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1.
BMC Health Serv Res ; 19(1): 951, 2019 Dec 10.
Artigo em Inglês | MEDLINE | ID: mdl-31823781

RESUMO

BACKGROUND: Responsive regulation assumes that the parties being regulated are trustworthy and motivated by social responsibility. This assumes that regulation based upon trust will improve the regulated organization more effectively than other regulation models. The purpose of our qualitative study was to unravel the most important elements of trust in the inspectee which can support the inspector's work and to develop a model and a framework of trust that can be used by the inspectors to legitimize their trust in the inspectee. METHODS: We conducted an empirical study on trust regarding the regulation of care services to reveal how trust in the inspectee is conceptualized and assessed. Based on literature and empirical research, we synthesized the concept of trust into six elements, five regarding behavior, and a sixth looking at information about its context. We developed a practical framework for the concept to reduce the conceptual ambiguity, strengthen regulatory assessment, and support appropriate tailoring of the regulatory response. RESULTS: Six elements with respect to trust emerged from the data: showing integrity; transparency; ability to learn; accepting feedback; showing actual change in behavior; context information. These five behavioral elements, plus the context information were merged into a Framework of Trust and designed into an interactive PDF document. CONCLUSIONS: This study has sought to address a gap in the empirical knowledge regarding the assessment of trust in the inspectee. The results aim to inform and clarify the regulatory conceptualization and understanding of trust in the inspectee. Other inspectorates may learn from these results for their own practice and explore whether operational deployment of our Framework of Trust effects their assessment and enforcement strategies.


Assuntos
Formação de Conceito , Assistência à Saúde/normas , Fiscalização e Controle de Instalações , Confiança , Pesquisa Empírica , Humanos , Países Baixos , Pesquisa Qualitativa
2.
J Bone Joint Surg Am ; 101(12): e55, 2019 Jun 19.
Artigo em Inglês | MEDLINE | ID: mdl-31220031

RESUMO

BACKGROUND: The Emergency Medical Treatment and Active Labor Act (EMTALA) was enacted in 1986 in the United States to address "patient dumping," or refusing to provide emergency care to patients and instead transferring them to other hospitals. Under EMTALA, the "reverse-dumping" provision prevents hospitals from refusing patients who require specialized capabilities or facilities if the hospital has the capacity to treat them. Despite this provision, patients continue to be transferred to distant tertiary care centers. METHODS: We reviewed the literature on EMTALA in the context of a critically ill woman with an infection associated with an orthopaedic implant who was rejected from 2 geographically closer tertiary care centers and was ultimately transferred by helicopter ambulance to an academic teaching hospital that was 169 miles away from her home. RESULTS: After transfer to our tertiary care, level-I trauma center, the patient spent 61 days in the intensive care unit; she required 9 operative procedures, which totaled 1,520 minutes of operative time. Eighteen medical specialties and 8 ancillary medical consulting teams were involved in her care. She underwent 1,436 laboratory and 83 radiographic studies. The total reimbursement from Medi-Cal (California's Medicaid program) for her care in our tertiary care center was $463,753; the hospital charges were more than tenfold higher. CONCLUSIONS: Dumping and reverse dumping continue despite compromise of patient care and the high financial burden of the accepting institutions. This may be due to ineffective monitoring and enforcement, lack of uniformity among the courts, and lack of incentive to receive uninsured or poorly funded patients. Under EMTALA, it is difficult for tertiary care centers to argue lack of specialized capabilities or capacity to accept patients, and neither hospitals nor physicians are compensated for the charges of providing care to uninsured or underinsured patients. Moving forward, efforts to better align financial incentives through cost-sharing between community hospitals and tertiary care centers, increased clinician literacy regarding the provisions of EMTALA, and increased transparency with hospital transfers may help improve EMTALA compliance and patient care.


Assuntos
Serviço Hospitalar de Emergência/organização & administração , Fiscalização e Controle de Instalações/legislação & jurisprudência , Acesso aos Serviços de Saúde/legislação & jurisprudência , Transferência de Pacientes/legislação & jurisprudência , Evolução Fatal , Feminino , Prótese de Quadril/efeitos adversos , Humanos , Pessoa de Meia-Idade , Úlcera/terapia , Estados Unidos
3.
Int J Equity Health ; 18(1): 75, 2019 05 24.
Artigo em Inglês | MEDLINE | ID: mdl-31126292

RESUMO

BACKGROUND: Government regulation has played a crucial role in ensuring the quality, safety and equity of health care. However, few empirical studies have investigated Chinese governmental oversight of health care facilities in terms of regulatory arrangements and approaches. This study aims to explore the regulatory regime and main activities within the health sector in Shanghai, a city featuring abundant health care resources and a complex medical system, to provide policy implications for better regulation and offer valuable reference for elsewhere in China and other developing countries. METHODS: We explored the structure and main activities of government regulation over health care facilities in Shanghai, compared it with the regulatory system in Hong Kong and Taipei through a literature review and analyzed the data on regulatory activities conducted by the local Health Supervision Agencies using descriptive statistical analysis. The data were collected from the Shanghai Statistical Yearbook 2014-2018 and the centralized data bank of the Shanghai Health Supervision Authority. RESULTS: Shanghai has established a unique governmental regulatory system compared to Hong Kong and Taipei. We found health care facilities in Shanghai underwent less frequent inspections between 2013 and 2017, as average annual inspections at individual facilities decreased from 3.8 to 2.7. The number of annual administrative penalties and notifications issued for accumulating points on local health care facilities' violations decreased by 24.8 and 40.7%, respectively, and complaints against health care facilities decreased by 29.1% during the study period. CONCLUSIONS: The local governmental regulatory system played a vital role in overseeing the health care facilities and ensuring their legal compliance by exerting the various regulatory activities. Both annual administrative penalties and notifications of accumulating points on local health care facilities' violations decreased considerably, with complaints against health care facilities reducing. As our study identified significant challenges, including regulatory fragmentation and no risk-based approach used, we offer recommendations to develop new policies and establish new mechanisms for better regulation.


Assuntos
Fiscalização e Controle de Instalações/legislação & jurisprudência , Regulamentação Governamental , China , Humanos
5.
Bioethics ; 33(1): 207-214, 2019 01.
Artigo em Inglês | MEDLINE | ID: mdl-30328125

RESUMO

Whether institutions and not just individual doctors have a right to not participate in medical assistance in dying (MAID) is controversial, but there is a tendency to frame the issue of institutional non-participation in a particular way. Conscience is central to this framing. Non-participating health centres are assumed to be religious and full participation is expected unless a centre objects on conscience grounds. In this paper we seek to reframe the issue. Institutional non-participation is plausibly not primarily, let alone exclusively, about conscience. We seek to reframe the issue by making two main points. First, institutional non-participation is primarily a matter of institutional self-governance. We suggest that institutions have a natural right of self-governance which, in the case of health centres such as hospitals or hospices, includes the right to choose whether or not to offer MAID. Second, there are various legitimate reasons unrelated to conscience for which a health centre might not offer MAID. These range from considerations such as institutional capacity and expertise to a potential contradiction with palliative care and a concern to not conflate palliative care and MAID in public consciousness. It is a mistake to frame the conversation simply in terms of conscience-based opposition to MAID or full participation. Our goal is to open up new space in the conversation, for reasons unrelated to conscience as well as for non-religious health centres who might nonetheless have legitimate grounds for not participating in MAID.


Assuntos
Temas Bioéticos , Consciência , Instalações de Saúde , Suicídio Assistido , Dissidências e Disputas , Fiscalização e Controle de Instalações , Direitos Humanos , Humanos , Cuidados Paliativos , Recusa do Médico a Tratar , Religião e Medicina , Assistência Terminal
6.
Radiographics ; 38(6): 1744-1760, 2018 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-30303792

RESUMO

Ensuring the safety of patients and staff is a core effort of all health care organizations. Many regulatory agencies, from The Joint Commission to the Occupational Safety and Health Administration, provide policies and guidelines, with relevant metrics to be achieved. Data on safety can be obtained through a variety of mechanisms, including gemba walks, team discussion during safety huddles, audits, and individual employee entries in safety reporting systems. Data can be organized on a scorecard that provides an at-a-glance view of progress and early warning signs of practice drift. In this article, relevant policies are outlined, and instruction on how to achieve compliance with national patient safety goals and regulations that ensure staff safety and Joint Commission ever-readiness are described. Additional critical components of a safety program, such as department commitment, a just culture, and human factors engineering, are discussed. ©RSNA, 2018.


Assuntos
Fiscalização e Controle de Instalações , Joint Commission on Accreditation of Healthcare Organizations , Administração da Prática Médica/normas , Serviço Hospitalar de Radiologia/normas , Gestão da Segurança/normas , Humanos , Estados Unidos
7.
Stud Health Technol Inform ; 256: 33-39, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-30371458

RESUMO

Universal design was introduced as an ideological and technical concept in Norway in 1996 and was introduced in the first law in 2003. Since then universal design has replaced accessibility for people with disabilities in national policies, laws, regulations, standards, projects and everyday language. Accessibility is now used to characterize solutions made more exclusively for people with disabilities or when a high, general quality is not required. Few countries have made this extensive use of the concept of universal design and the concept has faced several challenges from lawmakers, architects, economists, user organizations, entrepreneurs and debaters. This paper reflects on some aspects of more than 20 years of extensive use of the concept of universal design and try to answer the question: Is universal design an academic invention with little extra positive impact compared to accessibility for people with disability, or does the concept defend its supposed role as a step towards a society with equal opportunities for all?


Assuntos
Acessibilidade Arquitetônica , Pessoas com Deficiência , Fiscalização e Controle de Instalações , Humanos , Noruega , Políticas
8.
BMC Public Health ; 18(1): 1096, 2018 Oct 04.
Artigo em Inglês | MEDLINE | ID: mdl-30285702

RESUMO

BACKGROUND: Many jurisdictions have enacted indoor tanning legislation in response to the health risks of artificial ultraviolet (UV) radiation exposure. Key components of these legislations include banning minors' access, requiring parental consent or accompaniment, providing protective eyewear, posting health warning signs, and communicating important health risk information. However, legislation must be complied with to be impactful. Evidence around compliance with indoor tanning legislations has not been synthesized and is an important step toward determining changes in practice due to legislation. METHODS: A systematic review was conducted to obtain peer-reviewed literature about compliance with indoor tanning legislation worldwide. Six databases were searched, resulting in 12,398 citations. Sixteen studies met the inclusion criteria (peer-reviewed scientific studies, published in English, focused primarily on compliance with indoor tanning legislations, and focused on commercial indoor tanning in indoor tanning facilities). RESULTS: Compliance with most aspects of indoor tanning legislation varied widely. There was good compliance for provision of protective eyewear (84 to 100%; mean = 92%; SD = 8). Compliance with age restrictions ranged from 0 to 100% (mean = 65%; SD = 25), while compliance with posting warning labels in the required locations within a tanning facility ranged from 8 to 72% (mean = 44%; SD = 27). Variation in compliance may be due to true differences, study methodology, or temporal trends. CONCLUSIONS: Variability in compliance with indoor tanning legislation, as found in this systematic review, indicates the legislations may not be having their intended protective effects on the public's health. The reasons for such low and varied compliance with certain aspects of legislation, and high compliance with other aspects of legislation, deserve further attention in future research to inform best practices around ensuring high and consistent compliance with indoor tanning legislations worldwide.


Assuntos
Indústria da Beleza/legislação & jurisprudência , Fiscalização e Controle de Instalações/legislação & jurisprudência , Fidelidade a Diretrizes/estatística & dados numéricos , Banho de Sol/legislação & jurisprudência , Saúde Global , Humanos
9.
Prog Community Health Partnersh ; 12(1S): 101-109, 2018.
Artigo em Inglês | MEDLINE | ID: mdl-29755053

RESUMO

BACKGROUND: New licensing regulations require Louisiana early care and education centers (ECEs) to limit children's screen time and increase physical activity. A community- academic partnership involving academic, community, government, and ECE stakeholders launched two initiatives: (1) an evaluation of the implementation of licensing regulations at the local level and (2) a statewide effort to develop technical assistance for ECE directors. OBJECTIVES: To describe the methods and lessons learned and to establish recommendations based on this ongoing participatory action research. METHODS: A case study approach was used to identify the lessons learned and recommendations thus far, based on partners' perspectives and ECE directors' participation. LESSONS LEARNED: Recommendations include to share power and funding among stakeholders, to engage directors as partners to overcome recruitment challenges, and to start with the end in mind to ensure meaningful community engagement. CONCLUSIONS: This participatory action approach is leading to innovative, feasible strategies to increase children's physical activity.


Assuntos
Creches/legislação & jurisprudência , Fiscalização e Controle de Instalações/legislação & jurisprudência , Licenciamento/legislação & jurisprudência , Tempo de Tela , Desenvolvimento Infantil , Pré-Escolar , Pesquisa Participativa Baseada na Comunidade , Guias como Assunto , Humanos , Sudeste dos Estados Unidos
11.
Telemed J E Health ; 24(11): 934-937, 2018 11.
Artigo em Inglês | MEDLINE | ID: mdl-29652624

RESUMO

PURPOSE: Telemedicine is a growing and important platform for medical delivery in the emergency department. Emergency telemedicine outlays often confront and conflict with important federal healthcare regulations. Because of this, academic medical centers, critical access hospitals, and other providers interested in implementing emergency telemedicine have often delayed or forgone such services due to reasonable fears of falling out of compliance with regulatory restrictions imposed by the Emergency Medical Treatment and Labor Act ("EMTALA"). This article offers insights into methods for implementing emergency telemedicine services while maintaining EMTALA compliance. METHODOLOGY: Critical analysis of EMTALA and its attendant regulations. RESULTS: The primary means of ensuring EMTALA compliance while implementing emergency telemedicine programs include incorporating critical clinical details into the services contracts and implementing robust written policies that anticipate division of labor issues, the need for backup coverage, triaging, patient transfer protocols, and credentialing issues. With adequate up-front due diligence and meaningful contracting, hospitals and telemedicine providers can avoid common EMTALA liability pitfalls.


Assuntos
Serviços Médicos de Emergência , Fiscalização e Controle de Instalações , Fidelidade a Diretrizes/organização & administração , Telemedicina/legislação & jurisprudência , Estados Unidos
13.
Int J Technol Assess Health Care ; 33(4): 434-441, 2017 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-29241476

RESUMO

BACKGROUND: There is growing trend for some surgical procedures previously performed in hospitals to be done in alternative settings, including office-based facilities. There has been some safety concerns reported in the media, which document serious adverse events following procedures performed in an office-based setting. To understand the current regulatory oversight of surgery in this setting ASERNIP-S conducted a review of the legislative and accreditation process governing these facilities in Australia. METHODS: Using rapid review methodology, internet searches targeted government Web sites for relevant publicly-available documents. Use of consolidated versions of legislative instruments ensured currency of information. Standards were sourced directly from the issuing authorities or those that oversee the accreditation process. RESULTS: Within Australia, healthcare facilities for surgery and their licensing are defined by each state and territory, which results in significant jurisdictional variation. These variations relate to the need for anesthesia beyond conscious sedation and listing of procedures in legislative instruments. In 2013, Australia adopted National Safety and Quality Health Service standards (NSQHS standards) for the accreditation of hospitals and day surgery centers; however, there is no NSQHS standard for office-based facilities. The main legislative driver for compliance is access to reimbursement schemes for service delivery. CONCLUSIONS: The legislative and accreditation framework creates a situation whereby healthcare facilities that provide services outside the various legal definitions of surgery and those not covered by a reimbursement scheme, can operate without licensing and accreditation oversight. This situation exposes patients to potential increased risk of harm when receiving treatment in such unregulated facilities.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/legislação & jurisprudência , Procedimentos Cirúrgicos Ambulatórios/normas , Credenciamento/normas , Fiscalização e Controle de Instalações/legislação & jurisprudência , Fiscalização e Controle de Instalações/normas , Acreditação/normas , Austrália , Certificação/normas , Sedação Consciente , Humanos , Licenciamento/normas , Segurança do Paciente/legislação & jurisprudência , Segurança do Paciente/normas
15.
J Environ Health ; 79(10): 20-5, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-29154529

RESUMO

The Food and Drug Administration recommended restaurant inspection scores change to a format that incorporated three new categories of violations: priority, priority foundation, and core. It was uncertain whether interested consumers would value the more in-depth information or become more confused. The purpose of this study was to assess consumer perception of the recommended inspection system. Data were collected from an online survey. Results showed that consumers want convenient access to the information either online or on the wall of restaurants, and some consumers do want to read inspection reports and use them in making dining decisions. Choice of restaurant inspection format did appear to change consumer understanding and perceptions about some of the violations. Results also demonstrated the importance of the words used to categorize violations.


Assuntos
Comportamento do Consumidor , Fiscalização e Controle de Instalações , Contaminação de Alimentos/prevenção & controle , Inspeção de Alimentos/normas , Restaurantes/normas , Adulto , Escolaridade , Feminino , Inspeção de Alimentos/métodos , Humanos , Internet , Masculino , Pessoa de Meia-Idade , Avaliação de Programas e Projetos de Saúde , Distribuição Aleatória , Medição de Risco , Inquéritos e Questionários , Estados Unidos , United States Food and Drug Administration , Adulto Jovem
16.
J Environ Health ; 79(10): 26-31, 2017 06.
Artigo em Inglês | MEDLINE | ID: mdl-29155182

RESUMO

The Food and Drug Administration publishes the Food Code to guide restaurant inspections. The most recent version proposes a three-tier system categorizing violations as priority, priority foundation, and core. This study used a scenario-based questionnaire to examine inspector perceptions and preferences for inspection formats. Results suggest that inspectors would be able to maintain consistent evaluations when changing to the three-tier system, although the classifying terms under the three-tier system were confusing. Additionally, inspectors were not very positive about the new system; they were concerned that the new system would not be easy to understand and use, inspections would take a longer time, it would not accurately reflect the amount of risk associated with violations, and it would not be easy for consumers and managers to understand and use. The results suggest the need for additional training for inspectors before adoption, especially on the rationale and benefits of changing to a three-tier system.


Assuntos
Fiscalização e Controle de Instalações , Contaminação de Alimentos/prevenção & controle , Inspeção de Alimentos/normas , Capacitação em Serviço , Restaurantes/normas , Participação da Comunidade , Inspeção de Alimentos/métodos , Inspeção de Alimentos/tendências , Humanos , Indiana , Percepção , Inquéritos e Questionários , Estados Unidos , United States Food and Drug Administration
17.
Allergol Immunopathol (Madr) ; 45 Suppl 1: 1-3, 2017 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-29108764

RESUMO

Allergen medicinal products in the European Union are regulated differently across the different Member States. Thus, whereas in some countries strict quality, safety and efficacy requirements are in place, in others, most allergens are on the market as Named Patient Products, without any regulatory oversight. This situation results on European allergic patients being exposed to totally different standards depending on where they live. Initiatives to correct this situation are needed.


Assuntos
Alérgenos/uso terapêutico , Dessensibilização Imunológica/métodos , Hipersensibilidade/terapia , Animais , União Europeia , Fiscalização e Controle de Instalações , Humanos , Hipersensibilidade/imunologia , Padrões de Referência
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