Using a quantitative risk register to promote learning from a patient safety reporting system.

BACKGROUND: Patient safety reporting systems are now used in most health care delivery organizations. These systems, such as the one in use at Virginia Mason (Seattle) since 2002, can provide valuable reports of risk and harm from the front lines of patient care. In response to the challenge of how to quantify and prioritize safety opportunities, a risk register system was developed and implemented. METHODS: Basic risk register concepts were refined to provide a systematic way to understand risks reported by staff. The risk register uses a comprehensive taxonomy of patient risk and algorithmically assigns each patient safety report to 1 of 27 risk categories in three major domains (Evaluation, Treatment, and Critical Interactions). For each category, a composite score was calculated on the basis of event rate, harm, and cost. The composite scores were used to identify the "top five" risk categories, and patient safety reports in these categories were analyzed in greater depth to find recurrent patterns of risk and associated opportunities for improvement. RESULTS: The top five categories of risk were easy to identify and had distinctive "profiles" of rate, harm, and cost. The ability to categorize and rank risks across multiple dimensions yielded insights not previously available. These results were shared with leadership and served as input for planning quality and safety initiatives. This approach provided actionable input for the strategic planning process, while at the same time strengthening the Virginia Mason culture of safety. CONCLUSIONS: The quantitative patient safety risk register serves as one solution to the challenge of extracting valuable safety lessons from large numbers of incident reports and could profitably be adopted by other organizations.

Postoperative opioid-induced respiratory depression: a closed claims analysis.

BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.

Autopsy utilization in medicolegal defense of anesthesiologists.

BACKGROUND: The rate of autopsy in hospital deaths has declined from more than 50% to 2.4% over the past 50 yr. To understand the role of autopsies in anesthesia malpractice claims, we examined 980 closed claims for deaths that occurred in 1990 or later in the American Society of Anesthesiologists Closed Claims Project Database. METHODS: Deaths with autopsy were compared with deaths without autopsy. Deaths with autopsy were evaluated to answer the following four questions: Did autopsy findings establish a cause of death? Did autopsy provide new information? Did autopsy identify a significant nonanesthetic contribution to death? Did autopsy help or hurt the defense of the anesthesiologist? Reliability was assessed by κ scores. Differences between groups were compared with chi-square analysis and Kolmogorov-Smirnov test with P < 0.05 for statistical significance. RESULTS: Autopsies were performed in 551 (56%) of 980 claims for death. Evaluable autopsy information was available in 288 (52%) of 551 claims with autopsy. Patients in these 288 claims were younger and healthier than those in claims for death without autopsy (P < 0.01). Autopsy provided pathologic diagnoses and an unequivocal cause of death in 21% of these 288 claims (κ= 0.71). An unexpected pathologic diagnosis was found in 50% of claims with evaluable autopsy information (κ = 0.59). Autopsy identified a significant nonanesthetic contribution in 61% (κ = 0.64) of these 288 claims. Autopsy helped in the defense of the anesthesiologist in 55% of claims and harmed the defense in 27% (κ = 0.58) of claims with evaluable autopsy information. CONCLUSIONS: Autopsy findings were more often helpful than harmful in the medicolegal defense of anesthesiologists. Autopsy identified a significant nonanesthetic contribution to death in two thirds of claims with evaluable autopsy information.

Liability related to peripheral venous and arterial catheterization: a closed claims analysis.

BACKGROUND: Serious complications after peripheral IV and arterial vascular cannulations have been reported. To assess liability associated with these peripheral vascular catheters for anesthesiologists, we reviewed claims in the American Society of Anesthesiologists Closed Claims database. METHODS: Claims related to peripheral vascular catheterization were categorized as related to IV or arterial catheters. Complications related to IV catheters were categorized as to type of complication. Patient and case characteristics, severity of injury, and payments were compared between claims related to IV catheters and all other (nonperipheral catheter) claims in the database. Payment amounts were adjusted to 2007-dollar amounts using the consumer price index. RESULTS: Claims related to peripheral vascular catheterization accounted for 2% of claims in the database (n = 140 of 6894 claims), most (91%) associated with IV catheters (n = 127). The most common complications were skin slough (28%), swelling/infection (17%), nerve damage (17%), fasciotomy scars (16%), and air embolism (8%). Approximately half of these complications (55%) occurred after extravasation of drugs or fluids. Compared with other claims, IV claims involved a larger proportion of cardiac surgery (25% vs 2% for other, P < 0.001) and smaller proportion of emergency procedures (8% vs 22% for other, P < 0.001). Claims related to arterial catheters were few (n = 13, 8%), with only seven associated with radial artery catheterization. CONCLUSIONS: Claims related to IV catheters were an important source of liability for anesthesiologists, approximately half of which resulted from extravasation of drugs or fluid. Claims related to radial arterial catheterization were uncommon.

Complications associated with eye blocks and peripheral nerve blocks: an american society of anesthesiologists closed claims analysis.

BACKGROUND AND OBJECTIVES: Concern for block-related injury and liability has dissuaded many anesthesiologists from using regional anesthesia for eye and extremity surgery, despite many studies demonstrating the benefits of regional over general anesthesia. To determine injury patterns and liability associated with eye and peripheral nerve blocks, we re-examined the American Society of Anesthesiologists Closed Claims Database as part of the American Society of Regional Anesthesia and Pain Medicine's Practice Advisory on Neurologic Complications of Regional Anesthesia and Pain Medicine. METHODS: Claims with eye or peripheral nerve blocks performed perioperatively from 1980 through 2000 were analyzed. The liability profile of anesthesiologists who provided both the eye block and sedation for eye surgery was compared with the profile of anesthesiologists who provided sedation only. The injury patterns associated with peripheral nerve blocks and payment factors were analyzed. RESULTS: Anesthesiologists who provided both the eye block and sedation for eye surgery (n = 59) had more injuries associated with block placement (P < .001), a higher proportion of claims with permanent injury (P < .05), and a higher proportion of claims with plaintiff payment (P < .05), compared with anesthesiologists who provided sedation only (n = 38). Peripheral nerve blocks (n = 159) were primarily associated with temporary injuries (56%). Local anesthetic toxicity was associated with 7 of 19 claims with death or brain damage. CONCLUSIONS: Performance of eye blocks by anesthesiologists significantly alters their liability profile, primarily related to permanent eye damage from block needle trauma. Though most peripheral nerve block claims are associated with temporary injuries, local anesthetic toxicity is a major cause of death or brain damage in these claims.

An update on pediatric anesthesia liability: a closed claims analysis.

BACKGROUND: Respiratory complications were associated with half of pediatric malpractice claims from the 1970s to 1980s in the ASA Closed Claims Database. Advances in pediatric anesthesia practice have occurred in the 1980s and 1990s and may be reflected in liability trends. METHODS: We reviewed 532 pediatric (age < or =16 yr) malpractice claims from our database over three decades (1973-2000), using logistic regression analysis to evaluate trends over time. Claims from 1990 to 2000 (1990s) were reviewed in detail to determine damaging events and injuries. Multiple logistic regression analysis evaluated factors associated with claims for death/brain damage (BD) compared with claims for less severe injuries. RESULTS: From 1973 to 2000, there was a decrease in the proportion of claims for death/BD (P = 0.002) and respiratory events (P < 0.001), particularly for inadequate ventilation/oxygenation (P < 0.001). However, claims for death (41%) and BD (21%) remained the dominant injuries in pediatric anesthesia claims in the 1990s. Half of the claims in 1990-2000 involved patients 3 yr or younger and one-fifth were ASA 3-5. Cardiovascular (26%) and respiratory (23%) events were the most common damaging events. Factors associated with claims for death/BD in the 1990s when compared with claims for less severe injuries were cardiovascular events (odds ratio [OR] = 6.6, 95% confidence interval [CI] = 2.5-17.8), respiratory events (OR = 3.7, 95% CI = 1.5-9.4), and ASA status 3-5 (OR = 3.1, 95% CI = 1.3-7.8). CONCLUSIONS: Death/BD remained the dominant injuries in pediatric anesthesia malpractice claims in the 1990s. Cardiovascular events joined respiratory events as the major sources of liability.

Trends in anesthesia-related death and brain damage: A closed claims analysis.

BACKGROUND: The authors used the American Society of Anesthesiologists Closed Claims Project database to determine changes in the proportion of claims for death or permanent brain damage over a 26-yr period and to identify factors associated with the observed changes. METHODS: The Closed Claims Project is a structured evaluation of adverse outcomes from 6,894 closed anesthesia malpractice claims. Trends in the proportion of claims for death or permanent brain damage between 1975 and 2000 were analyzed. RESULTS: Claims for death or brain damage decreased between 1975 and 2000 (odds ratio, 0.95 per year; 95% confidence interval, 0.94-0.96; P < 0.01). The overall downward trend did not seem to be affected by the use of pulse oximetry and end-tidal carbon dioxide monitoring, which began in 1986. The use of these monitors increased from 6% in 1985 to 70% in 1989, and thereafter varied from 63% to 83% through the year 2000. During 1986-2000, respiratory damaging events decreased while cardiovascular damaging events increased, so that by 1992, respiratory and cardiovascular damaging events occurred in approximately the same proportion (28%), a trend that continued through 2000. CONCLUSION: The significant decrease in the proportion of claims for death or permanent brain damage from 1975 through 2000 seems to be unrelated to a marked increase in the proportion of claims where pulse oximetry and end-tidal carbon dioxide monitoring were used. After the introduction and use of these monitors, there was a significant reduction in the proportion of respiratory and an increase in the proportion of cardiovascular damaging events responsible for death or permanent brain damage.

The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss.

BACKGROUND: Postoperative visual loss after prone spine surgery is increasingly reported in association with ischemic optic neuropathy, but its etiology is unknown. METHODS: To describe the clinical characteristics of these patients, the authors analyzed a retrospectively collected series of 93 spine surgery cases voluntarily submitted to the American Society of Anesthesiologists Postoperative Visual Loss Registry on standardized data forms. RESULTS: Ischemic optic neuropathy was associated with 83 of 93 spine surgery cases. The mean age of the patients was 50 +/- 14 yr, and most patients were relatively healthy. Mayfield pins supported the head in 16 of 83 cases. The mean anesthetic duration was 9.8 +/- 3.1 h, and the median estimated blood loss was 2.0 l (range, 0.1-25 l). Bilateral disease was present in 55 patients, with complete visual loss in the affected eye(s) in 47. Ischemic optic neuropathy cases had significantly higher anesthetic duration, blood loss, percentage of patients in Mayfield pins, and percentage of patients with bilateral disease compared with the remaining 10 cases of visual loss diagnosed with central retinal artery occlusion (P < 0.05), suggesting they are of different etiology. CONCLUSIONS: Ischemic optic neuropathy was the most common cause of visual loss after spine surgery in the Registry, and most patients were relatively healthy. Blood loss of 1,000 ml or greater or anesthetic duration of 6 h or longer was present in 96% of these cases. For patients undergoing lengthy spine surgery in the prone position, the risk of visual loss should be considered in the preoperative discussion with patients.

Injury and liability associated with monitored anesthesia care: a closed claims analysis.

BACKGROUND: To assess the patterns of injury and liability associated with monitored anesthesia care (MAC) compared with general and regional anesthesia, the authors reviewed closed malpractice claims in the American Society of Anesthesiologists Closed Claims Database since 1990. METHODS: All surgical anesthesia claims associated with MAC (n = 121) were compared with those associated with general (n = 1,519) and regional (n = 312) anesthesia. A detailed analysis of MAC claims was performed to identify causative mechanisms and liability patterns. RESULTS: MAC claims involved older and sicker patients compared with general anesthesia claims (P < 0.025), often undergoing elective eye surgery (21%) or facial plastic surgery (26%). More than 40% of claims associated with MAC involved death or permanent brain damage, similar to general anesthesia claims. In contrast, the proportion of regional anesthesia claims with death or permanent brain damage was less (P < 0.01). Respiratory depression, after absolute or relative overdose of sedative or opioid drugs, was the most common (21%, n = 25) specific damaging mechanism in MAC claims. Nearly half of these claims were judged as preventable by better monitoring, including capnography, improved vigilance, or audible alarms. On-the-patient operating room fires, from the use of electrocautery, in the presence of supplemental oxygen during facial surgery, resulted in burn injuries in 20 MAC claims (17%). CONCLUSION: Oversedation leading to respiratory depression was an important mechanism of patient injuries during MAC. Appropriate use of monitoring, vigilance, and early resuscitation could have prevented many of these injuries. Awareness and avoidance of the fire triad (oxidizer, fuel, and ignition source) is essential to prevent on-the-patient fires.

Management of the difficult airway: a closed claims analysis.

BACKGROUND: The purpose of this study was to identify the patterns of liability associated with malpractice claims arising from management of the difficult airway. METHODS: Using the American Society of Anesthesiologists Closed Claims database, the authors examined 179 claims for difficult airway management between 1985 and 1999 where a supplemental data collection tool was used and focused on airway management, outcomes, and the role of the 1993 Difficult Airway Guidelines in litigation. Chi-square tests and multiple logistic regression analysis compared risk factors for death or brain damage (death/BD) from two time periods: 1985-1992 and 1993-1999. RESULTS: Difficult airway claims arose throughout the perioperative period: 67% upon induction, 15% during surgery, 12% at extubation, and 5% during recovery. Death/BD with induction of anesthesia decreased in 1993-1999 (35%) compared with 1985-1992 (62%; P < 0.05; odds ratio, 0.26; 95% confidence interval, 0.11-0.63; P = 0.003). In contrast, death/BD associated with other phases of anesthesia did not significantly change over the time periods. The odds of death/BD were increased by the development of an airway emergency (odds ratio, 14.98; 95% confidence interval, 6.37-35.27; P < 0.001). During airway emergencies, persistent intubation attempts were associated with death/BD (P < 0.05). Since 1993, the Airway Guidelines were used to defend care (8%) and criticize care (3%). CONCLUSIONS: Death/BD in claims from difficult airway management associated with induction of anesthesia but not other phases of anesthesia decreased in 1993-1999 compared with 1985-1992. Development of additional management strategies for difficult airways encountered during maintenance, emergence, or recovery from anesthesia may improve patient safety.

Injuries associated with regional anesthesia in the 1980s and 1990s: a closed claims analysis.

BACKGROUND: The authors used the American Society of Anesthesiologists Closed Claims Project database to identify specific patterns of injury and legal liability associated with regional anesthesia. Because obstetrics represents a unique subset of patients, claims with neuraxial blockade were divided into obstetric and nonobstetric groups for comparison. METHODS: The American Society of Anesthesiologists Closed Claims Project is a structured evaluation of adverse anesthetic outcomes collected from closed anesthesia malpractice insurance claims of professional liability companies. An in-depth analysis of 1980-1999 regional anesthesia claims was performed with a subset comparison between obstetric and nonobstetric neuraxial anesthesia claims. RESULTS: Of the total 1,005 regional anesthesia claims, neuraxial blockade was used in 368 obstetric claims and 453 of 637 nonobstetric claims (71%). Damaging events in 51% of obstetric and 41% of nonobstetric neuraxial anesthesia claims were block related. Obstetrics had a higher proportion of neuraxial anesthesia claims with temporary and low-severity injuries (71%) compared with the nonobstetric group (38%; P

Introduction: guidelines and advisory development.

Since 1992, the American Society of Anesthesiologists has produced 12 evidence-based practice guidelines, 2 practice advisories, and 3 guideline updates. These documents have assisted anesthesiologists and practitioners in many other specialties. Their brevity, practicality, and ease of use, coupled with a thorough and systematic evaluation of the evidence have been instrumental in bringing together the science and practice of medicine. The application of formal evidence-collection processes for literature and opinion and efficient analytic evaluations combine with the experience and practical knowledge of clinicians to produce widespread application of the guidelines. The evidence-based process developed by the ASA has been found to be adaptable to a wide variety of issues relating to clinical practice. The goal is to systematically collect and evaluate evidence from multiple sources and apply it ina comprehensive manner to the guideline recommendations. The ASA guideline and advisory development process is continuing to evolve in response to changes in medical technology, research, and practice. By providing synthesized evidence from multiple sources and robust clinical recommendations the ASA offers the practice of anesthesiology, an invaluable bridge between science and clinical practice.

Chronic pain management: American Society of Anesthesiologists Closed Claims Project.

BACKGROUND: The practice of chronic pain management has grown steadily in recent years. The purpose of this study was to identify and describe issues and trends in liability related to chronic pain management by anesthesiologists. METHODS: Data from 5,475 claims in the American Society of Anesthesiologists Closed Claims Project database between 1970 and 1999 were reviewed to compare liability related to chronic pain management with that related to surgical and obstetric (surgical/obstetric) anesthesia. Acute pain management claims were excluded from analysis. Outcomes and liability characteristics between 284 pain management claims and 5,125 surgical/obstetric claims were compared. RESULTS: Claims related to chronic pain management increased over time (P < 0.01) and accounted for 10% of all claims in the 1990s. Compensatory payment amounts were lower in chronic pain management claims than in surgical/obstetric anesthesia claims from 1970 to 1989 (P < 0.05), but during the 1990s, there was no difference in size of payments. Nerve injury and pneumothorax were the most common outcomes in invasive pain management claims. Epidural steroid injections accounted for 40% of all chronic pain management claims. Serious injuries, involving brain damage or death, occurred with epidural steroid injections with local anesthetics and/or opioids and with maintenance of implantable devices. CONCLUSIONS: Frequency and payments of claims associated with chronic pain management by anesthesiologists increased in the 1990s. Brain damage and death were associated with epidural steroid injection only when opioids or local anesthetics were included. Anesthesiologists involved in home care of patients with implanted devices such as morphine pumps and epidural injections or patient-controlled analgesia should be aware of potential complications that may have severe outcomes.