Medical Professional Liability in Obstetrics and Gynecology: A Pilot Study of Criminal Proceedings in the Public Prosecutor's Office at the Court of Rome.

Criminal trials and claims against physicians for malpractice-related damages have increased dramatically in recent years, and, with Obstetrics and Gynecology being one of the medical specialties that is at the highest risk, we carried out a retrospective analysis aimed at examining all Obstetrics- and Gynecology-related medical professional liability prosecutions within the General Register of Criminal Records of the Rome Public Prosecutor's Office between the years 2000 and 2014. The number of prosecutions increased steadily in the years 2000-2005, with varying trends in the following years. A total of 727 healthcare professionals were involved in criminal charges, and most prosecuted crimes were related to Articles 590 and 589 of the Italian Penal Code, followed by violations of Article 17 of Law 194/78. In most cases, filing was requested and granted without opposition. In 95 cases, an expert witness was appointed by the Court, and in 68 cases, the technical consultants of the State Prosecutor found culpable conduct. Public hospitals, private nursing homes and outpatient clinics, or private practices were mostly involved; in 45% of the cases, the physicians were hospital employees. In this setting, Italy is prepared to introduce new measures and regulations to address the issues posed by defensive medicine and charges of professional liability for healthcare providers.

Analysis of Medico-Legal Complaint Data: A Retrospective Study of Three Large Italian University Hospitals.

(1) Background: Identifying hospital-related critical, and excellent, areas represents the main goal of this paper, in both a national and local setting. Information was collected and organized for an internal company's reports, regarding civil litigation that has been affecting the hospital, to relate the obtained results with the phenomenon of medical malpractice on a national scale. This is for the development of targeted improvement strategies, and for investing available resources in a proficient way. (2) Methods: In the present study, data from claims management in Umberto I General Hospital, Agostino Gemelli University Hospital Foundation and Campus Bio-Medico University Hospital Foundation, from 2013 to 2020 were collected. A total of 2098 files were examined, and a set of 13 outcome indicators in the assessment of "quality of care" was proposed. (3) Results: From the total number, only 779 records (37.1%) were attributable to the categories indexable for the present analysis. This data highlights how, following a correct and rigorous categorization of hospital events, it is possible to analyze these medico-legal aspects using a small number of indicators. Furthermore, it is important to consider how a consistent percentage of remaining events was difficult to index, and was also of poor scientific interest. (4) Conclusions: The proposed indicators do not require standards to be compared to, but provide a useful instrument for comparative purposes. In fact, in addition to comparative assessment between different business realities distributed throughout the territory, the use of outcome indicators allows for a longitudinal analysis evaluating the performance of an individual structure over time.

Comparative Impact Analysis of Low-Deductible Insurance Versus In-house Hospital Assumption of Risk and Management on Medical Malpractice Claims.

OBJECTIVES: Claims management is critical to ensure the safe and high-quality medical care for which liability insurers and/or hospitals are responsible. The aim of this research is to determine whether increasing hospital malpractice risk exposure, with increasing deductibles, has an impact on malpractice claims and payouts. METHODS: The study was conducted at a single tertiary hospital, the Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy. Payouts on closed reported and registered claims were analyzed during 4-study periods, which ranged from 1.5 million euro annual aggregate deductibles entirely managed by the insurance company to 5 million euro annual aggregate deductibles entirely managed by the hospital. We retrospectively analyzed 2034 medical malpractice claims submitted between January 1, 2007, and August 31, 2021. Four periods were examined depending on the claims management model adopted, ranging from total outsourcing to the insurer (period A) to an almost total hospital assumption of risk method (period D). RESULTS: We found that progressive hospital assumption of risk is associated with a decrease in the incidence of medical malpractice claims (average variation per year: -3.7%; P = 0.0029 if the 2 initial periods and the 2 last periods-characterized by the highest risk retention-are respectively aggregated and compared), an initial decrease in the mean claims cost followed by an increase that is still lower than the national increase (-5.4% on average), and an increase in the total claims cost (when compared with the period where the insurer solely managed claims). We also found that the rate of increase in payouts was less than the national average. CONCLUSIONS: The assumption of more malpractice risk by the hospital was associated with the adoption of numerous patient safety and risk management initiatives. The decrease in claims incidence could be due to the implementation of patient safety policies, while the cost increase could be attributed to inflation and rising costs of healthcare services and claims. Notably, only the hospital assumption of risk model with a high-deductible insurance coverage is sustainable for the studied hospital, while also being profitable for the insurer. In conclusion, as hospitals progressively assumed more risk and management responsibility of malpractice claims, there was a progressive decrease in the total number of claims, and a less rapid rise in claim payouts as compared with the national average. Even a small assumption of risk appeared to elicit meaningful changes in claim filings and payouts.

A Fifteen-Year Survey for Orthopedic Malpractice Claims in the Criminal Court of Rome.

The number of legal disputes in the field of medical liability has increased exponentially in the last decades. The aim of this study is to investigate the outcomes of criminal cases against healthcare professionals in Italian criminal courts. The hypothesis is that the majority of cases are dismissed and/or most professionals in these cases are acquitted. This retrospective analysis considers criminal proceedings related to medical professional liability registered with the general register of crime reports of the Public Prosecutor's Office of Rome in the time interval between 1 January 2000 and 31 December 2015. A total of 4793 criminal proceedings were ultimately identified. Proceedings related to the field of orthopedic trauma were then examined and identified. A complete analysis of 132 of the identified files (76.7%) was carried out. The field with the highest risk of disputes was determined to be the field of trauma. The most frequent complaint was found to arise from unsatisfactory surgical outcomes following elective surgery. The most affected anatomical district is the lower limb in both elective and trauma cases, followed by the upper limb in traumatology and spine cases. The surgeon is the most frequently quoted role of the professional involved. The number of physicians actually convicted (3.93%) and for whom liability was thus recognized, i.e., the existence of a causal link between their conduct and the event that took place was established, appears to be extremely small when compared with the far more significant values related to dismissals (53%) and acquittals (14.2%). Adequate legal reform aiming to reduce this disproportion is necessary to ensure physicians experience a more relaxed daily profession and to restore the original connotations of the doctor-patient relationship with the abolition of defensive medicine.

Malpractice Claims and Incident Reporting: Two Faces of the Same Coin?

Incident reporting is an important method to identify risks because learning from the reports is crucial in developing and implementing effective improvements. A medical malpractice claims analysis is an important tool in any case. Both incident reports and claims show cases of damage caused to patients, despite incident reporting comprising near misses, cases where no event occurred and no-harm events. We therefore compare the two worlds to assess whether they are similar or definitively different. From 1 January 2014 to 31 December 2021, the claims database of Policlinico Universitario A. Gemelli IRCCS collected 843 claims. From 1 January 2020 to 31 December 2021, the incident-reporting database collected 1919 events. In order to compare the two, we used IBNR calculation, usually adopted by the insurance industry to determine loss to a company and to evaluate the real number of adverse events that occurred. Indeed, the number of reported adverse events almost overlapped with the total number of events, which is indicative that incurred-but-not-reported events are practically irrelevant. The distribution of damage events reported as claims in the period from 1 January 2020 to 31 December 2021 and related to incidents that occurred in the months of the same period, grouped by quarter, was then compared with the distribution of damage events reported as adverse events and sentinel events in the same period, grouped by quarter. The analysis of the claims database showed that the claims trend is slightly decreasing. However, the analysis of the reports database showed that, in the period 2020-2021, the reports trend was increasing. In our study, the comparison of the two, malpractice claims and incident reporting, documented many differences and weak areas of overlap. Nevertheless, this contribution represents the first attempt to compare the two and new studies focusing on single types of adverse events are, therefore, desirable.

Effect of Lockdowns on Hospital Staff in a COVID Center: A Retrospective Observational Study.

At the onset of the SARS-CoV-2 pandemic, individual and social measures were strengthened through restrictive non-pharmaceutical interventions, labelled with the term "lockdown". In Italy, there were two lockdowns (9 March 2020−3 May 2020 and 3 November 2020−27 March 2021). As part of preventive measures, healthcare workers and the administrative staff population of Policlinico A. Gemelli underwent nasopharyngeal swab tests from 1 March 2020 to 9 February 2022, a long time interval that includes the two aforementioned lockdowns. The population included 8958 people from 1 March 2020 to 31 December 2020; 8981 people from 1 January 2021 to 31 December 2021; and 8981 people from 1 January 2022 to 9 February 2022. We then analysed pseudo-anonymized data, using a retrospective observational approach to evaluate the impact of the lockdown on the incidence of SARS-CoV-2 infections within the population. Given the 14 day contagious period, the swab positivity rate (SPR) among the staff decreased significantly at the end of the first lockdown, every day prior to 18 May 2020, by 0.093 (p < 0.0001, CI = (−0.138−−0.047)). After the fourteenth day post the end of the first lockdown (18 May 2020), the SPR increased daily at a rate of 0.024 (p < 0.0001, 95% CI = (0.013−0.034)). In addition, the SPR appeared to increase significantly every day prior to 17 November 2020 by 0.024 (p < 0.0001, CI = (0.013−0.034)). After the fourteenth day post the start of the second lockdown (17 November 2020), the SPR decreased daily at a rate of 0.039 (p < 0.0001, 95% CI = (−0.050−−0.027)). These data demonstrate that, in our Institution, the lockdowns helped to both protect healthcare workers and maintain adequate standards of care for COVID and non-COVID patients for the duration of the state of emergency in Italy.

Microbiological screening tests for SARS-CoV-2 in the first hour since the hospital admission: A reliable tool for enhancing the safety of pediatric care.

Introduction/purpose: Since a significant proportion of SARS-CoV-2 infections occur within healthcare facilities, a multidisciplinary approach is required for careful and timely assessment of the risk of infection in asymptomatic patients or those whose COVID-19 diagnosis has not yet been made. The aim of this study was to investigate whether an adaptative model based on microbiological testing can represent a valid risk management strategy. Material and methods: We collected data from the risk management unit database of a 1,550-bed tertiary hospital (Fondazione Policlinico Gemelli IRCCS, Rome, Italy) concerning pediatric admissions to the Emergency Department (ED) from 1 March 2020 to 31 December 2021. The study period was subdivided in period A and period B according to the technique used for the microbiological screening, respectively reverse-transcription polymerase chain reaction (RT-PCR) and antigen-detection test. Results: In Period A, 426 children (mean age: 6 years) underwent microbiological screening at the ED. The total number of molecular tests performed was 463. 459/463 tested negative at the molecular test. In Period B, 887 children (mean age: 6 years) underwent microbiological screening in the ED. The total number of molecular tests performed was 1,154. 1,117/1,154 tested negative at the molecular test. Neither in Period A nor in Period B hospital-acquired SARS-CoV-2 infections were reported. Discussion and conclusion: Despite high volumes, no cases of hospital-acquired SARS-CoV-2 infection have been reported. SARS-CoV-2 antigen-based tests can be used as a first-line option as they provide rapid results compared to RT-PCR, reducing the risk of infection in ED waiting rooms.

Dying "from" or "with" COVID-19 during the Pandemic: Medico-Legal Issues According to a Population Perspective.

There is still a lack of knowledge concerning the pathophysiology of death among COVID-19-deceased patients, and the question of whether a patient has died with or due to COVID-19 is still very much debated. In Italy, all deaths of patients who tested positive for SARS-CoV-2 are defined as COVID-19-related, without considering pre-existing diseases that may either contribute to or even cause death. Our study included nine subjects from two different nursing homes (Cases 1-4, Group A; Cases 5-9, Group B). The latter included patients who presumably died from CO poisoning due to a heating system malfunction. All subjects tested positive for COVID-19 both ante- and post-mortem and were examined using post-mortem computed tomography prior to autopsy. COVID-19 was determined to be a contributing cause in the deaths of four out of nine subjects (death due to COVID-19; i.e., pneumonia and sudden cardiac death). In the other five cases, for which CO poisoning was identified as the cause of death, the infection presumably had no role in exitus (death with COVID-19). In our attempt to classify our patients as dying with or due to COVID-19, we found the use of complete assessments (both histological analyses and computed tomography examination) fundamental.

Postmortem CT and autopsy findings in nine victims of terrorist attack.

In a foreign country, a religious terrorist group raided a restaurant, using pipe bombs, sharp-edged weapons, and various types of firearms (handguns, submachine guns, and AK-47 assault rifles) loaded with normal and prohibited bullets to kill foreigner customers, some of whom were Italian tourists. Local pathologists performed forensic autopsies on the bodies, but we were asked to perform additional external examinations, postmortem computed tomography (PMCT) scans, and then a second round of complete autopsies on nine victims (5 females and 4 males). Four victims had slash wounds inflicted by sharp-edged weapons, mostly localized in the head and neck. All but two victims had gunshot wounds. Finally, three casualties had injuries caused by the explosion of improvised explosive devices. In all cases, PMCT was a reliable source of information and provided strategic guide during autopsies, helping identify and describe the injuries and thus reconstruct the events. Therefore, in these cases, we suggest integrating the autopsy findings with the postmortem radiological data.

An Exceptional Case of Acute Respiratory Failure Caused by Intra-Thoracic Gastric Perforation Secondary to Overeating.

An 18-year-old female patient arrived at the emergency department complaining of abdominal pain and fullness after a heavy meal. Physical examination revealed she was filthy and cover in feces, and she experienced severe abdominal distension. She died in ED and a diagnostic autopsy examination was requested. At external examination, the pathologist observed a significant dilation of the anal sphincter and suspected sexual assault, thus alerting the Judicial Authority who assigned the case to our department for a forensic autopsy. During the autopsy, we observed anal orifice expansion without signs of violence; food was found in the pleural cavity. The stomach was hyper-distended and perforated at three different points as well as the diaphragm. The patient was suffering from anorexia nervosa with episodes of overeating followed by manual voiding of her feces from the anal cavity (thus explaining the anal dilatation). The forensic pathologists closed the case as an accidental death.

Sudden death due to catecholaminergic polymorphic ventricular tachycardia following negative stress-test outcome: genetics and clinical implications.

This paper discusses the case of a young boy who died suddenly during a football match. The victim's personal and family medical histories were negative for cardiac events. He had undergone a cardiological investigation some months before his death, enabling him to participate in competitive sports. Only post-mortem molecular analysis allowed for a clearer determination of the most plausible cause of death, which was identified as inherited arrhythmogenic heart disease, known as catecholaminergic polymorphic ventricular tachycardia. It was possible to detect a novel, previously undescribed, variant in the RYR2 gene. This case report highlights the importance of a meaningful forensic multidisciplinary investigation in such cases, and also discusses possible medical malpractice claims.

Medico-legal perspectives on sudden cardiac death in young athletes.

Sudden cardiac death (SCD) in a young athlete represents a dramatic event, and an increasing number of medico-legal cases have addressed this topic. In addition to representing an ethical and medico-legal responsibility, prevention of SCD is directly correlated with accurate eligibility/disqualification decisions, with an inappropriate pronouncement in either direction potentially leading to legal controversy. This review summarizes the common causes of SCD in young athletes, divided into structural (hypertrophic cardiomyopathy, arrhythmogenic cardiomyopathy, congenital coronary artery anomalies, etc.), electrical (Brugada, congenital LQT, Wolf-Parkinson-White syndrome, etc.), and acquired cardiac abnormalities (myocarditis, etc.). In addition, the roles of hereditary cardiac anomalies in SCD in athletes and the effects of a positive result on them and their families are discussed. The medico-legal relevance of pre-participation screening is analyzed, and recommendations from the American Heart Association and European Society of Cardiology are compared. Finally, the main issues concerning the differentiation between physiologic cardiac adaptation in athletes and pathologic findings and, thereby, definition of the so-called gray zone, which is based on exact knowledge of the mechanism of cardiac remodeling including structural or functional adaptions, will be addressed.

The periprostatic venous plexus: an unusual source of fatal pulmonary embolism during corporoplasty.

When a sudden death occurs during a minor surgical intervention, it may require a careful and extensive postmortem investigation. One such case concerns a 61-year-old male patient affected by Peyronie's disease, who died suddenly during a corporoplasty procedure. Autopsy and histologic examinations showed a massive bilateral pulmonary micro-embolism brought on by periprostatic venous plexus thrombosis. The cause of death was attributed to intraoperative fatal pulmonary micro-embolism. Pulmonary thromboembolism is a major cause of death and is known to be a possible complication of surgery. Nevertheless, the periprostatic venous plexus is an unusual site of thrombosis, as it has been demonstrated that the majority of emboli originate in the legs. In this case, the embolism was massive and fatal and occurred during a minor surgical procedure, even though the patient was not at risk for venous thromboembolism, nor did he have a significant past medical history.

Integrating engineering principles into the medico-legal investigation of a rare fatal rollover car accident involving complex dynamics.

Rollover car accidents can be the result of forceful steering or hitting an obstacle that acts like a ramp. Mortality from this type of car accident is particularly high, especially when occupants are thrown out of the vehicle. We report a case of a 67-year-old man who died after a rollover accident that occurred when he was driving a car equipped with a glass moonroof. He was found inside his car with his safety belt correctly fastened and the roof shattered. At autopsy, a wide avulsion injury of the head was observed, which was associated with an atlanto-axial dislocation and full-thickness fracture of the cervical body and posterior facet joints of the seventh cervical vertebra. The data collected at the scene of the accident were integrated with the autopsy results to yield a forensic engineering reconstruction. This reconstruction elucidated the dynamics of the event and correctly ascribed the lesions observed at autopsy to the phases of the rollover. Afterward, an analysis of the scientific literature concerning rollover crash tests was conducted to understand why the driver sustained fatal injuries even though his seatbelt was properly fastened.

Suicidal or homicidal sharp force injuries? A review and critical analysis of the heterogeneity in the forensic literature.

The differential diagnosis between self-inflicted and nonself-inflicted, suicidal and homicidal, injuries is difficult or impossible in many cases and, above all, cannot be made on the basis of information obtained solely from the autopsy or the medicolegal clinical examination. The purpose of this study is to analyze the literature on suicidal and homicidal sharp force injuries and identify the relevant parameters that may help differentiate between suicidal and homicidal deaths. To achieve this goal, a review of 595 potentially relevant articles was performed. After excluding the nonrelevant papers by screening the titles, all abstracts were reviewed, and articles meeting the inclusion criteria underwent a full-text review. The following parameters were compiled into a table: number of cases, localization of the injuries, and number of injuries. The data were statistically analyzed and compared with those available in the forensic literature. On the basis of the heterogeneity of data revealed by the present review, a simple and short checklist of the parameters that should be included when reporting suicides and homicides by sharp force has been proposed.

Subarachnoid hemorrhage and carbon monoxide exposure: accidental association or fatal link?

This case study reports a fatal subarachnoid hemorrhage (SAH) with concomitant accidental carbon monoxide (CO) exposure in 32-year-old man. Autopsy results indicated an antemortem aspiration of smoke, and a massive SAH was identified as the cause of death. Intriguingly, the carboxyhemoglobin level was 30%, suggesting that CO could have played a specific role. Intracranial hemorrhages following CO exposure in brain areas and tissues such as the basal ganglia, globus pallidus, or white matter are rare, but well characterized, whereas SAH related to CO exposure has not been previously described. In this case report, the possible role of CO, either as a primary cause or as a facilitating factor, in the pathogenesis of SAH is discussed. In particular, we propose the hypothesis that the excessive vasodilating effects produced by CO on the cerebral endothelium results in consequential loss of microvascular integrity.