How different countries respond to adverse events whilst patients' rights are protected.

Patient safety is high on the policy agenda internationally. Learning from safety incidents is a core component in achieving the important goal of increasing patient safety. This study explores the legal frameworks in the countries to promote reporting, disclosure, and supporting healthcare professionals (HCPs) involved in safety incidents. A cross-sectional online survey was conducted to ascertain an overview of the legal frameworks at national level, as well as relevant policies. ERNST (The European Researchers' Network Working on Second Victims) group peer-reviewed data collected from countries was performed to validate information. Information from 27 countries was collected and analyzed, giving a response rate of 60%. A reporting system for patient safety incidents was in place in 85.2% (N = 23) of countries surveyed, though few (37%, N = 10) were focused on systems-learning. In about half of the countries (48.1%, N = 13) open disclosure depends on the initiative of HCPs. The tort liability system was common in most countries. No-fault compensation schemes and alternative forms of redress were less common. Support for HCPs involved in patient safety incidents was extremely limited, with just 11.1% (N = 3) of participating countries reporting that supports were available in all healthcare institutions. Despite progress in the patient safety movement worldwide, the findings suggest that there are considerable differences in the approach to the reporting and disclosure of patient safety incidents. Additionally, models of compensation vary limiting patients' access to redress. Finally, the results highlight the need for comprehensive support for HCPs involved in safety incidents.

The Impact of Incident Disclosure Behaviors on Medical Malpractice Claims.

OBJECTIVES: To provide preliminary estimates of incident disclosure behaviors on medical malpractice claims. METHODS: We conducted a descriptive analysis of data on medical malpractice claims obtained from the Controlled Risk Insurance Company and Risk Management Foundation of Harvard Medical Institutions (Cambridge, Massachusetts) between 2012 and 2013 (n = 434). The characteristics of disclosure and apology after medical errors were analyzed. RESULTS: Of 434 medical malpractice claims, 4.6% (n = 20) medical errors had been disclosed to the patient at the time of the error, and 5.9% (n = 26) had been followed by disclosure and apology. The highest number of disclosed injuries occurred in 2011 (23.9%; n = 11) and 2012 (34.8%; n = 16). There was no incremental increase during the financial years studied (2012-2013). The mean age of informed patients was 52.96 years, 58.7 % of the patients were female, and 52.2% were inpatients. Of the disclosed errors, 26.1% led to an adverse reaction, and 17.4% were fatal. The cause of disclosed medical error was improper surgical performance in 17.4% (95% confidence interval, 6.4-28.4). Disclosed medical errors were classified as medium severity in 67.4%. No apology statement was issued in 54.5% of medical errors classified as high severity. CONCLUSIONS: At the health-care centers studied, when a claim followed a medical error, providers infrequently disclosed medical errors or apologized to the patient or relatives. Most of the medical errors followed by disclosure and apology were classified as being of high and medium severity. No changes were detected in the volume of lawsuits over time.

Eleven-year descriptive analysis of closed court verdicts on medical errors in Spain and Massachusetts.

OBJECTIVES: To evaluate and compare the characteristics of court verdicts on medical errors allegedly harming patients in Spain and Massachusetts from 2002 to 2012. DESIGN, SETTING AND PARTICIPANTS: We reviewed 1041 closed court verdicts obtained from data on litigation in the Thomson Reuters Aranzadi Westlaw databases in Spain (Europe), and 370 closed court verdicts obtained from the Controlled Risk and Risk Management Foundation of Harvard Medical Institutions (CRICO/RMF) in Massachusetts (USA). We included closed court verdicts on medical errors. The definition of medical errors was based on that of the Institute of Medicine (USA). We excluded any agreements between parties before a judgement. RESULTS: Medical errors were involved in 25.9% of court verdicts in Spain and in 74% of those in Massachusetts. The most frequent cause of medical errors was a diagnosis-related problem (25.1%; 95% CI 20.7% to 31.1% in Spain; 35%; 95% CI 29.4% to 40.7% in Massachusetts). The proportion of medical errors classified as high severity was 34% higher in Spain than in Massachusetts (p=0.001). The most frequent factors contributing to medical errors in Spain were surgical and medical treatment (p=0.001). In Spain, 98.5% of medical errors resulted in compensation awards compared with only 6.9% in Massachusetts. CONCLUSIONS: This study reveals wide differences in litigation rates and the award of indemnity payments in Spain and Massachusetts; however, common features of both locations are the high rates of diagnosis-related problems and the long time interval until resolution.

[Analysis of barriers and legal-ethical opportunities for disclosure and apology for medical errors in Spain]. / Análisis de las barreras y oportunidades legales-éticas de la comunicación y disculpa de errores asistenciales en España.

OBJECTIVE: To identify opportunities for disclosing information on medical errors in Spain and issuing an apology, as well as legal-ethical barriers. METHOD: A cross-sectional study was conducted through a questionnaire sent to health law and bioethics experts (n=46). RESULTS: A total of 39 experts (84.7%) responded that health providers should always disclose adverse events and 38 experts (82.6%) were in favour of issuing an apology. Thirty experts (65.2%) reported that disclosure of errors would not lead to professional liability. The main opportunity for increasing disclosure was by enhancing trust in the physician-patient relationship and the main barrier was fear of the outcomes of disclosing medical errors. CONCLUSIONS: There is a broad agreement on the lack of liability following disclosure/apology on adverse events and the need to develop a strategy for disclosure among support for physicians.

A retrospective review of medical errors adjudicated in court between 2002 and 2012 in Spain.

OBJECTIVES: This paper describes verdicts in court involving injury-producing medical errors in Spain. DESIGN, SETTING AND PARTICIPANTS: A descriptive analysis of 1041 closed court verdicts from Spain between January 2002 and December 2012. It was determined whether a medical error had occurred, and among those with medical error (n = 270), characteristics and results of litigation were analyzed. Data on litigation were obtained from the Thomson Reuters Aranzadi Westlaw databases. MAIN OUTCOME MEASURES: All verdicts involving health system were reviewed and classified according to the presence of medical error. Among those, contributory factors, medical specialty involved, health impact (death, disability and severity) and results of litigation (resolution, time to verdict and economic compensations) were described. RESULTS: Medical errors were involved in 25.9% of court verdicts. The cause of medical error was a diagnosis-related problem in 25.1% and surgical treatment in 22.2%, and Obstetrics-Gynecology was the most frequent involved specialty (21%). Most of them were of high severity (59.4%), one-third (32%) caused death. The average time interval between the occurrence of the error and the verdict was 7.8 years. The average indemnity payment was €239 505.24; the highest was psychiatry (€7 585 075.86) and the lowest was Emergency Medicine (€69 871.19). CONCLUSIONS: This study indicates that in Spain medical errors are common among verdicts involving the health system, most of them causing high-severity adverse outcomes. The interval between the medical error and the verdict is excessive, and there is a wide range of economic compensation.

[Perspective of nursing students on the communication and apologies to patients for adverse events: a descriptive study]. / Perspectiva de los estudiantes de Enfermería sobre la comunicación y disculpa de los eventos adversos a los pacientes: estudio descriptivo.

OBJECTIVES: To describe the approach to the communication and blame of an adverse by nursing students. METHOD: A descriptive study on disclosure and apologies for adverse events by nursing students in the academic years 2011-12 and 2012-13. The study included group discussion and drafting a written communication to the injured patient about adverse events during hospitalization. An ad hoc checklist was used and an analysis was performed on items related to the disclosure and apologies issues. RESULTS: A total of 126 nursing students were involved, and they created 21 written The facts about adverse events were reported in 81% of written communications, and 47.1% chose an abbreviated disclosure of the facts with no detailed explanation of adverse events. The facts were accurately reproduced in only 9.5% of written communications to the patients. One third (33.3%) apologized for the mistakes, and 47.6% required that the communication was signed by the Management. All (100%) of the nursing students chose not to report the health professionals who had participated during the events. CONCLUSIONS: There is a fear to acknowledge errors within health centers. It is recommended that tools are developed for these future nursing professionals to make an open and honest disclosure of adverse events, as well as the apologies for them.

[Assessing the economic impact of adverse events in Spanish hospitals by using administrative data]. / Impacto económico de los eventos adversos en los hospitales españoles a partir del Conjunto Mínimo Básico de Datos.

OBJECTIVE: To evaluate the incidence and costs of adverse events registered in an administrative dataset in Spanish hospitals from 2008 to 2010. METHODS: A retrospective study was carried out that estimated the incremental cost per episode, depending on the presence of adverse events. Costs were obtained from the database of the Spanish Network of Hospital Costs. This database contains data from 12 hospitals that have costs per patient records based on activities and clinical records. Adverse events were identified through the Patient Safety Indicators (validated in the Spanish Health System) created by the Agency for Healthcare Research and Quality together with indicators of the EuroDRG European project. RESULTS: This study included 245,320 episodes with a total cost of 1,308,791,871€. Approximately 17,000 patients (6.8%) experienced an adverse event, representing 16.2% of the total cost. Adverse events, adjusted by diagnosis-related groups, added a mean incremental cost of between €5,260 and €11,905. Six of the 10 adverse events with the highest incremental cost were related to surgical interventions. The total incremental cost of adverse events was € 88,268,906, amounting to an additional 6.7% of total health expenditure. CONCLUSIONS: Assessment of the impact of adverse events revealed that these episodes represent significant costs that could be reduced by improving the quality and safety of the Spanish Health System.