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OBJECTIVES: To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. METHODS: Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. RESULTS: This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. CONCLUSIONS: These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find.

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BACKGROUND: Nursing checklists have been shown to improve communication, reduce the occurrence of adverse events, and promote safe, quality care in different care settings. However, to date, there is no validated patient care safety checklist for nurses caring for infants in Neonatal Intensive Care Units (NICU). AIM: To describe development and content validation of the "Safe Nursing Care Checklist for Infants Hospitalized in the Neonatal Intensive Care Unit". STUDY DESIGN: Online Survey. METHODS: Based upon an integrative literature review, we developed a checklist focused on safe nursing care for infants in the NICU. Nursing experts participated in three rounds of a content validation process where they rated the items online. An agreement level ≥0.90 was required for inclusion in the checklist. Forty- three expert nurses with experience working in the NICU and who were certified in neonatal nursing or had a master's or doctoratal degree in child health provided content validation of the patient care checklist. RESULTS: The final checklist contained 45 items with content validation index scores greater than 90%. The instrument was structured into six dimensions including patient identification, effective communication, medication safety, infection prevention, fall prevention, and pressure injuries/skin injuries prevention. CONCLUSION: Content validity was established for the "Safe Nursing Care Checklist for Infants Hospitalized in the Neonatal Intensive Care Unit" which can identify strengths and weaknesses in safe nursing care for infants in the NICU as well as direct educational interventions to promote nursing care based on scientific evidence. RELEVANCE TO CLINICAL PRACTICE: This checklist can potentially be used by bedside nurses to promote provision of safe care to infants in the NICU and to guide corrective strategies and encourage evidence-based decision-making. Validation in the clinical setting is needed.

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OBJECTIVE: To evaluate the impact of adherence to the cardiac surgical checklist on mortality at the teaching hospital. METHODS: A retrospective cohort study after the implementation of the cardiac surgical safety checklist in a reference hospital in Latin America. All patients undergoing coronary artery bypass surgery and/or heart valve surgery from 2013 to 2019 were analyzed. After the implementation of the project InCor-Checklist "Five steps to safe cardiac surgery" in 2015, the correlation between adherence and completeness of this instrument with surgical mortality was assessed. The EuroSCORE II was used as a reference to assess the risk of expected mortality for patients. Cross-sectional questionnaires were during the implementation of the InCor-Checklist. To perform the correlation, Pearson's coefficient was calculated using R software. RESULTS: Since 2013, data from 8139 patients have been analyzed. The average annual mortality was 5.98%. In 2015, the instrument was used in only 58% of patients; in contrast, it was used in 100% of patients in 2019. There was a decrease in surgical mortality from 8.22% to 3.13% for the same group of procedures. The results indicate that the greater the checklist use, the lower the surgical mortality (r = 88.9%). In addition, the greater the InCor-Checklist completeness, the lower the surgical mortality (r = 94.1%). CONCLUSION: In the formation of the surgical patient safety culture, the implementation and adherence to the InCor-Checklist "Five steps to safe cardiac surgery" was associated with decreased mortality after cardiac surgery.

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Abstract Objectives To evaluate the impact of adherence to the cardiac surgical checklist on mortality at the teaching hospital. Methods A retrospective cohort study after the implementation of the cardiac surgical safety checklist in a reference hospital in Latin America. All patients undergoing coronary artery bypass surgery and/or heart valve surgery from 2013 to 2019 were analyzed. After the implementation of the project InCor-Checklist "Five steps to safe cardiac surgery" in 2015, the correlation between adherence and completeness of this instrument with surgical mortality was assessed. The EuroSCORE II was used as a reference to assess the risk of expected mortality for patients. Cross-sectional questionnaires were during the implementation of the InCor-Checklist. To perform the correlation, Pearson's coefficient was calculated using R software. Results Since 2013, data from 8139 patients have been analyzed. The average annual mortality was 5.98%. In 2015, the instrument was used in only 58% of patients; in contrast, it was used in 100% of patients in 2019. There was a decrease in surgical mortality from 8.22% to 3.13% for the same group of procedures. The results indicate that the greater the checklist use, the lower the surgical mortality (r = 88.9%). In addition, the greater the InCor-Checklist completeness, the lower the surgical mortality (r = 94.1%). Conclusion In the formation of the surgical patient safety culture, the implementation and adherence to the InCor-Checklist "Five steps to safe cardiac surgery" was associated with decreased mortality after cardiac surgery. HIGHLIGHTS Checklists avoid human errors and are commonly used in high-reliability industries. The "InCor Checklist" was associated with decreased mortality over time. Adherence, completeness, and sustainability within public policies are necessary.

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BACKGROUND: Children requiring gastrostomy tubes (GT) have high resource utilization. In addition, wide variation exists in the decision to perform concurrent fundoplication, which can increase the morbidity of enteral access surgery. We implemented a hospital-wide standardized pathway for GT placement. METHODS: The standardized pathway included mandatory preoperative nasogastric feeding tube (FT) trial, identification of FT medical home, and standardized postoperative order set, including feeding regimen and parent education. An algorithm to determine whether concurrent fundoplication was indicated was also created. We identified children referred for GT placement from 2015 to 2018 and compared concurrent fundoplication rates and outcomes pre- and postimplementation. RESULTS: We identified 332 patients who were referred for GT. Of these, 15 avoided placement. Concurrent fundoplication decreased postpathway (48% vs 22%, p < 0.0001). After adjusting for reflux and cardiac disease, prepathway patients were 3.5 times more likely to undergo concurrent fundoplication. ED visits (46% vs 27%, p = 0.001) and postoperative LOS (median (IQR) 10 days (5-36) to 5.5 days (1-19), p = 0.0002) decreased. CONCLUSIONS: A standardized pathway for GT placement prevented unnecessary GT placement and fundoplication with reduction in postoperative LOS and ED visits. This approach can significantly reduce resource utilization while improving outcomes. TYPE OF STUDY: Prognosis study. LEVEL OF EVIDENCE: Level II.

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Introdução: A segurança do paciente nas Unidades de Terapia Intensiva Neonatal (UTIN) é complexa, considerando os problemas concernentes com os eventos adversos (EA) e as lacunas quanto à falta de instrumentos que direcionem o cuidado de enfermagem. Objetivo: Validar o conteúdo de checklists de cuidados de enfermagem pautados na segurança do paciente internado em UTIN nos momentos da admissão, internação e preparação para a alta. Metodologia: Estudo metodológico, realizado entre 2017 e 2018. A primeira etapa incluiu a revisão integrativa para a construção dos instrumentos guiada pela pergunta norteadora: Quais elementos devem compor checklists de cuidados de enfermagem na admissão, internação e preparo para alta, com vistas à segurança do paciente internado em UTIN? A segunda foi a validação de conteúdo dos checklists por enfermeiros especialistas no tema, realizada em três rodadas. Foram avaliados conforme os critérios metodológicos propostos por Pasquali os títulos, os cabeçalhos, as orientações de preenchimento, os itens e as instruções de preenchimento correspondentes, baseados nas Metas Internacionais da Segurança do Paciente e no Programa Nacional de Segurança do Paciente, considerando para a validação o Índice de Validade de Conteúdo (IVC) ≥ 0,90. Utilizou-se a plataforma Survey Monkey® para desenvolvimento e análise descritiva dos dados. Na primeira rodada participaram 43 enfermeiros especialistas, 33 na segunda e 32 na terceira, os quais foram solicitados a considerar pertinência, objetividade, clareza e relevância dos itens. Resultados: Dentre os 111 itens avaliados no total dos três checklists, 110 foram validados com IVC (Índice de Validade de Conteúdo) ≥ a 0,90 após as modificações sugeridas e um único item foi excluído do checklist de admissão por ter apresentado o IVC=0,88. Conclusão: Concluiu-se que o conteúdo dos Checklists de segurança do paciente no cuidado de enfermagem nos momentos da admissão, internação e preparação para a alta da UTIN foi considerado válido pelo comitê de especialistas. Ressalta-se a necessidade de aperfeiçoamento constante dos checklists. Os resultados da pesquisa limitam-se à validade de conteúdo, recomendando, posteriormente, a validação clínica dos instrumentos.(AU)

Introduction: Introduction: Patient safety in Neonatal Intensive Care Units (NICUs) is complex, considering the problems related to adverse events (AEs) and gaps in the lack of instruments that guide nursing care. Objective: Validate the check-in of nursing care during hospitalization and preparation for discharge. Methodology: Methodological study, conducted between 2017 and 2018. The first stage included the integrative review for the construction of the instruments guided by the guiding question: Which elements should compose nursing care checklists at admission, hospitalization and preparation for discharge, with a view to safety of the patient admitted to a NICU? The second was the validation of content of the checklists by nurses specialists in the theme, held in three rounds. According to the methodological criteria proposed by Pasquali, the corresponding headings, headings, fill-in guidelines, items and instructions, based on the International Patient Safety Goals and the National Patient Safety Program, were considered for validation the Content Validity Index (IVC) ≥ 0.90. The Survey Monkey® platform was used for data analysis and descriptive analysis. The first round was attended by 43 specialist nurses, 33 in the second and 32 in the third, who were asked to consider the relevance, objectivity, clarity and relevance of the items. Results: Of the 111 items evaluated in the total of the three checklists, 110 were validated with IVC (Content Validity Index) ≥ 0.90 after the suggested modifications and a single item was excluded from the admission checklist for presenting the IVC = 0.88. Conclusion: It was concluded that the contents of the Patient Safety Checklists in the nursing care at the time of admission, hospitalization and preparation for discharge from the NICU were considered valid by the committee of specialists. The need for constant improvement of checklists is emphasized. The results of the research are limited to the content validity, recommending, later, the clinical validation of the instruments.(AU)

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BACKGROUND: Universal protocol implementation can be challenging in low-income or middle-income countries, particularly when providers work together across language barriers. The aim of this quality improvement initiative was to test the implementation of a colour-coded universal protocol in a Guatemalan hospital staffed by US and Guatemalan providers. METHODS: From 2013 to 2016, a US and Guatemalan team implemented a universal protocol at a Guatemalan surgical centre for children undergoing general surgical or urologic procedures. The protocol was a two-step patient identification and documentation checklist, with the first step of all chart element verification in the preoperative area, after which a blue hat was placed on the patient as a visual cue that this was completed. The second step included checklist confirmation in the operating room prior to the procedure. We tested protocol implementation over three phases, identifying implementation barriers and modifying clinical workflow after each phase. We measured the error rate in documentation or other universal protocol steps at each phase and made modifications based on iterative analysis. RESULTS: Over the course of programme implementation, we substantially decreased the rate of errors in documentation or other universal protocol elements. After the first phase, 30/51 patients (58.8%) had at least one error. By the third phase, only 2/43 patients (4.6%) had any errors. All errors were corrected prior to surgery with no adverse outcomes. CONCLUSIONS: Care teams of providers from different countries pose potential challenges with patient safety. Implementation of a colour-coded universal protocol in this setting can prevent and reduce errors that could potentially lead to patient harm.

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A fines del 2017 el Depto.de Anestesiología del Hospital de Clínicas realizó la presentación del MANUAL: MANEJO de CRISIS en SALA de OPERACIONES. A continuación hacemos una síntesis de los fundamentos que llevaron a la elaboración-adaptación de dicho manual para nuestro país (basado en ''OR Crisis Checklists '' disponible en www.proyectcheck.org/crisis).

At late 2017`s the Anesthesiology Department of "Hospital de Clinicas" presented the manual named: Crisis Management in operation room. Following, we make a summary of the bases that lead to the making-adaptation of such manual for our country (based on "OR Crisis Checklists" available atwww.proyectcheck.org/crisis).

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A fines del 2017 el Depto. de Anestesiología del Hospital de Clínicas realizó la presentación del MANUAL: MANEJO de CRISIS en SALA de OPERACIONES. A continuación hacemos una síntesis de los fundamentos que llevaron a la elaboración-adaptación de dicho manual para nuestro país (basado en ‘OR Crisis Checklists ‘ disponible en www.proyectcheck.org/crisis).

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