A Systematic Framework for Radio Frequency Identification (RFID) Hazard Mitigation in the Blood Transfusion Supply Chain from Donation to Distribution

The RFID Consortium is developing what will be the first FDA-approved use of radio frequency identification (RFID) technology to identify, track, manage, and monitor blood throughout the entire blood transfusion supply chain. The iTraceTM is an innovative technological system designed to optimize the procedures currently employed when tracing blood from the donor to the recipient. With all novel technologies it is essential to consider not only the advantages, but also the potential harms that may come about from using the system. The deployment of the iTraceTM consists of two phases: 1) Phase One - application of the iTraceTM from the donor to blood center distribution, and 2) Phase Two - application of the iTraceTM from blood center distribution to transfusion. This dissertation seeks to identify the possible hazards that may occur when utilizing the iTraceTM during Phase One, and to assess the mitigation and correction processes to combat these hazards. A thorough examination of verification and validation tests, as well as of the system design, requirements, and standard operating procedures was performed to qualify and quantify each hazard into specific categories of severity and likelihood. A traceability matrix was also established to link each hazard with its associated tests and/or features. Furthermore, a series of analyses were conducted to determine whether the benefits of implementing the iTraceTM outweighed the risks and whether the mitigation and correction strategies of the hazards were effective. Ultimately, this dissertation serves as a usable, generalizable framework for the management of RFID-related hazards in the blood transfusion supply chain from donor to blood center distribution

Recent developments in military transfusion practice and their impact on civilian healthcare

Introduction. Massive haemorrhage is the leading cause of preventable death following trauma. The mortality rate is high unless actively managed from Point of Injury (POI). However, during the last decade advances in military medicine, including transfusion support, appear to have delivered extraordinary survival advantages. A new transfusion policy was introduced in 2007 in response to the emerging analysis of combat experience underpinned by a revised understanding of the pathophysiology of trauma. Transfusion support was redesigned as part of Damage Control Resuscitation (DCR) to mitigate Trauma Induced Coagulopathy. The Massive Transfusion Capability was an ambitious programme designed to provide transfusion support throughout the continuum of care. The success has led to transfusion support being considered in military and civilian environments where there is a risk of haemorrhage but there is minimal medical infrastructure. Developments such as: a more portable cold chain; whole blood and lyophilised products offered Remote Damage Control Resuscitation (RDCR) whilst addressing the logistic tail. The delivery of the military capability has required considerable innovation during an era in which transfusion practice became subject to an increase in legislative and regulatory measures. The overall objective of this study is to evaluate the recent developments in military transfusion practice and to assess the impact on civilian practice. Methods. The study describes the developments in military transfusion support in a linear sequence from 2006 to 2016. The adoption of military principles and practice is then explored in the context of civilian practice and national emergency transfusion preparedness for Mass Casualty Events (MCE). The source material thesis is derived from the author’s military and civilian, professional and academic practice. The thesis submission is structured around four aims; two military thematic areas which are the recent changes in UK military blood transfusion practice and the development of prehospital transfusion. These are followed by two civilian themes; the introduction of Massive Transfusion Protocols (MTPs) and transfusion planning for Mass Casualty Events (MCEs). The military data has been extracted from the UK Joint Theatre Trauma Registry complimented by quality management systems. The civilian data is derived from the relevant Trauma Registries, Patient Administration Systems and Laboratory Information Management Systems. Descriptive statistics were used to summarize the number of components by year, speciality and patient demographics. Statistical analysis was performed using a variety of software tools. Results. The paradigm of military transfusion has changed in the last decade. The developments have been credited with contributing to survival of the critically injured. Survival is the product of the entire system of care, which – in this setting of combat, incorporates the early external haemorrhage control, hybrid resuscitation; rapid and physician-led recovery from the battlefield, damage control surgery, transfusion support and expert critical care. It is thus not possible to ascertain the individual contribution of transfusion however it has been an important element. Transfusion support is increasingly being considered in at risk environments with minimal infrastructure and logistic support. The collection of Whole blood from a pre-tested Emergency Donor panel is a viable transfusion management option. Knowledge sharing from the Bergen based Blood Far Forward program has enabled the further development of UK military practice. In addition, the concept of the safe universal whole blood donor has informed the wider transfusion community leading to the acceptance of group O Low titre as a new standard. Massive Transfusion Protocols (MTP) have been successfully introduced into civilian practice for both trauma and other causes of massive haemorrhage. Massive Transfusion (MT) is a phenomenon of surgery not trauma and the organisational principles can be applied to all causes of haemorrhage. MT is resource intensive and has implications for both hospital and blood service organisation. However, the civilian studies have not demonstrated a survival advantage and the definitions of MT require standardisation to allow comparison of practice and the design of further studies. The pattern of blood use in civilian Mass Casualty Events differs from that seen in the recent military experience in Afghanistan and Iraq. Far fewer injured require blood and few require Massive Transfusion and haemostatic component support. However, military style planning has added value to the preparation for MCEs and the response to Major Incidents. Elements of military planning have included the optimisation of pre-hospital care, haemorrhage control, transfusion triage, MTPs and emergency donor management. Transfusion Emergency Preparedness should become an integrated part of healthcare emergency planning. Conclusions. Transfusion has emerged as an essential and successful element of modern combat care. The success must be placed in the context of the whole healthcare system, especially pre-hospital care. The nature of military and civilian trauma differs however, many of the recent lessons identified have been intelligently applied to civilian hospital healthcare. Military practice has also informed both pre-hospital emergency care, blood component development and transfusion planning for MCEs. In turn, combat care has benefitted from civilian transfusion governance and regulatory expertise. The continued military-civilian collaboration and innovation in transfusion practice has the potential to benefit not only the military, but also the wider healthcare community

Aerospace medicine and biology: A continuing bibliography with indexes (supplement 386)

This bibliography lists 117 reports, articles and other documents introduced into the NASA Scientific and Technical Information System during Mar. 1994. Subject coverage includes: aerospace medicine and physiology, life support systems and man/system technology, protective clothing, exobiology and extraterrestrial life, planetary biology, and flight crew behavior and performance

Study of RBC shape transitions induced by nanoparticles

Aquesta tesi descriu l'estudi de les propietats del medi extracel·lular sobre la criopreservació de glòbuls vermells i la possible aplicació de nanopartícules de sílice com a co-agents per al lliurament intracel·lular de trehalosa, un crioprotector natural. La primera part de l™estudi es va centrar en les condicions de congelació i descongelació i en les propietats del medi extracel·lular per a la congelació. Es van analitzar diferents propietats segons la seva influència en la taxa de supervivència dels glòbuls vermells, que es va avaluar mitjançant l™assaig d™hemòlisi i es va analitzar l™efecte de la congelació mitjançant anàlisi morfològica d™imatges de glòbuls vermells. La segona part de l'estudi investiga la interacció de nanopartícules de sílice carregades de manera diferent amb els glòbuls vermells per a futures aplicacions com a co-agent per al lliurament de la trehalosa. La toxicitat de les nanopartícules de sílice es va determinar mitjançant un assaig d™hemòlisi i la seva distribució espacial es va estudiar mitjançant l™examen de glòbuls vermells que flotaven lliurement mitjançant microscòpia confocal d™escaneig làser (LSCM). Es va desenvolupar un nou mètode de visualització 3D de gran rendiment i aplicat a les imatges LSCM per tal de corregir la deriva al llarg de la z-stack permetent l'anàlisi de les imatges. Els resultats es van confirmar interactuant les nanopartícules de sílice amb vesícules gegants unilamellars (GUV) com a sistema experimental.Esta tesis describe el estudio de las propiedades del medio extracelular en la crioconservación de los glóbulos rojos y la posible aplicación de nanopartículas de sílice como coagentes para la entrega intracelular de trehalose, un crioprotector natural. La primera parte del estudio se centró en las condiciones de congelación y descongelación, y en las propiedades del medio extracelular para la congelación. Se analizaron diferentes propiedades de acuerdo con su influencia en la tasa de supervivencia de los glóbulos rojos, según se evaluó mediante el ensayo de hemólisis, y se analizó el efecto de la congelación mediante el análisis morfológico de las imágenes de los glóbulos rojos. La segunda parte del estudio investiga la interacción de nanopartículas de sílice, cargadas de manera diferente, con glóbulos rojos para su futura aplicación como coagente para la entrega de trehalose. La toxicidad de la nanopartícula de sílice se determinó mediante un ensayo de hemólisis y su distribución espacial se estudió mediante la obtención de imágenes de los glóbulos rojos que flotan libremente usando microscopía confocal (LSCM). Se desarrolló un nuevo método de visualización 3D de alto rendimiento que se aplicó a las imágenes LSCM para corregir la deriva en toda la pila z permitiendo el análisis de las imágenes. Los resultados se confirmaron mediante la interacción de las nanopartículas de sílice con vesículas unilamelares gigantes (GUV) como un sistema de modelo experimental.This thesis describes the study of the properties of extracellular medium on the cryopreservation of red blood cells and the potential application of silica nanoparticles as co-agents for the intracellular delivery of trehalose, a natural cryoprotectant. The first part of the study focused on the freezing and thawing conditions, and on the properties of the extracellular medium for freezing. Different properties were analyzed according to their influence on the survival rate of red blood cells as assessed by hemolysis assay and the effect of freezing was analyzed by morphological analysis of images of red blood cells. The second part of the study investigates the interaction of differently charged silica nanoparticles with red blood cells for future application as co-agent for trehalose delivery. Silica nanoparticle toxicity was determined by hemolysis assay and their spatial distribution was studied by imaging freely floating red blood cells using laser scanning confocal microscopy (LSCM). A novel high-throughput 3D visualization method was developed and applied to LSCM images in order to correct the drift throughout the z-stack allowing the analysis of the images. Results were confirmed by interacting the silica nanoparticles with giant unilamellar vesicles (GUV) as an experimental model system

Life-cycle information management and acquisition for blood products

Ten of thousands patients die every year because of medical errors. Many more patients suffer permanent damage and have to be medicated for the rest of their life. In the context of a blood donation, blood production and blood transfusion process, a lack of consistent and complete trace and tracking of individual blood bags has been identified as a source of medical errors. This research aims to address this challenge to help organisations such as blood banks to track the donation, manufacture, distribution and in-use of blood products, to remove/minimise the potential medical errors. Although the major goal of this research study is to increase patient security, reduction of wastage is also part of the research aims because donated blood is a scarce resource. Nowadays, up to 20% of the blood bags are put to scrap without use and each of the blood bag costs 220 Euro to produce (i.e. from collection, production and storage until it is consumed/discarded). In Austria alone, 5.6 million Euros could be saved each year if the wastage can be removed. Besides the economic issue, donated human blood is a scarce resource and always gives a poor psychological response from the general public when preventable wastage occurs. This research study approaches the challenges through a life-cycle point of view because it sees the goal can only be achieved through ‘real-time’ life-cycle information that governs the quality and life-span of such products. As a result, a new RF based semi-active transponder (13.56 MHz, ISO 15693 compatible HF interface) with integrated data storage and temperature sensor, which is able to sustain high g - forces have been developed to provide the ‘real-time’ temperature data and other related information support. The developed life-cycle information system has been trialled at the University Clinic of Graz not only to test its effectiveness, but also used as a case study for this research study. Due to the resources constraints (e.g. time), the case study does not create sufficient data to establish any statistical significance to quantify the benefits of the proposed systems. However, all the involved persons including both the operational and professional staff at University Clinique of Graz, have agreed the proposed RFID transponders, together with its lifecycle management system provides better decision support to handle individual blood bag at any stage of its lifecycle. They believe the proposed system will improve patients’ safety and reduce the wastage of blood bags. During the trail, it happened that two blood bags ready for transfusion were detected to be below 0°C somehow during their life-cycle. A blood transfusion would have been 100% mortal to the patients. The detection of this fatal mistake did save at least the life of one human being and illustrated the importance of an objective, overarching and complete life-cycle system for blood products. Although this research is focused on blood products for blood banks and medical environments, the benefits of the system approach and methodologies could also apply to other types of sensitive and fragile goods that require life-cycle information support

Aerospace medicine and biology: A continuing bibliography with indexes (supplement 402)

This bibliography lists 244 reports, articles and other documents introduced into the NASA Scientific and Technical Information System during Nov. 1992. Subject coverage includes: aerospace medicine and physiology, life support systems and man/system technology, protective clothing, exobiology and extraterrestrial life, planetary biology, and flight crew behavior and performance

Annual SHOT Report 2021

SHOT is affiliated to the Royal College of Pathologists. This report is produced by SHOT working with MHRAPartnering with patients to enhance safety: Staff must ensure that they involve, engage and listen to patients as ‘partners’ in their own care, including transfusion support. Engaging patients, their families, and carers as ‘safety partners’ helps co-create safer systems, identify, and rectify preventable adverse events. Investing in safety - well-resourced systems with safe staffing levels: Healthcare leaders must ensure that systems are designed to support safe transfusion practice and allocate adequate resources in clinical and laboratory areas to ensure safe staffing levels, staff training in technical and non-technical skills and appropriate equipment, including IT systems. Just and learning safety culture: All healthcare leaders must promote a just, learning safety culture with a collective, inclusive, and compassionate leadership. Effective leaders must ensure staff have: access to adequate training, mentorship, and support. All staff in clinical and laboratory areas have a responsibility to speak up in case of any concerns and help embed the safety culture in teams

Prehospital blood transfusion after combat injury and platelet function in an animal model of complex military trauma

PhD ThesisThe management of trauma has been transformed by recent conflict and by improvements in understanding of the response to injury, particularly coagulopathy. Clotting abnormalities can appear early after trauma and have multiple causes, including tissue injury, shock and the effects of treatment. There is increasing understanding of the contribution of coagulation molecules to these abnormalities. Platelets are recognised as being central to the clotting cascade in the current cell-based model of coagulation but have been incompletely studied after traumatic injury. There has been widespread adoption of the practice of “haemostatic resuscitation” using blood products rather than crystalloid fluids with a high ratio of plasma to red blood cells to correct the coagulopathy of trauma while restoring the patient’s physiology. The British Armed Forces have pushed this forward of the hospital using physician-led medical teams. However, this practice has unquantified benefit and potential for harm, and is a logistical challenge. The first study in this thesis assesses whether available clinical data support the use of prehospital transfusion. It compared recipients of the treatment with similarly injured controls. Although mortality was halved, confounding changes in hospital transfusion practice made it impossible to rely on these data to establish the efficacy of prehospital transfusion. To allow further study, an animal model of complex military trauma was developed. The author focused on developing a flow cytometry assay for the assessment of platelet activation and response to in vitro stimulation. This was successful. The performance of the assay was assessed in the context of the animal model. Surgical preparation of the model appeared to affect the expression of the relevant activation marker. While the assay proved incompatible with unavoidable constraints of the model, its development acted as the basis for the establishment of a human platelet study of combat casualties in Afghanistan

Aerospace medicine and biology: A continuing bibliography with indexes (supplement 394)

This bibliography lists 71 reports, articles and other documents introduced into the NASA Scientific and Technical Information System during Nov. 1994. Subject coverage includes: aerospace medicine and physiology, life support systems and man/system technology, protective clothing, exobiology and extraterrestrial life, planetary biology, and flight crew behavior and performance