[What regulations have launched autonomous communities to going forward on patient safety culture in healthcare organizations?] / ¿Qué normativas han desarrollado las comunidades autónomas para avanzar en cultura de seguridad del paciente en sus organizaciones sanitarias?

INTRODUCTION: Patient Safety Culture is based on learning from incidents, developing preventive strategies to reduce the likelihood to happen and recognizing and accompanying those who have suffered unnecessary and involuntary harm derived from the health care received. To go ahead on patient safety culture entails facilitating the implementation of these behaviors and attitudes in healthcare professionals. Objective was to describe the regulations of some autonomous communities and national proposals for regulations changes. MATERIAL AND METHODS: Search of normative changes made in the autonomous communities of Catalonia, Navarra and the Basque Country. Proposals for legislative changes at national level were agreed. RESULTS: Activities and normative changes made in the autonomous communities of Catalonia, Navarre and the Basque Country are described and proposals for normative changes at the national level at short-term and long-term changes are made. In such a way that it is easier to advance in creating culture of patient safety in the whole National Health System CONCLUSION: Currently there is no global regulation that facilitates to advance in patient safety culture. Changes at the national legislation level are essential. It is at the Inter-territorial Council where the proposed legislative amendment should be defined, promoted by the representatives of the health systems of the autonomous communities.

Exploring the system capacity to meet occupational health and safety needs: the case of the ready-made garment industry in Bangladesh.

BACKGROUND: Since the 2013 Rana Plaza incident in Bangladesh, the government of Bangladesh has been under pressure to improve health and safety conditions for workers in the ready-made garment industry. Its efforts have focused heavily on structural safety of the buildings but have largely ignored broader occupational health system issues. This qualitative study explores contextual factors and system challenges that create barriers for ensuring a healthy and safe workplace in the ready-made garment industry in Bangladesh. METHODS: Data were collected through key informant interviews (n = 14) with government officials from the Department of Inspection for Factories and Establishments (DIFE), factory employers, factory doctors and representatives from the Bangladesh Garment Manufacturers and Exporters Association (BGMEA). A thematic analysis was conducted using Atlas-ti v 5.2. RESULTS: A thematic analysis suggests that the capacity of the DIFE to provide adequate occupational health services remains a problem. There is a shortage of both appropriately trained staff and equipment to monitor occupational health and safety in factories and to gather useful data for evidence-based decision-making. Another barrier to effective occupational health and safety of workers is the lack of cooperation by employers in recording data on workers' health and safety problems. Finally, government officials have limited resources and power to enforce compliance with regulations. Such deficiencies threaten the health and safety of this important, largely female, working population. CONCLUSION: This case example focused on the valuable ready-made garment industry sector of Bangladesh's economy. It identifies the critical need for occupational health system strengthening. Specifically system capacity needs to be improved by both increasing human resources for in-factory hazards and health monitoring, regulatory inspection, enforcement, and improved training of government officials around monitoring and reporting.

Actions for safety in the prescription, use and administration of medications in emergency care units. / Ações para segurança na prescrição, uso e administração de medicamentos em unidades de pronto atendimento.

OBJECTIVE: To identify what risks and incidents related to the drug therapy process are presented in an Emergency Care Unit (UPA) and to present proposals for management actions and safe practices, in the perception of the nursing team. METHOD: Qualitative research, in the research-action modality, developed in the scenario of UPA, located in the interior of São Paulo. Data collection was done through interviews and focus groups with 33 professionals, between June 2015 and April 2016. For the data treatment, the Content Analysis Technique was used. RESULTS AND DISCUSSION: From the participants' reports, thematic categories were organized, with the risks and incidents related to the drug therapy process being one of the listed categories, as well as proposals for actions. CONCLUSION: The study allowed the implementation of patient safety actions related to the administration of drugs in a PAU, offering a higher quality of care.

Building Road Safety Institutions in Low- and Middle-Income Countries: The Case of Argentina.

Traffic injuries remain a leading health concern in most low- and middle-income countries (LMICs). However, most LMICs have not established institutions that have the legislative mandate and financial resources necessary to coordinate large-scale interventions. Argentina provides a counterexample. Argentina is a federal country where the decentralization of authority to provincial governments was a key barrier to effective national interventions. In 2008, Argentina passed a law establishing a national road safety agency and subsequently received a World Bank loan to build the agency's capacity to coordinate actions. Although traffic injuries in Argentina have not yet begun to decline, these developments raise important questions:Why did Argentina come to view road safety as aproblem?Why was institutional reform the chosen solution? What was the political process for achieving reform? What are the broader implications for institutional reform in LMICs?We explore these questions using a descriptive case study (single-case, holistic design) of Argentina. The case illustrates that focusing events, like the Santa Fe tragedy that killed nine children, and advocacy groups are important for raising political attention and creating an opportunity for legislative reform. It highlights the importance of policy entrepreneurs who used the opportunity to push through new legislation. Though the political dynamic was predominantly local, international actors worked with local advocates to build demand for safety and develop solutions that could be deployed when the opportunity arose. Most important, the case emphasizes the importance of developing institutions with the resources and authority necessary for managing national road safety programs.

Ações para segurança na prescrição, uso e administração de medicamentos em unidades de pronto atendimento / Acciones para la seguridad en la prescripción, consumo y administración de medicamentos en una unidad de pronta atención / Actions for safety in the prescription, use and administration of medications in emergency care units

Resumo OBJETIVO Identificar os riscos e incidentes relacionados ao processo de terapia medicamentosa no cenário de uma Unidade de Pronto Atendimento (UPA) e propor ações de gerenciamento e práticas seguras, na percepção da equipe de enfermagem. MÉTODO Pesquisa qualitativa, na modalidade pesquisa-ação, desenvolvida no cenário de uma UPA, localizada no interior de São Paulo. A coleta dos dados foi realizada por meio de entrevistas e grupos focais com 33 profissionais, entre junho de 2015 a abril de 2016. Para o tratamento dos dados utilizou-se a Técnica de Análise de Conteúdo. RESULTADOS E DISCUSSÃO A partir dos relatos dos participantes foram organizadas categorias temáticas, sendo os riscos e incidentes relacionados ao processo de terapia medicamentosa uma das categorias elencadas, assim como propostas de ações. CONCLUSÃO O estudo possibilitou a implementação de ações de segurança ao paciente relacionadas à administração de medicamentos em uma UPA, oferecendo maior qualidade do cuidado.

Resumen OBJETIVO Identificar cuáles son los riesgos e incidentes relacionados con el proceso de terapia medicamentosa en una Unidad de Pronta Atención (UPA) y presentar propuestas de acciones de gestión y prácticas seguras en la percepción del equipo de enfermería. MÉTODO Investigación cualitativa, en la modalidad investigación-acción, desarrollada en el escenario de una UPA, ubicada en el interior de San Pablo. Se recolectaron los datos a través de entrevistas y grupos focales con 33 profesionales, entre junio de 2015 y abril de 2016. Para procesar los datos, se utilizó la Técnica de Análisis de Contenido. RESULTADOS Y DISCUSIÓN A partir de los relatos de los participantes, se organizaron categorías temáticas, siendo los riesgos e incidentes relacionados al proceso de terapia medicamentosa una de las categorías enumeradas, así como las propuestas de acciones. CONCLUSIÓN El estudio permitió implementar acciones de seguridad del paciente relacionadas con la administración de medicamentos en una UPA, ofreciendo mayor calidad del cuidado.

ABSTRACT Objective: To identify what risks and incidents related to the drug therapy process are presented in an Emergency Care Unit (UPA) and to present proposals for management actions and safe practices, in the perception of the nursing team. Method: Qualitative research, in the research-action modality, developed in the scenario of UPA, located in the interior of São Paulo. Data collection was done through interviews and focus groups with 33 professionals, between June 2015 and April 2016. For the data treatment, the Content Analysis Technique was used. Results and discussion: From the participants' reports, thematic categories were organized, with the risks and incidents related to the drug therapy process being one of the listed categories, as well as proposals for actions. Conclusion: The study allowed the implementation of patient safety actions related to the administration of drugs in a PAU, offering a higher quality of care.

Filling Voice Promotion Gaps in Healthcare through a Comparative Analysis of Error Reporting and Learning Systems and Open Communication and Disclosure Policies in the United States and Germany.

Voice in healthcare is crucial because of its ability to improve organizational performance and prevent medical errors. This paper contends that a comparative analysis of voice promotion in the American and German healthcare industries can strengthen a culture of safety in both countries. It provides a brief introduction to the concept of voice in healthcare, including its impact on safety culture, barriers to voice, and the dual influences of confidentiality and transparency on voice promotion policies. It then examines the theoretical basis, practical workings, and legal aspects of voluntary error reporting and error disclosure as avenues for exercising voice in the U.S. and Germany. Finally, it identifies transferable practices that can remedy shortcomings in each country's voice promotion policy.

Optimising implementation of reforms to better prevent and respond to child sexual abuse in institutions: Insights from public health, regulatory theory, and Australia's Royal Commission.

The Australian Royal Commission Into Institutional Responses to Child Sexual Abuse has identified multiple systemic failures to protect children in government and non-government organizations providing educational, religious, welfare, sporting, cultural, arts and recreational activities. Its recommendations for reform will aim to ensure organizations adopt more effective and ethical measures to prevent, identify and respond to child sexual abuse. However, apart from the question of what measures institutions should adopt, an under-explored question is how to implement and regulate those measures. Major challenges confronting reform include the diversity of organizations providing services to children; organizational resistance; and the need for effective oversight. Failure to adopt theoretically sound strategies to overcome implementation barriers will jeopardize reform and compromise reduction of institutional child sexual abuse. This article first explains the nature of the Royal Commission, and focuses on key findings from case studies and data analysis. It then analyzes public health theory and regulatory theory to present a novel analysis of theoretically justified approaches to the implementation of measures to prevent, identify and respond to CSA, while isolating challenges to implementation. The article reviews literature on challenges to reform and compliance, and on prevention of institutional CSA and situational crime prevention, to identify measures which have attracted emerging consensus as recommended practice. Finally, it applies its novel integration of regulatory theory and public health theory to the context of CSA in institutional contexts, to develop a theoretical basis for a model of implementation and regulation, and to indicate the nature and functions of a regulatory body for this context.

["Even the best law will never replace reflection in the field"]. / « La meilleure des lois ne fera jamais l'économie d'une réflexion sur le terrain ¼.

Implemented in 2006 by the French minister for health, the resource centres for people working with sex offenders (CRIAVS) provide support for professionals and non-professionals, concerned with transgressive sexual behaviour. They offer tools for legal, health and social professionals to facilitate the supervision of sex offenders. Florent Cochez, a psychiatrist and medical examiner, manager of the Aquitaine CRIAVS, describes in this interview the missions of these regional structures, their link with court-ordered therapy and his practice.

Agricultural anaerobic digestion power plants in Ireland and Germany: policy and practice.

The process of anaerobic digestion (AD) is valued as a carbon-neutral energy source, while simultaneously treating organic waste, making it safer for disposal or use as a fertilizer on agricultural land. The AD process in many European nations, such as Germany, has grown from use of small, localized digesters to the operation of large-scale treatment facilities, which contribute significantly to national renewable energy quotas. However, these large AD plants are costly to run and demand intensive farming of energy crops for feedstock. Current policy in Germany has transitioned to support funding for smaller digesters, while also limiting the use of energy crops. AD within Ireland, as a new technology, is affected by ambiguous governmental policies concerning waste and energy. A clear governmental strategy supporting on-site AD processing of agricultural waste will significantly reduce Ireland's carbon footprint, improve the safety and bioavailability of agricultural waste, and provide an indigenous renewable energy source. © 2016 Society of Chemical Industry.

Moving and handling: reducing risk through assessment.

Manual handling injuries can occur almost anywhere in a healthcare environment, and most staff perform a variety of moving and handling tasks every day. Heavy lifting, awkward posture, and previous or existing injury can increase the risk of musculoskeletal disorders. A healthcare professional's involvement in moving and handling is more widespread than it might appear, and their actions and understanding of techniques, legislation and guidelines have a direct effect on patient care. Every situation that involves the handling, or partial handling, of a person presents varying levels of risk to the patient and the carer. Maintaining a good level of patient mobility and independence is an essential part of care delivery and can reduce the risk of long-term physical and psychological effects. Delivery of care should focus on the individual's capacity, not their incapacity, to ensure that they are treated with dignity and respect.

Challenging the cost of clinical negligence.

Healthcare professionals in South Africa (SA) are facing challenging times. As the clinical negligence claims environment in SA deteriorates, the impact is being felt by healthcare professionals, but also by the wider public owing to the strain that costs place on the public purse. The authors look at the current claims environment, and explain why a debate about reform is so important.

Galactose oxidation using 13C in healthy and galactosemic children

Galactosemia is an inborn error of galactose metabolism that occurs mainly as the outcome of galactose-1-phosphate uridyltransferase (GALT) deficiency. The ability to assess galactose oxidation following administration of a galactose-labeled isotope (1-13C-galactose) allows the determination of galactose metabolism in a practical manner. We aimed to assess the level of galactose oxidation in both healthy and galactosemic Brazilian children. Twenty-one healthy children and seven children with galactosemia ranging from 1 to 7 years of age were studied. A breath test was used to quantitate 13CO2 enrichment in exhaled air before and at 30, 60, and 120 min after the oral administration of 7 mg/kg of an aqueous solution of 1-13C-galactose to all children. The molar ratios of 13CO2 and 12CO2 were quantified by the mass/charge ratio (m/z) of stable isotopes in each air sample by gas-isotope-ratio mass spectrometry. In sick children, the cumulative percentage of 13C from labeled galactose (CUMPCD) in the exhaled air ranged from 0.03% at 30 min to 1.67% at 120 min. In contrast, healthy subjects showed a much broader range in CUMPCD, with values from 0.4% at 30 min to 5.58% at 120 min. The study found a significant difference in galactose oxidation between children with and without galactosemia, demonstrating that the breath test is useful in discriminating children with GALT deficiencies.

[The network of official medicines control laboratories]. / Das Netzwerk der Official Medicines Control Laboratories.

Licensing, control and surveillance by competent authorities is the basis for ensuring efficacy, safety and quality of medicines in Europe. The control of the quality of medicines by national control laboratories, known as Official Medicines Control Laboratories (OMCLs) is an essential step in this process; it encompasses controls before and after granting a marketing authorisation. For certain groups of biomedical medicines (vaccines for human and veterinary use, medicines derived from human plasma) even each batch is controlled before it can be placed on the market. As single OMCLs would not be able to cope with their task, given the large number and diversity of medicines, in 1994 the OMCL network was founded upon initiative of the European Directorate for the Quality of Medicines & HealthCare, in close collaboration with the Commission of the European Union. Currently 68 OMCLs from 39 countries are part of the network. Prerequisite for the smooth operation of the OMCL network is the harmonisation of the quality management system of the individual OMCLs, based on the ISO 17025 standard, internal guidelines and the European Pharmacopoeia. Compliance with these standards is checked through regular audits, thus creating the basis for mutual recognition of test results. The collaboration in the OMCL network for the surveillance of the medicines market, the official control authority batch release and the fight against counterfeiting and illegal medicines enables OMCLs to keep pace with the developments in the field of medicines and to control the broad spectrum of medicines. In the 20 years since its start, the OMCL network has become a European success story.