Encontro com Especialistas - Cuidado Seguro de RN e crianças

Encontro com as Especialistas Roseli Calil, médica neonatologista da Universidade Estadual de Campinas (Unicamp); Eduarda Ribeiro dos Santos, enfermeira e advogada, docente na Faculdade Israelita Albert Einstein; Aline Hennemann, enfermeira especialista na área materno infantil, assessora da CACRIAD/DGCI/SAPS/MS; e Zeni Lamy, médica neonatologista da Universidade Federal do Maranhão (UFMA).

Implicaciones jurídicas de los sistemas de notificación y registro de eventos adversos en la esfera sanitaria / [Legal implications of notification and registration systems for adverse events in the healthcare sphere]

La notificación de eventos adversos constituye uno de los instrumentos esenciales de cara a la consecución de mejoras significativas en materia de seguridad del paciente. El presente trabajo pretende concretar las implicaciones jurídicas de las pautas sentadas a nivel internacional (OMS, Consejo de Europa y UE) de cara al establecimiento de un marco legal nacional favorable a la notificación de eventos adversos en la esfera sanitaria. (AU)

The reporting of adverse events is one of the key elements in achieving significant improvements in the field of patient safety. Based on international guidelines (WHO, Council of Europe and EU) this paper aims to analyse their juridical implications when settling a national legal framework for reporting adverse events in the sphere of healthcare. (AU)

Confiabilidade da autoavaliação das práticas de segurança do paciente instituídas pelo Sistema Nacional de Vigilância Sanitária: um estudo piloto / Reliability of patient safety self-assessment practices established by the National Health Surveillance System: a pilot study

Resumo Introdução: A Autoavaliação das Práticas de Segurança do Paciente é um ato regulatório para melhoria da qualidade do cuidado. Porém, há dúvidas sobre a validade das suas informações. O objetivo deste estudo foi analisar a sua confiabilidade. Método: Estudo piloto de análise da confiabilidade de 21 indicadores simples e um composto da autoavaliação como forma de embasar uma amostra nacional em estudos futuros. Participaram hospitais com leitos de terapia intensiva e comparou dados da Autoavaliação (AA) e Autoavaliação Revisada (AR) pela vigilância sanitária (Visa) com a Inspeção Presencial (IP). A análise incluiu os coeficientes Kappa e de correlação intraclasse. Resultados: Comparando com a IP, a concordância foi aceitável (Kappa≥0,4) em 12 indicadores da AA e em 18 da AR. Os indicadores menos confiáveis são relativos a protocolos de prevenção de infecções. Quanto ao indicador composto do nível de adesão, a confiabilidade melhorou com revisão da Visa (AA=0,89 e AR=0,94), embora a concordância da classificação de alta conformidade tenha sido baixa. Conclusões: A AR se mostrou essencial para melhorar a confiabilidade da Autoavaliação. Ademais, identificou-se necessidade de revisar alguns indicadores e o instrumento de verificação pela Visa.

Abstract Introduction: The Patient Safety Self-Assessment Practices is a regulatory action to enhance quality of care. However, validation of its information requires attention. This study aimed to analyze reliability of the Patient Safety Self-Assessment Practices. Methods: Pilot study analyzing the reliability of 21 simple indicators and 1 composite of self-assessment to provide a national sample in future studies. Hospitals with intensive unit care beds participated in the study, and data from self-assessment (SA) and revised self-assessment (RSA) by the health surveillance (HS) were compared with on-site inspection (OSI). Analyses included Kappa and intraclass correlation coefficients. Results: Concordance was satisfactory (Kappa ≥ 0.4) in 12 indicators of SA and 18 indicators of RSA compared with OSI. The least reliable indicators were related to infection prevention protocols. Reliability of the adherence level composite indicator improved with HS revision (SA = 0.89 and RSA = 0.94), despite the low concordance of the high compliance classification. Conclusion: RSA was essential to improve reliability of SA. In addition, some indicators and assessment tools of the HS need revision.

Patient safety management systems and activities related to promoting voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues: A cross-sectional study.

Both voluntary in-hospital reporting and mandatory national-level reporting systems for patient safety issues need to work well to develop a patient safety learning system that is effective in preventing the recurrence of adverse events. Some of the hospital systems and activities may increase voluntary in-hospital reporting and mandatory national-level reporting. This study aimed to identify the hospital systems and activities that increase voluntary in-hospital reporting and mandatory national-level reporting for patient safety issues. An anonymous mail survey of hospitals in Japan was conducted in 2017. The hospitals were selected by stratified random sampling according to number of beds. The survey examined the annual number of reported events in the voluntary in-hospital reporting system for patient safety and experience of reporting unexpected patient deaths possibly due to medical interventions to the mandatory national-level reporting system in the last 2 years. The relationship of the answer to the questions with the patient safety management systems and activities at each hospital was analyzed. The response rate was 18.8% (603/3,215). The number of in-hospital reports per bed was positively related to identifying events by referring complaints or questions of patients or family members, using root cause analysis for analyzing reported events, and developing manuals or case studies based on reported events, and negatively related to the unification and standardization of medical devices and equipment. The experience with mandatory national-level reporting of serious adverse events was positively related to identifying problematic cases by a person in charge of patient safety management from the in-hospital reporting system of complications and accidental symptoms. Enhanced feedback for reporters may promote voluntary in-hospital reporting of minor cases with low litigation risks. Developing an in-hospital mechanism that examines all serious complications and accidental symptoms may promote mandatory national-level reporting of serious adverse events with high litigation risks.

How can Never Event data be used to reflect or improve hospital safety performance?

The absolute number of Never Events is used by UK regulators to help assess hospital safety performance, without account of hospital workload. We applied funnel plots, as an established means of taking workload into account, to published Never Event data for 151 acute Trusts in NHS England, matched to finished consultant episodes for 3 years, 2017-2020. Trusts with excess event rates should have the most Never Events if absolute number is a valid way to judge performance. The absolute number of Never Events was correlated with workload (r2 = 0.51, p < 0.001), but the five Trusts above the upper 95% confidence limit did not have the highest number of Never Events. However, a limitation to interpretation was that the data were skewed; 12 out of 151 Trusts lay below the lower 95% limit. This skew probably arises because funnel plots pool all Never Events and workload data; whereas, ideally, different Never Events should use as denominator only the relevant workload actions that could cause them. We conclude that the manner in which Never Event data are currently used by regulators, in part to judge or rate hospitals, is mathematically invalid. The focus should shift from identifying 'outlier' hospitals to reducing the overall national mean Never Event rate through shared learning and an integrated system-wide approach.

Analysis of Medical Device Alerts Issued by the Portuguese Medicines Agency: Scoping the Purpose of New Regulatory Recommendations.

INTRODUCTION: Medical devices are healthcare technologies with a significantly growing market worldwide. This study aims to analyze medical device alerts issued by the Portuguese Medicines Agency, INFARMED, I.P. during 2017, as well as to identify the respective regulatory actions and to suggest additional recommendations. MATERIAL AND METHODS: All alerts on medical device alerts publicly available in the website of INFARMED, I.P. were identified and analyzed, including actions taken. Additionally, reports on medical devices from the Portuguese national competent authorities were compared with reports from other European Union member states such as Germany. RESULTS: A total of 32 safety alerts were identified: 18 (56%) related with devices without identified records of commercialization in Portugal, six (19%) related with devices voluntarily withdrawn from the market, such as counterfeit products, and eight (25%) categorized as 'other'. In both Portugal and Germany, 0.28 and 4.53 reports of national competent authorities per million inhabitants were identified, respectively. Diverse regulatory actions were taken, such as six compulsory indications to not acquire or use devices. DISCUSSION: Considering that the European Union is an open market where citizens should have equal access to medical devices, the Portuguese system of medical device safety alerts seems to be functioning normally. The identified safety alerts seemed relevant, with Portugal registering a proportionally slightly lower number of alerts when compared with higher sales volume markets, which may be explained by an underreporting of this type of problems. Further studies are needed to confirm these preliminary results, although the development of databases comprising data on patients using medical devices is recommended in order to generate automatic email and text message alerts. CONCLUSION: A limited number of safety alerts on medical devices was identified in Portugal, with few reported cases of counterfeit or falsified devices. The Portuguese Medicines Agency contributes to the citizens' access to quality medical devices, by issuing safety alerts, recommendations and mandatory market withdrawals for unsuitable or unsafe medical devices.

Introdução: Os dispositivos médicos são tecnologias de saúde com um significativo crescimento a nível mundial. Foi objetivo deste trabalho analisar os alertas sobre dispositivos médicos emitidos pela Agência Portuguesa do Medicamento: INFARMED, I.P. durante 2017, identificar as respetivas ações regulatórias e sugerir recomendações. Material e Métodos: Todos os alertas e ações sobre dispositivos médicos publicamente disponíveis no website do INFARMED, I.P. foram identificados e analisados. Adicionalmente, os relatórios da autoridade competente nacional sobre dispositivos médicos foram comparados com relatórios de outros países da União Europeia como a Alemanha. Resultados: Identificou-se um total de 32 alertas de segurança de dispositivos médicos: 18 (56%) sem registos de comercialização em Portugal, seis (19%) voluntariamente retirados do mercado, como produtos contrafeitos, e oito (25%) categorizados como 'outros'. Em Portugal e na Alemanha foram identificados 0,28 e 4,53 relatórios de autoridades competentes por milhão de habitantes, respetivamente. Diversas ações regulamentares foram tomadas, como seis indicações obrigatórias para não adquirir ou utilizar dispositivos médicos. Discussão: Considerando que a União Europeia é um mercado aberto no qual os cidadãos detêm igual acesso à utilização de dispositivos médicos, o sistema Português de alertas de segurança sobre estes dispositivos parece ter uma atividade normal. Os alertas de segurança identificados aparentam ser relevantes, com Portugal a registar um número ligeiramente inferior de alertas quando proporcionalmente comparado com outros mercados de maior volume de vendas, o que eventualmente pode ser explicado por uma subnotificação deste tipo de problemas. São necessários estudos adicionais para confirmar estes resultados preliminares, sendo o desenvolvimento de bases de dados sobre o uso de dispositivos médicos pelos doentes recomendado de forma a gerar emails e alertas telefónicos automáticos. Conclusão: Foi identificado um número limitado de alertas de segurança em dispositivos médicos em Portugal, com escassas notificações de contrafação ou falsificação. A Agência Portuguesa de Medicamentos contribui para o acesso dos cidadãos a dispositivos médicos de qualidade, através da emissão de alertas de segurança, recomendações e retirada obrigatória de dispositivos médicos inadequados ou inseguros do mercado.

The Key Elements of Medical Negligence-Duty.

American tort law (a.k.a. negligence) is designed to be flexible and elastic to adapt to changes in time and public policy. It provides a structure of elements and factors to be applied to each case's specific facts on a case-by-case basis. The purpose of this structure is to achieve as much uniformity as possible in the application of tort law. One side effect is that this structure makes predicting the outcome difficult because of so many variables. In addition, there is no national tort law. Instead, each state has developed its own law in the area of torts, which has resulted in differing exceptions and requirements based on where the medical care was given. The purpose of this article is to explain the first element of a negligence case-"duty to use care"-and its accompanying factors/variables. The first element that must be established in a medical negligence case is a duty to use care. In short, this means the physician must use a certain level of care in providing medical services. The physician typically owes her or his patient the duty to exercise care. However, there are special situations in which a physician may not owe a duty of care and thus cannot be held liable for medical negligence. This article is designed to provide an overview of the most common situations and summarizes the processes to determine whether a duty is owed.

Vascular surgery-related violations of the Emergency Medical Treatment and Labor Act.

OBJECTIVE: The Emergency Medical Treatment and Labor Act (EMTALA) is a federal law established in 1986 to ensure that patients who present to an emergency department receive medical care regardless of means. Violations are reported to the Centers for Medicare and Medicaid Services and can result in significant financial penalties. Our objective was to assess all available EMTALA violations for vascular-related issues. METHODS: EMTALA violations in the Centers for Medicare and Medicaid Services publicly available hospital violations database from 2011 to 2018 were evaluated for vascular-related issues. Details recorded were case type, hospital type, hospital region, reasons for violation, disposition, and mortality. RESULTS: There were 7001 patients identified with any EMTALA violation and 98 (1.4%) were deemed vascular related. The majority (82.7%) of EMTALA violations occurred at urban/suburban hospitals. Based on the Association of American Medical Colleges United States region, vascular-related EMTALA violations occurred in the Northeast (7.1%), Southern (56.1%), Central (18.4%), and Western (18.4%) United States. Case types included cerebrovascular (28.6%), aortic related (22.4%; which consisted of ruptured aortic aneurysms [8.2%], aortic dissection [11.2%], and other aortic [3.1%]), vascular trauma (15.3%), venous-thromboembolic (15.3%), peripheral arterial disease (9.2%), dialysis access (5.1%), bowel ischemia (3.1%), and other (1%) cases. Patients were transferred to another facility in 41.8% of cases. The most common reasons for violation were specialty refusal or unavailability (30.6%), inappropriate documentation (29.6%), misdiagnosis (18.4%), poor communication (17.3%), inappropriate triage (13.3%), failure to obtain diagnostic laboratory tests or imaging (12.2%), and ancillary or nursing staff issues (7.1%). The overall mortality was 19.4% and 31.6% died during the index emergency department visit. Vascular conditions associated with death were venous thromboembolism (31.6%), ruptured aortic aneurysm (21.1%), aortic dissection (21.1%), other aortic causes (10.5%), vascular trauma (10.5%), and bowel ischemia (5.3%). CONCLUSIONS: Although the frequency of vascular-related EMTALA violations was low, improvements in communication, awareness of vascular disease among staff, specialty staffing, and the development of referral networks and processes are needed to ensure that patients receive adequate care and that institutions are not placed at undue risk.

Mandatory reporting legislation in Canada: improving systems for patient safety?

Patient safety is a complex systems issue. In this study, we used a scoping review of peer-reviewed literature and a case study of provincial and territorial legislation in Canada to explore the influence of mandatory reporting legislation on patient safety outcomes in hospital settings. We drew from a conceptual model that examines the components of mandatory reporting legislation that must be in place as a part of a systems governance approach to patient safety and used this model to frame our results. Our results suggest that mandatory reporting legislation across Canada is generally designed to gather information about - rather than respond to and prevent - patient safety incidents. Overall, we found limited evidence of impact of mandatory reporting legislation on patient safety outcomes. Although legislation is one lever among many to improve patient safety outcomes, there are nonetheless several considerations for patient safety legislation to assist in broader system improvement efforts in Canada and elsewhere. Legislative frameworks may be enhanced by strengthening learning systems, accountability mechanisms and patient safety culture.

Obstetrics, genetics, and litigation.

INTRODUCTION: Claims of medical negligence are universal. Unexpected adverse pregnancy outcome may trigger litigation. Such outcomes, especially with neurodevelopmental sequelae, may be compounded by a genetic disorder, congenital abnormality, or syndrome. MATERIAL AND METHODS: This is a report of 297 cases in which a pregnancy complication, error, or incident occurred that was followed by progeny with a genetic disorder, congenital abnormality, or syndrome that spawned litigation. The author assessed, opined, and in many cases, testified about causation. RESULTS: Pregnancies complicated by hypoxic ischemic encephalopathy were not infrequently compounded by offspring with a genetic disorder, congenital abnormality, or syndrome. Multiple cases were brought because of missed ultrasound or laboratory diagnoses, or failures in carrier detection. Teratogenic medication prescribed before or during pregnancy invited legal purview. Failure to refer (or confer) for genetic evaluation or counseling in the face of significant risk, occurred repeatedly. Ethical breaches and hubris promptly led to litigation. CONCLUSIONS: Many lessons and recommendations emerge in this report. These include the realization that the vast majority of errors in this series involved at least two caregivers, serial ultrasound studies are important, decreased fetal movements may signal a genetic disorder, congenital abnormality, or syndrome, family history and ethnicity are vital, cognitive biases profoundly affect decision-making. Finally, the simplest of errors have the potential for causing life-long grief.

Advancing the Culture of Patient Safety and Quality Improvement.

The American health care system has many great successes, but there continue to be opportunities for improving quality, access, and cost. The fee-for-service health care paradigm is shifting toward value-based care and will require accountability around quality assurance and cost reduction. As a result, many health care entities are rallying health care providers, administrators, regulators, and patients around a national imperative to create a culture of safety and develop systems of care to improve health care quality. However, the culture of patient safety and quality requires rigorous assessment of outcomes, and while numerous data collection and decision support tools are available to assist in quality assessment and performance improvement, the public reporting of this data can be confusing to patients and physicians alike and result in unintended negative consequences. This review explores the aims of health care reform, the national efforts to create a culture of quality and safety, the principles of quality improvement, and how these principles can be applied to patient care and medical practice.

The Unintended Consequences of Adverse Event Information on Medicines' Risks and Label Content.

Patients and prescribers need to be aware of adverse drug events to minimize the risk of their occurrence and the severity with which they appear. However, numerous studies show that being informed about adverse events can increase the possibility of suffering from them. Patients tend to overestimate the likelihood of experiencing the adverse events included in the label, and this can contribute to worsening the negative expectations which are at the root of the nocebo effect. In fact, patients can become anxious after reading the undesirable effects section of the leaflet and, in addition to suffering from the nocebo effect, might not take a drug they could benefit from due to the fear of experiencing adverse events. In addition, patients' attention can focus towards non-specific symptoms of daily living that can be misattributed to the drug and included in the labelling. This article proposes a number of suggestions to reduce the abovementioned unintended effects associated with labelling, namely, an increased focus on the excess risk of experiencing adverse events rather than crude incidence, using attribute framing to help patients to better understand the risk of experiencing adverse events, dividing the undesirable effect section of the leaflet into subsections according to the level of evidence supporting causal relationships and, finally, restricting the addition of non-specific adverse events that are also symptoms of daily living to only those where there is enough evidence to show they have been caused by the drug. More studies on how to minimize the nocebo effect induced by adverse event information should be performed, and these should be done in collaboration with health authorities, to reach a shared consensus on how to better present adverse event information in the label.

Webpalestra: prevenção e manejo de quedas de idosos em domicílio

Leaving Hospital: A Step too Far for Risk-Based Regulation?

Discharges from hospital are internationally recognised as a dangerous time in the care pathway of a patient, posing a risk to both their physical wellbeing and dignity. This article examines the effectiveness of risk-based regulation as a tool to address patient safety incidents linked to the hospital discharge process within the English National Health Service. It examines how the risk of this process is identified, conceptualised, and prioritised amongst the relevant statutory regulators, and argues that the risk is neither uniformly recognised by the statutory regulators within the English NHS, nor sufficiently addressed. Professional regulators in particular appear to have a poor awareness of the risk and their role in addressing it. Until these issues are resolved, patients leaving hospitals will continue to be exposed to patient safety incidents which should be avoidable.