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1.
Lab Med ; 55(3): 251-254, 2024 May 02.
Artigo em Inglês | MEDLINE | ID: mdl-38175635

RESUMO

BACKGROUND: Due to chemotherapy-induced neutropenia or hematologic malignancies, immunocompromised cancer patients may have higher incidence of febrile nonhemolytic transfusion reactions compared with the general population and frequently require platelet transfusions. This quality improvement project compared the safety of transfusion using prestorage leukocyte-reduced and pooled whole blood-derived platelets (Acrodose/WBD) with conventionally produced poststorage WBD platelets (RDP) using an active hemovigilance system. METHODS: Every patient receiving a blood product at the hospital was virtually monitored in real time by trained nurses from a remote hemovigilance unit. These nurses monitor a digital dashboard, which populates a watch list of patients from the time blood product administration is initiated until 12 hours posttransfusion. Over the course of 6 months, 371 patients receiving 792 RDP transfusions and 423 patients receiving 780 Acrodose/WBD platelets transfusions were monitored for transfusion reactions. RESULTS: We identified 26 transfusion reactions in RDP but only 12 transfusion reactions in the Acrodose/WBD platelet group. CONCLUSION: Acrodose platelet transfusion was associated with fewer transfusion reactions, which resulted in significant cost savings.


Assuntos
Redução de Custos , Transfusão de Plaquetas , Humanos , Transfusão de Plaquetas/efeitos adversos , Transfusão de Plaquetas/métodos , Transfusão de Plaquetas/economia , Masculino , Feminino , Pessoa de Meia-Idade , Reação Transfusional/prevenção & controle , Idoso , Segurança do Sangue/métodos , Segurança do Sangue/economia , Adulto , Procedimentos de Redução de Leucócitos/métodos
2.
Vox Sang ; 118(9): 721-729, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37533234

RESUMO

BACKGROUND AND OBJECTIVES: The severity grading tool (SGT) was recently designed by the Association for Advancement of Blood and Biotherapies (AABB) to have more objectivity in severity assignment for an adverse donor reaction after blood donation. A study was performed in India to assess the knowledge (post-training) and determine the degree of agreement of the SGT between participating centres and the subject expert group. MATERIALS AND METHODS: This prospective cross-sectional survey-based study was conducted by the National Coordinating Centre (NCC) of the National Blood Donor Vigilance Programme (NBDVP) of India. Thirty-five real-world case scenarios, validated by seven national and two international experts, were sent to the participating centres, and their responses received (diagnosis and severity grade) were compared and analysed. RESULTS: A total of 50 blood centres participated in the study. The overall agreement between the participating centres and the expert group was 66.4%, with a fair Kendall's coefficient of concordance (W) of 0.271 (p-value < 0.05). The degree of agreement was observed to be more than 80% for 12 centres, 60%-80% for 27 centres and <60% for 11 centres. The overall degree/percentage of agreement for cases with single and multiple types of donor adverse reaction was 71.3% and 42.6%, respectively. CONCLUSION: The SGT will be an efficient mode to have uniform objective reporting of the adverse donor reactions and may be implemented in the NBDVP of India. This study also highlights the need for training of the blood centres on the basic definitions and categorization of the donor's adverse reaction.


Assuntos
Doadores de Sangue , Segurança do Sangue , Humanos , Estudos Prospectivos , Estudos Transversais , Índia
3.
Lancet ; 401(10384): 1252-1254, 2023 04 15.
Artigo em Inglês | MEDLINE | ID: mdl-37062289
4.
Rev. enferm. UFSM ; 13: 17, 2023.
Artigo em Inglês, Espanhol, Português | LILACS, BDENF - Enfermagem | ID: biblio-1428832

RESUMO

Objetivo: identificar os indicadores relacionados ao processo transfusional. Método: revisão integrativa de literatura realizada entre março e maio de 2022, em nove fontes de informação no período de 2001 a 2021. Como estratégia de busca, utilizaram-se os descritores "Indicadores de Qualidade em Assistência à Saúde", "Indicadores de Serviços", "Indicadores Básicos de Saúde", "Serviço de Hemoterapia", "Transfusão de Sangue", "Segurança do Sangue", com os operadores boleanos "AND" e "OR" em três idiomas, sendo analisados 49 artigos. Resultados: foram identificados 53 indicadores, os quais se agruparam para: gestão do estoque de hemocomponentes, de produção do processo transfusional, para avaliação do processo transfusional e de suporte do processo transfusional. Conclusão: os indicadores identificados possibilitam avaliação do processo transfusional, apesar de atividades, como a avaliação do cuidado, apresentarem poucos indicadores, evidenciando a necessidade de estudos sobre a temática e construção de novos indicadores para dar sustentação à avaliação mais aprimorada do processo transfusional.


Objective: to identify transfusion-related indicators. Method: an integrative literature review carried out between March and May 2022, in nine sources of information from 2001 to 2021. As a search strategy, the descriptors "Quality Indicators in Health Care", "Service Indicators", "Basic Health Indicators", "Hemotherapy Service", "Blood Transfusion", "Blood Safety" were used, with Boolean operators "AND" and "OR" in three languages, with 49 articles being analyzed. Results: a total of 53 indicators were identified, which were grouped for: blood component stock management, transfusion process production, transfusion process assessment and transfusion process support. Conclusion: the identified indicators make it possible to assess the transfusion process, although activities, such as care assessment, present few indicators, highlighting the need for studies on the subject and the construction of new indicators to support a more improved transfusion process assessment.


Objetivo: identificar indicadores relacionados con el proceso de transfusión. Método: revisión integrativa de la literatura, realizada entre marzo y mayo de 2022, en nueve fuentes de información de 2001 a 2021. Como estrategia de busca, se utilizaron los descriptores "Indicadores de Calidad en la Atención de Salud", "Indicadores de Servicio", "Indicadores Básicos de Salud", "Servicio de Hemoterapia", "Transfusión de Sangre", "Seguridad de la Sangre", con operadores booleanos "AND" y "OR" en tres idiomas, analizando 49 artículos. Resultados: se identificaron 53 indicadores, los cuales fueron agrupados en: gestión del stock de hemocomponentes, producción del proceso transfusional, evaluación del proceso transfusional y apoyo al proceso transfusional. Conclusión: los indicadores identificados posibilitan la evaluación del proceso transfusional, aunque actividades, como la evaluación del cuidado, presenten pocos indicadores, destacando la necesidad de estudios sobre el tema y la construcción de nuevos indicadores que apoyen una evaluación más perfeccionada del proceso de transfusión.


Assuntos
Humanos , Transfusão de Sangue , Indicadores de Serviços , Indicadores de Qualidade em Assistência à Saúde , Serviço de Hemoterapia , Segurança do Sangue
7.
Transfusion ; 62(6): 1241-1250, 2022 06.
Artigo em Inglês | MEDLINE | ID: mdl-35502143

RESUMO

BACKGROUND: To better balance the safety of the blood supply and the inclusion of men who have sex with men (MSM), further improvements are needed to the risk management strategy employed in the Netherlands to reduce transfusion-transmissible infections (TTIs). A gender-neutral individual risk assessment could provide a solution by determining donor eligibility based on sexual behaviors known to increase the risk of TTIs. Our objective is to estimate the proportion of blood donors that would be deferred by such an assessment, as well as their discomfort answering such questions. STUDY DESIGN AND METHODS: Two surveys were distributed in May 2020 to assess sexual behavior in blood donors in the last 4, 6, and 12 months, as well as their discomfort reporting such information. A combination of both surveys measured the extent to which discomfort was associated with reporting sexual behavior. A high-risk sexual behavior pattern was defined as having had multiple sexual partners and having engaged in anal sex, without consistent condom use. RESULTS: Of all 2177 participating whole blood donors, 0.8% report engaging in high-risk sexual behaviors over the last 4 months and would therefore be ineligible to donate. When accounting for the additional proportion of donors that reported such questions would stop them from donating, 2.0% and 3.2% of female and male donors, respectively, would be lost. DISCUSSION: Gender-neutral eligibility criteria based on high-risk sexual behaviors may reduce the overall number of eligible donors in the Netherlands, but could make blood donation more accessible to a broader group of donors.


Assuntos
Infecções por HIV , Minorias Sexuais e de Gênero , Doadores de Sangue , Segurança do Sangue , Seleção do Doador , Feminino , Homossexualidade Masculina , Humanos , Masculino , Países Baixos , Medição de Risco , Comportamento Sexual
8.
Vox Sang ; 117(6): 839-846, 2022 Jun.
Artigo em Inglês | MEDLINE | ID: mdl-35266552

RESUMO

BACKGROUND AND OBJECTIVES: The accreditation of blood services promotes continuous quality improvement in blood and transfusion services. The Africa Society for Blood Transfusion (AfSBT) conducted 20 baseline assessments of National Blood Transfusion Services (NBTS) or blood banks as part of the Step-Wise Accreditation Programme (SWAP) in 10 sub-Saharan African (SSA) countries from 2016 to 2018. This paper aims to elucidate the process and findings of the baseline assessments. MATERIALS AND METHODS: This is a descriptive study of 20 baseline assessments of NBTS. Eleven sections of the AfSBT assessment were reviewed, and 48 out of 68 standards and 356 out of 466 criteria were assessed. Each standard was assigned a value of 1 if it was fully achieved, 0.5 if partially achieved and 0 if not achieved. We defined average section scores >75% as having 'met AfSBT Standards', ≤25% as not meeting standards, 26%-50% as needs major improvement, and 51%-75% as needs some improvement and >75% as meets standards. RESULTS: The AfSBT SWAP standards were met in 4 out of the 11 sections: donor management, blood collection, component production and compatibility testing. Three sections were determined to need some improvement (quality system; handling, transport and storage and testing of donated blood), and three sections were determined to need major improvement (haemovigilance, blood administration and national blood service accreditation). One section (receipt, ordering, and issuing of blood) did not meet standards. CONCLUSION: Despite improvements in the quality of blood services in SSA over the past two decades, governments may consider the importance of prioritizing investments in NBTS, ensuring these institutions meet international accreditation standards that are aligned with safe blood transfusion services.


Assuntos
Acreditação , Transfusão de Sangue , África Subsaariana , Bancos de Sangue , Segurança do Sangue , Humanos
9.
Transfusion ; 61(12): 3361-3371, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34643286

RESUMO

BACKGROUND: The balance between ensuring blood donor and recipient safety while maintaining a sufficient blood supply can be affected by excessive deferral of blood donors. In 2018, a biannual regulatory review of donor eligibility criteria provided the South African National Blood Service (SANBS) the opportunity to review the existing criteria. Changes to these criteria were implemented in April 2019 after an extensive review. STUDY DESIGN AND METHODS: We conducted a cross-sectional study of SANBS whole-blood donor presentations to determine the impact of the changed donor eligibility criteria on deferrals and blood safety. We compared donor presentations, deferrals, and HIV-positive cases for the 12-month period (April 2019-March 2020) after the implementation of the updated donor eligibility criteria to those of the previous year. RESULTS: Of the 2,112,917 donor presentations, 51.1% (1079506) occurred in the post-implementation study period. Overall, deferrals decreased from 18.6% to 14.5%, whereas HIV-positive donations increased by 0.03%. A multivariable logistic regression analysis adjusted for sex, age, geographical location, donor, and clinic type showed significantly lower odds of deferral (OR 0.70; 95% CI: 0.69-0.70) and greater odds of HIV-positive cases in the study period than those in the control period (OR 1.17; 95% CI: 1.10-1.25). CONCLUSION: We confirmed that the change in donor eligibility criteria was associated with a decrease in deferrals and an increase in the country's blood supply. The impact of the increased number of HIV-positive donations on blood safety in a country performing individual donation nucleic acid amplification testing requires further investigation.


Assuntos
Doadores de Sangue , Soropositividade para HIV , Segurança do Sangue , Estudos Transversais , Seleção do Doador , Humanos , África do Sul
10.
Transfusion ; 61(12): 3402-3412, 2021 12.
Artigo em Inglês | MEDLINE | ID: mdl-34651313

RESUMO

BACKGROUND: Despite the promise of pathogen reduction for reducing transfusion-associated adverse events in sub-Saharan Africa, no health-economic assessment is publicly available. STUDY DESIGN AND METHODS: We developed a mathematical risk reduction model to estimate the impact of nationwide whole blood pathogen reduction in Ghana on the incidence of six infectious and one non-infectious transfusion-associated adverse events. We estimated the lifetime direct healthcare costs and disability-adjusted life years lost for each adverse event. For HIV, HCV, and HBV, we simulated disease progression using Markov models, accounting for the likelihood and timing of clinical detection and treatment. We performed probabilistic and univariate sensitivity analysis. RESULTS: Adding whole blood pathogen reduction to Ghana's blood safety portfolio would avert an estimated 19,898 (11,948-27,353) adverse events and 38,491 (16,444-67,118) disability-adjusted life years annually, primarily by averting sepsis (49%) and malaria (31%) infections. One year of pathogen reduction would cost an estimated $8,037,191 ($6,381,946-$9,880,760) and eliminate $8,656,389 ($4,462,614-$13,469,448) in direct healthcare spending on transfusion-associated adverse events. We estimate a 58% probability that the addition of pathogen reduction would reduce overall direct healthcare spending. Findings were most sensitive to uncertainty in the probability that a bacterially contaminated blood donation causes sepsis. CONCLUSION: Whole blood pathogen reduction would substantially reduce the burden of known transfusion-associated adverse events in Ghana and may reduce overall healthcare spending. Additional benefits not captured by this analysis may include averting secondary transmission of infectious diseases, reducing non-medical costs, and averting new or re-emerging transfusion-transmitted infections.


Assuntos
Doenças Transmissíveis , Sepse , Reação Transfusional , Segurança do Sangue , Análise Custo-Benefício , Gana/epidemiologia , Humanos , Reação Transfusional/epidemiologia , Reação Transfusional/prevenção & controle
12.
Transfus Clin Biol ; 28(4): 386-390, 2021 Nov.
Artigo em Francês | MEDLINE | ID: mdl-34464711

RESUMO

Haemovigilance and blood safety became closely linked initially to the quality system, then very quickly to risk management in health-care institutions. The complexity of the transfusion process and the uniqueness of the transfusion act have been the source of a wide range of in-depth analyzes, via methods most often derived from the industry, that aimed at preventing the occurrence of unwanted situations with potential adverse effects on transfused patients. Though these methods have widely been successful, the experience gained over more than two decades indicates that many reported incidents are still avoidable. The time devoted to training, file analyzes (even in the absence of any reported incident), and simulating patient care remains essential. It is fundamental to bear in mind that there is no such thing as risk zero, no one is immune, and this does not happen to others. In this context, developing a different perspective, a new reflection, a vision integrating the complexity of fieldwork and the idea of risk may be an approach worthy of investigation. Indeed, an analysis centered on both of the ways a team copes with difficult situations and the variety of the interactions between professionals would allow medical practitioner to better position themselves through a better assessment and understanding of their role. Such a deeper reflection, through the mobilization of all the stakeholders of the many successful steps of the transfusion process, would increase blood safety and the overall resilience of the system.


Assuntos
Segurança do Sangue , Transfusão de Sangue , Pessoal de Saúde , Humanos , Gestão de Riscos
13.
Transfus Apher Sci ; 60(4): 103207, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-34353706

RESUMO

Blood transfusions come with risks and high costs, and should be utilized only when clinically indicated. Decisions to transfuse are however not always well informed, and lack of clinician knowledge and education on good clinical transfusion practices contribute to the inappropriate use of blood. Low and middle-income countries in particular take much strain in their efforts to address blood safety challenges, demand-supply imbalances, high blood costs as well as high disease burdens, all of which impact blood usage and blood collections. Patient blood management (PBM), which is a patient-focused approach aimed at improving patient outcomes by preemptively diagnosing and correcting anaemia and limiting blood loss by cell salvage, coagulation optimization and other measures, has become a major approach to addressing many of the challenges mentioned. The associated decrease in the use of blood and blood products may be perceived as being in competition with blood conservation measures, which is the more traditional, but primarily product-focused approach. In this article, we hope to convey the message that PBM and blood conservation should not be seen as competing concepts, but rather complimentary strategies with the common goal of improving patient care. This offers opportunity to improve the culture of transfusion practices with relief to blood establishments and clinical services, not only in South Africa and LMICs, but everywhere. With the COVID-19 pandemic impacting blood supplies worldwide, this is an ideal time to call for educational interventions and awareness as an active strategy to improve transfusion practices, immediately and beyond.


Assuntos
Bancos de Sangue/organização & administração , Transfusão de Sangue , Procedimentos Médicos e Cirúrgicos sem Sangue , Anemia/terapia , Bancos de Sangue/economia , Perda Sanguínea Cirúrgica , Segurança do Sangue , Transfusão de Sangue/economia , Infecções Transmitidas por Sangue/prevenção & controle , Procedimentos Médicos e Cirúrgicos sem Sangue/economia , COVID-19 , Tomada de Decisão Clínica , Países em Desenvolvimento , Seleção do Doador/economia , Medicina Baseada em Evidências , Feminino , Infecções por HIV/epidemiologia , Infecções por HIV/prevenção & controle , Necessidades e Demandas de Serviços de Saúde , Humanos , Masculino , Pandemias , Hemorragia Pós-Parto/terapia , Guias de Prática Clínica como Assunto , Gravidez , Prevalência , Utilização de Procedimentos e Técnicas , SARS-CoV-2 , África do Sul/epidemiologia , Medicina Transfusional/educação
14.
Transfusion ; 61(9): 2701-2709, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34240750

RESUMO

BACKGROUND: Chagas disease (CD) serological screening at blood banks is usually performed by a single highly sensitive serological assay, with chemiluminescent immunoassays (CLIAs) being the method of choice. CLIAs employ recombinant, fusion peptides and/or chimeric antigens that selectively capture anti-Trypanosoma cruzi antibodies. However, despite high sensitivity, the ability of these tests to identify CD-positive cases should be evaluated against T. cruzi strains circulating in specific locales. Herein, we used a latent class analysis (LCA) approach employing an array of four chimeric antigens to assess the diagnostic performance of the Liaison XL Murex Chagas CLIA for the detection of anti-T. cruzi IgG in serum samples. STUDY DESIGN AND METHODS: The study included a panel of 5014 serum samples collected from volunteer blood donors at the Hematology and Hemotherapy Foundation of the State of Bahia, submitted to anti-T. cruzi antibody detection using Liaison Chagas CLIA and LCA as a reference test in the absence of a gold standard. RESULTS: LCA classified 4993 samples as negative, while positivity for T. cruzi antibodies was predicted in 21 samples. Compared with LCA, CLIA demonstrated sensitivity and specificity of 76.2% and 99.5%, respectively, providing an overall accuracy of 99.4%. DISCUSSION: In blood banks lacking a de facto highly sensitive screening immunoassay, the low sensitivity offered by Liaison Chagas CLIA renders it unsuitable for standalone use in serological screening procedures for CD. Moreover, blood banks are encouraged to carefully assess the ability of diagnostic methods to identify local T. cruzi strains in circulation.


Assuntos
Doadores de Sangue , Segurança do Sangue , Doença de Chagas/diagnóstico , Trypanosoma cruzi/isolamento & purificação , Anticorpos Antiprotozoários/sangue , Anticorpos Antiprotozoários/imunologia , Antígenos de Protozoários/sangue , Antígenos de Protozoários/imunologia , Doença de Chagas/sangue , Doença de Chagas/imunologia , Humanos , Medições Luminescentes , Trypanosoma cruzi/imunologia
15.
Transfusion ; 61(10): 2885-2897, 2021 10.
Artigo em Inglês | MEDLINE | ID: mdl-34289101

RESUMO

BACKGROUND: Large volume delayed sampling (LVDS) and pathogen reduction technology (PRT) are strategies for platelet processing to minimize transfusion of contaminated platelet components (PCs). This study holistically compares the economic and clinical impact of LVDS and PRT in the United States. STUDY DESIGN AND METHODS: A decision model was constructed to simulate collection, processing, and use of PCs and to compare processing strategies: PRT with 5-day shelf life, LVDS with 7-day shelf life (LVDS7), and LVDS with 5-day shelf life extended to 7 days with secondary testing (LVDS5/2). Target population was adults requiring two or more transfusions. Collection, processing, storage, and distribution data were obtained from the National Blood Collection and Utilization Survey and published literature. Patient outcomes associated with transfusions were obtained from AABB guidelines, meta-analyses, and other published clinical studies. Costs were obtained from reimbursement schedules and other published sources. RESULTS: Given 10,000 donated units, 9512, 9511, and 9651 units of PRT, LVDS5/2, and LVDS7 PCs were available for transfusion, respectively. With these units, 1502, 2172, and 2329 transfusions can be performed with similar levels of adverse events. Assuming 30 transfusions a day, a hospital would require 69,325, 47,940, and 45,383 units of PRT, LVDS5/2, and LVDS7 platelets to perform these transfusions. The mean costs to perform transfusions were significantly higher with PRT units. CONCLUSIONS: Compared with PRT, LVDS strategies were associated with lower costs and higher PC availability while patients experienced similar levels of adverse events. Increased utilization of LVDS has the potential to improve efficiency, expand patient access to platelets, and reduce health care costs.


Assuntos
Plaquetas , Segurança do Sangue/métodos , Plaquetas/microbiologia , Plaquetas/parasitologia , Plaquetas/virologia , Segurança do Sangue/economia , Humanos , Contagem de Plaquetas , Transfusão de Plaquetas/economia , Transfusão de Plaquetas/métodos , Esterilização/economia , Esterilização/métodos , Estados Unidos
16.
Transfusion ; 61(9): 2688-2700, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34173987

RESUMO

BACKGROUND: The prevalence of hepatitis B surface antigen is estimated to be 6.7% in the South African population and in April 1995 the nation introduced universal hepatitis B virus (HBV) vaccination for newborns and infants. We studied the temporal association of this program with HBV prevalence in young blood donors and the contemporary HBV incidence and residual risk of transfusion-transmitted HBV infection (TT-HBV). METHODS: We used blood donation data from January 2011 to December 2019. Estimation of HBV prevalence donations made by first-time blood donors were analyzed by birth cohort and covariates. To estimate the incidence and residual risk of TT-HBV, mathematical models used data from both first time and repeat donors. RESULTS: HBV prevalence in first-time donors decreased from 0.84% (95% confidence interval [CI] 0.78-0.90) in 2011 to 0.66% (95% CI 0.61-0.70) in 2019. The post-1995 birth cohort had a significantly lower HBV prevalence of 0.14% (95% CI 0.13-0.15) than the pre-1985 birth cohort of 1.29% (95% CI 1.25-1.33) and the odds of HBV infection were reduced in a multivariable model (odds ratio [OR] = 0.28, 95% CI 0.24-0.34). The residual risk of TT-HBV occurring from window-period, occult, and possible vaccine breakthrough infections were estimated at 36.9, 5.8, and 2.2 per million red blood cell transfusions, respectively. CONCLUSION: Donors born after the start of routine HBV immunization had significantly lower prevalence of HBV infection, supporting the effectiveness of the vaccination program. The contemporary residual risk of TT-HBV has decreased and should decline further as more vaccinated young people join the donor pool.


Assuntos
Doadores de Sangue , Segurança do Sangue , Vírus da Hepatite B/isolamento & purificação , Hepatite B/diagnóstico , Adulto , Hepatite B/epidemiologia , Hepatite B/prevenção & controle , Vacinas contra Hepatite B/uso terapêutico , Humanos , Programas de Imunização , Lactente , Prevalência , África do Sul/epidemiologia , Reação Transfusional/epidemiologia , Adulto Jovem
17.
Transfus Apher Sci ; 60(4): 103154, 2021 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-33994107

RESUMO

BACKGROUND: Convalescent plasma (CP) has been used in the past in various pandemics, in particular in H1N1, SARS and MERS infections. In Spring 2020, when ongoing the SARS-CoV-2 pandemics, the Veneto Region (V-R) has proposed setting-up an anti-SARS-CoV-2 CP (CCP) Bank, with the aim of preparing a supply of CCP immediately available in case of subsequest epidemic waves. MATERIALS AND METHODS: Key-points to be developed for a quick set-up of the V-R CCP Bank have been recruitment of donors recovered from COVID-19 infection, laboratory analysis for the biological qualification of the CCP units, including titre of neutralizing antibodies and reduction of pathogens, according to National Blood Centre (CNS) Directives, adaptation of the V-R Information Technology systems and cost analysis. Some activities, including diagnostic and viral inactivation processes, have been centralized in 2 or 3 sites. Laboratory analysis upon preliminary admission of the donor included all tests required by the Italian laws and the CNS directives. RESULTS: From April to August 2020, 3,298 people have contacted the V-R Blood Transfusion Services: of these, 1,632 have been evaluated and examined as first time donors and those found to be suitable have carried out 955 donations, from which 2,626 therapeutic fractions have been obtained, at a cost around 215,00 Euro. Since October 2020, the number of COVID-19 inpatients has had a surge with a heavy hospital overload. Moreover, the high request of CCP therapy by clinicians has been just as unexpected, showing a wide therapeutic use. CONCLUSIONS: The organizational model here presented, which has allowed the rapid collection of a large amount of CCP, could be useful when facing new pandemic outbreaks, especially in low and middle income countries, with generally acceptable costs.


Assuntos
Bancos de Sangue/organização & administração , COVID-19/terapia , Defesa Civil/organização & administração , Pandemias , Anticorpos Neutralizantes/sangue , Anticorpos Antivirais/sangue , Bancos de Sangue/economia , Doadores de Sangue , Segurança do Sangue/métodos , Infecções Transmitidas por Sangue/prevenção & controle , Custos e Análise de Custo , Seleção do Doador/legislação & jurisprudência , Humanos , Imunização Passiva/estatística & dados numéricos , Itália , Modelos Organizacionais , Plasma , SARS-CoV-2/imunologia , Inativação de Vírus , Soroterapia para COVID-19
18.
Transfusion ; 61(2): 503-515, 2021 02.
Artigo em Inglês | MEDLINE | ID: mdl-33368381

RESUMO

BACKGROUND: Risk-based decision making is increasingly recognized as key to support national blood policy makers and blood operators concerning the implementation of safety interventions, especially to address emerging infectious threats and new technology opportunities. There is an urgent need for practical decision support tools, especially for low- and middle-income countries that may not have the financial or technical capability to develop risk models. WHO supported the development of such a tool for blood safety. The tool enables users to perform both a quantitative Multi-Criteria Decision Assessment and a novel step-by-step qualitative assessment. STUDY DESIGN AND METHODS: This paper summarizes the content, functionalities, and added value of the new WHO tool. A fictitious case study of a safety intervention to reduce the risk of HIV transmission by transfusion was used to demonstrate the use and usefulness of the tool. RESULTS: Application of the tool highlighted strengths and weaknesses of both the quantitative and qualitative approaches. The quantitative approach facilitates assessment of the robustness of the decision but lacks nuances and interpretability especially when multiple constraints are taken into consideration. Conversely, while unable to provide an assessment of robustness, the step-by-step qualitative approach helps structuring the thought process and argumentation for a preferred intervention in a systematic manner. CONCLUSION: The relative strengths and weaknesses of the quantitative and step-by-step qualitative approach to risk-based decision making are complementary and mutually enhancing. A combination of the two approaches is therefore advisable to support the selection of appropriate blood safety interventions for a particular setting.


Assuntos
Segurança do Sangue , Sistemas de Apoio a Decisões Clínicas , Política de Saúde , Gestão de Riscos/métodos , Doadores de Sangue , Transfusão de Sangue/estatística & dados numéricos , Patógenos Transmitidos pelo Sangue , Sistemas de Apoio a Decisões Clínicas/economia , Estudos de Avaliação como Assunto , Humanos , Infecções/epidemiologia , Mortalidade , Risco , Organização Mundial da Saúde
19.
Transfus Apher Sci ; 60(1): 102957, 2021 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-32972861

RESUMO

Low- and middle-income countries (LMICs) remain neglected in the Coronavirus 19 (COVID-19) pandemic. COVID-19 convalescent plasma (CCP) (i.e. plasma collected from individuals after their recovery from COVID-19) has emerged as a leading medical treatment for COVID-19. Studies to date support the safety-and increasingly the efficacy-of CCP to treat COVID-19. This has motivated large-scale procurement and transfusion of CCP, notably in the United States (US), where inventories of CCP have been attained, and government-supported stockpiling of CCP is underway. CCP is a therapy that could be implemented in LMICs. However, systemic and transfusion-specific challenges (e.g. capacity for donor mobilization and collections) impede local procurement of this resource in sufficient volumes to meet clinical demand. This raises the question as to whether there are strategies to facilitate sharing of CCP with LMICs and/or bolstering local capacity for collection to contend with the health crisis. While compelling, there are cost-related, logistical and regulatory barriers to both approaches. For one, there is complexity in diverting national interest (e.g. in the US) away from an epidemic that displays few signs of abating. There are also concerns regarding equitable distribution of CCP in LMICs and how that might be overcome. Further, the barriers to blood donation in general apply to collection of CCP; these obstacles are longstanding, accounting for the inability of many LMICs to meet their blood transfusion needs. Nonetheless, CCP affords dual opportunity for humanitarian outreach while tackling a broader challenge of blood transfusion safety and availability.


Assuntos
Segurança do Sangue , COVID-19/terapia , Países em Desenvolvimento , Acessibilidade aos Serviços de Saúde , Plasma , SARS-CoV-2 , COVID-19/epidemiologia , Humanos , Imunização Passiva , Soroterapia para COVID-19
20.
Vox Sang ; 116(5): 564-573, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33277934

RESUMO

BACKGROUND AND OBJECTIVES: Taiwan is among the few hepatitis B virus (HBV) high-endemic countries that implement universal mini-pool nucleic acid testing (MP-NAT) and hepatitis B surface antigen (HBsAg) testing together with confirmatory individual donor nucleic acid testing (ID-NAT) for its blood supply since 2013. The aim of this study was to reappraise the value of HBsAg test in Taiwan's HBV testing strategy. MATERIALS AND METHODS: A Markov model was constructed, and cost-effectiveness analysis was conducted in order to reappraise the existing HBV screening strategy in Taiwan. RESULTS: The incremental cost-effectiveness ratio (ICER) for the current testing strategy in Taiwan was estimated to be $US 443 154 per quality-adjusted life year (QALY) gained. This is almost six times the willingness-to-pay (WTP) threshold that reflects local preferences. CONCLUSION: Universal HBsAg and MP-8-NAT together with confirmatory ID-NAT testing prevents a significant amount of HBV infections from entering the Taiwan blood supply. However, this comes at a disproportionate increase in cost.


Assuntos
Doadores de Sangue/estatística & dados numéricos , Segurança do Sangue/economia , Hepatite B/sangue , Técnicas de Diagnóstico Molecular/economia , Testes Sorológicos/economia , Segurança do Sangue/métodos , Custos e Análise de Custo , Vírus da Hepatite B/genética , Vírus da Hepatite B/imunologia , Humanos , Técnicas de Diagnóstico Molecular/métodos , Reação em Cadeia da Polimerase/economia , Reação em Cadeia da Polimerase/métodos , Testes Sorológicos/métodos , Taiwan
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