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.

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.