HFE at the frontiers of COVID-19. Human factors/ergonomics to support the communication for safer care in Italy during the COVID-19 pandemic.

Italy was the first country after China to be affected by COVID-19. The wave of the emergency found our country unprepared to cope with the surge of patients going to first aid departments to seek assistance in the almost complete paralysis of community health. Human factors and ergonomics (HFE) can effectively contribute to, and improve the effectiveness of, a pandemic response working on several key areas: training, adapting workflows and processes, restructuring teams and tasks, effective mechanisms and tools for communication, engaging patients and families and learning from failures and successes. In Italy, HFE expertise has been able to provide our healthcare systems with some easy-to-realize solutions (particularly dedicated to improving communication, team work and situational awareness) in order to cope with the need for rapid adaptations to new and unknown scenarios: ensuring information and communication continuity in the different levels of the healthcare system; identifying hazard opportunity through risk management tool; providing training through simulation; organizing regular briefing and debriefing; enhancing the reporting and learning system as an informal way of communicating adverse events and supporting information campaign and education initiatives for the public.

Paediatric surgery and COVID-19: urgent lessons to be learned.

BACKGROUND: The dissemination of scientific data on coronavirus disease 2019 (COVID-19) continually builds but, in April 2020, could not keep up with the spread of the disease. Through technology, surgeons in Italy and the UK, representing both peak and pre-peak infective time zones, were able to communicate so that the urgent lessons on the huge expected demands of care learned in Italy could be brought to the UK in advance. This paper specifically discusses the issues related to paediatric surgery, currently under-reported in the literature. METHODS: The aim of this paper is to conjoin experience from the field to provide a framework for a safe assessment and treatment of paediatric patients by adopting a systemic approach aimed at reducing the risk of contamination. We reviewed the processes and good practices that were undertaken in contexts of emergency such as in Italy and the UK and then adapted them within the Systems Engineering Initiative for Patient Safety (SEIPS) framework to provide an assessment of how to reorganize the services in order to cope with an unexpected situation. The SEIPS model is the adopted theoretical framework, which allows to analyse the system in its main components with a human factors and ergonomics (HFE) perspective. RESULTS: The results introduce some of the good practices and recommendations developed during the emergency in the surgical scenario with a focus on the paediatric patients. They represent the lessons learned from the combination of the little existing evidence of literature and the experience from surgical teams who responded in an impromptu and unrehearsed way. CONCLUSIONS: Lessons learned from the frontline 'on the fly' during COVID-19 emergency should be consolidated and taken into the future. In order to prepare proactively for the next phases and get ahead of the curve of these hospital accesses, there is a need for a risk assessment of the new clinical pathways with a multidisciplinary approach centred on HFE with the adoption of the SEIPS model and an involvement of all the surgical teams.

Human factors and ergonomics at time of crises: the Italian experience coping with COVID-19.

Several of the key organizational issues that we have had to face with the emergence of COVID-19 crisis are related to human factors/ergonomics (HFE) and the safety culture. During the crisis the main activities of the healthcare services have been profoundly affected. Patient safety and risk management units have also experienced the need to adapt rapidly. What can we do as HFE experts, now that the scenario has completely changed? We contend that: (a) we can favour and support the heuristics that are applied to manage the load of psycho-cognitive stress. (b) We can observe, collect strategies and develop analytic schemes, thereby creating a memory of the organization for improvement in the future. (c) And we can support in educating and engaging the public. This crisis has forced the community of healthcare experts to broaden their reflections: for the future to come, our communities of experts in the field of risk management HF/E, quality and safety of care and public health should play together an important role from the very beginning, from the time of peace.

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.

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.

World Patient Safety Day: the Tuscany region at the forefront of quality of care.

Echoing the World Health Organization's (WHO) request, the Patient Safety Declaration, launched by Health First Europe at the European Parliament, calls on policymakers, authorities and health professionals, patients and citizens to come together to build health systems that can help health professionals work better for patient-centred outcomes. The objective is to prevent the occurrence of adverse events arising from clinical care activities to focus resources on reducing the impact of the disease by promoting safer health systems and higher quality standards for patient safety in Europe. The Declaration intends to promote a European patient safety culture, starting with safety practices and exchanging effective practices to reduce adverse events arising from health activities. Tuscany, the fifth largest region of Italy, is strongly committed to make this happen. Its Regional Centre for Clinical Risk Management and Patient Safety and WHO Collaborating Centre (GRC Centre-Centro Gestione Rischio Clinico e Sicurezza del Paziente) aims at developing and promoting practices for safety, awareness raising and the analysis of adverse events for the constant improvement of care delivery.

Prevalence and multicenter observational study on falls of hospitalized children and Italian, linguistic-cultural validation of the Humpty Dumpty Fall Scale.

INTRODUCTION: Falls in hospitals are a major problem also in pediatric settings. No Pediatric Fall Risk Assessment Scales (PFRAS) are validated in Italian. GOALS: to perform the Italian validation of the Humpty-Dumpty Falls Scale (HDFS); to assess its predictive performance; to estimate the frequency of falls in hospitalized children and to analyze possible associations between children's clinical variables and falls. METHODS: The study's first step was the cultural-linguistic validation of HDFS in Italian. Second, evaluation of the Italian HDFS's performance on 1500 hospitalized children. Third, modifications of the Italian HDFS to improve its performance. Fourth, analysis of falls frequency and associations between falls and patients' clinical variables. RESULTS: The Italian HDFS (HDFS-ita) showed good Validity (SCVI=0.92) and inter-rater Reliability (Cohen's kappa=0.965), but poor Sensitivity (77.8%) and Specificity (36.6%). A new 3-item version of the HDFS-ita (HDFS-ita-M) was set, with a cut-off of 7, only for subjects 1 to 15 year-old. Although better, the HDFS-ita-M's performance remains poor (Sensitivity=77.8%, Specificity=53.3%, ROC curve's AOC=0.670). The frequency of pediatric falls was 6.38 per thousand children (CI95% 3.36-12.08) with a maximum frequency in children aged 3 to 6 years (11.28 per thousand children, CI95% 3.84-32.63). Motor/walking disorders (p=0.005), enuresis (p=0.0002), being in single room (p=0.04), admittance to pediatric neuropsychiatry/neurology wards (p=0.001), and neurological disorders (p=0.02) were associated to falls. DISCUSSION: HDFS-ita-M has a better but still poor performance than HDFS-ita. This study provides useful data about pediatric falls and their possible risk factors which will help pediatric hospitals in determining patient safety policies. Further studies are needed to determine an adequate panel of variables to estimate pediatric falls risk.

Ergonomics in the Future World: Perspectives from Australia and New Zealand.

BACKGROUND: The International Ergonomics Association is a professional association for human factors and ergonomics (HFE) professionals. Australia and New Zealand are two of 52 Federated Societies within the IEA. OBJECTIVE: This paper describes an Ergonomics and the Future World (EFW) workshop held at the IEA Triennial Congress in 2018 (IEA2018), and reports the findings of the Australia / New Zealand (Southern Cross) Cluster (SCC). METHODS: Four questions were developed by the IEA EFW committee to evaluate the ergonomics state-of-play in various world regions. Southern Cross delegates (N = 17) participated in a 90-minute workshop discussion at IEA2018 (45% participation rate for SCC delegates). A summary was presented during the IEA2018 closing ceremony and as a written report for the IEA. RESULTS: Three themes emerged from the SCC discussions: (i) the impact of technology advances on HFE professional practice;(ii) communication with internal and external stakeholders; and (iii) HFE education. CONCLUSIONS: The workshop findings are similar to issues raised at local discussions in Australia and New Zealand over past decades and mirror comments and opinions published by authors in the HFE profession. They provide a benchmark for current SCC opinion and may provide direction for future discussion of these recurring issues.

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".

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.

[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].

The collaborative communication model for patient handover at the interface between high-acuity and low-acuity care.

BACKGROUND: Cross-unit handovers transfer responsibility for the patient among healthcare teams in different clinical units, with missed information, potentially placing patients at risk for adverse events. OBJECTIVES: We analysed the communications between high-acuity and low-acuity units, their content and social context, and we explored whether common conceptual ground reduced potential threats to patient safety posed by current handover practices. METHODS: We monitored the communication of five content items using handover probes for 22 patient transitions of care between high-acuity 'sender units' and low-acuity 'recipient units'. Data were analysed and discussed in focus groups with healthcare professionals to acquire insights into the characteristics of the common conceptual ground. RESULTS: High-acuity and low-acuity units agreed about the presence of alert signs in the discharge form in 40% of the cases. The focus groups identified prehandover practices, particularly for anticipatory guidance that relied extensively on verbal phone interactions that commonly did not involve all members of the healthcare team, particularly nursing. Accessibility of information in the medical records reported by the recipient units was significantly lower than reported by sender units. Common ground to enable interpretation of the complete handover content items existed only among selected members of the healthcare team. CONCLUSIONS: The limited common ground reduced the likelihood of correct interpretation of important handover information, which may contribute to adverse events. Collaborative design and use of a shared set of handover content items may assist in creating common ground to enable clinical teams to communicate effectively to help increase the reliability and safety of cross-unit handovers.

[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.

Handover process: how to improve quality and safety through an ergonomic solution.

Patient safety practices for enhancing the quality and safety of handover are context sensitive interventions. In this article we explore the use of cultural probes as a qualitative technique with a twofold objective: eliciting implicit activity pattern and tools that may constitute resources for the design of effective handover solutions and prompting health care practitioners' participation and involvement.