Reducing Wrong-level Spinal Surgeries Through Root Cause Analyses: A 10-year Longitudinal Analysis of a Single Tertiary Institution's Iterative Policy Improvements.

MINI: This study is a comprehensive narrative of all wrong-level spine surgeries and prevention strategies employed at our institution between 2008 and 2019, and aims to provide a roadmap for developing a rigorous prevention protocol. We systematically track root cause analyses and policy changes to determine which prevention strategies are most effective.

Retrospective review. We aim to create a comprehensive narrative of all wrong-level spinal surgeries (WLSS) and subsequent prevention strategies employed at our institution and provide a roadmap for developing a rigorous prevention protocol. There is currently no published evidence-based protocol to prevent WLSS. Previous studies are limited to multi-institution surgeon surveys and opinion pieces; the impact of serial interventions to eliminate WLSS is lacking. No studies have longitudinally analyzed a single institution's serial root cause analyses (RCA) of individual WLSS cases and the stepwise impact of targeted interventions to reduce WLSS occurrence. We reviewed all wrong-site spine surgeries and prevention strategies employed at our institution between 2008 and 2019, and corresponding WLSS-related RCAs were collected from institutional records. We conducted a longitudinal analysis of these reports and tracked policy implementations that resulted along with the incidence of WLSS following each policy. Fifteen WLSS were identified with 13 corresponding RCAs of 21,179 spine surgeries between 2008 and 2019. Three policy categories emerged: imaging, operating room (OR) culture, and vertebral body marking. The salient changes from each category were: requiring two immovable vertebral markers (2013); requiring intraoperative radiographs with markers and retractors positioned (2014); open-ended questioning during spinal level verification by residents and fellows (2015); and requiring an impartial radiologist to have verbal contact with the operating surgeon intraoperatively to collaboratively discuss localization (2018). Each change resulted in WLSS incidence decline (five in 2014, three in 2015, 0 in 2019). Stepwise process improvement based on WLSS case review is necessary, as no one change in standard operating procedure effectively eliminated WLSS. Improvements in communication between OR staff, surgeon, and radiologist, as well as intraoperative imaging and marking optimization all contributed to improvements in WLSS rates. By focusing on lessons learned from RCAs using this methodology, institutions can iteratively improve rates of WLSS. Level of Evidence: 4.

Claims in orthopedic foot/ankle surgery, how can they help to improve quality of care? A retrospective claim analysis.

BACKGROUND: Orthopedic foot/ankle surgery is a high risk specialty when it comes to malpractice claims. This study aims to evaluate the incidence, characteristics and outcome of claims in this area. METHODS: This was a retrospective, 10-year claim analysis, with data from an anonymous database. Baseline claim/claimant characteristics were collected from all orthopedic foot/ankle-related cases. RESULTS: Of 460 claims in total, most were related to delay in/wrong diagnosis or to (complications of) elective surgical procedures. Whether a claim was settled was related to type of injury (fracture) and type of claim (diagnostic mistake). Median amount disbursed in settled claims was €12,549. Claim incidence did not increase over the years. CONCLUSION: Missed fracture diagnosis and "failed"/disappointing results of elective surgical procedures were the most common causes for claims. Sufficient knowledge of missed (foot) fractures and clear communication/expectation management before elective procedures could help to improve quality of healthcare and patient satisfaction.

The cost of consent: why healthcare providers must be compliant with the Montgomery principles.

The cost of clinical negligence in the UK has continued to rise despite no increase in claims numbers from 2016 to 2019. In the US, medical malpractice claim rates have fallen each year since 2001 and the payout rate has stabilized. In Germany, malpractice claim rates for spinal surgery fell yearly from 2012 to 2017, despite the number of spinal operations increasing. In Australia, public healthcare claim rates were largely static from 2008 to 2013, but private claims rose marginally. The cost of claims rose during the period. UK and Australian trends are therefore out of alignment with other international comparisons. Many of the claims in orthopaedics occur as a result of "failure to warn", i.e. lack of adequately documented and appropriate consent. The UK and USA have similar rates (26% and 24% respectively), but in Germany the rate is 14% and in Australia only 2%. This paper considers the drivers for the increased cost of clinical negligence claims in the UK compared to the USA, Germany and Australia, from a spinal and orthopaedic point of view, with a focus on "failure to warn" and lack of compliance with the principles established in February 2015 in the Supreme Court in the case of Montgomery v Lanarkshire Health Board. The article provides a description of the prevailing medicolegal situation in the UK and also calculates, from publicly available data, the cost to the public purse of the failure to comply with the principles established. It shows that compliance with the Montgomery principles would have an immediate and lasting positive impact on the sums paid by NHS Resolution to settle negligence cases in a way that has already been established in the USA. Cite this article: Bone Joint J 2020;102-B(5):550-555.

Malpractice Litigation for Compartment Syndrome.

BACKGROUND: The aim of this study was to analyze litigation involving compartment syndrome to identify the causes and outcomes of such malpractice suits. A better understanding of such litigation may provide insight into areas where clinicians may make improvements in the delivery of care. METHODS: Jury verdict reviews from the Westlaw database from January 1, 2010 to January 1, 2018 were reviewed. The search term "compartment syndrome" was used to identify cases and extract data on the specialty of the physician defendant, the demographics of the plaintiff, the allegation, and the verdict. RESULTS: A total of 124 individual cases involving the diagnosis of compartment syndrome were identified. Medical centers or the hospital was included as a defendant in 51.6% of cases. The most frequent physician defendants were orthopedic surgeons (45.96%) and emergency medicine physicians (20.16%), followed by cardiothoracic/vascular surgeons (16.93%). Failure to diagnose was the most frequently cited claim (71.8% of cases). Most plaintiffs were men, with a mean age of 36.7 years, suffering injuries for an average of 5 years before their verdict. Traumatic compartment syndrome of the lower extremity causing nerve damage was the most common complication attributed to failure to diagnose, leading to litigation. Forty cases (32.25%) were found for the plaintiff or settled, with an average award of $1,553,993.66. CONCLUSIONS: Our study offers a brief overview of the most common defendants, plaintiffs, and injuries involved in legal disputes involving compartment syndrome. Orthopedic surgeons were most commonly named; however, vascular surgeons may also be involved in these cases because of the large number of cases with associated arterial involvement. A significant percentage of cases were plaintiff verdicts or settled cases. Failure to diagnosis or delay in treatment was the most common causes of malpractice litigation. Compartment syndrome is a clinical diagnosis and requires a high level of suspicion for a timely diagnosis. Lack of objective criteria for diagnosis increases the chances of medical errors and makes it an area vulnerable to litigation.

Risk Management and Avoiding Legal Pitfalls in the Emergency Treatment of High-Risk Orthopedic Injuries.

Many orthopedic injuries can have hidden risks that result in increased liability for the emergency medicine practitioner. It is imperative that emergency medicine practitioners consider the diagnoses of compartment syndrome, high-pressure injury, spinal epidural abscess, and tendon lacerations in the right patient. Consideration of the diagnosis and prompt referrals can help to minimize the complications these patients often develop.

Malpractice claims in spine surgery in Germany: a 5-year analysis.

STUDY DESIGN: Retrospective analysis of anonymized malpractice claims. SUMMARY OF BACKGROUND DATA: Spine surgery is considered a high-risk specialty with regards to malpractice claims. However, limited data is available for Germany. We analyzed the rate, subject, and legal outcome of malpractice claims faced by spine surgeons in one of the largest Medical Council coverage areas in Germany, representing 60,000 physicians and a population of 10 million. METHODS: Analysis of all malpractice claims regarding spinal surgeries completed by the Review Board of the North Rhine Medical Council (NRMC) from 2012 to 2016. Claim merit, content, and actual treatment errors were reviewed. Severity of damage was graded from negligible (1) to death (6). RESULTS: A total of 8,381 malpractice cases were reviewed by the NRMC from 2012 to 2016. Four percent (340 cases: 181 females, 159 males) pertained to patients undergoing spinal surgery with 94.7% of patients undergoing inhospital treatment and 5.3% as outpatients. Malpractice claims most frequently involved neurosurgery (48.5%) and orthopedic surgery (37.6%). Trauma surgery was involved in 9.1% and other specialties in 4.8%. Actual treatment errors were found in 89 of 340 cases (26.2%).Of those, 81 resulted in treatment-associated health impairment. Negligible and/or temporary impairment was found in 49.3%. Negligible to moderate but permanent damage was observed in 39.5%. Nine patients suffered severe permanent damage or death (11.1%). The treated diagnosis was degenerative disc disease in 34 patients (41.9%), spinal canal stenosis in 13 (16%), vertebral body fractures in 10 (12.3%), spondylolisthesis in 6 (7.4%), and other diagnoses accounting for the remaining 18 (22.2%). Errors involved actual surgical treatment in 40.7%, surgical indication and preoperative workup in 28.4%, postoperative treatment in 25.9%, and patient consent in 4.9%. CONCLUSIONS: Spinal surgery claims account for 4% of all claims reviewed by the NRMC in the 5-year period from 2012 to 2016. Eighty-nine (26.2%) were deemed justified. The majority of treatment errors (59.3%) occurred during workup, indication and consent, or during postoperative care. Errors during actual surgery were responsible for 40.7% of all treatment-associated damages. Understanding the distribution and content of claims is key to improving patient satisfaction not only by honing surgical skills, but also by improving pre- and postoperative communication and care.

Trends and Risk Factors in Orthopedic Lawsuits: Analysis of a National Legal Database.

Orthopedic surgeons frequently encounter medical malpractice claims. The purpose of this study was to assess trends and risk factors in lawsuits brought against orthopedic surgeons using a national legal database. A legal research service was used to search publicly available settlement and verdict reports between 1988 and 2013 by terms "orthopaedic or orthopedic" and "malpractice." Temporal trends were evaluated, and logistic regression was used to identify independent risk factors for case outcomes. A total of 1562 publicly reported malpractice cases brought against orthopedic surgeons, proceeding to trial during a 26-year period, were analyzed. The plaintiffs won 462 (30%) cases, with a mean award of $1.4 million. The frequency of litigation and pay-outs for plaintiffs increased 215% and 280%, respectively, between the first and last 5-year periods. The mean payout for plaintiff-favorable verdicts was highest in pediatrics ($2.6 million), followed by spine ($1.7 million) and oncology ($1.6 million). Fracture fixation (363 cases), arthroplasty (290 cases), and spine (231 cases) were the most commonly litigated procedures, while plaintiffs were most successful for fasciotomy (48%), infection-treating procedures (43%), and carpal tunnel release (37%). When analyzing data by state and region, adjusted for population, northeastern states had a higher frequency of lawsuits. Malpractice liability has increased during the past 3 decades while orthopedic surgeons continue to win most of the cases making it to court. As patients search for medical care via publicly available information, it is important for orthopedic surgeons to understand what aspects of their own practice carry different risks of litigation. [Orthopedics. 2019; 42(2):e260-e267.].

Alleged malpractice in orthopaedics. Analysis of a series of medmal insurance claims.

BACKGROUND: Medical malpractice is an important topic worldwide, and orthopedics is a clinical branch that is considered to be at a high risk for claims. The analysis of a series of medmal insurance claims allows forensic pathologists, clinicians, and insurance companies to probe the risk of a specific clinical branch for medical malpractice claims and highlights areas where care may be improved. We investigated the main features of a major Italian insurance broker's archive in order to identify recurrent pitfalls in this field. MATERIALS AND METHODS: A retrospective study was carried out on orthopedics claims. The archive covered claims from 2002 to 2013 that targeted 1980 orthopedists. RESULTS: 635 claims were found and analyzed with a focus on the clinical activity invocked in the claim, the presence of alleged team malpractice, the clinical outcome of the case, and the final forensic decision regarding the claim. 299 orthopedists had at least one malpractice claim made against them during the available period; 146 orthopedists were subject to more than one malpractice claim. Most of the claims regarded perioperative and operative cases, usually originating from civil litigation. The anatomical sites most commonly involved were the hip or knees, and sciatic nerve lesions were the main contributor. CONCLUSIONS: Orthopedics is a medical specialty with a high risk for malpractice claims. In our study, medical malpractice was observed in nearly 50% of the cases-typically in surgery-linked cases resulting in permanent impairment of the patient. Death from orthopedics malpractice seemed to be rare. LEVEL OF EVIDENCE: IV.

Can spinal surgery in England be saved from litigation: a review of 978 clinical negligence claims against the NHS.

PURPOSE: The aim of this study is to evaluate the true incidence of all clinical negligence claims against spinal surgery performed by orthopaedic spinal surgeons and neurosurgeons in the National Health Service (NHS) in England, including both open and closed claims. METHODS: This study was a retrospective review of 978 clinical negligence claims held by NHS Resolution against spinal surgery cases identified from claims against 'Neurosurgery' and 'Orthopaedic Surgery'. This category included all emergency, trauma and elective work and all open and closed cases without exclusion between April 2012 and April 2017. RESULTS: Clinical negligence claims in spinal surgery were estimated to cost £535.5 million over this five-year period. There is a trend of both increasing volume and estimated costs of claims. The most common causes for claims were 'judgement/timing' (512 claims, 52.35%), 'interpretation of results/clinical picture' (255 claims, 26.07%), 'unsatisfactory outcome to surgery' (192 claims, 19.63%), 'fail to warn/informed consent' (80 claims, 8.13%) and 'never events' including 'wrong site surgery' or 'retained instrument post-operation' (26 claims, 2.66%). A sub-analysis of 3 years including 574 claims revealed the most prevalent pathologies were iatrogenic nerve damage (132 claims, 23.00%), cauda equina syndrome (CES) (131 claims, 22.82%), inadequate decompression (91 claims, 15.85%), iatrogenic cord damage (72 claims, 12.54%), and infection (51 claims, 8.89%). CONCLUSIONS: The volume and costs of clinical negligence claims is threatening the future of spinal surgery. If spinal surgery is to continue to serve the patients who need it, most thorough investigation, implementation and sharing of lessons learned from litigation claims must be systematically carried out. These slides can be retrieved under Electronic Supplementary Material.

Regenerative Medicine in Orthopaedics and Trauma: Challenges, Regulation and Ethical Issues.

The ability of stem cells to self-renew and differentiate into cell types of different lineages forms the basis of regenerative medicine, which focuses on repairing or regenerating damaged or diseased tissues. This has a huge potential to revolutionize medicine. It is anticipated that in future, stem cell therapy will be able to restore function in all major organs. Intensive research has been on-going to bring stem cell therapy from bench to bedside as it holds promise of widespread applications in different areas of medicine. This is also applicable to orthopaedics, where stem cell transplantation could benefit complications like spinal cord injury, critical bone defects, cartilage repair or degenerative disc disorders. Stem cell therapy has a potential to change the field of orthopaedics from surgical replacements and reconstructions to a field of regeneration and prevention. This article summarizes advances in stem cell applications in orthopaedics as well as discussing regulation and ethical issues related to the use of stem cells.

Medical Malpractice in Orthopedic Surgery: A Westlaw-Based Demographic Analysis.

A recent study that evaluated the risk of facing a malpractice claim by physician specialty found that orthopedic surgeons were at a significantly greater risk of being sued than other medical specialists. To date, no studies have characterized trends in orthopedic surgery malpractice claims. The Westlaw legal database was used to locate state and federal jury verdicts and settlements related to medical malpractice and orthopedic surgery from 2010 to 2016. Eighty-one cases were analyzed. The mean age of the affected patients and/or plaintiffs was 53.4 years. Spine surgery (21 cases; 25.9%), knee surgery (17 cases; 21.0%), and hip surgery (11 cases; 13.6%) were litigated most often. Procedural error (71 cases; 87.7%) and negligence (58 cases; 71.6%) were the 2 most commonly cited reasons for litigation. The jury found in favor of the defendant in most (50 cases; 61.7%) of the cases. The mean plaintiff (17 cases; 21.0%) verdict payout was $3,015,872, and the mean settlement (13 cases; 16.0%) value was $1,570,833. Unnecessary surgery (odds ratio [OR], 12.29; 95% confidence interval [CI], 1.91-108.46; P=.040) and surgery resulting in death (OR, 26.26; 95% CI, 2.55-497.42; P=.040) were significant predictors of a verdict in favor of the plaintiff. Patient death (OR, 0.05; 95% CI, 0.01-0.38; P=.021) and male patient sex (OR, 0.26; 95% CI, 0.09-0.71; P=.033) were significant negative predictors of a verdict in favor of the defendant. The jury found in favor of the defendant orthopedic surgeon in most cases. Procedural error and/or negligence were cited most commonly by the plaintiffs as the bases for the claims. Verdicts in favor of the plaintiffs resulted in payouts nearly double those of settlements. [Orthopedics. 2018; 41(5):e615-e620.].

No-go decision: A newly identified adverse event in orthopaedic surgery - causes and medico-legal implications.

BACKGROUND: No-go designates a decision not to perform surgery when it becomes apparent that safety and/or feasibility requirements are not met. No-go decisions can occur at any time between patient admission to a hospital department and immediately before the first incision. The primary objective of this study was to assess the causes of no-go decisions reported as healthcare-associated adverse events (HAAEs). HYPOTHESIS: Most no-go decisions in orthopaedic surgery are related to problems with medical devices. MATERIAL AND METHODS: A preliminary retrospective study assessed HAAEs reported over the 1-year period from 1st October 2014 to 30th September 2015, using the risk-management tool ALARM. A prospective survey was then performed by emailing a 15-item questionnaire to the 1828 members of Orthorisq (the French orthopaedic surgeon accreditation agency). Responses were either yes/no or open. Statistical comparisons were performed, using the paired Wilcoxon signed-rank test to estimate p values. RESULTS: Among reported HAAEs, 5.6% were no-go decisions. Of the 101 reported no-go decisions, 43.5% and 45.2% were due to problems with managing implantable medical devices in the retrospective and prospective assessments, respectively. In over 85% of cases, surgery was cancelled or postponed. Over half the no-go decisions were associated with unnecessary anaesthesia. Checklist completion was performed in only half the cases and was not associated with no-go decisions (p>0.8). DISCUSSION: This study provides descriptive data on no-go decisions in orthopaedic surgery. Healthcare professionals use many methods to enhance patient safety by preventing adverse events or diminishing their impact. Errors in managing implantable medical devices are the leading cause of no-go decisions. The current checklist is not appropriate for managing implantable medical devices in orthopaedic surgery, in part because it does not include checking devices upon receipt. Before surgery, patients should be informed of the risk of a no-go decision, since unnecessary anaesthesia occurs in over half the cases. LEVEL OF EVIDENCE: IV, prospective study.

Epidemiology of malpractice claims in the orthopedic and trauma surgery department of a French teaching hospital: A 10-year retrospective study.

INTRODUCTION: Orthopedic and trauma surgery is the specialty for which claims for compensation are most often filed. Little data exists on the subject in France, especially in a teaching hospital. We conducted a retrospective study aimed at (1) identifying the epidemiological characteristics of patients filing claims against the orthopedic surgery and traumatology department of a teaching hospital in France, (2) analyzing the surgical procedures involved, the type of legal proceedings, and the financial consequences. HYPOTHESIS: The epidemiological profile of proceedings seeking damages in France is consistent with the data from European and American studies. MATERIALS AND METHODS: An observational, retrospective, single-center study of all claims for damages between 2007 and 2016 involving the orthopedic and trauma surgery department of a teaching hospital was carried out. Patients' epidemiological data, the surgical procedure, type of legal proceeding, and financial consequences were analyzed. RESULTS: Of the 51,582 surgical procedures performed, 71 claims (0.0014%) were analyzed (i.e., 1/726 procedures). A significant increase in the number of cases (p=0.040) was found over a 10-year period. Of these, 36/71 (53.7%) were submitted to the French regional conciliation and compensation commission (CRCI), 23/71 (32.8%) were filed with the administrative court, and 12/71 (13.4%) were submitted for an amicable settlement. The most common reason for which patients filed claims was hospital-acquired infections, with 36/71 (50.7%) cases. Twenty-nine complaints (40.8%) resulted in monetary damages being awarded to the patient, with an average award of € 28,301 (€ 2,400-299,508). Damage awards were significantly higher (p<0.05) for cases involving surgery on a lower limb than those involving an upper limb. CONCLUSION: Claims against orthopedic surgeons have been increasing significantly over the last 10 years. Although rare, they represent a significant cost to society. Hospital-acquired infections are the main reason for disputes in our specialization. LEVEL OF EVIDENCE: IV, retrospective study.