Disclosure following a medical error: lessons learned from a national initiative of workshops with patients, healthcare teams, and executives.

BACKGROUND: Despite the increase in disclosures of medical errors, transparency remains a challenge. Recognized barriers include shame, fear of litigation, disciplinary actions, and loss of patient trust. In 2018, the Israeli Ministry of Health initiated a series of workshops about disclosure of medical errors. The workshops involved medical center executives, healthcare providers, patients, and family members of patients who had previously been harmed by a medical error. This study presents the lessons learned about perceived challenges in disclosure of errors in 15 such workshops. METHODS: Data collection included participant observations in 15 workshops, full audio recordings of all of the workshops, and documentation of detailed field notes. Analysis was performed under thematic analysis guidelines. RESULTS: We identified four main themes: "Providers agree on the value of disclosure of a medical error to the patient"; "Emotional challenges of disclosure of medical error to patients"; "The medico-legal discourse challenges transparency"; and "Providers and patients call for a change in the culture regarding disclosure of medical errors". Participant observations indicated that the presence of a patient who had experienced a tragedy in another hospital, and who was willing to share it created an intimate atmosphere that enabled an open conversation between parties. CONCLUSION: The study shows the moral, human, and educational values of open discourse in a protective setting after the occurrence of a medical error. We believe that workshops like these may help foster a culture of institutional disclosure following medical errors. We recommend that the Ministry of Health extend such workshops to all healthcare facilities, establish guidelines and mandate training for skills in disclosure for all providers.

Remote Communications between Patients and General Practitioners: Do Patients Choose the Most Effective Communication Routes?

The use of remote communication between patients and general practitioners has greatly increased worldwide, especially following the COVID-19 outbreak. Yet, it is important to evaluate the impact of this shift on healthcare quality. This study aimed at evaluating remote healthcare quality by comparing four remote patient-to-physician communication modes used in Israel. The research methodology entailed criteria-based analysis conducted by healthcare quality experts and a subjective patient-perception questionnaire regarding the healthcare quality attributed to each mode and the extent to which each mode was used. Our findings indicate that the extent to which each mode is used was found to be inversely related to its rated quality. As such, the common assumption whereby patients tend to choose the mode of communication that will most likely ensure high service quality is refuted. Our findings also indicate that remote services often hinder the physician's understanding of the patient's clinical issues, as patients encounter difficulties in correctly articulating and conveying them; such services also hinder the patient's understanding of the recommended course of treatment. These findings should be addressed by policymakers for improving remote communication services to ensure optimal healthcare service quality.

Caring for COVID-19 patients: Nurses' perceptions of the most critical issues and their impact on their well-being and performance.

AIMS: (1) Exploring nurses' perceptions of issues that impacted the quality of patient care and their own performance on COVID-19 wards; (2) examining nurses' perceptions of how these issues impacted their psychological state and level of performance; and (3) presenting recommendations for improving healthcare policies. BACKGROUND: Nurses played a critical role in caring for hospitalized COVID-19 patients and managing the disease. METHODS: Semistructured interviews were conducted with 50 nurses (32 females), aged 31-58 years, 6-37 years' tenure, from eight hospitals across Israel. Prior to working in COVID-19 wards, they worked in internal medicine, emergency rooms, or intensive care units. Based on the COREQ checklist, these interviews were recorded and transcribed, and categorized into themes and subthemes. FINDINGS: The findings indicate that the unpreparedness of healthcare systems for the pandemic outbreak rendered nurses paying a high price at the personal and professional levels, which in turn may have impacted the levels of care that they provided. CONCLUSION: The rich, qualitative data source revealed important interactions between clinical, personal, social, and familial factors in determining distress levels and performance impairment. A nuanced understanding of the link between these stressors is key to developing and implementing policies that could mitigate deficiencies in the management of epidemics and pandemics in the future. IMPLICATIONS FOR NURSING AND HEALTH POLICIES: Changes should be made to government directives and healthcare policies, with an emphasis on increasing the nursing workforce, providing emotional support, ensuring availability of equipment and beds, optimizing work practices, developing transparent means of communication within teams, and clearly defining the areas of responsibility of nurses-in times of routine and crises.

Crisis management for Patient Safety Officers: lessons learned from the Covid-19 pandemic.

BACKGROUND: There is no consensus for the role definition for Patient Safety Officers (PSOs) in healthcare during pandemics or other crises as opposed to their routine activities. This study aimed to examine the contribution of personality traits and systemic factors on the performance of PSOs during the pandemic, and to compare these variables during the first and third waves of the Covid-19 pandemic in Israel. METHODS: This cross-sectional study invited 117 PSOs to complete a questionnaire addressing their role during the Covid-19 pandemic. The questionnaire included items concerning: Personal and socio-demographic characteristics; Uncertainty; Personal initiative; Burnout; Professional functioning; Patient Safety and Risk Management policies and practices; Organizational functioning; and Personal Involvement in risk management activities. Qualitative data was collected by two open-ended questions. RESULTS: A total of 78 PSOs (67%) completed the questionnaire. The results revealed that many PSOs reduced their involvement in risk management processes or even left their position temporarily in order to return to their primary specialization as clinicians. Only 51.3% and 57.7% reported practicing risk management in the first and third waves, respectively. The three main factors that kept PSOs functioning were managerial support, mobilization of their team, and the belief in the importance of their position. CONCLUSIONS: A crisis generates uncertainty, a plethora of frequent and urgent tasks, and the need to adapt policy to changing circumstances and to the increased risks. The risk manager must be a member of the crisis management team and participate in every important discussion in order to represent essential staff and patient safety issues and ensure that these are fully addressed already in the early stages of planning.

Factors contributing to preventing operating room "never events": a machine learning analysis.

BACKGROUND: A surgical "Never Event" is a preventable error occurring immediately before, during or immediately following surgery. Various factors contribute to the occurrence of major Never Events, but little is known about their quantified risk in relation to a surgery's characteristics. Our study uses machine learning to reveal and quantify risk factors with the goal of improving patient safety and quality of care. METHODS: We used data from 9,234 observations on safety standards and 101 root-cause analyses from actual, major "Never Events" including wrong site surgery and retained foreign item, and three random forest supervised machine learning models to identify risk factors. Using a standard 10-cross validation technique, we evaluated the models' metrics, measuring their impact on the occurrence of the two types of Never Events through Gini impurity. RESULTS: We identified 24 contributing factors in six surgical departments: two had an impact of > 900% in Urology, Orthopedics, and General Surgery; six had an impact of 0-900% in Gynecology, Urology, and Cardiology; and 17 had an impact of < 0%. Combining factors revealed 15-20 pairs with an increased probability in five departments: Gynecology, 875-1900%; Urology, 1900-2600%; Cardiology, 833-1500%; Orthopedics,1825-4225%; and General Surgery, 2720-13,600%. Five factors affected wrong site surgery's occurrence (-60.96 to 503.92%) and five affected retained foreign body (-74.65 to 151.43%): two nurses (66.26-87.92%), surgery length < 1 h (85.56-122.91%), and surgery length 1-2 h (-60.96 to 85.56%). CONCLUSIONS: Using machine learning, we could quantify the risk factors' potential impact on wrong site surgeries and retained foreign items in relation to a surgery's characteristics, suggesting that safety standards should be adjusted to surgery's characteristics based on risk assessment in each operating room. . TRIAL REGISTRATION NUMBER: MOH 032-2019.

[CONFIDENTIALITY OF ADVERSE EVENTS INVESTIGATIONS - THE PRESENT STATUS AND WHAT IS NEEDED].

INTRODUCTION: The goal of the medical staff is to provide proper, effective and efficient treatment to the patient and to take care of his well-being. An error in medical care that causes a serious outcome or mortality, can be considered negligence when the caregiver did not meet the requirements of a reasonable physician for reasonable care and did not take the necessary precautions in providing the treatment, in light of the information available to him. The perception of punishment and compensation due to harm, caused to a patient as a result of a medical error, changed dramatically over the years. Starting with direct and severe punishment according to Hammurabi laws and ending with the "no fault" approach that is accepted widely in some countries. Following an adverse event that occurred in medical treatment, a process should be conducted in order to draw lessons to reduce the likelihood of recurrence of similar incidents in the future, by answering 4 questions: What happened? How did it happen? Why did it happen? and What should be done to prevent similar incidents in the future? The Patient Rights Act does not suggest conducting a safety investigation but recommends an examination board in cases of negligence or error in treatment. By law, the protocols of the examination board are confidential and can be removed by the court in case the protocol contains evidence of importance that is unlikely to be found in the medical record. Lack of confidentiality may cause medical staff to be reluctant of conducting a safety investigation due to fear of using its findings for a lawsuit or appointing an examination board whose conclusions will be reported to the victim and his family. The "no fault" method overcomes these barriers by enabling a thorough safety investigation and has important professional, economic and social aspects with a direct impact on the quality and safety of treatment. The method expands the accessibility of victims to compensation, reduces the number of claims and the burden on the courts. Among additional benefits are transparency and consistency in decisions, promoting patient safety due to physicians' willingness to report failures, reduction in "defensive medicine" and spending in the health care system.

Improving Patient Safety in General Hospitals Using Structured Handoffs: Outcomes From a National Project.

Background: Promoting quality and patient safety is one of the health policy pillars of Israel's Ministry of Health. Communication among healthcare professionals is of utmost importance and can be improved using a standardized, well-known handoff tool such as the Introduction, Situation, Background, Assessment, and Recommendations (ISBAR). This study aims to present implementation process and participants' satisfaction of a national project that used a standardized tool for team communication. Methods: This national intervention project included process implementation teams from 17 Israeli general hospitals evaluating the ISBAR implementation process for transferring patients from intensive care units to medical/surgical wards. The project, conducted between January 2017 and March 2018, used Fischer's test and logistic regression. The project evaluation was based on the participants' assessment of and satisfaction with the handoff process. Results: Eighty-seven process implementers completed the questionnaire. A statistically significant increase in satisfaction scores in terms of four variables (p < 0.001) was observed following the implementation of the project. Nurses reported higher satisfaction at the end of the process (0.036). Participants who perceived less missing information during handoffs were more satisfied with the process of information flow between wards (84.9%) than those who perceived more missing information (15.6%). Participants who responded that there was no need to improve information flow were more satisfied with the project information flow (95.6%) compared to the group which responded that it was necessary to improve information flow (58.2%). Three out of four variables predicted satisfaction with the process. Being a nurse also predicted satisfaction with information flow with a point estimate of 2.4. The C value of the total model was 0.87. Conclusions: Implementation of a safety project at a national level requires careful planning and the close involvement of the participating teams. A standardized instrument, a well-defined process, and external controls to monitor and manage the project are essential for success. Disparities found in the responses of nurses vs. physicians suggest the need for a different approach for each profession in planning and executing a similar project in the future.

Patient safety and staff psychological safety: A mixed methods study on aspects of teamwork in the operating room.

Objectives: To predict the amount of teamwork that takes place throughout a surgery, based on performing a preoperative safety standards (surgical safety checklist and surgical count) and to explore factors affecting patient safety and staff psychological safety during a surgery, based on interprofessional teamwork. Methods: This mixed methods study included quantitative and qualitative analyses. Quantitative data included 2,184 direct observations of surgical cases with regard to the performance of safety standards during surgeries in 29 hospitals, analyzed using multivariate binary logistic regressions. Qualitative data were obtained from an analysis of 25 semi-structured interviews with operating room (OR) clinicians and risk managers, using an inductive thematic analysis approach. Results: Analysis of the OR observations revealed that a lack of teamwork in the preoperative "sign-in" phase doubled the chances of there being a lack of teamwork during surgery [odds ratio = 1.972, 95% confidence interval (CI) 1.741, 2.233, p < 0.001] and during the "time-out" phase (odds ratio = 2.142, 95% CI 1.879, 2.441, p < 0.001). Consistent presence of staff during surgery significantly increased teamwork, by 21% for physicians and 24% for nurses (p < 0.05), but staff turnover significantly decreased teamwork, by 73% for physicians (p < 0.05). Interview data indicated that patient safety and staff psychological safety are related to a perception of a collaborative team role among OR staff, with mutual commitment and effective interprofessional communication. Conclusions: Healthcare organizations should consider the key finding of this study when trying to identify factors that affect teamwork during a surgery. Effective preoperative teamwork positively affects intraoperative teamwork, as does the presence of more clinicians participating in a surgery, with no turnover. Other factors include working in a fixed, designated team, led by a surgeon, which functions with effective interprofessional communication that promotes patient safety and staff psychological safety.

Accessing unproven interventions in the COVID-19 pandemic: discussion on the ethics of 'compassionate therapies' in times of catastrophic pandemics.

Since the onset of the SARS-CoV-2 pandemic, an array of off-label interventions has been used to treat patients, either provided as compassionate care or tested in clinical trials. There is a challenge in determining the justification for conducting randomised controlled trials over providing compassionate use in an emergency setting. A rapid and more accurate evaluation tool is needed to assess the effect of these treatments. Given the similarity to the Ebola Virus Disease (EVD) pandemic in Africa in 2014, we suggest using a tool designed by the WHO committee in the aftermath of the EVD pandemic: Monitored Emergency Use of Unregistered and Investigational Interventions (MEURI). Considering the uncertainty around SARS-CoV-2, we propose using an improved MEURI including the Plan-Do-Study-Act tool. This combined tool may facilitate dynamic monitoring, analysing, re-evaluating and re-authorising emergency use of unproven treatments and repeat it in cycles. It will enable adjustment and application of outcomes to clinical practice according to changing circumstances and increase the production of valuable data to promote the best standard of care and high-quality research-even during a pandemic.

Myocarditis after BNT162b2 mRNA Vaccine against Covid-19 in Israel.

BACKGROUND: Approximately 5.1 million Israelis had been fully immunized against coronavirus disease 2019 (Covid-19) after receiving two doses of the BNT162b2 messenger RNA vaccine (Pfizer-BioNTech) by May 31, 2021. After early reports of myocarditis during adverse events monitoring, the Israeli Ministry of Health initiated active surveillance. METHODS: We retrospectively reviewed data obtained from December 20, 2020, to May 31, 2021, regarding all cases of myocarditis and categorized the information using the Brighton Collaboration definition. We analyzed the occurrence of myocarditis by computing the risk difference for the comparison of the incidence after the first and second vaccine doses (21 days apart); by calculating the standardized incidence ratio of the observed-to-expected incidence within 21 days after the first dose and 30 days after the second dose, independent of certainty of diagnosis; and by calculating the rate ratio 30 days after the second dose as compared with unvaccinated persons. RESULTS: Among 304 persons with symptoms of myocarditis, 21 had received an alternative diagnosis. Of the remaining 283 cases, 142 occurred after receipt of the BNT162b2 vaccine; of these cases, 136 diagnoses were definitive or probable. The clinical presentation was judged to be mild in 129 recipients (95%); one fulminant case was fatal. The overall risk difference between the first and second doses was 1.76 per 100,000 persons (95% confidence interval [CI], 1.33 to 2.19), with the largest difference among male recipients between the ages of 16 and 19 years (difference, 13.73 per 100,000 persons; 95% CI, 8.11 to 19.46). As compared with the expected incidence based on historical data, the standardized incidence ratio was 5.34 (95% CI, 4.48 to 6.40) and was highest after the second dose in male recipients between the ages of 16 and 19 years (13.60; 95% CI, 9.30 to 19.20). The rate ratio 30 days after the second vaccine dose in fully vaccinated recipients, as compared with unvaccinated persons, was 2.35 (95% CI, 1.10 to 5.02); the rate ratio was again highest in male recipients between the ages of 16 and 19 years (8.96; 95% CI, 4.50 to 17.83), with a ratio of 1 in 6637. CONCLUSIONS: The incidence of myocarditis, although low, increased after the receipt of the BNT162b2 vaccine, particularly after the second dose among young male recipients. The clinical presentation of myocarditis after vaccination was usually mild.

Bullying and Its Prevention Among Intensive Care Nurses.

PURPOSE: International studies report that nurse bullying is a common occurrence. The intensive care unit (ICU) is known for its high stress levels, one factor thought to increase bullying. No studies were found that investigated bullying in this population. The purpose of this study was to describe the prevalence of ICU nurse bullying and what measures were taken to prevent bullying. DESIGN: This was a descriptive study of a convenience sample of 156 ICU nurses from five medical centers in Israel. Data collection was conducted over a 10-month period in 2012 and 2013. METHODS: After ethical approval, three questionnaires (background characteristics, Negative Acts Questionnaire-Revised, and Prevention of Bullying Questionnaire) were administered according to unit preference. Descriptive statistics were calculated for all responses and a Pearson product moment correlation was calculated to determine the relationship between bullying and its prevention. FINDINGS: Most of the nurses in the study were married, female staff nurses with a baccalaureate in nursing. No participant responded that they had been bullied daily, but 29% reported that they were a victim of bullying. The mean bullying score was 1.6 ± 1.4 out of 5. The mean prevention score was 2.4 ± 0.3 out of 4. Significant differences were found between hospitals on bullying, F (4,155) = 2.7, p = .039, and between hospitals, F (4,155) = 2.9, p = .026, and units, F (5,143) = 3.4, p = .006, on prevention. The Prevention Scale significantly correlated with the bullying scale (r = .58, p < .001). No other variables were found to be associated with either bullying or prevention scores. CONCLUSIONS: An alarming percentage of nurses were victims of bullying. Levels of bullying were low to moderate. Level of prevention was weak or moderate. The higher the level of bullying, the lower the level of prevention. The work environment as opposed to individual characteristics seems to have an impact on bullying and its prevention. CLINICAL RELEVANCE: More measures must be taken to prevent bullying. Nurses must be educated to accept only a zero tolerance to bullying and to report bullying when confronted by bullying.

Translation of oral care practice guidelines into clinical practice by intensive care unit nurses.

PURPOSE: The purpose of this study was to determine whether there was a change in the oral care practices of intensive care unit (ICU) nurses for ventilated patients after a national effort to increase evidence-based oral care practices. DESIGN: Descriptive comparison of ICU nurses in 2004-2005 and 2012. METHOD: Two convenience national surveys of ICU nurses were collected in 2004-2005 (n = 218) and 2012 (n = 233). After the results of the initial survey were reported, a national effort to increase awareness of evidence-based oral care practices was conducted that included in-service presentations; publication of an evidence-based protocol in a national nursing journal; publication of the survey findings in an international nursing journal; and reports to the local press. A repeat survey was conducted 7 to 8 years later. The same survey instrument was used for both periods of data collection. This questionnaire included questions about demographic and personal characteristics and a checklist of oral care practices. Nurses rated their perceived priority level concerning oral care on a scale from 0 to 100. An evidence-based practice (EBP)[O4] score was computed representing the sum of 14 items related to equipment, solutions, assessments, and techniques associated with the evidence. The EBP score, priority score, and oral care practices were compared between the two samples. A regression model was built based on those variables that were associated with the EBP score in 2012. FINDINGS: There was a statistically significant increase in the use of EBPs as shown by the EBP score and in the perceived priority level of oral care. Increased EBPs were found in the areas of teeth brushing and oral assessment. Decreases were found in the use of non-evidence-based practices, such as the use of gauze pads, tongue depressors, lemon water, and sodium bicarbonate. No differences were found in the use of chlorhexidine, toothpaste, or the nursing documentation of oral care practices. A multiple regression model was found to be significant with the time of participation (2004-2005 vs. 2012) and priority level of oral care significantly contributing to the regression model. CONCLUSIONS: The national effort was partially successful in improving evidence-based oral care practices; however, increased awareness to EBP also might have come from other sources. Other strategies related to knowledge translation need to be attempted and researched in this clinical setting such as the use of opinion leaders, audits and feedback, small group consensus, provider reminder systems, incentives, clinical information systems, and computer decision support systems. CLINICAL RELEVANCE: This national effort to improve EBP did reap some rewards; however, other knowledge translation strategies should be used to further improve clinical practice.