Trial and Error: Learning From Malpractice Claims in Childhood Surgery.

INTRODUCTION: The purpose of this study was to analyze a nationwide database of malpractice lawsuits involving pediatric surgical patients to identify contributing factors in liability claims. METHODS: Using the CRICO (Controlled Risk Insurance Company Strategies' Comparative Benchmarking System) database, malpractice claims involving patients ≤18 y old were reviewed from 2008 to 2017. Data were analyzed using descriptive statistics and logistic regression. RESULTS: Of the 844 claims, 76% of the patients were older than age 5. While the average total indemnity paid was $544,325, cases with claimants <1-year-old accounted for 24% of the total indemnity paid, with an average of $1,135,240 per claimant. The most frequently named responsible services were Orthopedics (34%), General Surgery (15%), and Otolaryngology (11%). Fracture or dislocation, appendectomy, skin/breast surgery, arthroscopy, and tonsillectomy/adenoidectomy were among the frequently involved procedures for the cohort of cases. The most common contributing factors for the top procedures involve issues surrounding patient assessment, technical performance, and communication. Cases with a contributing factor of failure to appreciate and reconcile relevant sign/symptom/test results were associated with a higher likelihood of payment (OR 6.6, P < 0.05). Issues surrounding the selection of therapy also led to an increased likelihood of an indemnity payment (OR 2.8, P < 0.05). CONCLUSIONS: Malpractice claims related to pediatric surgical procedures involve a wide range of specialties. Patient evaluations, technical performance, and communication are modifiable factors to improve surgical care in children. The contributing factors assigned to each procedure may represent an opportunity for focused improvement to improve patient outcomes.

Evidence That Nurses Need to Participate in Diagnosis: Lessons From Malpractice Claims.

OBJECTIVES: There is a pressing need for nurses to contribute as equals to the diagnostic process. The purpose of this article is twofold: (a) to describe the contributing factors in diagnosis-related and failure-to-monitor malpractice claims in which nurses are named the primary responsible party and (b) to describe actions healthcare leaders can take to enhance the role of nurses in diagnosis. METHODS: We conducted a review of the Controlled Risk Insurance Company Strategies' repository of malpractice claims, which contain approximately 30% of United States claims. We analyzed the malpractice claims related to diagnosis (n = 139) and physiologic monitoring (n = 647) naming nurses as the primary responsible party from 2007 to 2016. We used logistic regression to determine the association of contributing factors to likelihood of death, indemnity, and expenses incurred. RESULTS: Diagnosis-related cases listing communication among providers as a contributing factor were associated with a significantly higher likelihood of death (odds ratio [OR] = 3.01, 95% confidence interval [CI] = 1.50-6.03). Physiologic monitoring cases listing communication among providers as a contributing factor were associated with significantly higher likelihood of death (OR = 2.21, 95% CI = 1.49-3.27), higher indemnity incurred (U.S. $86,781, 95% CI = $18,058-$175,505), and higher expenses incurred (U.S. $20,575, 95% CI = $3685-$37,465). CONCLUSIONS: Nurses are held legally accountable for their role in diagnosis. Raising system-wide awareness of the critical role and responsibility of nurses in the diagnostic process and enhancing nurses' knowledge and skill to fulfill those responsibilities are essential to improving diagnosis.

Breakdowns in the initial patient-provider encounter are a frequent source of diagnostic error among ischemic stroke cases included in a large medical malpractice claims database.

Background Misdiagnosis of dangerous cerebrovascular disease is a substantial public health problem. We sought to identify and describe breakdowns in the diagnostic process among patients with ischemic stroke to facilitate future improvements in diagnostic accuracy. Methods We performed a retrospective, descriptive study of medical malpractice claims housed in the Controlled Risk Insurance Company (CRICO) Strategies Comparative Benchmarking System (CBS) database from 1/1/2006 to 1/1/2016 involving ischemic stroke patients. Baseline claimant demographics, clinical setting, primary allegation category, and outcomes were abstracted. Among cases with a primary diagnosis-related allegation, we detail presenting symptoms and diagnostic breakdowns using CRICO's proprietary taxonomy. Results A total of 478 claims met inclusion criteria; 235 (49.2%) with diagnostic error. Diagnostic errors originated in the emergency department (ED) in 46.4% (n = 109) of cases, outpatient clinic in 27.7% (n = 65), and inpatient setting in 25.1% (n = 59). Across care-settings, the most frequent process breakdown was in the initial patient-provider encounter [76.2% (n = 179 cases)]. Failure to assess, communicate, and respond to ongoing symptoms was the component of the patient-provider encounter most frequently identified as a source of misdiagnosis in the ED. Exclusively non-traditional presenting symptoms occurred in 35.7% (n = 84), mixed traditional and non-traditional symptoms in 30.6% (n = 72), and exclusively traditional in 23.8% (n = 56) of diagnostic error cases. Conclusions Among ischemic stroke patients, breakdowns in the initial patient-provider encounter were the most frequent source of diagnostic error. Targeted interventions should focus on the initial diagnostic encounter, particularly for ischemic stroke patients with atypical symptoms.

A contemporary medicolegal analysis of perioperative vision loss from 2007 to 2016.

INTRODUCTION: Perioperative vision loss (POVL) is a rare but catastrophic event. Closed claim databases are useful for investigating risk factors of POVL to help guide practices in risk mitigation and risk management strategies. METHODS: We retrospectively analyzed the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System database for perioperative nerve injuries from when claims were closed between 2007 and 2016. We then extracted, deidentified, and analyzed all the POVL cases. RESULTS: Of 53 nerve injury claims closed between 2007 and 2016, we found 9 pertaining to POVL. Of these 9 cases, 100% resulted in permanent injury, 76% were associated with spine surgery, 89% of the patients were positioned prone intraoperatively, 67% were noted to have improper or missing documentation, and 56% of the patients claimed they were not informed of the risk of vision loss during preoperative consenting. Four of the 9 cases were settled, with a mean settlement amount of $906,250 (standard deviation, ± $745,647). CONCLUSIONS: POVL often results in permanent injury with costly burden on the health care system. Risk reduction strategies need to be instituted on the provider and system level, involving a multidisciplinary health care team to develop and execute clinical protocols and patient communication strategies that will help prevent POVL.

A closed claims analysis of vocal cord injuries related to endotracheal intubation between 2004 and 2015.

STUDY OBJECTIVE: To provide a contemporary medicolegal analysis of claims brought against anesthesiologists for injuries related to endotracheal intubation. DESIGN: A retrospective study of closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database between 2004 and 2015. SETTING: Closed claims that occurred in any surgical specialty in which the patient was undergoing general anesthesia and anesthesiology was named as the primary responsible service. PATIENTS: Twenty claims were identified for analysis in 7 surgical specialties. Patient ages ranged from 45 to 76. Data regarding patient comorbidities and case history were obtained when available. INTERVENTIONS: None. MEASUREMENTS: Data collected includes patient demographics such as age, outcome severity, alleged complication, plaintiff allegations, contributing factors to the injury, the surgical specialty in which the injury occurred, and the ultimate result of the claim (dismissed/denied/settled). MAIN RESULTS: Out of 20 claims, settlement payments were made in 10% of claims with a mean payment amount of $7669. Mean patient age was 55.6 years. Within severity of injuries, 65% of claims were classified as "Permanent Minor." The most common contributing factor in claims was "Technical Knowledge/Performance" and the most common plaintiff allegation was "Trauma from endotracheal tube placement." Bilateral vocal cord paralysis, unilateral (left-sided) vocal cord paralysis, and laryngeal nerve injury were the top alleged complications. The surgical specialty in which claims most often resulted was orthopedic surgery. CONCLUSIONS: Injuries related to endotracheal intubation remain an ongoing challenge to anesthesiologists. Their etiology is often multifactorial and was found in this study to stem most commonly from technical errors and patient co-morbidities. A detailed discussion of risks with patients during the consent process, careful documentation of such discussion, and prompt referral to specialists when needed are critical. Understanding the patterns related to injuries during intubation is essential in order to develop strategies for improved patient safety and outcomes.

A Contemporary Medicolegal Analysis of Injury Related to Peripheral Nerve Blocks.

BACKGROUND: Closed malpractice claims can provide insight into low-frequency adverse events in many areas of perioperative and chronic pain care. Over the last decade, there have been changes in surgical and regional anesthetic practice, likely impacting adverse event patterns. Given the wide variability and low frequency of complications associated with peripheral nerve blocks, the study of closed malpractice claims offers an opportunity to examine adverse events, and the patient, technical, and provider factors that led to the claim. Knowledge gained from examination of closed claims has already resulted in multiple improvements in processes of care and patient safety. OBJECTIVES: An investigation of the factors that contributed to medicolegal claims against anesthesia providers related to peripheral nerve blocks. STUDY DESIGN: Retrospective analysis. SETTING: Inpatient and outpatient surgery facilities. METHODS: The Comparative Benchmarking System database is a medical liability database that contains more than 400,000 malpractice claims from more than 400 academic and community-based institutions accounting for over 30% of malpractice claims in the United States. The present investigation reviewed all (n = 113) available closed malpractice claims related to regional anesthesia (RA) in surgical patients closed between 2006 and 2016, and investigated factors that may have contributed to patient injury, including type of nerve block, type of surgery, nerves injured, resulting neurologic deficits, and potential factors contributing to the injury. RESULTS: Our data analyzed 62 claims related to RA and showed that most closed claims were classified as permanent minor injuries. The greatest number of claims were for brachial plexus injuries associated with interscalene blocks performed for shoulder or rotator cuff repairs. Femoral and sciatic nerve blocks with resulting lower extremity injuries were the most common nerve blocks resulting in payment. The largest contributing factor to these injuries was noted to be "Technical Knowledge/Performance" of the regionalist followed by "Pre-existing Injury/Radiculopathy." Symptom onset from these claims was most likely to be delayed with the leading initial presenting symptom being paresthesia. LIMITATIONS: It is difficult to establish cause-effect relationship, and the small sample size limits the ability to detect clinical differences and associations with specific comorbidities or techniques. There was also limited information related to regional anesthetic techniques and medications used that would have helped explore further relationships between the procedure and cause for litigation. CONCLUSIONS: There remains significant room for risk reduction in regional anesthetic practice. Patterns based on the analysis of closed claims show that interscalene blocks are the most common peripheral nerve block resulting in litigation, even when compared with other blocks involving the brachial plexus. Furthermore, patients with existing nerve injury/radiculopathy may also warrant alternative techniques or greater emphasis during informed consent on the increased risk of injury. As most of the presenting symptoms associated with claims are delayed, an opportunity for improvement in postregional care may be better communication with patients following discharge to discuss their postoperative recovery. KEY WORDS: Regional, pain, anesthesia, complications, closed claims, liability, nerve, block, injury.

A Contemporary Analysis of Medicolegal Issues in Obstetric Anesthesia Between 2005 and 2015.

BACKGROUND: Detailed reviews of closed malpractice claims have provided insights into the most common events resulting in litigation and helped improve anesthesia care. In the past 10 years, there have been multiple safety advancements in the practice of obstetric anesthesia. We investigated the relationship among contributing factors, patient injuries, and legal outcome by analyzing a contemporary cohort of closed malpractice claims where obstetric anesthesiology was the principal defendant. METHODS: The Controlled Risk Insurance Company (CRICO) is the captive medical liability insurer of the Harvard Medical Institutions that, in collaboration with other insurance companies and health care entities, contributes to the Comparative Benchmark System database for research purposes. We reviewed all (N = 106) closed malpractice cases related to obstetric anesthesia between 2005 and 2015 and compared the following classes of injury: maternal death and brain injury, neonatal death and brain injury, maternal nerve injury, and maternal major and minor injury. In addition, settled claims were compared to the cases that did not receive payment. χ, analysis of variance, Student t test, and Kruskal-Wallis tests were used for comparison between the different classes of injury. RESULTS: The largest number of claims, 54.7%, involved maternal nerve injury; 77.6% of these claims did not receive any indemnity payment. Cases involving maternal death or brain injury comprised 15.1% of all cases and were more likely to receive payment, especially in the high range (P = .02). The most common causes of maternal death or brain injury were high neuraxial blocks, embolic events, and failed intubation. Claims for maternal major and minor injury were least likely to receive payment (P = .02) and were most commonly (34.8%) associated with only emotional injury. Compared to the dropped/denied/dismissed claims, settled claims more frequently involved general anesthesia (P = .03), were associated with delays in care (P = .005), and took longer to resolve (3.2 vs 1.3 years; P < .0001). CONCLUSIONS: Obstetric anesthesia remains an area of significant malpractice liability. Opportunities for practice improvement in the area of severe maternal injury include timely recognition of high neuraxial block, availability of adequate resuscitative resources, and the use of advanced airway management techniques. Anesthesiologists should avoid delays in maternal care, establish clear communication, and follow their institutional policy regarding neonatal resuscitation. Prevention of maternal neurological injury should be directed toward performing neuraxial techniques at the lowest lumbar spine level possible and prevention/recognition of retained neuraxial devices.

A medicolegal analysis of positioning-related perioperative peripheral nerve injuries occurring between 1996 and 2015.

STUDY OBJECTIVE: To provide an analysis of closed malpractice claims brought against anesthesiologists for positioning-related perioperative nerve injury (PRPNI). DESIGN: In this retrospective study, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database. SETTING: Closed claims involving nerve injuries that occurred between January 1, 1996 and December 31, 2015 in all surgical settings, provided the alleged damaging event occurred under general anesthesia. PATIENTS: Patient ages ranged from 23 to 94. Patients underwent a variety of surgical procedures. Severity of nerve injury ranged from "Insignificant" to "Grave" according to the NAIC Severity of Injury Code. INTERVENTIONS: None. MEASUREMENTS: Patient age and gender, alleged nerve injury type and severity, operating surgical specialty, contributing factors to the alleged nerve injury, and case outcome. Some of these data were drawn directly from coded variables in the CBS database, and some were gathered by the authors from CRICO-encoded narrative case summaries. MAIN RESULTS: Seventy-five claims were determined to represent PRPNI. Ninety-two percent of all PRPNI claims involved practitioner technical knowledge/performance. Of all the recorded nerve injuries in this series, 56% involved brachial plexus injuries, and supine patient positioning represented 55% of brachial plexus claims. Settlement payments were made in 33% of claims, and the average payment for all cases was $46,269. Twenty-four percent of PRPNI claims were found to be temporary, while 76% were permanent. CONCLUSIONS: PRPNI is multifactorial, and stems both from practitioner errors as well as from patient comorbidities and pre-existing neuropathies. Supine positioning can increase PRPNI risk. There are likely still causes of PRPNI of which we are not yet aware, given that despite concerted efforts towards positioning and padding interventions, injuries such as those described in this study still occur.

A Contemporary Medicolegal Analysis of Outpatient Interventional Pain Procedures: 2009-2016.

BACKGROUND: Closed malpractice claim studies allow a review of rare but often severe complications, yielding useful insight into improving patient safety and decreasing practitioner liability. METHODS: This retrospective observational study of pain medicine malpractice claims utilizes the Controlled Risk Insurance Company Comparative Benchmarking System database, which contains nearly 400,000 malpractice claims drawn from >400 academic and community medical centers. The Controlled Risk Insurance Company Comparative Benchmarking System database was queried for January 1, 2009 through December 31, 2016, for cases with pain medicine as the primary service. Cases involving outpatient interventional pain management were identified. Controlled Risk Insurance Company-coded data fields and the narrative summaries were reviewed by the study authors. RESULTS: A total of 126 closed claims were identified. Forty-one claims resulted in payments to the plaintiffs, with a median payment of $175,000 (range, $2600-$2,950,000). Lumbar interlaminar epidural steroid injections were the most common procedures associated with claims (n = 34), followed by cervical interlaminar epidural steroid injections (n = 31) and trigger point injections (n = 13). The most common alleged injuring events were an improper performance of a procedure (n = 38); alleged nonsterile technique (n = 17); unintentional dural puncture (n = 13); needle misdirected to the spinal cord (n = 11); and needle misdirected to the lung (n = 10). The most common alleged outcomes were worsening pain (n = 26); spinal cord infarct (n = 16); epidural hematoma (n = 9); soft-tissue infection (n = 9); postdural puncture headache (n = 9); and pneumothorax (n = 9). According to the Controlled Risk Insurance Company proprietary contributing factor system, perceived deficits in technical skill were present in 83% of claims. CONCLUSIONS: Epidural steroid injections are among the most commonly performed interventional pain procedures and, while a familiar procedure to pain management practitioners, may result in significant neurological injury. Trigger point injections, while generally considered safe, may result in pneumothorax or injury to other deep structures. Ultimately, the efforts to minimize practitioner liability and patient harm, like the claims themselves, will be multifactorial. Best outcomes will likely come from continued robust training in procedural skills, attention paid to published best practice recommendations, documentation that includes an inclusive consent discussion, and thoughtful patient selection. Limitations for this study are that closed claim data do not cover all complications that occur and skew toward more severe complications. In addition, the data from Controlled Risk Insurance Company Comparative Benchmarking System cannot be independently verified.

A contemporary medicolegal claims analysis of injuries related to neuraxial anesthesia between 2007 and 2016.

STUDY OBJECTIVE: To provide a contemporary medicolegal analysis of claims brought against anesthesia providers in the United States related to neuraxial blocks for surgery and obstetrics. DESIGN: In this retrospective analysis, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database between 2007 and 2016. SETTING: Closed claims from inpatient and outpatient settings related to neuraxial anesthesia for surgical procedures and obstetrics. PATIENTS: Forty-five claims were identified for analysis. These patients underwent a variety of surgical procedures, included both children and adults, and with ages ranging from 6 to 82. INTERVENTIONS: Patients receiving neuraxial anesthesia (spinals, epidurals) for surgery or obstetrics. MEASUREMENTS: Data collected includes patient demographics, alleged injury type/severity, surgical specialty, likely contributors to the alleged damaging event, and case outcome. Some of the data were drawn directly from coded variables in the CRICO database, and some were gathered from narrative case summaries. MAIN RESULTS: Settlement payments were made in 20% of claims. Reported adverse outcomes ranged from temporary minor to permanent major injuries. Most closed claims were classified as permanent minor injuries. The greatest number of claims involved residual weakness and radiculopathy resulting from epidurals. The largest contributing factor to these injuries was noted to be "Technical Knowledge/Performance" of the anesthesia provider followed by "Missing or Documentation Error." Over half of the claims arose from obstetric patients (31%) and patients undergoing orthopedic surgery (27%). CONCLUSIONS: Patients with pre-existing radiculopathy or comorbidities may warrant more thorough informed consent about the increased risk of injury. Additionally, prompt follow-up, monitoring, and documentation of post-operative symptoms, such as weakness or radiculopathy, are crucial for improving patient safety and satisfaction. More timely communication with the patient and the surgical team regarding residual neurologic symptoms is important for earlier diagnosis of injury.

Analysis of adverse outcomes in the post-anesthesia care unit based on anesthesia liability data.

STUDY OBJECTIVE: The aim of this study is to provide a contemporary medicolegal analysis of claims brought against anesthesiologists in the United States for events occurring in the post-anesthesia care unit (PACU). DESIGN: In this retrospective analysis, we analyzed closed claims data from the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS) database. SETTING: Claims closed between January 1, 2010 and December 31, 2014 were included for analysis if the alleged damaging event occurred in a PACU and anesthesiology was named as the primary responsible service. PATIENTS: Forty-three claims were included for analysis. Data regarding ASA physical status and comorbidities were obtained, whenever available. Ages ranged from 18 to 94. Patients underwent a variety of surgical procedures. Severity of adverse outcomes ranged from temporary minor impairment to death. INTERVENTIONS: Patients receiving care in the PACU. MEASUREMENTS: Information gathered for this study includes patient demographic data, alleged injury type and severity, operating surgical specialty, contributing factors to the alleged damaging event, and case outcome. Some of these data were drawn directly from coded variables in the CRICO CBS database, and some were gathered by the authors from narrative case summaries. RESULTS: Settlement payments were made in 48.8% of claims. A greater proportion of claims involving death resulted in payment compared to cases involving other types of injury (69% vs 37%, p = 0.04). Respiratory injuries (32.6% of cases), nerve injuries (16.3%), and airway injuries (11.6%) were common. Missed or delayed diagnoses in the PACU were cited as contributing factors in 56.3% of cases resulting in the death of a patient. Of all claims in this series, 48.8% involved orthopedic surgery. CONCLUSIONS: The immediate post-operative period entails significant risk for serious complications, particularly respiratory injury and complications of airway management. Appropriate monitoring of patients by responsible providers in the PACU is crucial to timely diagnosis of potentially severe complications, as missed and delayed diagnoses were a factor in a number of the cases reviewed.

A medicolegal analysis of malpractice claims involving anesthesiologists in the gastrointestinal endoscopy suite (2007-2016).

STUDY OBJECTIVE: Gastrointestinal endoscopy cases make up the largest portion of out of operating room malpractice claims involving anesthesiologists. To date, there has been no closed claims analysis specifically focusing on the claims from the endoscopy suite. We aim to identify associated case characteristics and contributing factors. DESIGN: Retrospective review of closed claims. SETTING: Multi-institutional setting of hospitals that submit data to the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System, a database representing approximately 30% of annual malpractice cases in the United States. PATIENTS: A total of 58 claims in the gastrointestinal endoscopy suite between January 1, 2007 and December 31, 2016. INTERVENTIONS: Gastrointestinal endoscopy procedures. MEASUREMENTS: We analyzed associated factors for each case as well as payments, and severity scores. MAIN RESULTS: There was a difference in the percent of cases that resulted in payment by procedure type, with 91% of endoscopic retrograde cholangiopancreatography (ERCP) cases resulting in payment compared with 37.5% of colonoscopy cases, 25% of combined esophagogastroduodenoscopy (EGD)/colonoscopy cases, 21.4% of EGD cases and 0.0% of endoscopic ultrasound cases (P = 0.0008). Oversedation was a possible contributing factor in 62.5% of cases. The mean payment for all claims involving anesthesiologists in the endoscopy suite was $99,754. CONCLUSIONS: There are differences in the rates of payment of malpractice claims between procedures. ERCPs made up a disproportionate percentage of the total amount paid to patients. While a significant percent of cases involved possible oversedation, these errors were compounded by other factors, such as failure to resuscitate or recognize the acute clinical change. With medically complex patients undergoing endoscopic procedures, it is critical to have well prepared anesthesia providers.

A Contemporary Medicolegal Analysis of Outpatient Medication Management in Chronic Pain.

BACKGROUND: Opioids are frequently used in chronic pain management but are associated with significant morbidity and mortality in some patient populations. An important avenue for identifying complications-including serious or rare complications-is the study of closed malpractice claims. The present study is intended to complement the existing closed claims literature by drawing on claims from a more recent timeframe through a partnership with a large malpractice carrier, the Controlled Risk Insurance Company (CRICO). The goal of this study was to identify patient medical comorbidities and aberrant drug behaviors, as well as prescriber practices associated with patient injury and malpractice claims. Another objective was to identify claims most likely to result in payments and use this information to propose a strategy for reducing medicolegal risk. METHODS: The CRICO Strategies Comparative Benchmarking System is a database of claims drawing from >350,000 malpractice claims from Harvard-affiliated institutions and >400 other academic and community institutions across the United States. This database was queried for closed claims from January 1, 2009, to December 31, 2013, and identified 37 cases concerning noninterventional, outpatient chronic pain management. Each file consisted of a narrative summary, including expert witness testimony, as well as coded fields for patient demographics, medical comorbidities, the alleged damaging event, the alleged injurious outcome, the total financial amount incurred, and more. We performed an analysis using these claim files. RESULTS: The mean patient age was 43.5 years, with men representing 59.5% of cases. Payments were made in 27% of cases, with a median payment of $72,500 and a range of $7500-$687,500. The majority of cases related to degenerative joint disease of the spine and failed back surgery syndrome; no patients in this series received treatment of malignant pain. Approximately half (49%) of cases involved a patient death. The use of long-acting opioids and medical conditions affecting the cardiac and pulmonary systems were more closely associated with death than with other outcomes. The nonpain medical conditions present in this analysis included obesity, obstructive sleep apnea, chronic obstructive pulmonary disease, hypertension, and coronary artery disease. Other claims ranged from alleged addiction to opioids from improper prescribing to alleged abandonment with withdrawal of care. The CRICO analysis suggested that patient behavior contributed to over half of these claims, whereas deficits in clinical judgment contributed to approximately 40% of the claims filed. CONCLUSIONS: Claims related to outpatient medication management in pain medicine are multifactorial, stemming from deficits in clinical judgment by physicians, noncooperation in care by patients, and poor clinical documentation. Minimization of both legal risk and patient harm can be achieved by carefully selecting patients for chronic opioid therapy and documenting compliance and improvement with the treatment plan. Medical comorbidities such as obstructive sleep apnea and the use of long-acting opioids may be particularly dangerous. Continuing physician education on the safest and most effective approaches to manage these medications in everyday practice will lead to both improved legal security and patient safety.

Missed Diagnosis of Cardiovascular Disease in Outpatient General Medicine: Insights from Malpractice Claims Data.

BACKGROUND: Diagnostic errors are an underrecognized source of patient harm, and cardiovascular disease can be challenging to diagnose in the ambulatory setting. Although malpractice data can inform diagnostic error reduction efforts, no studies have examined outpatient cardiovascular malpractice cases in depth. A study was conducted to examine the characteristics of outpatient cardiovascular malpractice cases brought against general medicine practitioners. METHODS: Some 3,407 closed malpractice claims were analyzed in outpatient general medicine from CRICO Strategies' Comparative Benchmarking System database-the largest detailed database of paid and unpaid malpractice in the world-and multivariate models were created to determine the factors that predicted case outcomes. RESULTS: Among the 153 patients in cardiovascular malpractice cases for whom patient comorbidities were coded, the majority (63%) had at least one traditional cardiac risk factor, such as diabetes, tobacco use, or previous cardiovascular disease. Cardiovascular malpractice cases were more likely to involve an allegation of error in diagnosis (75% vs. 47%, p <0.0001), have high clinical severity (86% vs. 49%, p <0.0001) and result in death (75% vs. 27%, p <0.0001), as compared to noncardiovascular cases. Initial diagnoses of nonspecific chest pain and mimics of cardiovascular pain (for example, esophageal disease) were common and independently increased the likelihood of a claim resulting in a payment (p <0.01). CONCLUSION: Cardiovascular malpractice cases against outpatient general medicine physicians mostly occur in patients with conventional risk factors for coronary artery disease and are often diagnosed with common mimics of cardiovascular pain. These findings suggest that these patients may be high-yield targets for preventing diagnostic errors in the ambulatory setting.

A Contemporary Medicolegal Analysis of Implanted Devices for Chronic Pain Management.

BACKGROUND: Analysis of closed malpractice claims allows the study of rare but serious complications and likely results in improved patient safety by raising awareness of such complications. Clinical studies and closed claims analyses have previously reported on the common complications associated with intrathecal drug delivery systems (IDDS) and spinal cord stimulators (SCS). This study provides a contemporary analysis of claims from within the past 10 years. METHODS: We performed a closed claims analysis for a period January 1, 2009 to December 31, 2013 for cases with pain medicine as the primary service. These cases were identified using the Controlled Risk Insurance Company (CRICO) Comparative Benchmarking System (CBS), a database containing more than 300,000 malpractice claims from more than 400 academic and community institutions, representing approximately 30% of malpractice cases in the United States. The clinical narratives, which included medical files, claims files, depositions, and expert witness testimony, were reviewed by the authors, as were the CRICO coded variables, which included algorithmically determined contributing factors to the patient injury. RESULTS: Intrathecal drug delivery systems represented 17 of the closed claims; spinal cord stimulators represented 11 of the closed claims. The most common chronic pain diagnoses for which a device was implanted included failed back surgery syndrome and spasticity. The average total incurred for pain medicine claims was $166,028. Damaging events included IDDS refill errors (eg, subcutaneous administration of medication, reprogramming errors), intraoperative nerve damage, and postoperative infection (eg, epidural abscess, meningitis). High-severity outcomes included nerve damage (eg, paraplegia) and death. Medium-severity outcomes included drug reactions (eg, respiratory arrest from opioid overdose) and the need for reoperation. For both IDDS and SCS, deficits in technical skill were the most common contributing factor to injury, followed by deficits in clinical judgment, communication, and documentation. CONCLUSIONS: Implanted devices used for pain management involve a significant risk of morbidity and mortality. Proper education of providers and patients is essential. Providers must acquire the technical skills required for the implantation and refilling of these devices and the clinical skills required for the identification and management of complications such as intrathecal granuloma. Proper patient selection and clear communication between the provider and the patient about these possible complications are of paramount importance.

Effects of teamwork training on adverse outcomes and process of care in labor and delivery: a randomized controlled trial.

OBJECTIVE: To evaluate the effect of teamwork training on the occurrence of adverse outcomes and process of care in labor and delivery. METHODS: A cluster-randomized controlled trial was conducted at seven intervention and eight control hospitals. The intervention was a standardized teamwork training curriculum based on crew resource management that emphasized communication and team structure. The primary outcome was the proportion of deliveries at 20 weeks or more of gestation in which one or more adverse maternal or neonatal outcomes or both occurred (Adverse Outcome Index). Additional outcomes included 11 clinical process measures. RESULTS: A total of 1,307 personnel were trained and 28,536 deliveries analyzed. At baseline, there were no differences in demographic or delivery characteristics between the groups. The mean Adverse Outcome Index prevalence was similar in the control and intervention groups, both at baseline and after implementation of teamwork training (9.4% versus 9.0% and 7.2% versus 8.3%, respectively). The intracluster correlation coefficient was 0.015, with a resultant wide confidence interval for the difference in mean Adverse Outcome Index between groups (-5.6% to 3.2%). One process measure, the time from the decision to perform an immediate cesarean delivery to the incision, differed significantly after team training (33.3 minutes versus 21.2 minutes, P=.03). CONCLUSION: Training, as was conducted and implemented, did not transfer to a detectable impact in this study. The Adverse Outcome Index could be an important tool for comparing obstetric outcomes within and between institutions to help guide quality improvement. CLINICAL TRIAL REGISTRATION: (www.ClinicalTrials.gov), NCT00381056 LEVEL OF EVIDENCE: I.

Assessing quality obstetrical care: development of standardized measures.

BACKGROUND: No nationally accepted set of quality indicators exists in obstetrics. A set of 10 outcome measures and three quality improvement tools was developed as part of a study evaluating the effects of teamwork on obstetric care in 15 institutions and > 28,000 patients. Each outcome was assigned a severity weighting score. MEASURES: Three new obstetrical quality improvement outcome tools were developed. The Adverse Outcome Index (AOI) is the percent of deliveries with one or more adverse events. The average AOI during the pre-implementation data collection period of the teamwork study was 9.2% (range, 5.9%-16.6%). The Weighted Adverse Outcome Score (WAOS) describes the adverse event score per delivery. It is the sum of the points assigned to cases with adverse outcomes divided by the number of deliveries. The average WAOS for the preimplementation period was 3 points (range, 1.0-6.0). The Severity Index (SI) describes the severity of the outcomes. It is the sum of the adverse outcome scores divided by the number of deliveries with an identified adverse outcome. The average SI for the pre-implementation period was 31 points (range, 16-49). DISCUSSION: The outcome measures and the AOI, WAOS, and SI can be used to benchmark ongoing care within and among organizations. These tools may be useful nationally for determining quality obstetric care.