Access to and safety of COVID-19 convalescent plasma in the United States Expanded Access Program: A national registry study.

BACKGROUND: The United States (US) Expanded Access Program (EAP) to coronavirus disease 2019 (COVID-19) convalescent plasma was initiated in response to the rapid spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the causative agent of COVID-19. While randomized clinical trials were in various stages of development and enrollment, there was an urgent need for widespread access to potential therapeutic agents. The objective of this study is to report on the demographic, geographical, and chronological characteristics of patients in the EAP, and key safety metrics following transfusion of COVID-19 convalescent plasma. METHODS AND FINDINGS: Mayo Clinic served as the central institutional review board for all participating facilities, and any US physician could participate as a local physician-principal investigator. Eligible patients were hospitalized, were aged 18 years or older, and had-or were at risk of progression to-severe or life-threatening COVID-19; eligible patients were enrolled through the EAP central website. Blood collection facilities rapidly implemented programs to collect convalescent plasma for hospitalized patients with COVID-19. Demographic and clinical characteristics of all enrolled patients in the EAP were summarized. Temporal patterns in access to COVID-19 convalescent plasma were investigated by comparing daily and weekly changes in EAP enrollment in response to changes in infection rate at the state level. Geographical analyses on access to convalescent plasma included assessing EAP enrollment in all national hospital referral regions, as well as assessing enrollment in metropolitan areas and less populated areas that did not have access to COVID-19 clinical trials. From April 3 to August 23, 2020, 105,717 hospitalized patients with severe or life-threatening COVID-19 were enrolled in the EAP. The majority of patients were 60 years of age or older (57.8%), were male (58.4%), and had overweight or obesity (83.8%). There was substantial inclusion of minorities and underserved populations: 46.4% of patients were of a race other than white, and 37.2% of patients were of Hispanic ethnicity. Chronologically and geographically, increases in the number of both enrollments and transfusions in the EAP closely followed confirmed infections across all 50 states. Nearly all national hospital referral regions enrolled and transfused patients in the EAP, including both in metropolitan and in less populated areas. The incidence of serious adverse events was objectively low (<1%), and the overall crude 30-day mortality rate was 25.2% (95% CI, 25.0% to 25.5%). This registry study was limited by the observational and pragmatic study design that did not include a control or comparator group; thus, the data should not be used to infer definitive treatment effects. CONCLUSIONS: These results suggest that the EAP provided widespread access to COVID-19 convalescent plasma in all 50 states, including for underserved racial and ethnic minority populations. The study design of the EAP may serve as a model for future efforts when broad access to a treatment is needed in response to an emerging infectious disease. TRIAL REGISTRATION: ClinicalTrials.gov NCT#: NCT04338360.

Developing the COVID-19 intensive care medical equipment distribution platform: outcomes and lessons learned.

During the first wave of the coronavirus pandemic, the UK government took the decision to centralise the procurement, allocation and distribution of mission-critical intensive care unit (ICU) medical equipment. Establishing new supply chains in the context of global shortages presented significant challenges. This report describes the development of an innovative platform developed rapidly and voluntarily by clinical engineers, to mobilise the UK's shared medical equipment inventory, in order to match ICU capacity to dynamically evolving clinical demand. The 'Coronavirus ICU Medical Equipment Distribution' platform was developed to optimise ICU equipment allocation, distribution, collection, redeployment and traceability across the National Health Service. Although feedback on the platform has largely been very positive, the platform was built for a scenario that did not fully materialise in the UK and this affected the implementation approach. As such, it was not used to its full potential. Nonetheless, the platform and the insights derived and disseminated in its development have been extremely valuable. It provides a prototype for not only optimising system capacity in future pandemic scenarios but also a means for maximally exploiting the large amount of new equipment in the UK health system, as a result of the coronavirus pandemic. This early stage innovation has demonstrated that a system-wide pooled information resource can benefit the operations of individual organisations. It has also generated numerous lessons to be borne in mind in innovation projects.

Emergency department clinical leads' experiences of implementing primary care services where GPs work in or alongside emergency departments in the UK: a qualitative study.

BACKGROUND: To manage increasing demand for emergency and unscheduled care NHS England policy has promoted services in which patients presenting to Emergency Departments (EDs) with non-urgent problems are directed to general practitioners (GPs) and other primary care clinicians working within or alongside emergency departments. However, the ways that hospitals have implemented primary care services in EDs are varied. The aim of this study was to describe ED clinical leads' experiences of implementing and delivering 'primary care services' and 'emergency medicine services' where GPs were integrated into the ED team. METHODS: We conducted interviews with ED clinical leads in England (n = 19) and Wales (n = 2). We used framework analysis to analyse interview transcripts and explore differences across 'primary care services', 'emergency medicine services' and emergency departments without primary care services. RESULTS: In EDs with separate primary care services, success was reported when having a distinct workforce of primary care clinicians, who improved waiting times and flow by seeing primary care-type patients in a timely way, using fewer investigations, and enabling ED doctors to focus on more acutely unwell patients. Some challenges were: trying to align their service with the policy guidance, inconsistent demand for primary care, accessible community primary care services, difficulties in recruiting GPs, lack of funding, difficulties in agreeing governance protocols and establishing effective streaming pathways. Where GPs were integrated into an ED workforce success was reported as managing the demand for both emergency and primary care and reducing admissions. CONCLUSIONS: Introducing a policy advocating a preferred model of service to address primary care demand was not useful for all emergency departments. To support successful and sustainable primary care services in or alongside EDs, policy makers and commissioners should consider varied ways that GPs can be employed to manage variation in local demand and also local contextual factors such as the ability to recruit and retain GPs, sustainable funding, clear governance frameworks, training, support and guidance for all staff. Whether or not streaming to a separate primary care service is useful also depended on the level of primary care demand.

[Impact of an automated dispensing system for medical devices in cardiac surgery department]. / Impact de l'implantation d'armoires sécurisées dédiés aux dispositifs médicaux dans un service de chirurgie cardiaque.

To secure medical devices' management, the implementation of automated dispensing system in surgical service has been realized. The objective of this study was to evaluate security, organizational and economic impact of installing automated dispensing system for medical devices (ASDM). The implementation took place in a cardiac surgery department. Security impact was assessed by comparing traceability rate of implantable medical devices one year before and one year after installation. Questionnaire on nurses' perception and satisfaction completed this survey. Resupplying costs, stocks' evolution and investments for the implementation of ASDM were the subject of cost-benefit study. After one year, traceability rate is excellent (100%). Nursing staffs were satisfied with 87.5% by this new system. The introduction of ASDM allowed a qualitative and quantitative decrease in stocks, with a reduction of 30% for purchased medical devices and 15% for implantable medical devices in deposit-consignment. Cost-benefit analysis shows a rapid return on investment. Real stock decrease (purchased medical devices) is equivalent to 46.6% of investment. Implementation of ASDM allows to secure storage and dispensing of medical devices. This system has also an important economic impact and appreciated by users.

O julgamento do caso da fosfoetanolamina e a jurisprudência do Supremo Tribunal Federal / The judgment on the phosphoethanolamine case and the jurisprudence of the Brazilian Federal Supreme Court

Recentemente noticiou-se a difusão do uso da substância fosfoetanolamina sintética, conhecida como a pílula do câncer, entre portadores de neoplasia maligna. Ocorre que a substância, além de não contar com registro na Agência Nacional de Vigilância Sanitária, sequer havia concluído os estudos clínicos necessários à garantia de sua eficácia e segurança. Não obstante, o governo federal editou a Lei n. 13.269/2016, que autorizava o fornecimento pelo Sistema Único de Saúde sob determinadas condições, e diversas liminares foram concedidas obrigando o Estado a fornecê-la. A questão foi apreciada pelo Supremo Tribunal Federal em dois rumorosos julgamentos, em que a Corte suspendeu todas as liminares concedidas e suspendeu a eficácia da referida lei por indícios de inconstitucionalidade. Neste artigo analisamos os fundamentos das citadas decisões no contexto de posicionamentos anteriores da Corte e das orientações estabelecidas no julgamento do Agravo Regimental na Suspensão de Tutela Antecipada 175

Widespread use of the synthetic substance phosphoethanolamine, known as the cancer pill, was recently reported among patients with malignant neoplasm. However, the substance was not registered in the Brazilian National Health Surveillance Agency and the clinical studies necessary to guarantee its effectiveness and safety had not even been completed. Nevertheless, the federal government enacted Law number 13.269/2016, authorizing provision by the Brazilian National Public Health System under certain conditions, and various injunctions were granted that forced the state to provide it. The question was considered by the Supreme Court in two important judgments in which the Court suspended all injunctions granted and suspended the effectiveness of the law based on evidence of unconstitutionality. In this article, we analyze the legal grounds of the decisions in the context of previous positions of the Court and the guidelines established in judgment of STA 175-AgR/CE

Does Higher Spending Improve Survival Outcomes for Myocardial Infarction? Examining the Cost-Outcomes Relationship Using Time-Varying Covariates.

OBJECTIVES: Previous patient-level acute myocardial infarction (AMI) research has found higher hospital spending to be associated with improved survival; however, survivor-treatment selection bias traditionally has been overlooked. The purpose of this study was to examine the AMI cost-outcome relationship, taking into account this form of bias. DATA SOURCES: Hospital Discharge Abstract data tracked costs for AMI hospitalizations. Ontario Vital Statistics data tracked patient mortality. STUDY DESIGN: A standard Cox survival model was compared to an extended Cox model using hospital costs as a time-varying covariate to examine the impact of cost on 1-year survival in a cohort of 30,939 first-time AMI patients in Ontario, Canada, from 2007 to 2010. PRINCIPAL FINDINGS: Higher patient-level AMI spending decreased the hazard of dying (Standard Model: log-cost hazard ratio: 0.513, 95 percent CI: 0.479-0.549; Extended Model: log-cost hazard ratio: 0.700, 95 percent CI: 0.645-0.758); however, the protective effect was overestimated by 62 percent when survivor-treatment bias was overlooked. In the extended model, a 10 percent increase in spending was associated with a 3.6 percent decrease in hazard of death. CONCLUSION: The findings of this study suggest that if survivor-treatment bias is overlooked, future research may materially overstate the protective effect of patient-level spending on outcomes.

Gestão de compras em um hospital de ensino terciário:um estudo de caso um estudo de caso / Purchasing Management in a Tertiary Teaching Hospital: a case study

Modelo do Estudo: Estudo de Caso. Objetivo do Estudo: O presente trabalho visou estudar o processo de compras e programação de materiais de um hospital público de ensino de nível terciário e analisar os perfis de itens de materiais de consumo faltantes em determinado período, com a finalidade de identificar como ferramentas de gestão de materiais podem ajudar na definição de políticas de compras e estoque. Metodologia: O estudo foi elaborado com base em análises qualitativas e quantitativas. As primeiras foram feitas por meio de coleta de dados relativos ao entendimento dos processos e estrutura interna da Divisão de Materiais do Hospital através de observação e entrevistas semi estruturadas entre o período de setembro a novembro de 2013. A relação dos itens faltantes em 2012 e 2013 foi obtida através do sistema de informação da instituição e a partir destes dados foram feitas as análises quantitativas dos perfis destes itens segundo as classificações ABC e VEN (ou XYZ). Resultado: Os resultados apontam que dos 8.595 itens de materiais de consumo do Hospital apenas 5% em quantidade são classificados como A na curva ABC, no entanto tais itens correspondem a 42% em valores. Já os itens vitais representam 49% do valor e 46% em termos de quantidade. Quando analisadas em conjunto, as duas curvas apontam que a maioria das quantidades de materiais de consumo do Hospital são classificados como vitais da curva C (36,35%) e os itens não essenciais da curva A representam tanto em valor como em quantidade a menor parcela de materiais. O perfil dos itens faltantes em 2012 e 2013 são semelhantes,o maior índice de faltas está nos itens vitais da curva C e a menor nos itens não essenciais da curva...

Model Study: Case Study. Purpose of the Study: This study aims to explore the purchasing materials process in a tertiary teaching hospital and analyze the missing items profiles in a given period in order to identify how materials management tools can help optimizing purchasing and inventory policies. Methodology: The study was based on qualitative and quantitative analyses. The first was made by means of collecting data to understand both processes and internal structure of the Materials Division through observation and semi-structured interviews between September-November 2013. A list of missing items in 2012 and 2013 was obtained from system information in order to analyze the profiles of these items according to the ABC and VEN (or XYZ) ratings. Results: The results show that out of 8,595 items of consumable materials, only 5 % in volume are classified as A in ABC curve, however such items correspond to 42 % in value. On the other hand, vital items represent 49 % on value and 46 % in terms of quantity. When analyzed together, the two curves show that most quantities of consumables materials are classified as vital from the C curve (36.35%) where as non-essential items from the A curve represent both in value and in volume the smallest amount portion of materials. The missing items profile in 2012 and 2013 were similar, the highest rate of faults is from vital and C curve materials and the smaller, of nonessentials of the A curve...

Pediatric discharge content: a multisite assessment of physician preferences and experiences.

BACKGROUND AND OBJECTIVES: Professional medical societies endorse prompt, consistent discharge communication to primary care providers (PCPs) on discharge. However, evidence is limited about what clinical elements to communicate. Our main goal was to identify and compare the clinical elements considered by PCPs and pediatric hospitalists to be essential to communicate to PCPs within 2 days of pediatric hospital discharge. A secondary goal was to describe experiences of the PCPs and pediatric hospitalists regarding sending and receiving discharge information. METHODS: A survey of physician preferences and experiences regarding discharge communication was sent to 320 PCPs who refer patients to 16 hospitals, with an analogous survey sent to 147 hospitalists. Descriptive statistics were calculated, and χ² analyses were performed. RESULTS: A total of 201 PCPs (63%) and 71 hospitalists (48%) responded to the survey. Seven clinical elements were reported as essential by >75% of both PCPs and hospitalists: dates of admission and discharge; discharge diagnoses; brief hospital course; discharge medications; immunizations given during hospitalization; pending laboratory or test results; and follow-up appointments. PCPs reported reliably receiving discharge communication significantly less often than hospitalists reported sending it (71.8% vs 85.1%; P < .01), and PCPs considered this communication to be complete significantly less often than hospitalists did (64.9% vs 79.1%; P < .01). CONCLUSIONS: We identified 7 core clinical elements that PCPs and hospitalists consider essential in discharge communication. Consistently and promptly communicating at least these core elements after discharge may enhance PCP satisfaction and patient-level outcomes. Reported rates of transmission and receipt of this information were suboptimal and should be targeted for improvement.

Políticas de distribución del RR HH de Enfermería, Según sus nivel de formación, en relación a las Leyes vigentes del ejercicio profesional de Enfermería del Hospital Interzonal San Juan Bautista de la Provincia de CATAMARCA ûa±o 2012 / Distribution policies Nursing HR, according to their level of training, in relation to current practice Laws Interzonal Nursing Hospital San Juan Bautista of the Province of Catamarca -year 2012

El presente trabajo tiene la finalidad reflexionar sobre el uso de las teorías de Enfermería en la prßctica. A pesar de los esfuerzos de los profesionales de Enfermería en construir conocimiento a través de las teorías y modelos y del alto nivel alcanzado en la formación de Enfermería, aún no se evidencia en la prßctica la implementación de las teorías y odelos que fundamenten la misma. Por el contrario se ha considerado que la prßctica de Enfermería se ha basado en la técnica y el cumplimiento de las Leyes vigentes sobre los procedimientos rutinarios Se utilizó un abordaje Cuali-Cuantitativo-Descriptivo, interpretativo, estratificado por servicio, de corte transversal, en un universo de 165 enfermeros del Hospital Interzonal San Juan Bautista de la Provincia de Catamarca, cuya muestra seleccionada fue de 41 enfermeros de los servicios de Clínica, Terapia y Cirugía, seleccionada en forma estratificada por servicio en forma aleatoria...

The present work aims to reflect on the use of nursing theories in practice. Despite the efforts of professionals from nursing to build knowledge through the theories and models and the high level achieved in the training of nursing, still not evident in practice implementation of the theories and models that support the same. On the other hand has been considerednursing practice is based on the technique and the enforcement of existing laws on procedures routine was used an approach qualitative-quantitative-descriptive, interpretive, stratified by service, cross section, in a universe of 165 nurses of the Hospital Interzonal San Juan Bautista of the province of Catamarca, whose sample was 41 nursing of clinic services Therapy and surgery, selected as stratified by randomly service...

Don't break the chain: importance of supply chain management in the operating room setting.

Management of supplies within the operating room (OR) has considerable implications for decreasing healthcare costs while maintaining high-quality patient care. This area of healthcare therefore requires more monitoring by end-users including OR management, physicians, and nursing staff. This article is based on understanding supply chain management in the OR setting. Information provided throughout the article can be applied to small or large health care centers. It defines supply chain management and contains a brief overview of supply chain processes. It reviews the benefits of following these processes. The article also includes recommendations for improving the supply chain in the OR.

Management of conventional mass casualty incidents: ten commandments for hospital planning.

The successful management of mass casualty incidents (MCIs) requires standardization of planning, training, and deployment of response. Recent events in the United States, most importantly the Hurricane season in 2005, demonstrated a lack of a unified response plan at local, regional, state, and federal levels. A standard Israeli protocol for hospital preparedness for conventional MCIs, produced by the Office of Emergency Preparedness of the Israeli Ministry of Health, has been reviewed, modified, adapted, and tested in both drills and actual events at a large university medical center in the United States. Lessons learned from this process are herein presented as the10 most important steps (ie, Commandments) to follow when preparing hospitals to be able to respond to conventional MCIs. The standard Israeli emergency protocols have proved to be universally adaptable, flexible, and designed to be adapted by any healthcare institution, regardless of its size and location.

Implementation of a redistribution system for near-outdate red blood cell units.

CONTEXT: Many remote hospitals keep small on-site stocks of red blood cell (RBC) units for emergency use and to support patient care programs. In Canada, the blood supplier does not accept returned units into inventory. Discard rates can, therefore, be high. OBJECTIVE: To transport near-outdate RBC units to a high-usage hospital site, which would reduce overall discard rates, thereby increasing overall stock levels available in the blood system. DESIGN: A blood transportation system was developed and validated. The validation was presented to a high-usage site that agreed to accept near-outdate RBC units transported by this system. Stocks at the remote hospitals were optimized without increasing system-wide discard rates. The redistribution program was implemented in 4 remote sites in northern Alberta, Canada. The final disposition of each transported unit was tracked. Data from the first 2 years were analyzed. RESULTS: Between April 1, 2003, and March 31, 2005, 106 RBC units were successfully transported to and transfused at the high-usage site. The majority of the units were group O. None of the transfused units were involved in any reported transfusion reactions. The success rate of the transportation system varied among the sites (59%-78% successfully transported and transfused). Changes to the transport system were implemented as problems were discovered. The use of a temperature monitor in each shipment allowed for concurrent revalidation after each change. CONCLUSIONS: Redistribution systems can be an effective way to reduce RBC unit discard rates. Even simple transportation systems have many factors affecting the RBC unit temperature. Novel temperature stabilizing materials may make future transportation of RBC units more reliable.