Updated Findings From the Anesthesia Closed Claims Project.

Keep It Flowing: A Simulation Involving Defective Anesthetic Gas Delivery Equipment

Prior investigations have suggested that the rapidly growing population of adults with congenital heart disease is at increased risk of perioperative morbidity and mortality, but information is limited on the nature of those perioperative factors that may relate to adverse outcomes. We sought to use a national claims database to describe the contribution of perioperative factors to adverse outcomes and compare contributing factors in cardiac vs. noncardiac operations. The study is a retrospective in-depth structured analysis of cases from the Anesthesia Closed Claims Project database. We examined the largest national anesthesia malpractice claims database. We included all claims cases involving adult patients with congenital heart disease (CHD). Patients in this retrospective analysis were classified by type of surgery (cardiac or noncardiac). Perioperative factors contributing to an adverse event were assessed by an expert panel of cardiac anesthesiologists. Of 21 confirmed cases, 11 (52%) involved cardiac procedures and 10 (48%) noncardiac procedures. The most common factors contributing to the adverse event in cardiac cases were surgical technique (73% of cases) and intraoperative anesthetic care (55%), whereas in noncardiac cases, postoperative monitoring/care (50%), CHD (50%) and preoperative assessment or optimization (40%) were most common. The factors contributing to the patient injury differed similarly: in cardiac cases, the most common factors were intraoperative anesthetic care (55%) and surgical technique (45%) compared with postoperative monitoring/care (50%) and CHD (50%) in noncardiac cases. Within the limitations of a small number of events in a claims-based database, this study offers advantages of being a national, structured analysis of real cases to provide detailed information on phenomena that are otherwise abstract and hypothesized by expert opinion. These results should help affirm the role of anesthesiologists in acquiring and executing expertise as consultants in perioperative medicine for adults with congenital heart disease patients.

Perioperative pulmonary aspiration of gastric contents has been associated with severe morbidity and death. The primary aim of this study was to identify outcomes and patient and process of care risk factors associated with gastric aspiration claims in the Anesthesia Closed Claims Project. The secondary aim was to assess these claims for appropriateness of care. The hypothesis was that these data could suggest opportunities to reduce either the risk or severity of perioperative pulmonary aspiration. Inclusion criteria were anesthesia malpractice claims in the American Society of Anesthesiologists Closed Claims Project that were associated with surgical, procedural, or obstetric anesthesia care with the year of the aspiration event 2000 to 2014. Claims involving pulmonary aspiration were identified and assessed for patient and process factors that may have contributed to the aspiration event and outcome. The standard of care was assessed for each claim. Aspiration of gastric contents accounted for 115 of the 2,496 (5%) claims in the American Society of Anesthesiologists Closed Claims Project that met inclusion criteria. Death directly related to pulmonary aspiration occurred in 66 of the 115 (57%) aspiration claims. Another 16 of the 115 (14%) claims documented permanent severe injury. Seventy of the 115 (61%) patients who aspirated had either gastrointestinal obstruction or another acute intraabdominal process. Anesthetic management was judged to be substandard in 62 of the 115 (59%) claims. Death and permanent severe injury were common outcomes of perioperative pulmonary aspiration of gastric contents in this series of closed anesthesia malpractice claims. The majority of the patients who aspirated had either gastrointestinal obstruction or acute intraabdominal processes. Anesthesia care was frequently judged to be substandard. These findings suggest that clinical practice modifications to preoperative assessment and anesthetic management of patients at risk for pulmonary aspiration may lead to improvement of their perioperative outcomes.

In 1984, the Anesthesia Closed Claims Project was formed by the American Society of Anesthesiologists (ASA) in response to sky-rocking insurance premiums, which had left many physicians nearly unable to afford professional liability insurance. Through the analysis of insurance company closed claims, several areas of anesthetic-related patient injury were identified and deemed the focus of this project with the goal of delivering “better” anesthetic care. Ultimately, this resulted in the formation of the Anesthesia Closed Claims Project and its attendant Registries, including the Postoperative Visual Loss (POVL) Registry, Anesthesia Awareness Registry, Obstructive Sleep Apnea (OSA) Death and Near Miss Registry, Neurologic Injury after Non-Supine Shoulder Surgery (NINS) Registry, and Pediatric Perioperative Cardiac Arrest (POCA) Registry. Additionally, this chapter attempts to give some guidance to practicing anesthesiologists on best practices to avoid such devastating consequences. While firm recommendations for rare events are difficult to make, a review of available information is presented here.

Neonatal Injury and Resuscitation: A Liability for Anesthesiologists? An Update From the Anesthesia Closed Claims Project

Although dantrolene effectively treats malignant hyperthermia (MH), discrepant recommendations exist concerning dantrolene availability. Whereas Malignant Hyperthermia Association of the United States guidelines state dantrolene must be available within 10 min of the decision to treat MH wherever volatile anesthetics or succinylcholine are administered, a Society for Ambulatory Anesthesia protocol permits Class B ambulatory facilities to stock succinylcholine for airway rescue without dantrolene. The authors investigated (1) succinylcholine use rates, including for airway rescue, in anesthetizing/sedating locations; (2) whether succinylcholine without volatile anesthetics triggers MH warranting dantrolene; and (3) the relationship between dantrolene administration and MH morbidity/mortality. The authors performed focused analyses of the Multicenter Perioperative Outcomes Group (2005 through 2016), North American MH Registry (2013 through 2016), and Anesthesia Closed Claims Project (1970 through 2014) databases, as well as a systematic literature review (1987 through 2017). The authors used difficult mask ventilation (grades III and IV) as a surrogate for airway rescue. MH experts judged dantrolene treatment. For MH morbidity/mortality analyses, the authors included U.S. and Canadian cases that were fulminant or scored 20 or higher on the clinical grading scale and in which volatile anesthetics or succinylcholine were given. Among 6,368,356 queried outcomes cases, 246,904 (3.9%) received succinylcholine without volatile agents. Succinylcholine was used in 46% (n = 710) of grade IV mask ventilation cases (median dose, 100 mg, 1.2 mg/kg). Succinylcholine without volatile anesthetics triggered 24 MH cases, 13 requiring dantrolene. Among 310 anesthetic-triggered MH cases, morbidity was 20 to 37%. Treatment delay increased complications every 10 min, reaching 100% with a 50-min delay. Overall mortality was 1 to 10%; 15 U.S. patients died, including 4 after anesthetics in freestanding facilities. Providers use succinylcholine commonly, including during difficult mask ventilation. Succinylcholine administered without volatile anesthetics may trigger MH events requiring dantrolene. Delayed dantrolene treatment increases the likelihood of MH complications. The data reported herein support stocking dantrolene wherever succinylcholine or volatile anesthetics may be used.

Anesthesia hazards: lessons from the anesthesia closed claims project.

This retrospective case series analyzed 45 malpractice claims for delayed detection of esophageal intubation from the Anesthesia Closed Claims Project. Inclusion criteria were cases from 1995 to 2013, after adoption of identification of CO2 in expired gas to verify correct endotracheal tube position as a monitoring standard by the American Society of Anesthesiologists. Forty-nine percent (95% confidence interval 34%-64%) occurred in the operating room or other anesthesia location where CO2 detection equipment should have been available. The most common factors contributing to delayed detection were not using, ignoring, or misinterpreting CO2 readings. Misdiagnosis, as with bronchospasm, occurred in 33% (95% confidence interval 20%).

Difficult or failed intubation is a major contributor to morbidity for patients and liability for anesthesiologists. Updated difficult airway management guidelines and incorporation of new airway devices into practice may have affected patient outcomes. The authors therefore compared recent malpractice claims related to difficult tracheal intubation to older claims using the Anesthesia Closed Claims Project database. Claims with difficult tracheal intubation as the primary damaging event occurring in the years 2000 to 2012 (n = 102) were compared to difficult tracheal intubation claims from 1993 to 1999 (n = 93). Difficult intubation claims from 2000 to 2012 were evaluated for preoperative predictors and appropriateness of airway management. Patients in 2000 to 2012 difficult intubation claims were sicker (78% American Society of Anesthesiologists [ASA] Physical Status III to V; n = 78 of 102) and had more emergency procedures (37%; n = 37 of 102) compared to patients in 1993 to 1999 claims (47% ASA Physical Status III to V; n = 36 of 93; P < 0.001 and 22% emergency; n = 19 of 93; P = 0.025). More difficult tracheal intubation events occurred in nonperioperative locations in 2000 to 2012 than 1993 to 1999 (23%; n = 23 of 102 vs. 10%; n = 10 of 93; P = 0.035). Outcomes differed between time periods (P < 0.001), with a higher proportion of death in 2000 to 2012 claims (73%; n = 74 of 102 vs. 42%; n = 39 of 93 in 1993 to 1999 claims; P < 0.001 adjusted for multiple testing). In 2000 to 2012 claims, preoperative predictors of difficult tracheal intubation were present in 76% (78 of 102). In the 97 claims with sufficient information for assessment, inappropriate airway management occurred in 73% (71 of 97; κ = 0.44 to 0.66). A "can't intubate, can't oxygenate" emergency occurred in 80 claims with delayed surgical airway in more than one third (39%; n = 31 of 80). Outcomes remained poor in recent malpractice claims related to difficult tracheal intubation. Inadequate airway planning and judgment errors were contributors to patient harm. Our results emphasize the need to improve both practitioner skills and systems response when difficult or failed tracheal intubation is encountered.

An analysis of malpractice claims associated with massive hemorrhage from the Anesthesia Closed Claims Project appears in this issue of Anesthesiology. Hemorrhage claims were most common in obstetrics and spine surgery. Lack of timely diagnosis, transfusion, and return to the operating room were common factors among these claims. (Cover photo: J.P. Rathmell; cover illustration: A. Johnson, Vivo Visuals.)

Hemorrhage is a potentially preventable cause of adverse outcomes in surgical and obstetric patients. New understanding of the pathophysiology of hemorrhagic shock, including development of coagulopathy, has led to evolution of recommendations for treatment. However, no recent study has examined the legal outcomes of these claims. The authors reviewed closed anesthesia malpractice claims related to hemorrhage, seeking common factors to guide future management strategies. The authors analyzed 3,211 closed surgical or obstetric anesthesia malpractice claims from 1995 to 2011 in the Anesthesia Closed Claims Project. Claims where patient injury was attributed to hemorrhage were compared with all other surgical and obstetric claims. Risk factors for hemorrhage and coagulopathy, clinical factors, management, and communication issues were abstracted from claim narratives to identify recurrent patterns. Hemorrhage occurred in 141 (4%) claims. Obstetrics accounted for 30% of hemorrhage claims compared with 13% of nonhemorrhage claims (P < 0.001); thoracic or lumbar spine surgery was similarly overrepresented (24 vs. 6%, P < 0.001). Mortality was higher in hemorrhage than nonhemorrhage claims (77 vs. 27%, P < 0.001), and anesthesia care was more often judged to be less than appropriate (55 vs. 38%, P < 0.001). Median payments were higher in hemorrhage versus nonhemorrhage claims ($607,750 vs. $276,000, P < 0.001). Risk factors for hemorrhage and coagulopathy were common, and initiation of transfusion therapy was commonly delayed. Hemorrhage is a rare, but serious, cause of anesthesia malpractice claims. Understanding which patients are at risk can aid in patient referral decisions, design of institutional systems for responding to hemorrhage, and education of surgeons, obstetricians, and anesthesiologists.

Obstetric practice carries a high risk of medical liability and involves both obstetricians and anesthesiologists. Analysis of data from the Anesthesia Closed Claims Project database shows an increase in the proportion of anesthesia claims for maternal death and brain damage between the 1990s and 2000 and later, primarily due to hemorrhage. The proportion of claims for newborn brain damage remained unchanged while those for maternal nerve injury and minor injuries decreased. Use of massive transfusion protocols and clinical drills have been shown to improve outcomes from hemorrhage. Good communication and teamwork are critical for reducing obstetric liability.

Due to an increase in implantable device-related anesthesia pain medicine claims, the authors investigated anesthesia liability associated with these devices. After institutional review board approval, the authors identified 148 pain medicine device claims from 1990 or later in the Anesthesia Closed Claims Project Database. Device-related damaging events included medication administration events, infections, hematomas, retained catheter fragments, cerebrospinal fluid leaks, cord or cauda equina trauma, device placed at wrong level, stimulator incorrectly programmed, delay in recognition of granuloma formation, and other issues. The most common devices were implantable drug delivery systems (IDDS; 64%) and spinal cord stimulators (29%). Device-related care consisted of surgical device procedures (n = 107) and IDDS maintenance (n = 41). Severity of injury was greater in IDDS maintenance claims (56% death or severe permanent injury) than in surgical device procedures (26%, P < 0.001). Death and brain damage in IDDS maintenance claims resulted from medication administration errors (n = 13; 32%); spinal cord injury resulted from delayed recognition of granuloma formation (n = 9; 22%). The most common damaging events for surgical device procedures were infections, inadequate pain relief, cord trauma, retained catheter fragments, and subcutaneous hygroma. Care was more commonly assessed as less than appropriate (78%) and payments more common (63%) in IDDS maintenance than in surgical device procedure claims (P < 0.001). Half of IDDS maintenance claims were associated with death or permanent severe injury, most commonly from medication errors or failure to recognize progressive neurologic deterioration. Practitioners implanting or managing devices for chronic pain should exercise caution in these areas to minimize patient harm.

The authors examined changes in the frequency of pain medicine malpractice claims and associated treatment modalities and outcomes over time. The authors analyzed trends in pain medicine claims from 1980 to 2012 in the Anesthesia Closed Claims Project database by binary logistic regression on year of event. Pain procedures in claims from 2000 to 2012 were compared with the proportion of pain procedures reported to the National Anesthesia Clinical Outcomes Registry in 2010-2014. Malpractice claims for pain medicine increased from 3% of 2,966 total malpractice claims in the Anesthesia Closed Claims Project database in 1980-1989 to 18% of 2,743 anesthesia claims in 2000-2012 (odds ratio [OR], 1.088 per year; 95% CI, 1.078 to 1.098; P < 0.001). Outcomes in pain claims became more severe over time, with increases in death and permanent disabling injury (OR, 1.094 per year; P < 0.001). Nonneurolytic cervical injections increased to 27% of pain claims in 2000-2012 (OR, 1.054; P < 0.001), whereas National Anesthesia Clinical Outcomes Registry demonstrates that lumbar injections are a more common procedure. Claims associated with medication management increased to 17% of pain claims in 2000-2012 (OR, 1.116 per year; P < 0.001). Pain medicine claims have increased over time and have increased in severity. Claims related to cervical procedures were out of proportion to the frequency with which they are performed. These liability findings suggest that pain specialists should aggressively continue the search for safer and more effective therapies.

Postoperative opioid-induced respiratory depression (RD) is a significant cause of death and brain damage in the perioperative period. The authors examined anesthesia closed malpractice claims associated with RD to determine whether patterns of injuries could guide preventative strategies. From the Anesthesia Closed Claims Project database of 9,799 claims, three authors reviewed 357 acute pain claims that occurred between 1990 and 2009 for the likelihood of RD using literature-based criteria. Previously cited patient risk factors for RD, clinical management, nursing assessments, and timing of events were abstracted from claim narratives to identify recurrent patterns. RD was judged as possible, probable, or definite in 92 claims (κ = 0.690) of which 77% resulted in severe brain damage or death. The vast majority of RD events (88%) occurred within 24 h of surgery, and 97% were judged as preventable with better monitoring and response. Contributing and potentially actionable factors included multiple prescribers (33%), concurrent administration of nonopioid sedating medications (34%), and inadequate nursing assessments or response (31%). The time between the last nursing check and the discovery of a patient with RD was within 2 h in 42% and within 15 min in 16% of claims. Somnolence was noted in 62% of patients before the event. This claims review supports a growing consensus that opioid-related adverse events are multifactorial and potentially preventable with improvements in assessment of sedation level, monitoring of oxygenation and ventilation, and early response and intervention, particularly within the first 24 h postoperatively.