb peripheral nerve blocks (PNBs) (n—23,784): 1.7/10,000
					Lower limb PNBs (n—20,162): 4/10,000
	de Sèze et al.²⁵	France	2000	Incapacitating neurologic complications lasting ≥3 months after central neuraxial blockade	Non-obstetric SBs (n—67,884): 0.15/10,000 Non-obstetric epidural blocks (EBs) (n—65,464): 0.015/10,000

					obstetric EBs (n—116,639): 0.09/10,000
	Barrington et al.²⁶	USA	2006–2008	Late neurologic complications after PNB or plexus block (n—7,156 blocks)	4.2/10,000 PNBs
Awareness	Errando et al.²⁷	Spain	1995–1997 and 1998–2001	Awareness during GA (n—3,921)	99.5/10,000
	Sandin et al.²⁸	Sweden	1997–1998	Awareness associated with GA (n—11,785)	15.3/10,000 procedures
	Sebel et al.²⁹	USA	2001–2002	Awareness in patients ≥18 years old in seven academic medical centers (n—19,575)	12.8/10,000
	Avidan et al.³⁰	USA	2005–2006	Single-center prospective study in patients ≥18 years old (n—1,941)	20.6/10,000
	Xu et al.³¹	China	NA	Multicenter cohort study of awareness after GA with muscle relaxants (n—11,101)	41.4/10,000
Vision loss and eye injuries	Chang and Miller³²	USA	1983–2002	Vision loss due to perioperative ischemic optic neuropathy (ION) associated with spine surgery (n—14,102)	2.8/10,000
				Corneal abrasions	1.4/10,000
	Warner et al.³³	USA	1986–1998	New-onset visual loss or visual changes lasting >30 days after noncardiac surgery (n—125,234)	0.08/10,000 patients
	Roth et al.³⁴	USA	1988–1992	Eye injury after nonocular surgery (n—60,965)	5.6/10,000
				Corneal abrasions	3.4/10,000
				ION	0.16/10,000
	Patil et al.³⁵	USA	1993–2002	Visual loss or disturbances after spine surgery (n—4,728,815)	Any visual disturbance: 9.4/10,000 ION: 0.57/10,000 Central retinal artery occlusion: 0.10/10,000
	Holy et al.³⁶	USA	1998–2004	Retrospective chart review for ION (n—126,666)	ION: 1.3/10,000
	Shen et al.³⁷	USA	1996–2005	Vision loss in surgery	Overall: 2.35/10,000
					Cardiac surgery: 8.64/10,000
					Spinal fusion: 3.09/10,000
					Cholecystectomy 0.66/10,000
					Appendectomy: 0.12/10,000
	Warner et al.³⁸	USA	1999	New-onset blurred vision lasting ≥3 days (n—410,189 patients)	4.6/10,000
	Martin et al.³⁹	USA	2005	Postoperative corneal injury (n—84,796) Baseline	15.1/10,000
			2006–2007	Performance initiative postoperative corneal injury	7.9/10,000
			2007–2008	Follow-up postoperative corneal injury	4.7/10,000
Dental injury	Warner et al.⁴⁰	USA	1987–1997	Dental injuries within 7 days of anesthesia that required intervention (n—4,537)	2.2/10,000
				Dental injury under GA with tracheal intubation (n—2,805)	3.6/10,000
	Newland et al.⁴¹	USA	1989–2003	Dental injury with anesthesia (n—161,687 anesthetics)	4.8/10,000
	Gaudio et al.⁴²	Italy	2000–2009	Dental injuries in surgical procedures under GA with tracheal intubation (n—62,898)	37.4/10,000