Effects of the Italian Law on Patient Safety and Health Professional Responsibilities Five Years after Its Approval by the Italian Parliament.

The application of the Italian law No. 24/2017, which focused on patient safety and medical liability, in the Italian National Health Service has been evaluated by a survey conducted five years after the promulgation of the law. The law required the establishment of healthcare risk management and patient safety centers in all Italian regions and the appointment of a Clinical Risk Manager (CRM) in all Italian public and private healthcare facilities. This study demonstrates that five years after the approval of the law, it has not yet been fully implemented. The survey revealed a lack of adequate permanent staff in all the Regional Centers, with two employees on average per Center. Few meetings were held with the Regional Healthcare System decision-makers with less than four meetings per year. This reduces the capacity to carry out functions. In addition, the role of the CRMs is weak in most healthcare facilities. More than 20% of CRMs have other roles in the same organization. Some important tasks have reduced application, e.g., assessment of the inappropriateness risk (reported only by 35.3% of CRM) and use of patient safety indicators for monitoring hospitals (20.6% of CRM). The function of the Regional Centers during the COVID-19 pandemic was limited despite the CRMs being very committed. The CRMs units undertake limited research and have reduced collaboration with citizen associations. Despite most of the CRMs believing that the law has had an important role in improving patient safety, 70% of them identified clinicians' resistance to change and lack of funding dedicated to implementing the law as the main barriers to the management of risk.

Physical and stressful psychological impacts of prolonged personal protective equipment use during the COVID-19 pandemic: A cross-sectional survey study.

BACKGROUND: Healthcare workers (HCWs) caring for COVID-19 infected patients are exposed to stressful and traumatic events with potential for severe and sustained adverse mental and physical health consequences. Our aim was to assess the magnitude of physical and mental health outcomes of HCWs due to the prolonged use of personal protective equipment (PPE) treating COVID-19 patients. METHODS: This cross-sectional study assessed the symptoms of stress, anxiety, insomnia, and psychological resilience using the Stress and Anxiety to Viral Epidemics (SAVE) scale, Insomnia Severity Index (ISI), and Resilience Scale (RS), respectively, in Italy between 1st February and 31st March 2022. The physical outcomes reported included vertigo, dyspnea, nausea, micturition desire, retroauricular pain, thirst, discomfort at work, physical fatigue, and thermal stress. The relationships between prolonged PPE use and psychological outcomes and physical discomforts were analyzed using Generalized Linear Models (GLMs). We calculated the factor mean scores and a binary outcome to measure study outcomes. FINDINGS: We found that 23% of the respondents reported stress related symptoms, 33% anxiety, 43% moderate to severe insomnia, and 67% reported moderate to very low resilience. The GLMs suggested that older people (>55 years old) are less likely to suffer from stress compared to younger people (<35 y.o); conversely, HCW aged more than 35 years are more inclined to suffer from insomnia than younger people (<35 y.o). Female HCW reported a lower probability of resilience than males. University employed HCWs were less likely to report anxiety than those who worked in a community hospital. The odds of suffering from insomnia for social workers was significantly higher than for other HCWs. Female HCW>3 years old, enrolled in training programs for nursing, social work, technical training and other healthcare professionals increased the probability of reported physical discomforts. HCW that worked on non COVID-19 wards and used PPE for low-medium exposure level, were at lower risks for lasting physical side effects as compared to the HCW who worked in high-risk PPE intense, COVID-19 environments. INTERPRETATION: The study suggests that frontline HCWs who had extensive PPE exposure while directly engaged in the diagnosis, treatment, and care for patients with COVID-19 are at significant risks for lasting physical and psychological harm and distress.

Patient safety implications of wearing a face mask for prevention in the era of COVID-19 pandemic: a systematic review and consensus recommendations.

In the past, the use of face masks in western countries was essentially limited to occupational health. Now, because of the COVID-19 pandemic, mask-wearing has been recommended as a public health intervention. As potential side effects and some contraindications are emerging, we reviewed the literature to assess the impact of them in daily life on patient safety and to provide appropriate guidelines and recommendations. We performed a systematic review of studies investigating physiological impact, safety, and risk of masks in predefined categories of patients, which have been published in peer-reviewed journals with no time and language restrictions. Given the heterogeneity of studies, results were analyzed thematically. We used PRISMA guidelines to report our findings. Wearing a N95 respirator is more associated with worse side effects than wearing a surgical mask with the following complications: breathing difficulties (reduced FiO2, SpO2, PaO2 increased ETCO2, PaCO2), psychiatric symptoms (panic attacks, anxiety) and skin reactions. These complications are related to the duration of use and/or disease severity. Difficulties in communication is another issue to be considered especially with young children, older person and people with hearing impairments. Even if benefits of wearing face masks exceed the discomfort, it is recommended to take an "air break" after 1-2 h consecutively of mask-wearing. However, well-designed prospective studies are needed. The COVID-19 pandemic could represent a unique opportunity for collecting large amount of real-world data.

Improved FMEA Methods for Proactive Health Care Risk Assessment of the Effectiveness and Efficiency of COVID-19 Remote Patient Telemonitoring.

The COVID-19 pandemic exposed the need to more effectively harness and leverage digital tools and technology for remote patient monitoring (RPM). RPM gained great popularity given the need to provide effective, safe, efficient, and remote patient care. RPM is based on noninvasive digital technologies aimed at improving the safety and efficiency of health care delivery. We report on an RPM program in which 200 COVID-19 patients were followed remotely to evaluate the effectiveness in treating and monitoring patients in home settings. We analyzed the inherent risks using mixed methods, including failure mode and effect analysis, a prospective, team-based risk management methodology structured to identify high-risk process system failures before they occur in telemonitoring of remote patients. The RPM saved lives and improved decision-making during the pandemic and helped prevent the health system's collapse. The failure mode and effect analysis-based assessment offers important insights and considerations for evaluating future RPM implementation and direction. RPM solutions are technically feasible, staff friendly, and can achieve high adherence rates. Rigorous and ongoing evaluation of devices and platforms is essential to clarifying their value and guiding national health and insurance health coverage decisions and adoption programs.

Aggressions on Social Networks: What Are the Implications for Healthcare Providers? An Exploratory Research.

Incidents of violence by healthcare users against staff have been considered as sentinel events. New forms of aggression, i.e., cyberbullying, have emerged with the advent of social networks. Medical literature includes some reports about workplace cyberbullying on nurses and young doctors by colleagues/supervisors, but not by users. To investigate cyberbullying on healthcare providers via social networks, we carried out an exploratory quali-quantitative study, researching and analyzing posts and comments relating to a local Health Trust (ASL5) in Italy, published from 2013 until May 2020 on healthcare worker aggressions on social networks on every local community's Facebook page. We developed a thematic matrix through an analysis of the most recurring meaning categories (framework method). We collected 217 texts (25 posts and 192 comments): 26% positive and 74% negative. Positive posts were shared about ten times more than negative ones. Negative comments received about double the "Likes" than the positive ones. Analysis highlighted three main meaning categories: 1. lack of adequate and functional structures; 2. negative point of view (POV) towards some departments; 3. positive POV towards others. No significant differences were observed between the various categories of healthcare workers (HCW). Geriatric, medical wards and emergency department were the most frequent targets of negative comments. All the texts referred to first-line operators except for one. Online violence against HCW is a real, largely unknown, problem that needs immediate and concrete attention for its potentially disastrous consequences. Compared to traditional face-to-face bullying, it can be more dangerous as it is contagious and diffusive, without spatial, temporal or personal boundaries.

Looking for the right balance between human and economic costs during COVID-19 outbreak.

Since the beginning of Coronavirus 2019 (COVID-19) disease outbreak, there has been a heated debate about public health measures, as they can presumably reduce human costs in the short term but can negatively impact economies and well-being over a longer period. MATERIALS AND METHODS: To study the relationship between health and economic impact of COVID-19, we conducted a secondary research on Italian regions, combining official data (mortality due to COVID-19 and contractions in value added of production for a month of lockdown). Then, we added the tertiles of the number of people tested for COVID-19 and those of health aids to evaluate the correspondence with the outcome measures. RESULTS: Five regions out of 20, the most industrialized northern regions, which were affected both earlier and more severely by the outbreak, registered both mortality and economic value loss above the overall medians. The southern regions, which were affected later and less severely, had low mortality and less economic impact. CONCLUSIONS: Our analysis shows that considering health and economic outcomes in the assessment of response to pandemics offers a bigger picture perspective of the outbreak and could allow policymakers and health managers to choose systemic, 'personalized' strategies, in case of a feared second epidemic wave.

International survey of COVID-19 management strategies.

BACKGROUND: While individual countries have gained considerable knowledge and experience in coronavirus disease of 2019 (COVID-19) management, an international, comparative perspective is lacking, particularly regarding the measures taken by different countries to tackle the pandemic. This paper elicits the views of health system staff, tapping into their personal expertise on how the pandemic was initially handled. METHODS: From May to July 2020, we conducted a cross-sectional, online, purpose-designed survey comprising 70 items. Email lists of contacts provided by the International Society for Quality in Health Care, the Italian Network for Safety in Health Care and the Australian Institute of Health Innovation were used to access healthcare professionals and managers across the world. We snowballed the survey to individuals and groups connected to these organizations. Key outcome measures were attitudes and information about institutional approaches taken; media communication; how acute hospitals were re-organized; primary health organization; personal protective equipment; and staffing and training. RESULTS: A total of 1131 survey participants from 97 countries across the World Health Organization (WHO) regions responded to the survey. Responses were from all six WHO regions; 57.9% were female and the majority had 10 or more years of experience in healthcare; almost half (46.5%) were physicians; and all other major clinical professional groups participated. As the pandemic progressed, most countries established an emergency task force, developed communication channels to citizens, organized health services to cope and put in place appropriate measures (e.g. pathways for COVID-19 patients, and testing, screening and tracing procedures). Some countries did this better than others. We found several significant differences between the WHO regions in how they are tackling the pandemic. For instance, while overall most respondents (71.4%) believed that there was an effective plan prior to the outbreak, this was only the case for 31.9% of respondents from the Pan American Health Organization compared with 90.7% of respondents from the South-East Asia Region (SEARO). Issues with swab testing (e.g. delay in communicating the swab outcome) were less frequently reported by respondents from SEARO and the Western Pacific Region compared with other regions. CONCLUSION: The world has progressed in its knowledge and sophistication in tackling the pandemic after early and often substantial obstacles were encountered. Most WHO regions have or are in the process of responding well, although some countries have not yet instituted widespread measures known to support mitigation, for example, effective swab testing and social control measures.

Proactive Risk Assessment through FMEA of Home Parenteral Nutrition Care Processes: A Survey Analysis.

BACKGROUND: Home Parenteral Nutrition (HPN) is a lifesaving clinical care process. However, undetected hazards and vulnerabilities in care transitions from hospital to community care may pose risk to patient's safety. Avoidable complications and adverse events may hinder the benefits of treatment. OBJECTIVE: The analysis carried out aims at framing through Human Factors and Ergonomics (HF/E) the critical issues for patient safety related to clinical care practices for HPN in healthcare organization. METHODS: We present the results of a proactive risk assessment analysis based on the FMEA methodology (Failure Mode and Effects Analysis) carried out in three different areas of the regional health care system of Tuscany, Italy. The clinical risk management and patient safety unit assessed the risk perception of Healthcare Workers (HWs) in regard to patient safety and situational awareness throughout the HPN patient journey. RESULTS: The analysis revealed heterogeneity in the Risk Priority Index (RPI) expressed by HWs. A lower RPI is associated with a HPN process that deploys in continuity between hospital care and community care. A higher RPI is associated with a quality and safety improvement process that is still ongoing. We also observed HWs expressing low RPI in the areas of the region where HPN has a hospital- focused approach and has limited adherence to patient safety requirements. Low RPI for HPN process may relate both to extensively deployed continuity of care and to jeopardized awareness on HPN phases and coordination. The analysis carried out enabled the definition of a common HPN workflow used as reference schema allowing for the definition of a set of recommendations for improving the quality and safety of the care processes. Moreover, the outcome of the proactive risk assessment laid the groundwork for the advancement of the patient safety regional requirements. CONCLUSION: The analysis had the role of promoting the contextualization of the culture of quality and safety within the HPN process resulting in an improved awareness of the criticalities and the role of nutrition units throughout the care process.

Expanding frontiers of risk management: care safety in nursing home during COVID-19 pandemic.

BACKGROUND: Nursing homes provide long-term care and have residential-oriented hospitalizations characterized by medical, nursing and social-care treatments for a typically geriatric population. In the current emergency phase, the problem of infections in residential structures for the elderly is taking on considerable importance in relation to the significant prevalence rates of coronavirus disease 2019 (COVID-19). SAFETY IMPROVEMENT STRATEGIES: Prevention and control measures for severe acute respiratory syndrome coronavirus 2 infection in nursing homes should be planned before a possible outbreak of COVID-19 occurs and should be intensified during any exacerbation of the same. Each facility should identify a properly trained contact person-also external-for the prevention and control of infections, who can refer to a multidisciplinary support committee and who is in close contact with the local health authorities. The contact person should collaborate with professionals in order to prepare a prevention and intervention plan that considers national provisions and scientific evidence, the requirements for reporting patients with symptoms compatible with COVID-19 and the indications for the management of suspected, probable or confirmed cases of COVID-19. DISCUSSION: Adequate risk management in residential structures implies the establishment of a coordination committee with dedicated staff, the implementation of a surveillance program for the rapid recognition of the outbreaks, the identification of suitable premises and equipment, the application of universal precautions, the adaptation of care plans to reduce the possibility of contagion among residents and the protection of operators and staff training initiatives.

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.

Safety Assessment of the Pharmacotherapy Process at the Nurse and Midwife Level - An Observational Study.

PURPOSE: Pharmacological errors are among the most common in the healthcare system. This study aimed to determine the level of safety of the pharmacotherapy process at the stage performed by nurses and midwives by indicating the key risk factors affecting patients' safety. METHODS: A group of 1276 nurses and 136 midwives in Poland participated in the study. The survey was conducted in the period from May 2019 to August 2019. The original Nursing Risk in Pharmacotherapy (NURIPH) tool was used. RESULTS: The Cronbach alpha coefficient was 0.832. The low legibility of the medical orders (item 1) was indicated as the highest risk. A mean of 4.50 means that this factor's significance is assessed between "very significant" and "significant." The communication between physician, nurse and midwife, time pressure, and work organization were also rated high (Items 2, 3, and 4). The averages for these factors are higher than 4, so their evaluation is more than "significant.". CONCLUSION: Nurses and midwives involved in the pharmacotherapy process are exposed to many ergonomic factors triggering risk. A huge problem is the lack of readability of medical orders, which may be a factor triggering a medical error.

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.

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.