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BACKGROUND: Pandemic management and preparedness are more needed than ever before and there is widespread governmental interest in learning from the COVID-19 pandemic in order to ensure the availability of evidence-based Infection Prevention and Control measures. Contact tracing is integral to Infection Prevention and Control, facilitating breaks in the chain of transmission in a targeted way, identifying individuals who have come into contact with an infected person, and providing them with instruction/advice relating to testing, medical advice and/or self-isolation. AIM: This study aims to improve our understanding of the use of contact tracing technologies in healthcare settings. This research seeks to contribute to the field of Infection Prevention and Control by investigating how these technologies can mitigate the spread of nosocomial infections. Ultimately, this study aims to improve the quality and safety of healthcare delivery. METHODS: A systematic literature review was conducted, and journal articles investigating the use of contact tracing technologies in healthcare settings were retrieved from databases held on the OvidSP platform between March and September 2022, with no date for a lower limit. RESULTS: In total, 277 studies were retrieved and screened, and 14 studies were finally included in the systematic literature review. Most studies investigated proximity sensing technologies, reporting promising results. However, studies were limited by small sample sizes and confounding factors, revealing contact tracing technologies remain at a nascent stage. Investment in research and development of new testing technologies is necessary to strengthen national and international contact tracing capabilities. CONCLUSION: This review aims to contribute to those who intend to create robust surveillance systems and implement infectious disease reporting protocols.

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In recent years, the concept of despotic leadership has garnered considerable attention in sports. Despotic leadership significantly reflecting leaders' deviant behavior has today heightened the risk of health hazards in the workplace. In addition, the perceived organizational politics have also yielded a deleterious result on employees' well-being. In the dynamic landscape of healthcare, understanding the implications of organizational behavior on well-being is paramount for risk management. This study elucidates the relationships between despotic leadership, perceived organizational politics, workplace incivility, emotional exhaustion, person-organization unfit, and health harm, which can pose significant risks in a healthcare setting. The quantitative study was conducted using an empirical survey with respondents representing sports organizations. A Partial Least Squares Structural Equation Model (PLS-SEM) was used to analyze data from 429 participants using Smart PLS. The study findings suggest that despotic leadership and perceived organizational politics can lead to increased risks, manifested as workplace incivility, emotional exhaustion, and person-organization unfit. These organizational risks subsequently translate to tangible health harm for employees. Mediation analyses revealed that workplace incivility, emotional exhaustion, and person-organization unfit mediate the detrimental health outcomes rooted in leadership and organizational politics. The study underscores the urgent need for risk management strategies to foster a healthier organizational culture and leadership approach in healthcare settings. This will ensure enhanced employee well-being and a reduction in associated health risks, thus aligning with best practices in healthcare policy.

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This article looks at Healthcare and the issues that exist with current cybersecurity measures. As hacks including ransomware attacks become more commonplace it is important to provide safeguards to protect the data of the patients and the healthcare organization. Examples of breaches are looked at with insights on how they happened and what could have been done to prevent them. A newer approach known as Zero-Trust which addresses 7 key areas to protect is reviewed and shown how its applicability to healthcare can make a difference in protecting individuals and organizations.

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Objetivo El objetivo de este estudio es la implementación en una Unidad de Radiofarmacia Hospitalaria de una metodología de análisis de riesgos para poder identificar de forma proactiva los posibles modos de fallo y priorizar medidas correctivas. Material y métodos Mediante el análisis modal de fallos y efectos (AMFE) se identificaron los posibles modos de fallo de cada una de las etapas de los procesos de prescripción, preparación y administración de los radiofármacos de diagnóstico y de terapia. A partir de las variables de severidad, probabilidad y detectabilidad se cuantificó el riesgo mediante el número de prioridad de riesgo (NPR) para cada modo de fallo, subproceso y tipo de radiofármaco. Se establecieron medidas de mejora y se calculó la reducción en el NPR. Resultados Se identificaron 96 modos de fallos (58 para los radiofármacos de diagnóstico y 38 para los de terapia). La identificación biunívoca del paciente con el radiofármaco es el modo de fallo con mayor NPR (60) y el subproceso de marcaje celular el que presenta mayor riesgo (NPR 286). Como resultado de las medidas de mejora se disminuyó el NPR global en un 22% para los radiofármacos de diagnóstico y 20% para los de terapia. Esta reducción sería del 46 y el 31%, respectivamente, si se implantara un software de radiofarmacia y tecnología de código de barras en la administración. Conclusiones La aplicación de la metodología AMFE como herramienta de análisis de riesgos permite identificar los puntos críticos de los procesos relacionados con los radiofármacos y priorizar medidas para disminuir el riesgo (AU)

Aim The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. Materials and methods By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. Result A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. Conclusions The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk (AU)

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The development and administration of vaccines against COVID-19 was a key element in the fight against the pandemic, as it protected health systems and helped restore global economies. National implementation plans and vaccination strategies for COVID-19 vaccines ensured the immunization of large segments of the population in the shortest time. However, even before the start of the vaccination campaign, it was clear to decision-makers that the usual methods of vaccination were not suitable. The aim of this report is to share the experience of an Italian teaching hospital in the organisation of spaces and activities of healthcare workers to realise a safe vaccination campaign. An in-depth analysis of how the vaccination campaign was organised could be useful to understand strengths and weaknesses learnt from this experience and plan an effective, efficient, and resilient response to future pandemics right away. The adoption of a systemic clinical risk management (SCRM) could guarantee healthcare organizations a more adequate and resilient response in an ethics of a job well done perspective, allowing them to maintain high patient safety standards regardless of the contingent situation for which safety first should be the motto of a disaster response plan.

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During the Covid-19 health emergency, telemedicine was an essential asset through which health systems strengthened their response during the critical phase of the pandemic. According to the post-pandemic economic reform plans of many countries, telemedicine will not be limited to a tool for responding to an emergency condition but it will become a structural resource that will contribute to the reorganization of Healthcare Systems and enable the transfer of part of health care from the hospital to the home-based care. However, scientific evidences have shown that health care delivered through telemedicine can be burdened by numerous ethical and legal issues. Although there is an emerging discussion on patient safety issues related to the use of telemedicine, there is a lack of reseraches specifically designed to investigate patient safety. On the contrary, it would be necessary to determine standards and specific application rules in order to ensure safety. This paper examines the telemedicine-risk profiles and proposes a position statement for clinical risk management to support continuous improvement in the safety of health care delivered through telemedicine.

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AIM: The aim of this study is the implementation in a Hospital Radiopharmacy Unit of a risk analysis methodology in order to proactively identify possible failure modes and prioritize corrective measures. MATERIALS AND METHODS: By means of the failure modes and effects analysis (FMEA), the possible failure modes of each of the stages of the processes of prescription, preparation, and administration of radiopharmaceuticals for diagnostic and therapy were identified. From the variables of severity, probability and detectability, the risk was quantified using the Risk Priority Number (RPN) for each failure mode, sub-process, and type of radiopharmaceutical. Improvement measures were established and the reduction in the RPN value was calculated. RESULTS: A total of 96 failure modes were identified (58 for diagnostic radiopharmaceuticals and 38 for therapy). Biunivocal identification of the patient with the radiopharmaceutical is the failure mode with the highest RPN (60) and the radiolabeling cell sub-process the one that has the highest risk (RPN 286). As a result of the improvement measures, the overall RPN was reduced by 22% for diagnostic radiopharmaceuticals and 20% for therapy. This reduction would be 46% and 31% respectively if radiopharmacy software and a barcode technology in the administration were implemented. CONCLUSIONS: The application of the FMEA methodology as a risk analysis tool allows to identify the critical points of the processes related to radiopharmaceuticals and prioritize measures to reduce the risk.

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PURPOSE: A risk assessment matrix is a widely used tool for analyzing, assessing and setting priorities in risk management in many fields. This paper overviews critical variables, advantages, disadvantages, strengths and weaknesses of this tool, according to the ISO 31000 risk management framework. RESULTS: Risk assessment is one of the key stages in the Risk Management Process and involves specific steps: identifying hazards, analyzing and evaluating all possible risks. Several methods are developed to assess risks in the literature. A risk matrix method, also called "decision matrix risk assessment (DMRA) technique", is a systematic approach used to determine the risk level and to compare different risks and define which threats need to be controlled first. The actors involved in risk assessment are called on to manage different issues related to the choice of the most appropriate methodological approach, the assessment of the adequacy of the existing control measures, the articulation of risk consequence domains, the definition of the impact-consequences, the explanation of risk likelihood scales and the development of a risk matrix. CONCLUSION: We highlighted a number of recommendations in order to address these issues, especially useful when healthcare organizations provide insufficient guidance on how to use risk matrices as well as what to do in response to the existing criticisms on their use.

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BACKGROUND: The disease caused by the novel coronavirus SARS-CoV-2 has rapidly spread escalating the situation to an international pandemic. The absence of a vaccine or an efficient treatment with enough scientific evidence against the virus has generated a healthcare crisis of great magnitude. The precautionary principle justifies the selection of the recommended medicines, whose demand has increased dramatically. METHODS: we carried out an analysis of the healthcare risk management and the main measures taken by the state healthcare authorities to a possible shortage of medicines in the most affected countries of the European Union: Spain, France, Italy and Germany. RESULTS: the healthcare risk management in the European Union countries is carried out based on the precautionary principle, as we do not have enough scientific evidence to recommend a specific treatment against the new virus. Some measures aimed to guarantee the access to medicines for the population has been adopted in the most affected countries by the novel coronavirus. CONCLUSIONS: in Spain, Italy and Germany, some rules based on the precautionary principle were pronounced in order to guarantee the supply of medicines, while in France, besides that, the competences of pharmacists in pharmacy offices have been extended to guarantee the access to medicines for the population.

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This study aimed at assessing the knowledge about healthcare risk waste (HCRW) management among doctors, professional nurses, pharmacists and laboratory technicians, in accordance with National Environmental Management, Waste Act 59 of 2008, Constitution of South Africa and sustainable development goals (SDG). The quantitative cross-sectional study was conducted, using self-administered questionnaires and stratified random sampling was used. Data was analyzed using the descriptive and inferential statistics. One hundred and forty-four participants were included in the study. The majority 90.28% of the participants were aged 19-50 years, females (71%), professional nurses (36%), and they had 1-10 years of experience (71%). The health professionals were knowledgeable of sharps waste (89%), slightly over (52%) knew anatomical waste, whereas (27%) and (17%) knew radioactive and cytotoxic waste, respectively. Health professionals (92%) agreed that the sharps-waste container should be disposed of in a yellow bin container, at least (63%) and (27%) agreed that red liner and box should be used for both infectious non anatomical waste and for cytotoxic waste. The null hypothesis was tested on knowledge versus age, profession and gender, and evidence against it was found on waste storage period in all three variables where chi-square and Fisher exact p-values were less than the 5% significant level. More attention should be directed towards similar HCRW management training at the hospital for all health professionals and behavior modification. The hospital management must ensure that HCRW-trained health professionals and HCRW management officials put into practice what they have learnt.

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RATIONALE, AIMS, AND OBJECTIVES: Failure mode and effects analysis (FMEA) is a valuable reliability management tool that can preemptively identify the potential failures of a system and assess their causes and effects, thereby preventing them from occurring. The use of FMEA in the healthcare setting has become increasingly popular over the last decade, being applied to a multitude of different areas. The objective of this study is to review comprehensively the literature regarding the application of FMEA for healthcare risk analysis. METHODS: An extensive search was carried out in the scholarly databases of Scopus and PubMed, and we only chose the academic articles which used the FMEA technique to solve healthcare risk analysis problems. Furthermore, a bibliometric analysis was performed based on the number of citations, publication year, appeared journals, authors, and country of origin. RESULTS: A total of 158 journal papers published over the period of 1998 to 2018 were extracted and reviewed. These publications were classified into four categories (ie, healthcare process, hospital management, hospital informatization, and medical equipment and production) according to the healthcare issues to be solved, and analyzed regarding the application fields and the utilized FMEA methods. CONCLUSION: FMEA has high practicality for healthcare quality improvement and error reduction and has been prevalently employed to improve healthcare processes in hospitals. This research supports academics and practitioners in effectively adopting the FMEA tool to proactively reduce healthcare risks and increase patient safety, and provides an insight into its state-of-the-art.

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In an effort to emphasize the practical importance of patient safety to the next generation of podiatric surgeons, a short healthcare risk management seminar was implemented. The purpose of this course is to demonstrate how safer and more quality oriented practices such as better provider-patientcommunication can help reduce the risk of medical malpractice cases.

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Waste generated form healthcare facilities is a potential source of health risks to the public, if it is not properly handled from the point of generation to disposal. This study was conducted to assess the efficiency of healthcare risk waste (HCRW) management in Vhembe District of Limpopo Province, South Africa. Fifteen healthcare facilities were selected in Vhembe District for this study. Data were obtained through in-depth interviews, semi-structured questionnaires, observation and pictures. Qualitative data were thematically analyzed, while the quantitative data were analyzed using the Statistical Package for the Social Sciences, version 25. In all the healthcare facilities; mismanagement of HCRW was noted at different points along the management chain. Poor segregation, overfilling of waste bins, inappropriate transportation and storage of waste in substandard storage rooms were observed in the facilities. All the waste from the district are transported to a private-owned treatment facility outside the district, where they are mainly incinerated. Enforcement of healthcare risk waste guidelines, provision of standardized equipment for temporary storage, empowerment of each healthcare facility to treat at least some of the waste, and employment of non-burn techniques for treatment of waste are recommended for more efficient management of healthcare risk waste in Vhembe District.

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OBJECTIVE: In this study, we conducted a numerical analysis of exposure to electromagnetic fields (EMFs) in a hospital's intensive care unit that is one of the most crucial one in terms of hazardous areas among all service units. This is a new study for measuring exposure to EMFs in an intensive care unit as well as other healthcare services in Turkey. METHODS: We measured the EMFs in the intensive care unit with a SRM-3006 (selective radiation metre), which was used for measurement of the absolute and the limit values of high frequency EMFs. The measurement points were chosen to represent the highest levels of exposure to which a person might be subjected. We obtained a dataset that included 5929 observations, with 96 extreme values, through measuring the magnetic field in terms of V/m. RESULTS: The measurements show the frequency varies from 47 MHz to 2.5 GHz as 17 frequency ranges at the measurement point as well. According to these findings, the referenced maximum safety limit was not exceeded. However, it was also found that mobile telecommunication was the most critical cause of magnetic fields. CONCLUSION: Further studies need to be performed with different frequency antennas to assess the EMFs in intensive care units.

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[This corrects the article on p. 357 in vol. 6, PMID: 26858745.].

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BACKGROUND: In healthcare, a range of methods are used to improve patient safety through risk identification within the scope of risk management. However, there is no evidence determining what trust-level guidance exists to support risk identification in healthcare organisations. This study therefore aimed to determine such methods through the content analysis of trust-level risk management documents. METHOD: Through Freedom of Information Act, risk management documents were requested from each acute, mental health and ambulance trust in the East of England region of NHS for content analysis. Received documents were also compared with guidance from other safety-critical industries to capture differences between the documents from those industries, and learning points to the healthcare field. RESULTS: A total of forty-eight documents were received from twenty-one trusts. Incident reporting was found as the main method for risk identification. The documents provided insufficient support for the use of prospective risk identification methods, such as Prospective Hazard Analysis (PHA) methods, while the guidance from other industries extensively promoted such methods. CONCLUSION: The documents provided significant insight into prescribed risk identification practice in the chosen region. Based on the content analysis and guidance from other safety-critical industries, a number of recommendations were made; such as introducing the use of PHA methods in the creation and revision of risk management documents, and providing individual guidance on risk identification to promote patient safety further.

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Healthcare risks and clinical risks have been recognized as a major challenge in healthcare. Clinical risks can never be eliminated and can have serious adverse effects on patient safety. Thus, a clinical risk management (CRM) system has been introduced in the healthcare system to improve quality services. The aim of this study was to explore nurses' experiences related to the challenges of implementing CRM in the organizational context. This qualitative study was based on the conventional content analysis of the Lundman and Graneheim approach, and it consisted of 22 interview sessions with 20 nurses. The purposive sampling method was used to choose the participants from three hospitals affiliated with the Kerman University of Medical Sciences. We used semi-structured interviews and review of relevant documents to collect data. The analysis of the data led to the emergence of "rocky milieu" as the main theme, and it consisted of three categories that, along with their subcategories, explain the challenges of implementing CRM. The three categories and their subcategories were (1) organizational culture and leadership challenges (decision and performance of leadership and cultural resistance to change), (2) limitation of resources (financial, human, and physical and equipment resources), and (3) variations and complexities in working conditions (the emotional, psychological, and social atmosphere and the heaviness of workload). Attempts have been made to establish CRM through clinical governance and accreditation, but organizational challenges have created a rocky milieu for implementing CRM. However, from an organizational context concerning the suitability of healthcare in Iran, there are obvious needs to move toward quality improvement and safe practices through the effective implementation of CRM.

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Rapid innovation in (epi)genetics and biomarker sciences is driving a new drug development and product development pathway, with the personalized medicine era dominated by biologic therapeutics and companion diagnostics. Companion diagnostics (CDx) are tests and assays that detect biomarkers and specific mutations to elucidate disease pathways, stratify patient populations, and target drug therapies. CDx can substantially influence the development and regulatory approval for certain high-risk biologics. However, despite the increasingly important role of companion diagnostics in the realization of personalized medicine, in the USA, there are only 23 Food and Drug Administration (FDA) approved companion diagnostics on the market for 11 unique indications. Personalized medicines have great potential, yet their use is currently constrained. A major factor for this may lie in the increased complexity of the companion diagnostic and corresponding therapeutic development and adoption pathways. Understanding the market dynamics of companion diagnostic/therapeutic (CDx/Rx) pairs is important to further development and adoption of personalized medicine. Therefore, data collected on a variety of factors may highlight incentives or disincentives driving the development of companion diagnostics. Statistical analysis for 36 hypotheses resulted in two significant relationships and 34 non-significant relationships. The sensitivity of the companion diagnostic was the only factor that significantly correlated with the price of the companion diagnostic. This result indicates that while there is regulatory pressure for the diagnostic and pharmaceutical industry to collaborate and co-develop companion diagnostics for the approval of personalized therapeutics, there seems to be a lack of parallel economic collaboration to incentivize development of companion diagnostics.

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BACKGROUND: Risk assessment is widely used to improve patient safety, but healthcare workers are not trained to design robust solutions to the risks they uncover. This leads to an overreliance on the weakest category of risk control recommendations: administrative controls. Increasing the proportion of non-administrative risk control options (NARCOs) generated would enable (though not ensure) the adoption of more robust solutions. OBJECTIVES: Experimentally assess a method for generating stronger risk controls: The Generating Options for Active Risk Control (GO-ARC) Technique. METHODS: Participants generated risk control options in response to two patient safety scenarios. Scenario 1 (baseline): All participants used current practice (unstructured brainstorming). Scenario 2: Control group used current practice; intervention group used the GO-ARC Technique. To control for individual differences between participants, analysis focused on the change in the proportion of NARCOs for each group. CONTROL GROUP: Proportion of NARCOs decreased from 0.18 at baseline to 0.12. Intervention group: Proportion increased from 0.10 at baseline to 0.29 using the GO-ARC Technique. Results were statistically significant. There was no decrease in the number of administrative controls generated by the intervention group. CONCLUSION: The Generating Options for Active Risk Control (GO-ARC) Technique appears to lead to more robust risk control options.

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In recent years, the healthcare sector has adopted the use of operational risk assessment tools to help understand the systems issues that lead to patient safety incidents. But although these problem-focused tools have improved the ability of healthcare organizations to identify hazards, they have not translated into measurable improvements in patient safety. One possible reason for this is a lack of support for the solution-focused process of risk control. This article describes a content analysis of the risk management strategies, policies, and procedures at all acute (i.e., hospital), mental health, and ambulance trusts (health service organizations) in the East of England area of the British National Health Service. The primary goal was to determine what organizational-level guidance exists to support risk control practice. A secondary goal was to examine the risk evaluation guidance provided by these trusts. With regard to risk control, we found an almost complete lack of useful guidance to promote good practice. With regard to risk evaluation, the trusts relied exclusively on risk matrices. A number of weaknesses were found in the use of this tool, especially related to the guidance for scoring an event's likelihood. We make a number of recommendations to address these concerns. The guidance assessed provides insufficient support for risk control and risk evaluation. This may present a significant barrier to the success of risk management approaches in improving patient safety.

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