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.

[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.

Fresh-Frozen Plasma: Ordering Patterns and Utilization in the Operating Rooms of a Tertiary Referral Hospital.

BACKGROUND: Blood product transfusion is the most commonly performed hospital procedure. Intraoperative blood product utilization varies between institutions and anesthesiologists. In the United States in 2011, nearly 4 million plasma units were transfused. METHODS: A retrospective analysis of intraoperative plasma ordering patterns and utilization (thawing and transfusing) was performed at a tertiary, academic hospital between January 2015 and March 2016. RESULTS: Over 15 months, 46,002 operative procedures were performed. In 1540 of them, plasma was thawed or transfused: 8297 plasma units were thawed and 3306 of those units were transfused. These 3306 plasma units were transfused in 749 cases with a median of 2 plasma units (interquartile range, 2-4) transfused. The percentage of average monthly procedures with plasma thawed and none transfused was 51.3% (confidence interval, 49.0%-53.6%). The cardiac surgery service requested the greatest number of plasma units to be thawed (2143) but only transfused 712 (33.2%) of them. Of all plasma units not transfused, 45% were generated by procedures with 1 to 4 units of plasma thawed; 95.7% of these units were thawed as even integers (ie, 2, 4). CONCLUSIONS: For operative procedures, far more plasma was thawed than was transfused and this practice occurred across surgical specialties and anesthesiologists. Considering the plasma that was not transfused, 45% occurred in procedures with 4 or fewer units of plasma requested suggesting these low-volume requests were a primary source of potential waste. Further studies are needed to examine associations between plasma utilization and clinical outcomes.

Use of an automated drug distribution cabinet system in a disaster response mobile emergency department.

OBJECTIVE: This article describes the innovative use of an automated drug distribution cabinet system for medication supply in a disaster response mobile Emergency Department vehicle. Prior to the use of the automated drug distribution cabinet system described in this article, the mobile hospitals were stocked as needed with drugs in individual boxes and draws. Experience with multiple deployments found this method to be very cumbersome and labor intensive, both in preparation, operational use, and demobilization. SETTING: For a recent deployment to provide emergency medical care at the 2014 Super Bowl football event, the automated drug distribution cabinet system in the Institution's main campus Emergency Department was duplicated and incorporated into the mobile Emergency Department. RESULTS: This method of drug stocking and dispensing was found to be far more efficient than gathering and placing drugs in onboard draws and racks. CONCLUSIONS: Automated drug distribution cabinet systems can be used to significantly improve patient care and overall efficiency in mobile hospital deployments.

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.

[Research of regional medical consumables reagent logistics system in the modern hospital].

OBJECTIVE: To explore the modern hospital and regional medical consumable reagents logistics system management. METHODS: The characteristics of regional logistics, through cooperation between medical institutions within the region, and organize a wide range of special logistics activities, to make reasonable of the regional medical consumable reagents logistics. To set the regional management system, dynamic management systems, supply chain information management system, after-sales service system and assessment system. By the research of existing medical market and medical resources, to establish the regional medical supplies reagents directory and the initial data. The emphasis is centralized dispatch of medical supplies reagents, to introduce qualified logistics company for dispatching, to improve the modern hospital management efficiency, to costs down. RESULTS: Regional medical center and regional community health service centers constitute a regional logistics network, the introduction of medical consumable reagents logistics services, fully embodies integrity level, relevance, purpose, environmental adaptability of characteristics by the medical consumable reagents regional logistics distribution. CONCLUSIONS: Modern logistics distribution systems can increase the area of medical consumables reagent management efficiency and reduce costs.

[Quality improvement and performance evaluation of Monitoring and Tracking Medical Materials Lot Number].

With various increasing health sector's demand of medical materials, monitoring and tracking medical materials lot number has become the most important thing of hospital's medical materials management. This paper discussed and researched deeply the actual operation problem through data analysis and charts comparison, put forward realizing barcodes wireless scanning, and synchronizing information in local area network, so to improve the barcode input accuracy. Achieve the ultimate goal of completing medical materials lot number traceability.

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.

Evaluation of the effectiveness of the Pastormaster method for disinfection of legionella in a hospital water distribution system.

The Pastormaster method consists of heating the water of hospital distribution systems at a specific point to a sufficient temperature for a minimum amount of time to eradicate legionella. The object of this study was to evaluate the effectiveness of the Pastormaster method for legionella disinfection in a hospital environment. A two-phase procedure was performed: hydraulic optimization of the water supply circuit, and implementation of the Pastormaster method. Water samples were taken at 10 representative points in the hospital hot-water system and cultured microbiologically. Other physical and chemical measurements were also determined. Implementation of the Pastormaster method and correction of the deficiencies identified during a hydraulic system audit confirmed the absence of legionella in the hospital water distribution system. The combination of implementation of the Pastormaster method and conduction of a hydraulic audit designed to identify and remedy any possible problems in water circulation is effective in minimizing the risk of legionella contamination in hospital water distribution systems.

[General services]. / Servicios Generales.

The present article describes the activity performed by the medical support services and, more specifically, by operational services (which include mainly cleaning, laundry, and non-patient transport) and catering. We outline the normal activity of these services and then provide details of how they were affected on 11 March and subsequent days. Data relating to the Rehabilitation Centers and Ophthalmology Institute are not included as they were not significantly affected from the point of view discussed herein.

Managing the healthcare supply chain.

Explore the supply requisition process and the innovative ways to improve patient outcomes and enhance your bottom line.