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Since serious problematic cases regarding the technical safety of technically demanding operations were reported in Japan, the Ministry of Health, Labor and Welfare issued new regulations on June 10, 2016 requiring each hospital to check the status of informed consent, skill of surgery team and governance system of the surgical unit, when the highly difficult new medical technologies were introduced to a hospital. In order to firmly establish this new system for highly difficult new medical technologies, it is very important and informative to survey the current situation for guidelines and consensus regarding introduction of medical technology with special skills in Japan and overseas. Based on the survey of questionnaires, document retrieval, and expert interviews, we found that documentation related to the introduction process of highly difficult medical technologies is very rare, and the regulations were mainly issued by academic societies. Moreover, even if such documentation existed, the quality of the regulations is poor and not sufficient enough to perform surgical practice safely. Therefore, for medical practitioners, comprehensive and concrete regulations should be issued by the government or ministry to legally follow in regard to technically demanding operations. A new practice guideline was proposed by our special research group to regulate the introduction process of highly difficult new medical technologies in hospitals in Japan. This guideline, gained understanding from relevant academic societies, provided a comprehensive view on the interpretation of "high difficulty new medical technology" prescribed by the law and show the basic idea at a preliminary examination from the viewpoints of "Surgeon's requirement", "Guidance system", "Medical safety" , and "Informed consent". These efforts will contribute to the improvement of the quality of guidelines regarding "highly difficult new medical technology".

Co-management arrangements can be a very effective means of aligning physicians and their hospitals to gain care delivery efficiencies, control costs, and reduce variation in practices. In an era of value-based care delivery all aspects must be examined and the appropriate incentives put in place to reduce waste and optimize asset and resource utilization. This article will review legal considerations, define basic co-management structure and goals, and suggest examples of metrics used to achieve success.

Women's workplaces should guarantee healthy pregnancies while supporting pregnant women as workers. In Québec (Canada), a pregnant worker exposed to a "danger" for herself or her fetus may ask her employer to be reassigned to other work appropriate to her skills. This approach differs from other regulatory contexts in North America in that protection of fetal and maternal health is embedded in the health and safety legislation. The advantage is that the pregnant worker is guaranteed access to her full salary, but some may question whether specific provisions for pregnant women single out such women and produce risks for their careers or, conversely, pregnancy should receive even more special consideration. These questions are discussed using the results of a qualitative analysis of interviews with pregnant nurses, their supervisors, and their union representatives in ten hospitals in Québec. We think that the management of pregnancy under this legislation generally protects health, but that, in the absence of true employer commitment to the health of all workers, undue burdens may be placed upon other members of the work team. Résumé Les lieux de travail des femmes devraient garantir des grossesses saines tout en soutenant les femmes enceintes en tant que travailleurs. Au Québec (Canada), une travailleuse enceinte exposée à un danger pour elle-même ou son fœtus peut demander à son employeur d'être réaffectée à d'autres tãches sans danger et adaptéches à ses compétences. Cette approche diffère des autres contextes réglementaires en Amérique du Nord en ce sens que la protection de la santé foetale et maternelle est intégrée dans la législation sur la santé et la sécurité. Certains peuvent se demander si des dispositions spécifiques pour les femmes enceintes singularisent ces travailleuses et contribuent à la précarisation de leur emploi. Ou, à l'inverse, si la grossesse devrait recevoir une considération encore plus spéciale. Ces questions sont discutées à la lumière du récit d infirmières enceintes, de gestionnaires et de représentants syndicaux responsables des dossiers de conciliation travail-grossesse dans dix hôpitaux du Québec. Nous constatons que la gestion de la grossesse en vertu de cette législation est généralement protectrice de la santé, mais qu'en l'absence d'un véritable engagement de l'employeur envers la santé de tous les travailleurs, des charges excessives peuvent être imposées aux autres membres de l'équipe de travail.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Aim of the study: The German legislature reacted to the increasing number of nosocomial infections with a set of laws to strengthen hospital hygiene. The aim of the study is to measure the current and future importance of hospital hygiene in Germany. Methods: CEOs and hygiene staff from German hospitals took part in a survey on 13 items regarding the current and future importance of hospital hygiene. Statistical analyses were conducted to identify significances regarding the professional groups. Results: The results of the study show that hospital hygiene is currently of high importance and will be rising in the future. Hospital hygiene has a high economic impact, especially as a competitive factor. The patients' fear to suffer from a nosocomial infection, especially caused by multi-resistant bacteria, is countered with intensive educational work. Conclusion: The results demonstrate that the legislators' efforts are taken note of in German hospitals and the future strategic impact of hospital hygiene in a pay-for-performance reimbursement system has become clear., (© Georg Thieme Verlag KG Stuttgart · New York.)

Unlabelled: Sustainable management of hospital waste requires an active involvement of all key players. This study aims to test the hypothesis that three motivating factors, namely, Reputation, Liability, and Expense, influence hospital waste management. The survey for this study was conducted in two phases, with the pilot study used for exploratory factor analysis and the subsequent main survey used for cross-validation using confirmatory factor analysis. The hypotheses were validated through one-sample t tests. Correlations were established between the three motivating factors and organizational characteristics of hospital type, location, category, and size. The hypotheses were validated, and it was found that the factors of Liability and Expense varied considerably with respect to location and size of a hospital. The factor of Reputation, however, did not exhibit significant variation. In conclusion, concerns about the reputation of a facility and an apprehension of liability act as incentives for sound hospital waste management, whereas concerns about financial costs and perceived overburden on staff act as disincentives., Implications: This paper identifies the non economic motivating factors that can be used to encourage behavioral changes regarding waste management at hospitals in resource constrained environments. This study discovered that organizational characteristics such as hospital size and location cause the responses to vary among the subjects. Hence a policy maker must take into account the institutional setting before introducing a change geared towards better waste management outcomes across hospitals. This study covers a topic that has hitherto been neglected in resource constrained countries. Thus it can be used as one of the first steps to highlight and tackle the issue.

Background: The Hospital Readmissions Reduction Program, which is included in the Affordable Care Act (ACA), applies financial penalties to hospitals that have higher-than-expected readmission rates for targeted conditions. Some policy analysts worry that reductions in readmissions are being achieved by keeping returning patients in observation units instead of formally readmitting them to the hospital. We examined the changes in readmission rates and stays in observation units over time for targeted and nontargeted conditions and assessed whether hospitals that had greater increases in observation-service use had greater reductions in readmissions., Methods: We compared monthly, hospital-level rates of readmission and observation-service use within 30 days after hospital discharge among Medicare elderly beneficiaries from October 2007 through May 2015. We used an interrupted time-series model to determine when trends changed and whether changes differed between targeted and nontargeted conditions. We assessed the correlation between changes in readmission rates and use of observation services after adoption of the ACA in March 2010., Results: We analyzed data from 3387 hospitals. From 2007 to 2015, readmission rates for targeted conditions declined from 21.5% to 17.8%, and rates for nontargeted conditions declined from 15.3% to 13.1%. Shortly after passage of the ACA, the readmission rate declined quickly, especially for targeted conditions, and then continued to fall at a slower rate after October 2012 for both targeted and nontargeted conditions. Stays in observation units for targeted conditions increased from 2.6% in 2007 to 4.7% in 2015, and rates for nontargeted conditions increased from 2.5% to 4.2%. Within hospitals, there was no significant association between changes in observation-unit stays and readmissions after implementation of the ACA., Conclusions: Readmission trends are consistent with hospitals' responding to incentives to reduce readmissions, including the financial penalties for readmissions under the ACA. We did not find evidence that changes in observation-unit stays accounted for the decrease in readmissions.

The National Assembly of Lao People's Democratic Republic (Laos) approved the Health Sector Reform Strategy in 2012, which called for an assessment as to whether Laos should introduce hospital autonomy, and if so, in which ways. The purpose of this study is to assess the status quo of hospital governance in Laos and propose policy suggestions for hospital autonomy in the country. We formulated an analytic framework for hospital autonomy based on previous work by other researchers, collected qualitative data through key informant interviews and focus group discussions, and also performed secondary data analysis. Public hospitals in Laos enjoyed some informal autonomy with little accountability and Laos is facing key challenges of hospital governance. As a result, introducing hospital autonomy in Laos could bring risks, benefits and debates. Before Laos decides on granting autonomy to its public hospitals, we strongly suggest that the government do pilot in selected public hospitals with well-regulated governance framework first and conduct rigorous evaluations to examine whether the granted autonomy leads to the intended social goals of equity, quality, efficiency and sustainability. We recommend residual claimants should be monitored by the government and by the society with open and transparent approach, and active measures should be taken to improve performance and ensure social functions. The study findings may also provide some suggestions for low- and middle-income countries, which are contemplating the introduction of hospital autonomy in the public sector. Copyright © 2015 John Wiley & Sons, Ltd., (Copyright © 2015 John Wiley & Sons, Ltd.)

Monitoring hospitals performance is evolving over time in search of more efficiency by integrating additional levels of care, reducing costs and keeping staff up-to-date. To fulfill these three potentially divergent aspects and to monitor performance, healthcare administrators are using dissimilar management control tools. To explain why, we suggest to go beyond traditional contingent factors to assess the role of the different stakeholders that are at the heart of any healthcare organization. We rely first on seminal studies to appraise the role of the main healthcare players and their influence on some organizational attributes. We then consider the managerial awareness and the perception of a suitable management system to promote a strategy-focused organization. Our methodology is based on a qualitative approach of twenty-two case studies, led in two heterogeneous environments (Belgium and Lebanon), comparing the managerial choice of a management system within three different healthcare organizational structures. Our findings allow us to illustrate, for each healthcare player, his positioning within the healthcare systems. Thus, we define how his role, perception and responsiveness manipulate the organization's internal climate and shape the design of the performance monitoring systems. In particular, we highlight the managerial role and influence on the choice of an adequate management system.

Speaking of the public response to the deaths of children at the Bristol Royal Infirmary before 2001, the BMJ commented that the NHS would be 'all changed, changed utterly'. Today, two inquiries into the Mid Staffordshire Foundation Trust suggest nothing changed at all. Many patients died as a result of their care and the stories of indifference and neglect there are harrowing. Yet Bristol and Mid Staffordshire are not isolated reports. In 2011, the Health Services Ombudsman reported on the care of elderly and frail patients in the NHS and found a failure to recognise their humanity and individuality and to respond to them with sensitivity, compassion and professionalism. Likewise, the Care Quality Commission and Healthcare Commission received complaints from patients and relatives about the quality of nursing care. These included patients not being fed, patients left in soiled bedding, poor hygiene practices, and general disregard for privacy and dignity. Why is there such tolerance of poor clinical standards? We need a better understanding of the circumstances that can lead to these outcomes and how best to respond to them. We discuss the findings of these and other reports and consider whether attention should be devoted to managing individual behaviour, or focus on the systemic influences which predispose hospital staff to behave in this way. Lastly, we consider whether we should look further afield to cognitive psychology to better understand how clinicians and managers make decisions?, (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: Human resource deficit is an important management problem in Chilean public hospitals., Aim: To analyze the adequacy of Nutritionist (Dietician) resources in public hospitals., Material and Methods: A questionnaire about Nutritionist resources was sent to head Nutritionists of all public Chilean hospitals, asking about the number of Nutritionists per service, number of hospital beds and number of daily rations served. Results were analyzed based on the Technical Guideline about Nutritional and Feeding Services of public hospitals issued by the Chilean Ministry of Health in 2005., Results: According to the guideline, there should be 1,396 nutritionists working in public hospitals and the results of the survey showed that there were only 603 professionals with a 57% deficit., Conclusions: There is a huge gap between the amount of Nutritionists (Dieticians) required and those effectively working in public hospitals.

Antitrust enforcement has a crucial role to play in consolidated health care markets as providers undertake mergers, acquisitions, and other types of collaborations to integrate care and achieve greater size and scale. But antitrust enforcers and policy makers need to refine their approach in two fundamental ways. First, in addition to focusing on whether particular transactions or conduct will increase prices above competitive levels, a more pressing concern should be on assuring that health care markets are conducive to fundamental changes in how care is reimbursed and delivered - that is, the impact on payment and health care delivery innovation. Second, it is important to recognize the practical limits that apply to antitrust enforcement, both in terms of existing law and precedent and the constrained resources available to government enforcers. Government resources can be leveraged substantially through greater collaboration among federal and state antitrust enforcers, government payers, health care regulators, and economists and other policy makers. This can result in not only better-targeted antitrust enforcement actions but also payment and regulatory initiatives that can produce better-functioning and more competitive health care markets., (Copyright © 2015 by Duke University Press.)

Background: This contribution is a response to the current issue of corporate governance in hospitals in the Czech Republic, which draw a significant portion of funds from public health insurance. This not only has a significant impact on the economic efficiency of hospitals, but ultimately affects the whole system of healthcare provision in the Czech Republic. Therefore, the effectiveness of the corporate governance of hospitals might affect the fiscal stability of the health system and, indirectly, health policy for the whole country., Objectives: The main objective of this paper is to evaluate the success of the transformation in connection with the performance of corporate governance in hospitals in the Czech Republic. Specifically, there was an examination of the management differences in various types of hospitals, which differed in their ownership structure and legal form., Methodology/approach: A sample of 100 hospitals was investigated in 2009, i.e., immediately after the transformation had been completed, and then three years later in 2012. With regard to the different public support of individual hospitals, the operating subsidies were removed from the economic results of the corporations in the sample. The adjusted economic results were first of all examined in relationship to the type of hospital (according to owner and legal form), and then in relation to its size, the size of the supervisory board and the education level of the senior hospital manager. A multiple median regression was used for the evaluation., Findings: One of the basic findings was the fact that the hospital's legal form had no influence on economic results. Successful management in the form of adjusted economic results is only associated with the private type of facility ownership. From the perspective of our concept of corporate governance other factors were under observation: the size of the hospital, the size of the supervisory board and the medical qualifications of the senior manager had no statistically verifiable influence on the efficiency of the hospital management, though we did record certain developments as a result of the transformation process. The economic results that were reported were significantly distorted by the operating subsidies from the founder., Practical Implications: The results can be used immediately on several practical levels: on the macro level as part of the state's formulation of health policy, particularly in the optimization of the structure of healthcare providers, as well as for the completion of reforms in legal forms and hospital founders, and on the micro level as part of the effective administration and governance of hospitals through corporate governance regardless of the form of ownership., (Copyright © 2015 Elsevier Ireland Ltd. All rights reserved.)

The purpose of this study was to determine the effect of tort reform and quality improvement measures on medical liability claims in 2 groups of hospitals within the same multihospital organization: one in Texas, which implemented medical liability tort reform caps on noneconomic damages in 2003, and one in Louisiana, which did not undergo significant tort reform during the same time period. Significant reduction in medical liability claims per quarter in Texas was found after tort reform implementation (7.27 to 1.4; P<.05). A significant correlation was found between the increase in mean Centers for Medicare & Medicaid Services performance score and the decrease in the frequency of claims observed in Louisiana (P<.05). Although tort reform caps on noneconomic damages in Texas caused the largest initial decrease, increasing quality improvement measures without increasing financial burden also decreased liability claims in Louisiana. Uniquely, this study showed that increasing patient quality resulted in decreased medical liability claims., (© 2014 by the American College of Medical Quality.)

This study aimed to enhance understanding of the dimensions of accountability captured and not captured in acute care hospitals in Ontario, Canada. Based on an Ontario-wide survey and follow-up interviews with three acute care hospitals in the Greater Toronto Area, we found that the two dominant dimensions of hospital accountability being reported are financial and quality performance. These two dimensions drove both internal and external reporting. Hospitals' internal reports typically included performance measures that were required or mandated in external reports. Although respondents saw reporting as a valuable mechanism for hospitals and the health system to monitor and track progress against desired outcomes, multiple challenges with current reporting requirements were communicated, including the following: 58% of survey respondents indicated that performance-reporting resources were insufficient; manual data capture and performance reporting were prevalent, with the majority of hospitals lacking sophisticated tools or technology to effectively capture, analyze and report performance data; hospitals tended to focus on those processes and outcomes with high measurability; and 53% of respondents indicated that valuable cross-system accountability, performance measures or both were not captured by current reporting requirements., (Copyright © 2014 Longwoods Publishing.)

Ontario's acute care hospitals are subject to a number of tools, including legislation and performance measurement for fiscal accountability and accountability for quality. Examination of accountability documents used in Ontario at the government, regional and acute care hospital levels reveals three trends: (a) the number of performance measures being used in the acute care hospital sector has increased significantly; (b) the focus of the health system has expanded from accountability for funding and service volumes to include accountability for quality and patient safety; and (c) the accountability requirements are misaligned at the different levels. These trends may affect the success of the accountability approach currently being used., (Copyright © 2014 Longwoods Publishing.)

In order for a trauma surgeon to have an intelligent discussion with hospital administrators, healthcare plans, policymakers, or any other physicians, a basic understanding of the fundamentals of healthcare is paramount. It is truly shocking how many surgeons are unable to describe the difference between Medicare and Medicaid or describe how hospitals and physicians get paid. These topics may seem burdensome but they are vital to all business decision making in the healthcare field. The following chapter provides further insight about what we call "the basics" of providing medical care today. Most of the topics presented can be applied to all specialties of medicine. It is broken down into 5 sections. The first section is a brief overview of government programs, their influence on care delivery and reimbursement, and past and future legislation. Section 2 focuses on the compliance, care provision, and privacy statutes that regulate physicians who care for Medicare/Medicaid patient populations. With a better understanding of these obligations, section 3 discusses avenues by which physicians can stay informed of current and pending health policy and provides ways that they can become involved in shaping future legislation. The fourth section changes gears slightly by explaining how the concepts of trade restraint, libel, antitrust legislation, and indemnity relate to physician practice. The fifth, and final, section ties all of components together by describing how physician-hospital alignment can be mutually beneficial in providing patient care under current healthcare policy legislation.

Objectives: To report on what doctors at very different levels of seniority wrote, in their own words, about their concerns about the European Working Time Directive (EWTD) and its implementation in the National Health Service (NHS)., Design: All medical school graduates from 1993, 2005 and 2009 were surveyed by post and email in 2010., Setting: The UK., Methods: Using qualitative methods, we analysed free-text responses made in 2010, towards the end of the first year of full EWTD implementation, of three cohorts of the UK medical graduates (graduates of 1993, 2005 and 2009), surveyed as part of the UK Medical Careers Research Group's schedule of multipurpose longitudinal surveys of doctors., Results: Of 2459 respondents who gave free-text comments, 279 (11%) made unprompted reference to the EWTD; 270 of the 279 comments were broadly critical. Key themes to emerge included frequent dissociation between rotas and actual hours worked, adverse effects on training opportunities and quality, concerns about patient safety, lowering of morale and job satisfaction, and attempts reportedly made in some hospitals to persuade junior doctors to collude in the inaccurate reporting of compliance., Conclusions: Further work is needed to determine whether problems perceived with the EWTD, when they occur, are attributable to the EWTD itself, and shortened working hours, or to the way that it has been implemented in some hospitals.

Changes in modern societies originate the perception that ethical behaviour is essential in organization's practices especially in the way they deal with aspects such as human rights. These issues are usually under the umbrella of the concept of social responsibility. Recently the Report of the International Bioethics Committee of UNESCO on Social Responsibility and Health has addressed this concept of social responsibility in the context of health care delivery suggesting a new paradigm in hospital governance. The objective of this paper is to address the issue of corporate social responsibility in health care, namely in the hospital setting, emphasising the special governance arrangements of such complex organisations and to evaluate if new models of hospital management (entrepreneurism) will need robust mechanisms of corporate governance to fulfil its social responsiveness. The scope of this responsible behaviour requires hospitals to fulfil its social and market objectives, in accordance to the law and general ethical standards. Social responsibility includes aspects like abstention of harm to the environment or the protection of the interests of all the stakeholders enrolled in the deliverance of health care. In conclusion, adequate corporate governance and corporate strategy are the gold standard of social responsibility. In a competitive market hospital governance will be optimised if the organization culture is reframed to meet stakeholders' demands for unequivocal assurances on ethical behaviour. Health care organizations should abide to this new governance approach that is to create organisation value through performance, conformance and responsibility.

Objective: To determine whether, following implementation of California's minimum nurse staffing legislation, changes in acuity-adjusted nurse staffing and quality of care in California hospitals outpaced similar changes in hospitals in comparison states without such regulations., Data Sources/study Setting: Data from the American Hospital Association Annual Survey of Hospitals, the California Office of Statewide Health Planning and Development, the Hospital Cost Report Information System, and the Agency for Healthcare Research and Quality's Health Care Cost and Utilization Project's State Inpatient Databases from 2000 to 2006., Study Design: We grouped hospitals into quartiles based on their preregulation staffing levels and used a difference-in-difference approach to compare changes in staffing and in quality of care in California hospitals to changes over the same time period in hospitals in 12 comparison states without minimum staffing legislation., Data Collection/extraction Methods: We merged data from the above data sources to obtain measures of nurse staffing and quality of care. We used Agency for Healthcare Research and Quality's Patient Safety Indicators to measure quality., Principal Findings: With few exceptions, California hospitals increased nurse staffing levels over time significantly more than did comparison state hospitals. Failure to rescue decreased significantly more in some California hospitals, and infections due to medical care increased significantly more in some California hospitals than in comparison state hospitals. There were no statistically significant changes in either respiratory failure or postoperative sepsis., Conclusions: Following implementation of California's minimum nurse staffing legislation, nurse staffing in California increased significantly more than it did in comparison states' hospitals, but the extent of the increases depended upon preregulation staffing levels; there were mixed effects on quality., (© Health Research and Educational Trust.)