NEO-SAFE: a clinical model for patients and healthcare personnel safety in primary level hospitals.

Patient safety is a major concern in medicine. Approximately, 4 million infants die each year worldwide and 23% of these deaths are caused by perinatal asphyxia. To prevent the long-term damage of asphyxia, the resuscitation flowchart must be perfectly and promptly performed. However, high effectiveness in performing resuscitation can only be achieved and maintained if the algorithm is frequently executed. Therefore, maintaining a high level of patient care is difficult in some remote centres. The aim of this study was to evaluate the effectiveness of a new organizational model of care-network between Hub & Spoke hospitals to improve both the safety of the newborns in hospitals with a low number of births and the well-being of operators. Our project, NEO-SAFE (NEOnatal SAFety and training Elba), began in 2017 and involved the neonatal intensive care unit and the NINA Center of the Pisa University Hospital (hub) and the Hospital of Elba Island (spoke). It consisted of a continuous training program, both with 'classic' training course and 'on-job tutoring' (on side and remotely), of the health workers at spoke (i.e. nurses, midwives, and paediatricians). All four milestones of the study design were achieved. During the project, NINA Center instructors organized training courses for the staff in Portoferraio. These courses were based on learning technical and non-technical skills in a training course of increasing difficulty. Staff training needs were also monitored during the project by means of periodic questionnaires, sentinel events, and specific requests. The curve described by the rate of newborns transfer to the Pisa neonatal intensive care unit (hub) shows a monotonous decreasing trend line. On the other hand, this project allowed operators to develop greater self-confidence and greater safety in managing emergency situations, reducing stress for them and improving patient safety. The project allowed the creation of a safe, effective, low-cost, and reproducible organizational model for centres with a low number of births. Moreover, the tele-medicine approach is an important improvement in the assistance and is a window on the future.

Second Victim Experience and Support Tool: An Assessment of Psychometric Properties of Italian Version.

INTRODUCTION: Second victim syndrome is a hidden pitfall inside health care organizations. The impact of a patient safety incident on health and safety of health care workers (HCWs) is still a matter with limited evidence in terms of prevalence, etiology, and effects. The aims of this study were to validate the Italian version of the Second Victim Experience and Support Tool (I-SVEST) and determine its psychometric properties in a group of HCWs exposed to patient safety incidents. MATERIALS AND METHODS: An observational cross-sectional study was conducted using an online survey. Construct validity for the total score and for each of the 7 subscales was assessed using principal component analysis and internal consistency using Cronbach α coefficient. RESULTS: The prevalence of second victims in our sample was 35.4% (85/240). The component SVEST was positively associated with turnover intentions but not directly related to absenteeism and sociodemographic characteristics. Absenteeism and sociodemographic characteristics components were positively associated with turnover intentions. Factor analysis confirmed that the questionnaire has 7 dimensions: psychological distress, physical distress, colleague support, supervisor support, institutional support, non-work-related support, and professional self-efficacy. Cronbach α for the Italian version was strong at α = 0.855. Cronbach α ranged from 0.613 for colleague support to 0.882 for supervisor support. CONCLUSIONS: The Italian version of the SVEST has excellent psychometric properties and can be used to detect prevalence in different contexts, to support studies and preventive interventions for Italian HCWs. The SVEST provides a robust model to describe the concept of second victim and to conduct comparisons with cross-sectional and longitudinal studies.

Medication Reconciliation During Hospitalization and in Hospital-Home Interface: An Observational Retrospective Study.

OBJECTIVE: Medication errors are one of the leading causes of patient harms. Medication reconciliation is a fundamental process that to be effective, it should be embraced during each single care transition. Our objectives were to investigate current medication reconciliation practices in the 2 Fondazione Toscana Gabriele Monasterio hospitals and comprehensively assess the quality of medication reconciliation practices between inpatient and outpatient care by analyzing the medication patterns 6 months before admission, during hospitalization, and 9 months after discharge for a selected group of patients with cardiovascular diseases. METHODS: A retrospective observational study was conducted in the Cardiothoracic Department of the Fondazione Toscana Gabriele Monasterio hospitals. Medication history was reviewed for all the patients admitted from and discharged to the community, from January to March 2013. Patients were excluded if they had less than 4 drugs or less than 2 drugs for cardiovascular system in their prescription list at admission or if they died during follow-up. We selected 714 patients, and we obtained the clinical charts and all drug prescriptions collected during patients' hospitalization by the electronic clinical recording system. We also analyzed the list of prescriptions of this sample of patients, from 6 months before admission to 9 months after discharge, extracted from the regional prescription registry. In the resulting sample, prescriptions were analyzed to assess unintentional discrepancies. RESULTS: The study included 298 patients (mean age, 71.2 years), according to the inclusion and exclusion criteria. Among 14,573 prescriptions analyzed, we found 4363 discrepancies (14.6 discrepancies per patient). Among these discrepancies, 1310 were classified as unintentional (4.4 discrepancies per patient). Among unintentional discrepancies, only 63 (4.8%) took place during hospitalization. Although at the hospital-home interface, 33.1% of unintentional discrepancies were detected through the comparison between the patients' declared therapy and the previous medication consumption and 62.1% were identified in the comparison between the prescription at the discharge and the following medication pattern at home. CONCLUSIONS: Medication errors have important implications for patient safety, and their identification is a main target for improving clinical practice. The comparison between the medication patterns acquired through the regional prescription registry before and after hospitalization outlined critical touchpoint in the current medication reconciliation process, calling for the definition of shared medication reconciliation standards between hospitals and primary care services to minimize medication discrepancies and enhance patient safety.

[Nursing handover: an observational study at the inpatient wards - cardiothoracic department]. / L'handover infermieristico: uno studio osservazionale presso le Degenze di un Dipartimento Cardiotoracico.

INTRODUCTION: The handover has relevant implications in terms of patient safety. An effective handover requires the use of a standardized and shared communication tool. AIM: This observational study explored the nursing handover at shift change in order to detect eventual omissions. Furthermore, it investigated the quality perceived by the nurses involved. METHOD: At each shift change, an external observer detected the referred and omitted information by the delivering nurse, through the use of a direct observational grid (modified ISBAR). The percentage of the omitted information was calculated excluding any unforeseen information, not linked to the patient care pathway and detected through the consultation of the nursing record. The quality perceived by the nurses involved was investigated through the use of the Handoff CEX tool. The data was processed through a descriptive and inferential statistical analysis. RESULTS: 256 handovers were observed and 256 nursing records were reviewed. The omissions were detected in 43.17% of the cases. The results highlight a propensity for a prospective approach. A high statistical significance emerges in relation to the modality of handover, the type of patient, the nurse/patients ratio and the number of interruptions. Referring to the perceived quality, 40 Handoff CEX evaluation forms were completed. The results show a more than satisfactory perception. However, the thematic analysis highlights scarcely detailed and dispersive handovers as well as the difficulty to focus on the information to deliver. CONCLUSION: According to the findings of this research, it is necessary to implement a standardized tool which supports the handover process.

Safety Analysis of 13 Suspicious Deaths in Intensive Care: Ergonomics and Forensic Approach Compared.

OBJECTIVES: Thirteen suspicious deaths occurred in an intensive care unit of Tuscany, Italy, in 2015. All patients developed sudden unexplained coagulopathy leading to severe bleeding. None of them had been prescribed heparin, but supertherapeutic concentrations of heparin were found. After a nurse was arrested on suspicion of murdering Human Factor and Ergonomics (HF/E) experts received a mandate to identify system failures. According to the judgment of the Court of First Instance on April 2019, the nurse was found guilty. METHODS: The HF/E group used a two-pronged safety analysis: understanding the conditions in which the healthcare practitioners were working in the period when the suspicious deaths emerged and reviewing the clinical records. RESULTS: Fourteen patients admitted to the intensive care unit in 2014 and 2015 were selected on the basis of markedly abnormal coagulation tests (n = 13) or a family member's complaint (n = 1). In 13 cases, a massive, abrupt hemorrhage in the presence of an unexpected abnormality of coagulation tests occurred, whereas the fourteenth patient had the only prolongation of coagulation markers without bleeding. All cases examined classified as adverse events related to a coagulation disorder. Human factor and ergonomics analysis identified a number of latent and active failures that contributed to the event and provided a set of important recommendations for safety improvement. CONCLUSIONS: When presented with a manifest, albeit suspected, wrongdoing with lethal consequences for patients, forensic investigators and safety investigators have distinctly different goals and methods. We believe that a memorandum of understanding between HF/E and forensic investigative teams provides an operative framework for allowing co-existence and fosters collaboration. The pursuit of safe care as a new emerging right for patients and balancing the right to legal justice with the right to safer healthcare merit further investigation and discussion.

Human factors engineering for medical devices: European regulation and current issues.

A large proportion of the patient injuries or deaths attributable to medical device (MD) misuse can be eliminated and/or mitigated by adopting an effective human factors and ergonomics (HFE) approach. The implementation of a usability engineering process is now mandatory for MD manufacturers seeking to obtain the European Union's CE Mark. Here, we describe the European Union's HFE regulation and highlight the challenges faced by (i) manufacturers implementing this regulation and (ii) regulatory bodies charged with assessing the compliance of usability files. In Europe, 95% of MD manufacturers are small- and medium-sized enterprises; compliance with the CE Mark regulations is a real challenge to their competitiveness. Levels of knowledge about HFE vary greatly from one regulatory organization to another, which can sometimes lead to very different expectations. We also present the specific use-related risk management approach required by the HFE regulation. Lastly, we focus on the limitations of the HFE regulation for MDs and on future HFE challenges in further reducing and/or eliminating MD use errors. The main challenge is the need to go beyond technology design and the premarket assessment and to look at the postproduction stage; the coupling between an MD and a sociotechnical system can lead to consequences that were not predicted during the design process. This implies the need to consider the emerging properties of technologies in use by involving all the stakeholders.

Reducing the risk of patient suicide in Tuscany.

Patient suicide is one of the most frequent incidents in healthcare facilities to be reported to the National Observatory of Sentinel Events in Italy. Despite national initiatives, in Tuscany potentially preventable patient suicides still occur in both acute and community care settings. We describe here an aggregated qualitative analysis of 14 patient suicides that took place in public health services between 2017 and 2018. We outline the methodology and results of an improvement action we enacted in the healthcare system that involved reviewing and reinforcing relevant managerial strategies and clinical activities, with the aim of reducing potentially preventable patient suicides.

Prolonged outbreak of New Delhi metallo-beta-lactamase-producing carbapenem-resistant Enterobacterales (NDM-CRE), Tuscany, Italy, 2018 to 2019.

In Tuscany, Italy, New Delhi metallo-beta-lactamase-producing carbapenem-resistant Enterobacterales (NDM-CRE) have increased since November 2018. Between November 2018 and October 2019, 1,645 samples were NDM-CRE-positive: 1,270 (77.2%) cases of intestinal carriage, 129 (7.8%) bloodstream infections and 246 (14.9%) infections/colonisations at other sites. Klebsiella pneumoniae were prevalent (1,495; 90.9%), with ST147/NDM-1 the dominant clone. Delayed outbreak identification and response resulted in sustained NDM-CRE transmission in the North-West area of Tuscany, but successfully contained spread within the region.

Human Factors and Ergonomics for a Safe Transition to Digital Health.

In this paper we elaborate a preliminary framework to fill this gap and describe the potential contributions of HFE to improve digital health interventions, at the macro, meso and micro level of a health system. Researchers present a practical approach, integrated with some limited reflections on methodological aspects, recently covered in a position paper [8], while previously in conference series and handbooks. This paper presents a HFES perspective on digital health - from the macro, meso and micro level to improve patient safety and delivery of quality care. Experts in HFE can play a key role in creating evidence for an ethical and effective design of digital health intervention and providing support to their implementation and evaluation at the macro, meso and micro level. This framework may help to integrate HFE at the different levels of the system and following the tracks of organization, technology and human factors.

New Rules on Patient's Safety and Professional Liability for the Italian Health Service.

BACKGROUND: The phenomenon of clinical negligence claims has rapidly spread to United States, Canada and Europe assuming the dimensions and the severity of a pandemia. Consequently, the issues related to medical malpractice need to be studied from a transnational perspective since they raise similar problems in different legal systems. METHODS: Over the last two decades, medical liability has become a prominent issue in healthcare policy and a major concern for healthcare economics in Italy. The failures of the liability system and the high cost of healthcare have led to considerable legislative activity concerning medical malpractice liability, and a law was enacted in 2012 (Law no. 189/2012), known as the "Balduzzi Law". RESULTS: The law tackles the mounting concern over litigation related to medical malpractice and calls for Italian physicians to follow guidelines. Briefly, the law provided for the decriminalisation of simple negligence of a physician on condition that he/she followed the guidelines and "good medical practice" while carrying out his/her duties, whilst the obligation for compensation, as defined by the Italian Civil Code, remained. Judges had to consider that the physician followed the provisions of the guidelines but nevertheless caused injury to the patient. CONCLUSION: However, since the emission of the law, thorny questions remain which have attracted renewed interest and criticism both in the Italian courts and legal literature. Since then, several bills have been presented on the topic and these have been merged into a single text entitled "Regulations for healthcare and patient safety and for the professional responsibility of healthcare providers".

What Quality and Safety of Care for Patients Admitted to Clinically Inappropriate Wards: a Systematic Review.

BACKGROUND: In countries with public health system, hospital bed reductions and increasing social and medical frailty have led to the phenomenon of "outliers" or "outlying hospital in-patients." They are often medical patients who, because of unavailability of beds in their clinically appropriate ward, are admitted wherever unoccupied beds are. The present work is aimed to systematically review literature about quality and safety of care for patients admitted to clinically inappropriate wards. METHODS: We performed a systematic review of studies investigating outliers, published in peer-reviewed journals with no time restrictions. Search and screening were conducted by two independent researchers (MLR and ER). Studies were considered potentially eligible for this systematic review if aimed to assess the quality and/or the safety of care for patients admitted to clinically inappropriate units. Our search was supplemented by a hand search of references of included studies. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. RESULTS: We collected 17 eligible papers and grouped them into six thematic categories. Despite their methodological limits, the included studies show increased trends in mortality and readmissions among outliers. Quality of care and patient safety are compromised as patients and health professionals declare and risk analysis displays. Reported solutions are often multicomponent, stress early discharge but have not been investigated in the control group. CONCLUSIONS: Published literature cannot definitely conclude on the quality and safety of care for patients admitted to clinically inappropriate wards. As they may represent a serious threat for quality and safety, and moreover often neglected and under valued, well-designed and powered prospective studies are urgently needed.

Testing the Integrative Quality Care Assessment Tool (INQUAT).

PURPOSE: Identifying the factors that contribute or hinder the provision of good quality care within healthcare institutions, from the managers' perspective, is important for the success of quality improvement initiatives. The purpose of this paper is to test the Integrative Quality Care Assessment Tool (INQUAT) that was previously developed with a sample of healthcare managers in the USA. DESIGN/METHODOLOGY/APPROACH: Written narratives of 69 good and poor quality care episodes were collected from 37 managers in Italy. A quantitative content analysis was conducted using the INQUAT coding scheme, to compare the results of the US-based study to the new Italian sample. FINDINGS: The core frame of the INQUAT was replicated and the meta-categories showed similar distributions compared to the US data. Structure (i.e. organizational, staff and facility resources) covered 8 percent of all the coded units related to quality aspects; context (i.e. clinical factors and patient factors) 10 percent; process (i.e. communication, professional diligence, timeliness, errors and continuity of care) 49 percent; and outcome (i.e. process- and short-term outcomes) 32 percent. However, compared to the US results, Italian managers attributed more importance to different categories' subcomponents, possibly due to the specificity of each sample. For example, professional diligence, errors and continuity of care acquired more weight, to the detriment of communication. Furthermore, the data showed that process subcomponents were associated to perceived quality more than outcomes. RESEARCH LIMITATIONS/IMPLICATIONS: The major limitation of this investigation was the small sample size. Further studies are needed to test the reliability and validity of the INQUAT. ORIGINALITY/VALUE: The INQUAT is proposed as a tool to systematically conduct in depth analyses of successful and unsuccessful healthcare events, allowing to better understand the factors that contribute to good quality and to identify specific areas that may need to be targeted in quality improvement initiatives.

Safety and quality in maternal and neonatal care: the introduction of the modified WHO Safe Childbirth Checklist.

Maternal and neonatal mortality and morbidity associated with childbirth is a problem of the highest priority. This research has been aimed at testing a modified version of the WHO Safe Childbirth Checklist in one Italian hospital and to evaluate the tool in terms of its impact on clinical practice and safety. Results show that the presence of correctly compiled partogram tool is strongly and significantly associated with the checklist implementation (OR = 14.9, 95% confidence interval [CI] = 3.5, 63.9). Compliance to the checklist was high for mid-wives (96%) and very low for obstetricians (3%). The discrepancy is the result of a misinterpretation by obstetricians: they signed only in case they prescribed therapy or when they identified risk factors, but not to underline that they checked for those factors independently by their existence. While the checklist promotes the interdisciplinary work, field studies generally show strong hierarchical rather than partnership interaction. Practitioner Summary: The study is aimed at evaluating: the checklist impact on clinical practice through a prospective pre- and post-intervention study based on clinical records review, the usability of the tool and the user's compliance. The research gives evidences on the importance of the tool for reducing risks related to delivery.

Interruptions and multitasking in surgery: a multicentre observational study of the daily work patterns of doctors and nurses.

The aim of this study was to obtain baseline data on doctors' and nurses' work activities and rates of interruptions and multitasking to improve work organisation and processes. Data were collected in six surgical units with the WOMBAT (Work Observation Method by Activity Timing) tool. Results show that doctors and nurses received approximately 13 interruptions per hour, or one interruption every 4.5 min. Compared to doctors, nurses were more prone to interruptions in most activities, while doctors performed multitasking (33.47% of their time, 95% CI 31.84-35.17%) more than nurses (15.23%, 95% CI 14.24-16.25%). Overall, the time dedicated to patient care is relatively limited for both professions (37.21%, 95% CI 34.95-39.60% for doctors, 27.22%, 95% CI 25.18-29.60% for nurses) compared to the time spent for registration of data and professional communication, that accounts for two-thirds of doctors' time and nearly half of nurses' time. Further investigation is needed on strategies to manage job demands and professional communications. Practitioner Summary: This study offers further findings on the characteristics and frequency of multitasking and interruptions in surgery, with a comparison of how they affect doctors and nurses. Further investigation is needed to improve the management of job demands and communications according to the results.

Patient Safety in Complementary Medicine through the Application of Clinical Risk Management in the Public Health System.

Aim: To develop a systematic approach to detect and prevent clinical risks in complementary medicine (CM) and increase patient safety through the analysis of activities in homeopathy and acupuncture centres in the Tuscan region using a significant event audit (SEA) and failure modes and effects analysis (FMEA). Methods: SEA is the selected tool for studying adverse events (AE) and detecting the best solutions to prevent future incidents in our Regional Healthcare Service (RHS). This requires the active participation of all the actors and external experts to validate the analysis. FMEA is a proactive risk assessment tool involving the selection of the clinical process, the input of a multidisciplinary group of experts, description of the process, identification of the failure modes (FMs) for each step, estimates of the frequency, severity, and detectability of FMs, calculation of the risk priority number (RPN), and prioritized improvement actions to prevent FMs. Results: In homeopathy, the greatest risk depends on the decision to switch from allopathic to homeopathic therapy. In acupuncture, major problems can arise, mainly from delayed treatment and from the modalities of needle insertion. Conclusions: The combination of SEA and FMEA can reveal potential risks for patients and suggest actions for safer and more reliable services in CM.

Variability of adverse events in the public health-care service of the Tuscany region.

The objective of the study is to analyze the variation of adverse events (AEs) according to the different structure of hospitals. The study is a multicenter, retrospective study. It involves 4 teaching hospitals (THs) and 32 community hospitals, distributed in 12 local trusts (LTs), of the Tuscany Regional Healthcare Service (RHS). A random sample of the clinical records of patients admitted in LTs and THs in 2008 was selected from the database of the hospital discharge records of the centers. Among 11,293 clinical records included, a total of 354 adverse events were identified. There was a significant higher incidence of AEs in the male and elderly (>65 years) population, and the incidence of AEs was more relevant in the THs (5.3, 95% CI 4.7-6.1) than in the LTs (1.8, 95% CI 1.5-2.2). AEs related to falls were significantly more preventable in THs (OR 19.22, 95% CI 2.45-151.02), while in LTs, AEs related to infections were the most preventable (OR 6.22, 95% CI 1.35-28.67). Concerning the consequence of AE, death is significantly more probable for AEs related to unexpected cardiac arrest in LTs, while disability and prolongation of the stay are significantly more probable consequences associated with re-admission in THs, and to transfer to ICU or HDU in LTs. Re-interventions, surgical complications and falls are the factors more correlated with AEs. In conclusion, the study shows a higher risk of incurring adverse events for the THs compared to the LTs, presumably connected with a major complexity of the clinical cases. Furthermore, the preventability of AEs is higher in the LTs (56.1 vs 42.2%), and this might be associated with lower expertise in managing complications in these settings. Concerning specialties, there are no significant differences in AEs distribution.

Adverse events in cardiac surgery, a mixed methods retrospective study in an Italian teaching hospital.

RATIONALE, AIMS, AND OBJECTIVES: Adverse events (AEs) are a major concern in surgery, but the evidence in cardiac surgery is limited, especially on the contributory factors. According to the data of the National Outcomes Program, a unit was selected to conduct a mixed methods investigation into the incidence, type, and cause of AE, given its mortality rate that was double the national average on coronary artery bypass grafting, valve reparation, and replacement. METHODS: A retrospective investigation on the performance of a cardiac surgery, combining the routinely collected data on process and outcome measures with a 2-stage structured review of 280 medical records performed by 3 expert clinicians, with the support of a methodologist. RESULTS: At least one risk had been verified in 137 of 280 cases (48.9%, 95% CI, 43.1-54.8). The total number of AE was 42, with an incidence of 15% (95% CI, 10.8-20.2) and a preventability of 80.9% (95% CI, 69.1-92.8). In 11.9% of AE, the consequence is death, disability in 40.5%, and extended hospital stay in 69% of the cases. Adverse events are associated with problems in care management at the ward (89/137, 64.9%, 95% CI, 56.9-72.9), followed by surgical complications (46/137, 33.6%, 95% CI, 25.7-41.5) and infection/sepsis (32/137, 23.4%, 95% CI, 16.3-30.4). An active error was made by the health care workers in 31 of 42 cases with AE, either during the decision making or during the execution of an action. A total of 36 AEs were due to deficiencies attributed to organizational factors and 31 were linked to poor teamwork. CONCLUSIONS: The mixed methods approach demonstrated how a deep understanding of AE and poor performance may emerge thanks to the combination of routinely available data and experts' evaluations. The main limitation of this study is its focus on the cardiac surgery rather than on the entire process of care. The evaluation could have been integrated with on-site observations and the analysis of reported incidents.

[Correction: Adverse events and preventable consequences: retrospective study in five large Italian hospitals]. / Correzione: Eventi avversi e conseguenze prevenibili: studio retrospettivo in cinque grandi ospedali italiani.

[This corrects the Table 4 of the article: pmid: 22828228].

[Adverse events and preventable consequences: retrospective study in five large Italian hospitals]. / Eventi avversi e conseguenze prevenibili: studio retrospettivo in cinque grandi ospedali italiani.

OBJECTIVE: To define the incidence of adverse events and their preventability in a representative sample of patients in five acute hospitals located in the North, the Centre and the South of Italy. Other objectives include the evaluation of the consequences of adverse events and their distribution according to specialties. DESIGN: Retrospective and multicentre study. The methodology is focused on the review of clinical records related to hospital admissions in the year 2008 with a sample of 5 hospitals belonging to the national healthcare system selected according to criteria of location (North, Centre and South of Italy) and complexity (regional reference hospitals). The clinical records included in the study were selected in a random way starting from the electronic archives of the hospital discharges of each participating centre. SETTING AND PARTICIPANTS: 7,573 clinical records were reviewed with a process of two stages managed by two reviewers each. The first stage of the review process involved 7 physicians, 1 nurse, 1 pharmacist and 1 biologist with skills and experiences in clinical risk management and in analysis of clinical documentation. The second stage was realized by 10 physicians (5 specialists, 3 experts in public health and 2 forensic physicians), also for the second stage every person involved had specific training in clinical risk management. The reviewers attended a 20-hour training course. MAIN OUTCOME MEASURES: Study of the incidence of adverse events identified during the admissions included. In the case of more than one adverse event for each admission, it is calculated the cumulative incidence of adverse events for each patient. We also considered the percentage of re-admitted patients for each adverse event, the percentage of adverse events which occurred in the phase of pre hospitalization and the degree of preventability of adverse events. A description of the identified adverse events was realized. The sample of the data included in the study was described in terms of included and excluded subjects with respect to the planned research design. Different products and results were tested and validated in the study and could be reused in the future research products. RESULTS: The overall average of the incidences of adverse events was 5.2%, the median was 5.5% and it is consistent with the expected results mentioned in the protocol of the study. The identified incidence of adverse events is lower than the median rate of international studies (9.2%). The distribution of adverse events for specialties underlines the majority of adverse events in the medical area (37.5%), in opposition to the results of other studies; the surgery is the second specialty for number of adverse events (30.1%), followed by the emergency room (6.2%) and obstetrics (4.4%). The study identified 56.7% of adverse events as preventable. The consequences of adverse events were classified in different typologies: the prolonged stay was the most frequent consequence, followed by the disability at discharge. The death of the patient had a median occurrence of 9.45%. The concordance between the two reviewers in the evaluation of the clinical records was very high (higher than 95%) except for two centres. CONCLUSIONS: The results were consistent with the results of other international studies similar in scope in terms of type of study (definition of the rate of adverse events) and epidemiological study design (retrospective study). The incidence rate, previously mentioned as 5.2%, coincides with the unfavorable rates of events determined in varied countries. The preventability resulted in an average of 56.7%. The variability of the results obtained in our inquiry are likely attributable to varied factors occurred during the study.