Impact of FDA's HCT/P ZIKV Recommendations on Cord Blood Unit Eligibility and Utilization in a Large Public Cord Blood Bank.

BACKGROUND: Cord blood units (CBUs) that are ineligible for licensure due to incomplete compliance with FDA recommendations may be used for hematopoietic stem cell transplantation under urgent medical need and an Investigational Drug Application. The largest reason for CBU donor ineligibility is Zika virus (ZIKV) risk. The study's objective was to analyze the impact of current FDA recommendations for ZIKA risk on a large public cord blood bank and propose updated recommendations. METHODS: We performed a retrospective analysis of Carolinas Cord Blood Bank (CCBB), an FDA licensed public CBB, using data from January 1, 2016 to November 21, 2023 and compared FDA recommendations for transfusion transmitted infections (TTI) for blood products and relevant communicable disease agents or diseases for human cell, tissue, or cellular or tissue-based products (HCT/Ps). RESULTS: CCBB: 9057 (84.3% licensed) CBUs were banked. 984/1682 (58.5%) of unlicensed CBUs had ZIKV risk. 22.0% of CBUs with ZIKV risk were from Hispanic parents, compared to 16.1% of all units. 31 of IND CBUs (11 due to ZIKV risk without reported ZIKV transmission) were safely infused. FDA Guidance: HCT/P ZIKV, HIV, and vCJD recommendations have not been updated since 2018 in contrast to FDA removal of ZIKV as a relevant TTI in 2021 and updating HIV and vCJD guidance related to TTI in 2023 and 2022, respectively. DISCUSSION: The FDA should consider new data to revise the HCT/P donor eligibility recommendations, which will increase the number of eligible HCT/P donors, and potentially improve access to therapies for a more diverse patient population.

Serological ineptitude in blood banks: is there an association with sexually transmitted infections? / Inaptidão sorológica em bancos de sangue: existe associação com infecções sexualmente transmissíveis?

Introduction: Sexually transmitted infections (STIs) are a serious public health problem, and some of these infections are also transmitted through blood transfusions. Objective: To identify publications in scientific journals in Brazil and in the world showing if there is an important association between serological inadequacy due to sexually transmitted infections traced in blood and blood products used for medical use. Methods: Systematic review of articles published from 2018 to 2023, using the LILACS, SciELO and PubMed databases, with a concomitant approach to the issues of serological disability and STI. Original studies or review articles in Portuguese, English and Spanish with Brazilian and international data were included. Editorial publications, letter to the editor, letter from the editor or comments on the subject were excluded. Results: The search found 571 articles, of which 106 (18.40%) met the inclusion criteria, that is, Serological disability and STI. In studies with international data, the prevalence of donors with hepatitis C ranged from 0.12 to 4.8%; with hepatitis B, from 1.3 to 8.2%; with HIV, from 0.0021 to 2.5%; with syphilis, from 1.73 to 2.4%; with HTLV, 0.66%; and with Chagas disease, from 0.017 to 2.76%. Among articles with Brazilian data, the prevalence of donors with seroreactive tests for hepatitis C ranged from 0.18 to 1.76%; with hepatitis B, from 0.05 to 7.9%; with HIV, from 0.03 to 0.82%; with syphilis, from 0.37 to 3.51%; with HTLV, from 0.02 to 0.3%, and with Chagas disease, from 0.8 to 0.5%. Conclusion: STIs are rarely discussed in the scientific literature in studies on serological inadequacy. In addition, a minority of articles were with Brazilian data. However, results show that STIs, despite being little discussed in the scientific literature in studies on the subject of serological inadequacy, have statistically significant percentages of seropositivity for STIs. Moreover, hepatitis C and B have a relevant seroprevalence, reaching 8.2% and 4.8%, respectively, in the international scenario. In Brazil, hepatitis B continues to occupy a prominent place with a seroprevalence of up to 7.9%. However, syphilis now holds a very important role, with a maximum percentage of 3.51%. More studies are needed for further reflection: although STIs are little addressed in studies about serological inadequacy in human blood banks, would they contribute to the maintenance and non-reduction of the general frequency of infections transmitted by blood transfusion

Introdução: As infecções sexualmente transmissíveis (IST) são um grave problema de saúde pública e algumas dessas infecções, também, transmitidas por intermédio de transfusões de sangue. Objetivo: Identificar publicações em periódicos científicos no Brasil e no mundo sobre se existe importante associação entre inaptidão sorológica por infecções sexualmente transmissíveis rastreadas em sangue e hemoderivados usados para uso médico. Métodos:Revisão sistemática de artigos publicados no período de 2018 a 2023, usando as bases de dados Literatura Latino-Americana e do Caribe em Ciências da Saúde (Lilacs), Scientific Electronic Library Online (SciELO) e United States National Library of Medicine (PubMed) com abordagem concomitante para os assuntos de inaptidão sorológica e IST. Incluíram-se estudos originais ou artigos de revisão nos idiomas português, inglês e espanhol com dados brasileiros e internacionais. Foram excluídas publicações do tipo editorial, carta ao editor, carta do editor ou comentários sobre o tema. Resultados:A busca localizou 571 artigos dos quais 106 (18,40%) se encaixavam nos critérios de inclusão, ou seja, inaptidão sorológica e IST. Em estudos com dados internacionais, a prevalência de doadores com hepatite C variou de 0,12 a 4,8%; com hepatite B de 1,3 a 8,2%; com HIV de 0,0021 a 2,5%; com sífilis de 1,73 a 2,4%; com HTLV 0,66%; e com doença de Chagas de 0,017 a 2,76 %. Já entre os artigos com dados brasileiros, a prevalência de doadores com exames soro-reatores para hepatite C variou de 0,18 a 1,76%; com hepatite B de 0,05 a 7,9%; com HIV de 0,03 a 0,82%; com sífilis de 0,37 a 3,51%; com HTLV 0,02 a 0,3%, e com doença de Chagas de 0,8 a 0,5%. Conclusão: As IST são pouco abordadas na literatura científica em estudos com o tema inaptidão sorológica. Além disso, uma minoria de artigos era com dados brasileiros. Entretanto, resultados demonstram que, apesar de pouco abordadas na literatura científica em estudos com o tema inaptidão sorológica, as IST possuem percentuais de soropositividade estatisticamente significativos. Além disso, as hepatites C e B possuem soroprevalência relevante, podendo chegar a 8,2 e 4,8%, respectivamente, no cenário internacional. Já no cenário nacional, brasileiro, a hepatite B continua ocupando um lugar de destaque, com soroprevalência de até 7,9%. Todavia, a sífilis passa a ocupar um papel de altíssima relevância, com percentual máximo de 3,51%. São necessários mais estudos para mais reflexão: apesar de as IST serem pouco abordadas em estudos acerca da inaptidão sorológica em bancos de sangue humano, seriam elas contribuintes para a manutenção e a não redução da frequência geral de infecções transmitidas por transfusão sanguínea?

Transfusion Safety Officers in the United States: Survey of characteristics and approaches to implementation.

BACKGROUND: Transfusion safety officers (TSO) function as liaisons between the blood bank and clinical staff, utilizing audits, quality improvement, reviews, communication, education, and general vigilance to enhance transfusion safety. While hospitals in Europe and Canada have long employed TSOs, a majority of institutions in the United States (US) have yet to implement this resource, despite the mounting evidence to support their effectiveness. STUDY DESIGN AND METHODS: An anonymous 20-question survey was administered to 104 hospitals with valid email contact information. Survey questions addressed the presence of a TSO, characteristics, backgrounds, and education of TSOs, the reporting and funding structure of the position, and role responsibilities. RESULTS: 53 responses were received, with 52 surveys completed (51 % response rate). The majority of responding institutions have a patient blood management (PBM) program (n = 40, 77 %) and 33 (63 %) have at least 1 TSO. 61 % of TSOs report an educational background in nursing, with 11 additional unique training backgrounds identified. TSO responsibilities are varied and include quality improvement, education, transfusion safety event analysis, and participation in PBM initiatives. Barriers to implementing a TSO position include lack of resources, financial impediments, and a lack of understanding of the position and its value by administrators and clinicians. DISCUSSION: The results of this survey highlight how TSOs contribute to transfusion safety and PBM and may provide guidance to hospitals interested in implementing a TSO position. It also elucidates the range of TSO responsibilities and approaches that institutions utilize to advocate for, and implement, this position in the US.

Red Blood Cell Transfusion Practices for Patients With Cervical Cancer Undergoing Radiotherapy.

Importance: Packed red blood cell (PRBC) transfusions are used to treat anemia in patients with cervical cancer undergoing radiotherapy (RT) owing to concerns of hypoxia-induced radioresistance. In the absence of high-quality evidence informing transfusion practices for patients receiving external beam RT (EBRT) and brachytherapy, various arbitrary hemoglobin target levels are used worldwide. Objective: To develop consensus statements to guide PRBC transfusion practices in patients with cervical cancer receiving curative-intent RT with EBRT and brachytherapy. Design, Setting, and Participants: This international Delphi consensus study was completed between November 1, 2019, and July 31, 2020. A total of 63 international clinical experts in gynecologic radiation oncology were invited; 39 (62%) accepted and consented to participate. Consensus building was achieved using a 3-round anonymous Delphi consensus method. Participants rated their agreement or disagreement with statements using a 5-point Likert scale. An a priori threshold of 75% or more was required for consensus. Main Outcomes and Measures: The preplanned primary outcome of this study was to assess hemoglobin transfusion thresholds and targets for both EBRT and brachytherapy by expert consensus. Results: Response rates of 100% (39 of 39), 92% (36 of 39), and 97% (35 of 36) were achieved for the first, second, and third rounds of surveys, respectively. Twenty-three experts (59%) practiced in Canada, 11 (28%) in the United States, 3 (8%) in South America, 1 (3%) in Europe, and 1 (3%) in Asia. Consensus was reached for 44 of 103 statements (43%), which were combined to form the final 27-statement consensus guideline. No specific hemoglobin transfusion threshold was agreed on by consensus for EBRT or brachytherapy. By consensus (89% [31 of 35]), a hemoglobin transfusion target for patients who receive a PRBC transfusion should be 9 g/dL or more and less than 12 g/dL. Conclusions and Relevance: This study presents the first international expert consensus guideline informing PRBC transfusion practices for patients with cervical cancer undergoing EBRT and brachytherapy. A minimum hemoglobin transfusion target of 9 g/dL was endorsed to balance tumor radiosensitivity with appropriate use of a scarce resource. Randomized clinical trials are required to evaluate the optimal transfusion threshold and target that maximize clinical benefit in this patient population.

Transfusion medicine and blood banking education and training for blood establishment laboratory staff: A review of selected countries in Africa.

BACKGROUND: Avoidable human error is a significant cause of transfusion adverse events. Adequately trained, laboratory staff in blood establishments and blood banks, collectively blood facilities, are key in ensuring high-quality transfusion medicine (TM) services. Gaps in TM education and training of laboratory staff exist in most African countries. We assessed the status of the training and education of laboratory staff working in blood facilities in Africa. STUDY DESIGN AND METHODS: A cross-sectional study using a self-administered pilot-tested questionnaire was performed. The questionnaire comprised 26 questions targeting six themes. Blood facilities from 16 countries were invited to participate. Individually completed questionnaires were grouped by country and descriptive analysis performed. RESULTS: Ten blood establishments and two blood banks from eight African countries confirmed the availability of a host of training programs for laboratory staff; the majority of which were syllabus or curriculum-guided and focused on both theoretical and practical laboratory skills development. Training was usually preplanned, dependent on student and trainer availability and delivered through lecture-based classroom training as well as formal and informal on the job training. There were minimal online didactic and self-directed learning. Teaching of humanistic values appeared to be lacking. CONCLUSION: We confirmed the availability of diverse training programs across a variety of African countries. Incorporation of virtual learning platforms, rather than complete reliance on didactic, in-person training programs may improve the education reach of the existing programs. Digitalization driven by the coronavirus disease 2019 pandemic may provide an opportunity to narrow the knowledge gap in low- and middle-income countries (LMICs).

New blood donors in times of crisis: Increased donation willingness, particularly among people at high risk for attracting SARS-CoV-2.

BACKGROUND: Traditionally, during crises the number of new blood donors increases. However, the current coronavirus disease 2019 (COVID-19) pandemic created additional barriers to donate due to governmental prevention measures and increased personal health risks. In this report, we examined how the pandemic affected new donor registrations in the Netherlands, especially among groups with higher risk profiles for severe COVID-19. Additionally, we explored the role of media for blood donation and new donor registrations. STUDY DESIGN AND METHODS: We analyzed new donor registrations and attention for blood donation in newspapers and on social media from January until May 2020, in comparison to the same period in 2017 to 2019. RESULTS: After the introduction of nationwide prevention measures, several peaks in new donor registrations occurred, which coincided with peaks in media attention. Interestingly, people with a higher risk profile for COVID-19 (e.g., due to age or region of residence) were overrepresented among new registrants. DISCUSSION: In sum, the first peak of the current pandemic has led to increased new blood donor registrations, despite the associated increased health risks. Time and future studies will have to tell whether these new donors are one-off 'pandemic' donors or if they will become regular, loyal donors.

Cord blood beyond transplantation: can we use the experience to advance all cell therapies?

Unrelated cord blood (CB) units, already manufactured, fully tested and stored, are high-quality products for haematopoietic stem cell transplantation and cell therapies, as well as an optimal starting material for cell expansion, cell engineering or cell re-programming technologies. CB banks have been pioneers in the development and implementation of Current Good Manufacturing Practices for cell-therapy products. Sharing their technological and regulatory experience will help advance all cell therapies, CB-derived or not, particularly as they transition from autologous, individually manufactured products to stored, 'off-the shelf' treatments. Such strategies will allow broader patient access and wide product utilisation.

A Tertiary Academic Medical Center Blood Bank's Experience With Four-Factor Prothrombin Complex Concentrate.

OBJECTIVES: The role of transfusion medicine consultative services in prospectively auditing (PA) orders for four-factor prothrombin complex concentrate (4F-PCC) was evaluated at an academic medical center. METHODS: Data from 4 years of 4F-PCC orders were obtained from the laboratory information system, and electronic health records of patients receiving concentrate were reviewed. RESULTS: 4F-PCC was ordered for 427 patients with warfarin-, apixaban-, or rivaroxaban-associated hemorrhage. Turnaround time (TAT) to prepare 4F-PCC was longer when PA-recommended dose adjustments were needed (85 vs 66 minutes, P = .03). There was no difference in TAT between patients who died and those who were ultimately discharged (60 vs 70, P = .22). TAT was shortest for orders originating in the emergency department (ED) compared with other locations (64 vs 85, P < .001), and ED TAT was not associated with patient outcomes in ED patients. PA and dose adjustments reduced amounts of concentrate issued by 27 IU per dose (P = .01). Median international normalized ratio less than 1.3 after 4F-PCC transfusion was achieved for all anticoagulants after dose adjustments. PA did not affect order cancellation or product wastage rates. CONCLUSIONS: PA can ensure 4F-PCC is dosed appropriately without affecting patient outcomes.

Kit para fraccionamiento automatizado de hemocomponentes con filtro leucorreductor en un solo paso / Kit for automated fractionation of blood components with leukoreductive filter in a single step

INTRODUCIÓN: Los pacientes con diagnóstico de neoplasias onco-hematológicas son una población que amerita una gran cantidad de transfusiones de hemocomponentes. El fraccionamiento semi-automatizado es una forma de obtención de hemocomponentes utilizado en muchas unidades de banco de sangre en nuestro país. Sin embargo, cuenta con limitaciones que dificultan una obtención rápida, la calidad de los hemocomponentes y la estandarización de procesos de fraccionamiento. El fraccionamiento automatizado ha surgido como una alternativa del procesamiento de hemocomponentes con múltiples beneficios. ESTRATEGIA DE BÚSQUEDA DE INFORMACIÓN: a) Pregunta Clínica: En los pacientes con diagnóstico oncológico del INEN que tienen indicación para transfusión de hemocomponentes, ¿Cuál es el beneficio del fraccionamiento automatizado de hemocomponentes con filtro leucorreductor comparado con el fraccionamiento semi-automatizado de hemocomponentes? b) RECOLECCIÒN DE LOS MANUSCRITOS A REVISAR: Tipos de estudios: La estrategia de búsqueda sistemática de información científica para el desarrollo del presente informe se realizó siguiendo las recomendaciones de la Pirámide jerárquica de la evidencia propuesta por Haynes y se consideró los siguientes estudios: Sumarios y guías de práctica clínica. Revisiones sistemáticas y/o meta-análisis. Ensayos Controlados Aleatorizados (ECA). Estudios Observacionales (cohortes, caso y control, descriptivos) No hubo limitaciones acerca de la fecha de publicación o el idioma para ningún estudio. DISCUSION: Los pacientes con neoplasias hematológicas suelen presentar disminución espontánea de las constantes corpusculares de forma moderada-severa. Los pacientes con neoplasias sólidas que reciben tratamiento con quimioterapia suelen presentar eventos adversos. Entre los más frecuentes bicitopenias y pancitopenias que ameritan muchas veces múltiples transfusiones de hemocomponentes y que incluso acuden a los servicios de emergencias para transfusión de hemocomponentes. La automatización del proceso de fraccionamiento permite la homogenización de los procedimientos del fraccionamiento. Permite disminuir la variable "error humano", permite mejor la calidad interna de las muestras y disminuir la cantidad de muestras desechadas. Recalcamos particularmente el menor tiempo en que demora el fraccionamiento automatizado, recordando que un buen porcentaje de pacientes amerita transfusión de hemocomponentes de forma rápida por alto riesgo de mortalidad y que el método automatizado genera hemocomponentes de forma más rápidas. La aplicación del fraccionamiento automatizado permitiría realizar la leucoreducción en banco de sangre, lo cual nos ofrece múltiples ventajas. Los estudios descritos encontraron que los métodos de fraccionamiento automatizados necesitaron menor tiempo del procesamiento y presentaron una mayor eficacia en comparación con la leucoreducción fuera del banco de sangre. La leucoreducción disminuye el riesgo de reacciones transfusionales. CONCLUSIONES: 1. Con la aplicación del fraccionamiento automatizado REVEOS obtenemos: homogeneidad de procedimientos, menor tiempo de fraccionamiento, disminuimos variable "Error Humano", optimizamos leucoreducción, mejoramos calidad de hemocomponentes y la disminuimos la eliminación de hemocomponentes. 2. La aplicación del fraccionamiento automatizado beneficiaria de múltiples formas el proceso de transfusión que es tan frecuente en la población oncológica.

Impact of 12-month cryopreservation on endogenous DNA damage in whole blood and isolated mononuclear cells evaluated by the comet assay.

The comet assay is an electrophoretic technique used to assess DNA damage, as a marker of genotoxicity and oxidative stress, in tissues and biological samples including peripheral blood mononuclear cells (PBMCs) and whole blood (WB). Although numerous studies are performed on stored samples, the impact of cryopreservation on artifactual formation of DNA damage is not widely considered. The present study aims to evaluate the impact of storage at different time-points on the levels of strand breaks (SBs) and formamidopyrimidine DNA glycosylase (Fpg)-sensitive sites in isolated PBMCs and WB. Samples were collected, aliquoted and stored at - 80 °C. DNA damage was analyzed on fresh samples, and subsequently on frozen samples every 2 months up to a year. Results have shown no changes in DNA damage in samples of PBMCs and WB stored for up to 4 months, while a significant increase in SBs and Fpg-sensitive sites was documented starting from 6-month up to 12-month storage of both the samples. In addition, fresh and frozen WB showed higher basal levels of DNA damage compared to PBMCs. In conclusion, WB samples show high levels of DNA damage compared to PBMCs. One-year of storage increased the levels of SBs and Fpg-sensitive sites especially in the WB samples. Based on these findings, the use of short storage times and PBMCs should be preferred because of low background level of DNA damage in the comet assay.

The Binns Program for Cord Blood Research: A novel model of cord blood banking for academic biomedical research.

Umbilical cord blood is an important graft source in the treatment of many genetic, hematologic, and immunologic disorders by hematopoietic stem cell transplantation. Millions of cord blood units have been collected and stored for clinical use since the inception of cord blood banking in 1989. However, the use of cord blood in biomedical research has been limited by access to viable samples. Here, we present a cost-effective, self-sustaining model for the procurement of fresh umbilical cord blood components for research purposes within hospital-affiliated academic institutions.

Blood supply management in times of SARS-CoV-2 pandemic - challenges, strategies adopted, and the lessons learned from the experience of a hospital-based blood centre.

INTRODUCTION: Numerous concerns regarding maintenance of blood inventory have been raised after SARS-CoV-2 pandemic outbreak. These concerns were based on the experience of blood centres in previous pandemics where shortage of blood components was reported. The present study had tried to understand the impact of SARS-CoV-2 pandemic on blood collection and demand as well as the impact of disaster planning in maintaining an adequate inventory. METHODS: Data related to blood supply and demand were collected retrospectively using blood bank management software for pre-COVID-19 and COVID-19 time period and compared. Strategies adopted and effects of changes in existing disaster plans to maintain an adequate inventory were studied. RESULTS: A drastic fall in the red cell inventory was observed as compared to pre-COVID-19 time period was observed due to disproportionate decrease in blood collection (1/6 to 1/9 of the previous collection) and demand (1/2 of the previous demand). The buffer stock fell gradually over a period of three weeks with cancellation of planned blood donation drives. A buffer stock equivalent to 2-week inventory led to adequate inventory in the initial lockdown periods. Similar fall was observed in the platelet inventory with reduction in the blood collection but almost a proportionate reduction in the platelet demand led to adequate inventory. No increase in wastage was observed for both red cells and platelets during this period. DISCUSSION: A buffer stock of blood and blood components, strict adherence to the transfusion triggers, good coordination with the clinical staff and a prospective review of blood transfusion requests to ensure rational blood transfusion were some of the steps which helped us to successfully maintain transfusion requirements in the initial phases of the COVID-19 pandemic. Use of first-in-first-out policy prevented any wastage due to outdating of blood.

Cold storage of platelets in platelet additive solution maintains mitochondrial integrity by limiting initiation of apoptosis-mediated pathways.

BACKGROUND: Cold storage of platelets in plasma maintains hemostatic function and is an attractive alternative to room temperature platelets (RTPs). We have recently shown that functional differences between cold-stored platelets (CSPs) and RTPs after 5-day storage are associated with mitochondrial respiration and that CSPs in platelet (PLT) additive solution (PAS) can maintain hemostatic function for at least 15 days. STUDY DESIGN AND METHODS: This study tested the hypothesis that cold storage in PAS preserves mitochondrial integrity by reducing PLT apoptosis. CSPs and RTPs in plasma or PAS were stored and assayed for up to 15 days for mitochondrial function and integrity, mitochondrial-associated mRNA transcript expression, apoptotic proteins, and apoptotic flow cytometry metrics. RESULTS: CSP preserved mitochondria-associated mRNA comparable to baseline levels, improved mitochondrial respiration, and minimized depolarization to Day 15. Additionally, CSPs had minimal induction of caspases, preservation of plasma membrane integrity, and low expression of pro-apoptotic Bax. Storage in PAS appeared to be protective for RTPs in some parameters and enhanced the effects of CSPs. CONCLUSION: Mitochondrial function and molecular analyses defined CSP priming as distinctly different from the well-documented RTP storage lesion. While current blood bank storage at room temperature is limited to 5 to 7 days, refrigeration and storage in PAS for up to 15 days may represent an opportunity to enhance inventories and access to PLT hemostatic support for bleeding patients.

Effects of Intercept pathogen reduction treatment on extended cold storage of apheresis platelets.

BACKGROUND: Platelets pose the greatest transfusion-transmitted infectious risk among blood products. Refrigeration of platelets can mitigate bacterial contamination and extend platelet shelf life. Implementation of pathogen reduction technologies (PRTs) at blood banks has become increasingly popular to protect against emerging and reemerging infectious diseases. In this study, we sought to evaluate the effects of Intercept PRT on platelets collected on different platforms and cold-stored for up to 21 days in plasma and platelet additive solution (PAS). METHODS: Double-dose apheresis platelets were collected with use of a Trima or Amicus system into either 100% plasma or 65% InterSol PAS/35% plasma and split equally between two bags. One bag served as control, while the other received Intercept PRT treatment. Bags were stored unagitated in the cold and evaluated on Days 1, 7, 14, and 21 to assess platelet metabolism, activation, aggregation, and clot formation and retraction. RESULTS: By Day 14 of storage, lactate levels reached approximately 13 mmol/L for all samples irrespective of Intercept treatment. Mean clot firmness dropped from the 62.2- to 67.5-mm range (Day 1) to the 28.4- to 51.3-mm range (Day 21), with no differences observed between groups. Clot weights of Intercept-treated Trima/plasma samples were significantly higher than control by Day 14 of storage (P = .004), indicating a reduced clot retraction function. Intercept treatment caused a higher incidence of plasma membrane breakdown in plasma-stored platelets (P = .0013; Trima/plasma Day 14 Control vs Intercept). CONCLUSIONS: Intercept treatment of platelets and subsequent cold storage, in plasma or PAS, results in comparable platelet metabolism platelets for up to 14 days of storage but altered clotting dynamics. Pathogen-reduced platelets with an extended shelf life would be beneficial for the deployed setting and would greatly impact transfusion practice among civilian transfusion centers.

Aprendizaje-servicio como estrategia metodológica en estudiantes de tecnología médica / Service-learning as methodological strategy in students of medical technology

INTRODUCCIÓN: La metodología de aprendizaje-servicio se presenta como una herramienta educativa que permite respon-der integradamente a tres dimensiones: una académica, que posibilita mayores y mejores aprendizajes en los estudiantes; otra, la contribución real a la solución de problemas comunitarios, y finalmente, generar un espacio de formación en valores para los estudiantes. OBJETIVO: El objetivo de la estrategia metodológica de aprendizaje-servicio fue fortalecer los aprendizajes declarados en las trayectorias relacionados con la donación altruista de sangre, junto con instaurar en los estudiantes la responsabilidad social de hacerse donantes y promotores de la donación como futuros profesionales de la salud, en coordinación con un socio comunitario. Sujetos y métodos: La actividad se desarrolló a través de charlas a comunidades objetivo. Los estudiantes contactaron con las comunidades, prepararon el material y desarrollaron la actividad. Se hizo evaluación a través de una encuesta a los estudiantes, con aseveraciones que debían responder de acuerdo con una escala de 1 a 4, siendo 4 el mayor nivel de acuerdo. RESULTADOS: La actividad de aprendizaje-servicio fue evaluada por los estudiantes con un promedio global de 3,69. El criterio mejor evaluado fue la actividad de aprendizaje-servicio potencia el desarrollo de responsabilidad profesional y social', con una media de 3,86. CONCLUSIÓN: Esta metodología de enseñanza mejora la adquisición de saberes pertenecientes a módulos disciplinares y fortalece el compromiso social en los estudiantes

INTRODUCTION: The service-learning methodology is presented as an educational tool that allows to respond integrally to three dimensions: an academic one, which enables greater and better learning in students; another to the real contribution to the solution a community problem; and finally, to generate a space for values training for students. AIM: The objective of the service-learning methodological strategy was to strengthen the declared learning in the trajectories related to altruistic blood donation, along with establishing in students the social responsibility of becoming donors and promoters of donation as future health professionals, in coordination with a community partner. Subjects and methods: The activity was developed through talks to target communities. The students contacted the communities, prepared the material, and developed the activity. Evaluation was made through a survey of students, with statements that they had to answer according to a scale of 1 to 4, with 4 being the highest level of agreement. RESULTS: The service-learning activity was evaluated by the students with a global average of 3.69. The best evaluated criterion was 'the service-learning activity enhances the development of professional and social responsibility', with a 3.86 grade point average. CONCLUSION: This teaching methodology improves the acquisition of knowledge belonging to disciplinary modules, and strengthens social commitment in students

Report from the GHPP-BloodTrain inspection workshop in Harare the 20th to the 24th of May 2019.

During the training workshop on Inspection of Blood Establishments, which was hosted by the PEI GHPP BloodTrain in Harare from the 20th to the 24th of May 2019, participants from the National Regulatory Authorities from seven Sub-Sahara African countries presented their current experiences related to regulation and inspection of blood establishments in their respective countries. While in all seven countries regulation and inspection of conventional medicinal products manufacturer is performed, the regulatory situation of blood and blood components as well as inspection of blood establishments is still heterogeneous.