Daniel M. Gainsburg, Ethan O. Bryson and Elizabeth A. M. Frost (eds.)Anesthesia for Urologic Surgery201410.1007/978-1-4614-7363-3_16© Springer Science+Business Media New York 2014
16. Medicolegal Considerations in Urologic Anesthesia
(1)
Department of Anesthesiology, Icahn School of Medicine at Mount Sinai, The Mount Sinai Medical Center, One Gustave L. Levy Place, New York, NY 10029, USA
Abstract
Extreme position changes, electrolyte changes, presence of comorbidities such as obstructive sleep apnea, long and complex surgeries, bleeding risks, and an elderly population combine together to increase the risk of perioperative complications during urologic procedures. Not uncommonly these complications may be rightly or wrongly interpreted as malpractice, and the case becomes entrenched in the medicolegal system. Understanding this system and developing strategies to avoid poor or even catastrophic outcomes are essential to the entire urologic team.
Introduction
Extreme position changes, electrolyte changes, presence of comorbidities such as obstructive sleep apnea, long and complex surgeries, bleeding risks, and an elderly population combine together to increase the risk of perioperative complications during urologic procedures. Not uncommonly these complications may be rightly or wrongly interpreted as malpractice, and the case becomes entrenched in the medicolegal system. Understanding this system and developing strategies to avoid poor or even catastrophic outcomes are essential to the entire urologic team.
Malpractice Risk
The “business” of medical malpractice has been around for more than 150 years. But for thousands of years before that, lawyers have governed medical practice and its consequences. The Code of Hammurabi is a well-preserved Babylonian law code, dating back to about 1772 B.C. It is one of the oldest deciphered writings of significant length in the world, enacted by the sixth Babylonian king, Hammurabi. The Code consists of 282 laws, with scaled punishments, adjusting “an eye for an eye, a tooth for a tooth” (lex talionis) as graded depending on social status, of slave versus freeman [1]. Nearly one-half of the Code deals with matters of contract, establishing, for example, the wages to be paid to an ox driver or a surgeon. In laws 215–223, the rewards and punishments for surgeons are made clear. “If a physician make a large incision with an operating knife and cure it, or if he open a tumor (over the eye) with an operating knife, and saves the eye, he shall receive 10 shekels in money.” This sum decreased to five shekels if the patient was the son of a plebian and to two shekels if the patient was a slave (fee to be paid by the owner). But “if a physician make a large incision with the operating knife, and kill him, or open a tumor with the operating knife, and cut out the eye, his hands shall be cut off.” If he killed a slave, then he had to replace him. Broken bones and soft tissue injury repair were to be compensated with five shekels. (The Code of Hammurabi Trans LW King Yale Law School accessed January 31, 2010 at http://Avalon.lawyale.edu/ancient/hamframe.asp.)
Simply typing “medical malpractice” to the internet yields some 25.5 million results (January 2012). The number drops to 3.45 million when “anesthesia” is added. The vast majority of these links are to lawyers and their practices. However, according to the American Society of Anesthesiologists (ASA) Closed Claims Project, approximately 60,000 medical malpractice claims are ongoing at any one time in the United States, representing about 10% of the physician population, although exact data are lacking on the proportion of physicians who face malpractice claims annually, the size of the claims and the risk according to specialty. The most recent review covered 25 specialties insured by a large professional liability carrier (233,738 physician years of coverage). The authors analyzed malpractice data from 1991 to 2005 [2]. For each year of the study, 7.4% of physicians had a malpractice claim and 1.6% had a claim leading to a payout. In other words, 78% of claims did not result in monetary award to the claimant. Looking at specialties, neurosurgeons were most likely to be sued (19.1%) followed by cardiothoracic surgeons (18.9%), and general surgeons (15.3%). Least likely to be sued were family practitioners (5.2%), pediatricians (3.1%), and psychiatrists (2.6%).The mean indemnity pay was about $275,000, a sum varied according to specialty (pediatrics, $521,000 to dermatology at $111,749).
Anesthesia is ranked the 12th highest of the specialties and represents about 3% of malpractice claims. The profile of anesthesia liability has changed over the decades, including the types of anesthesia care associated with claims as well as events and injuries leading to claims. The most common complications during the period between 1990 and 2007 were death, nerve injury, and permanent brain damage. The most common anesthesia-related events leading to claims were regional block related, respiratory, cardiovascular, and equipment related. [3] Similar findings (although on a smaller scale) have been reported in other countries. A Swiss report covering the years 1987–2008 found 171 events leading to anesthesia-related injuries [4]. The majority of claims (54%) related to regional anesthesia with general anesthesia accounting for 28% and other anesthesia-related procedures for 18%. The Swiss Society of Anaesthesiology and Reanimation judged the quality of care to be substandard in 55% of cases. Liability was accepted in 46%. Negative outcomes were death in 12% and permanent injury in 63%. An analysis of claims against the National Health Service in England from 1995 to 2007 found that of 841 claims, 366 were related to regional anesthesia [5]. While half of the claims related to obstetrical anesthesia, 81% of the rest were related to neuraxial block. Cost for non-obstetric claims was 30% higher, related probably to the more severe outcomes.
The most common reasons for anesthesia malpractice suits cited by the ASA Closed Claims Project are:
1.
Dental damage
2.
Death
3.
Nerve damage
4.
Brain damage
5.
Tissue injury
6.
Surgical complications
7.
Vision loss
8.
Burns
9.
Infection
10.
Retained instruments
Similar to anesthesia, urology ranks 12th of 28 in the number of claims reported from more than 20 member companies of the Physician Insurers Association of America. Out of the 230,000 claims reported, 5,577 related to urology. Most common reasons for suits were [5]:
1.
Improper performance
2.
Diagnostic errors
3.
Failure to monitor (malignancy of prostate, kidney, testis, and kidney in particular)
Claims and Damages
Claims for brain death related to anesthesia decreased between 1975 and 2000 (odds ratio 0.95 per year, 95% confidence interval, 0.94–0.096; p ≤ 0.01) [6]. Indeed over 20 years, anesthesia-related deaths have dropped from 1:10,000 anesthetics delivered to 1:400,000 for outpatient procedures, although the size of malpractice claims generally continues to rise about 4% annually [7]. The average payment grew 52% between 1991 and 2003. Increases are consistent with increases in the cost of health care. Payouts and claims made vary widely according to region and practice. For example, over a 10-year period, the overall incidence of malpractice claims against the Department of Anesthesia at the University of Chicago, an academic center, indicated an occurrence rate of 0.038%. This study also indicated that 23% cases involved regional techniques, 17% were dental injuries, but only 6% concerned airway problems [8]. Other studies have looked at a higher incidence of claims in nonoperating room situations, indicating the likelihood of more substandard care in these settings associated with fewer guidelines and regulations than is seen in operating rooms where the most common mechanism of injury was oxygenation/ventilation errors [9]. Claims associated with monitored anesthetic care tended to involve older and sicker patients [10]. Oversedation led to respiratory depression in obese patients with obstructive sleep apnea, most commonly during elective eye surgery (21%) or facial plastic surgery (26%) [11]. More than 40% of these claims involved death or permanent brain damage. As noted above, anesthesia is currently the 12th highest medical specialty out of 28 when it comes to the percentage of physicians in the specialty that has paid claims for malpractice. System errors contributed to 30% of settled claims between 2004 and 2006 [6]. In departments using anesthesia information systems (AIS), out of 41 cases filed, 30 were dropped and 11 went to settlement or litigation [12]. Of 21 respondents, 24 viewed AIS as valuable or essential for risk management. The electronic information management system can provide clear and concise information and has the potential to integrate information across the hospital system, improve quality of care, decrease risks, and decrease malpractice claims [13]. The systems ideally documents in real time and stores an audit trail that time stamps events. Thus the integrity of anesthesia care teams who prospectively chart document may be questioned [14].
It is important to note that most medical errors are not pursued in court, and the majority of claims do not result in payment to the patient. A study funded by Blue Cross Blue Shield of Michigan examined the effects of implementing a medical error disclosure program [15]. For the past 12 years, the University of Michigan Health System has had full disclosure and offered compensation to patients for medical errors. After implementation, the average monthly rate of new claims decreased from 7.03 to 4 > 52/100,000 patient encounters (rate ratio 0.64, 95% confidence index). The average monthly rate of lawsuits decreased from 2.13 to 0.75/100,000 patient encounters. Also the median time from claim reporting to resolution decreased from 1.36 to 0.95 years, and average monthly cost rates decreased for total liability, patient compensation, and non-compensation-related legal costs [16]. Thus, contrary to older beliefs, it would appear that full disclosure does not increase liability bit rather can decrease costs. Nevertheless, results of a recent questionnaire indicate that there is a wide gap between physician attitude and actual practice [17]. Doctors were less likely to disclose minor errors (40%) than major (50%) and noted that they did not disclose errors for fear of litigation (72%), losing patients’ trust (62%), and emotional reactions from patients and families. Although most physicians claimed they would disclose errors, only 17% (n = 8) had done so recently. At present direct and indirect costs of malpractice amount to 2.4% of the total health-care costs or about $55 billion. Small as this percentage appears to be, it is important to remember that, intent to sue letters usually result in a lawsuit unless action is taken.
The Medicolegal System
The overall injury rate in hospitals has stayed around 4%. However, only 1:8 patients in whom an error may have occurred file a claim, and often only after they have attempted to approach the hospital and/or physicians [17]. The next action by the patient is to consult an attorney. The lawyer will then consider the case and may immediately decide not to pursue it. Or he/she may seek the advice of an “expert” by initial consultation or by sharing hospital records or statements from the patient. This person may opine that the standard of care was met (in which case the case is usually discontinued unless the lawyer chooses to seek other opinions) or identify errors resulting in the damage implicating the anesthetic care team or other health-care workers. The “expert” may write an opinion letter (differs according to the state) and a claim is filed. Again, states’ laws differ regarding the statute of limitations, that is, the time from the “incident” until the suit is filed. This time also differs according to the age of the patient and the claimed damage. Many years may elapse. After a suit is filed, discovery begins and more extensive records are obtained, going back for years (including all medical records of the plaintiff), and the depositions of many individuals sought, including anesthetic care providers (everyone involved in the cases, even those providing relief for only a few minutes), surgeons, any physicians listed as part of the patient’s care, nurses, family members, actuaries, and usually the patient if he/she is still alive. Lawyers and “experts” prepare summaries. The insurance carrier may elect to settle the case if it appears to be financially a better solution. However, in the United States such action means that the anesthesiologist’s name will be added to the National Practitioner Data Bank, and declaration must be made whenever hospital privileges are made or renewed. The decision of the insurance carrier may be appealed. After distillations have been made of all summaries, a judge becomes involved. Mediation is attempted and the case may be dismissed (summary judgment), settled, or proceeded to trial. So far the process has taken 1–2 years. If preparation is to be made for trial, the action is then continued for another 2–6 years.
The medicolegal system today is a business. It relates to the presence and skill of lawyers and does not necessarily seek the truth. Attorneys work to obtain a favorable outcome for their clients. Experts on both sides are paid (on average $350–600/h): The plaintiff attorney is usually paid only if the case is settled or if the client is wealthy. He/she customarily receives 1/3 of the settlement plus all expenses (including all fees to “experts,” filing costs, secretarial support, etc.). The insurance carrier pays the defense attorney and the “experts” whatever the outcome. It may therefore be in the interest of either side to continue the case. While awards and verdicts sometimes follow logical patterns, jury or anticipated jury responses do not always result in a clearly understandable conclusion.
Should a liability verdict be returned against an anesthesiologist, he or she may challenge the testimony of the “expert” to the American Society of Anesthesiologists (ASA). The organization will then appoint a 5-person panel (usually former ASA presidents) to review the case. The “expert” must then justify the testimony both in writing and often in person to the panel at his/her own expense. The panel then considers the evidence and decides to dismiss the complaint or sanction the “expert.” Sanction consists of barring from future involvement as an “expert” and denial of membership in the ASA [18].
The ASA Closed Claims Project
Begun in 1985 under the auspices of the Committee on Professional Liability, the ASA Closed Claims Project is an in-depth investigation of closed anesthesia malpractice claims designed to identify major areas of loss, patterns of injury, and strategies for prevention [19]. Two basic aspects, damaging events and adverse outcomes, characterize claims. The damaging event is the specific incident (e.g., extreme position) that leads to an adverse outcome or injury (e.g., compartment syndrome). There are more adverse outcomes than damaging events, as the latter may not be identified or may be multiple with the ability to identify the primary cause impossible. Claims for dental injury, a very common and in most cases minor injury, were excluded. Cases in which the sequence of events and/or nature of injury could not be reconstructed were also excluded. Thus, in most cases, files have been collected from mishaps resulting in lawsuits, as files in these cases contained the most extensive information. The database also contains a narrative summary of each case describing the sequence of events and adding pertinent information. The project indicated that three adverse outcomes constitute 58% of claims paid out, namely, death (29%), nerve damage (19%), and permanent brain injury (10%) [20]. Payout for permanent brain injury is the highest, ranging from $7,650 to $46,400,000. The profile of anesthesia liability has changed over these three decades, including the types of anesthesia care associated with claims as well as events and injuries leading to claims. The most common complications in 1990–2007 were death (26%), nerve injury (22%), and permanent brain damage (9%). The most common anesthesia-related events leading to claims were regional block related (20%), respiratory (17%), cardiovascular (13%), and equipment related (10%) [20].
The closed claims project has four associated registries, established in response to recurring claims and in an attempt to identify common causes that might be eliminated and thus prevent damage. They are:
1.
Pediatric perioperative cardiac arrest (POCA) and death registry (from 1994 to 2005 a total of 373 cases of anesthesia-related cardiac arrests were reported in children). Analysis of the first group of 150 cases indicated medication errors accounted for 37% (cardiovascular depression from halothane). In the second group of 245 patients, medication errors fell to 18% (sevoflurane replaced halothane), but cardiac arrest increased from 32% to 41% due to hypovolemia from blood loss. Respiratory obstruction occurred in 27% from laryngospasm [21, 22].
2.
Postoperative visual loss (POVL) registry (from 1999 to date information on more than 200 cases has been collected). Postoperative visual loss due to posterior ischemic optic neuropathy (ION) is most likely to occur following spine surgery (0.2%) of complicated spine cases in the prone position [23]. While the precipitating cause in any one patient has not been identified, after multivariate analysis, the risk factors for ION after spinal fusion include male (CI 95%), obesity (CI 95%), Wilson frame use (CI 95%), long duration of anesthesia (CI 95%), large blood loss (CI 95%), and use of more crystalloid rather than colloid for blood replacement (CI 95%) [24]. Thus avoidance of as many of these risk factors as is feasible would seem prudent.
3.
Anesthesia awareness registry (about 200 potential subjects contacted the registry and 41 medical records were collected) [25, 26]. Deficiencies of labeling and vigilance were common causes for awake paralysis, whereas recall during general anesthesia represented a more diverse group. Claims for recall during general anesthesia were more likely in younger females and with nitrous-narcotic-relaxant techniques.
4.
Neurologic injury after non-supine shoulder surgery (NINS) registry has recently been established to investigate the mechanism of severe brain and spinal cord damage that has been reported after shoulder surgery in the sitting position [27]. Theories as to the etiology of these injuries include the following: (1) the loss of venous return and decreased cardiac output in the upright position, (2) loss of a compensatory sympathetic response to positional changes caused by anesthesia, (3) failure to correct for the difference in height between the site of blood pressure measurement and the head level, (4) the use of deliberate or permissive hypotension, (5) dynamic vertebral artery stenosis or occlusion with rotation of the head, and (6) air emboli.
As of December 2011, there are 9,214 claims in the database. The number is growing at the rate of about 300/year. Almost 100 ASA members are on the active reviewer list. Twenty-two insurance carriers who insure 13,000 anesthesiologists (there are 45,000 ASA members) participate. Most cases involve healthy adults undergoing nonemergency surgery under general anesthesia (93% age > 16, 78% nonemergency, 64% ASA 1 or 2, 63% general anesthesia, 59% female) [28].
At the time the project was initiated, professional liability insurance was high (average $36,224) and often difficult to obtain [29]. The intention of the closed claims project was to identify causes and thereby reduce the insurance problem for anesthesiologists, a goal that has been realized. Recently information from autopsy results has been included. Claims for deaths with evaluable autopsies were compared with deaths without autopsy from 1990 and later taken from the ASA Closed Claims Project database [29]. Autopsy findings were helpful for the defense in 55% and harmful in 27% of the claims against anesthesiologists. Two-thirds of evaluable claims identified a significant non-anesthetic contribution to death.
Urologic Cases
Claims resulting from urologic mishaps include a variety of situations, some involving only anesthetic care but many including surgical management also. While in some instances it is easy to determine that the problem arose from a particular surgery, in most cases in is more complicated. Some of the more common situations include:
1.
Failure of adequate preanesthetic evaluation
2.
Malpositioning resulting in compartment syndrome, skin burns, and nerve and soft body injuries
3.
Postoperative visual loss
4.
Loss of the airway, postoperatively and related to intraoperative position change
5.
Seizures
6.
Bleeding, especially postoperatively
7.
Complication related to comorbidities that may have prompted the surgery
8.
Long and complex surgeries
9.
Medication errors
Several possible case scenarios follow:
Preanesthetic Assessment
Evaluation of the patient prior to anesthesia is a standard of care for all procedures in all settings, not only by the anesthetic care provider but also by the surgeon and preoperative nursing staff. Vital signs should be assessed and documented. All protocols approved by the hospital should be followed especially including “time-outs”.
Case 1
A 35-year-old woman, on dialysis three times a week, was on the waiting list for a kidney transplant. Apart from polycystic kidney disease, with which she had been diagnosed at age 20, she was well. Although she had been diagnosed with hypertension, it was well controlled with amlodipine. There was a strong family history of kidney disease and both her siblings had inherited the disorder. Her mother had donated a kidney to her father some 20 years before but he had not awoken from the surgery. He had, however, suffered from several other comorbidities including uncontrolled hypertension, diabetes, and obesity. She was unmarried. No other relatives were available and she awaited a cadaver transplant. About 7 p.m. one evening, a suitable kidney became available and she was contacted. She agreed immediately to come to the hospital. At preoperative evaluation by the nurses and anesthesiologists, she was asked regarding the possibility of pregnancy, which she denied. As she was anuric, a urine test could not be done. Documentation was made of her statement. The kidney transplant was successful. However, she was approximately 8 weeks pregnant and suffered a miscarriage in the early postoperative days. She sued, stating that had she known she was pregnant, she would have waited until the baby was born and then had the transplant.
Analysis
As with most cases, several factors combined to cause this complication. Failure by the anesthetic team to perform a blood test to confirm or eliminate the chance of pregnancy, lack of documentation of the last period, and failure of the nursing staff and surgeon to also corroborate any of these basic findings were evident. Recent guidelines from the ASA indicate that about 95% of health-care facilities require that a pregnancy test result be available prior to the induction of anesthesia [30]. Only 3% of ASA members felt that routine pregnancy testing in women of childbearing age was not indicated. The ability to perform a blood test with the result available within a reasonable period of time was available in this case. Also, the failure to enquire (and document) the timing of the last period might have prompted the anesthesiologist to request a blood test for pregnancy. The hospital and department of anesthesiology had a policy in place that stated that ALL women of childbearing age would have the results of a pregnancy test documented on the chart prior to the administration of anesthesia. Should the test be positive, then a statement from the patient that she wished to proceed with surgery should be affixed.
Prevention
Prevention as in many scenarios depends on vigilance, communication, and adherence to established and board-approved protocols. It is easy to forget a crucial move such as doing that extra blood test, especially when the patient is so anxious to proceed and denies that pregnancy is possible. (Probable outcome – Liability: anesthesiologist, surgeon, hospital; settled before discovery)
Case 2
A 45-year-old woman was found to be a match for her boyfriend who had kidney failure due to hypertension. He was not on dialysis. Multiple tests had been done in the 3 months prior to the transplant. In one of the tests, the donor tested positive for hepatitis C but was not informed of this result by the hospital or her physicians and was not disqualified as a donor. She was asymptomatic and had no risk factors except for a questionable blood transfusion as a child. Prior to surgery an anesthesiologist who documented that he had reviewed the chart saw her. A month after the surgery, which was successful, she still tested positive for hepatitis C and was told at that time. Four months later, the donee also tested positive for hepatitis C. The hospital held a complete investigation and stated that the transplant was a “medical mistake” and human error was to blame. Undisclosed compensation and an assurance of continued medical care at no cost were offered to the couple. Although initially thinking of suing not only the hospital but also the surgeon and anesthesiologist, both donor and donee decided to accept the hospital’s offer.
Analysis
Over the past few years, more than 200 reports of unexpected disease transmission through organ transplantation have been reported to the Center for Disease Control (CDC). Of the cases that were confirmed, some had fatal outcomes. Clearly, transmission of infections through organ transplants remains a major patient safety. To address the problem, the CDC developed a 159-page draft 2011 Public Health Service (PHS) Guideline for Reducing Transmission of HIV, HBV, and HCV through Solid Organ Transplantation. The guideline was posted to the Federal Register in September 2011. Transmission of HIV, HBV, and HCV through organ transplantation is a critical patient safety and public health issue. Such events can result in serious illness and death in organ recipients who are immunosuppressed, particularly when transmission is unexpected. Unexpected transmission of HIV, HBV, and HCV from infected donors has been reported in heart, liver, kidney, and pancreas recipients (see Federal Register above). However, intentional transplantation of organs from HBV- and HCV-infected donors is an accepted medical practice in narrowly specified situations that clearly did not apply in this case. These organs are typically offered to recipients known also to be infected with the same pathogen or, in rare circumstances, to uninfected recipients in cases of urgent medical need where benefit is deemed to outweigh risks. In these situations, prophylaxis or treatment with immunizations, antivirals, and/or immunoglobulin is offered, if appropriate, to prevent transmission or reduce the disease severity. Although there may be a potential benefit of transplanting organs from HIV-infected donors into HIV-infected recipients, Organ Procurement and Transplantation Network (OPTN) policy, as required by the HHS Final Rule [42 CFR Part 121], prohibits the knowing acquisition and transplantation of organs infected with HIV.
It is not easy to determine the behavioral risk factors in a deceased donor. Thus selection and sensitivity of pretransplantation testing is critical. The incidence of HCV infection not detected by serologic screening for anti-HCV antibody varies from 1 in 5,000 for normal-risk patients to 1 in 1,000 for patients at high risk [31]. The window period (i.e., the time from exposure to detectable HCV antibody) has a mean of 65–70 days, a period shortened to 3–5 days with use of nucleic acid amplification technology (NAT) [32]. A transplant facility’s decision to use an organ is based on the organ procurement organization’s assessment of the donor’s risk status and on test results [31]. Multiple factors, including the urgent need for a potentially lifesaving transplant and informed consent of the transplant candidate, must be considered when determining whether benefits of transplantation outweigh the risk for transmitting HCV. The US Public Health Service recently drafted guidelines recommending testing of all organ donors with NAT for HCV regardless of risk status [33]. Even if test results are not available at the time of transplantation, results still can be used afterward to guide recipient evaluation and treatment.
Related posts:
Anesthesia for Urological Endoscopic Procedures
Anesthesia for Renal Transplantation: Donor and Recipient Care
Open Urologic Procedures: Radical Cystectomy with Diversion, Radical Prostatectomy, and Radical Nephrectomy Anesthetic Considerations
Anesthesia for Office-Based Urologic Procedures
Anesthesia for Laparoscopic and Robotic-Assisted Urological Procedures
Anesthesia for Pediatric Urology
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